Board Meeting - Louisiana...Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected] Table of Contents

NOTE: Pursuant to the Open Meetings Law at La. R.S. 42:16, the Board may, upon 2/3 affirmative vote of those members present and voting, enter into executive session for the limited purposes of (1) discussion of the character, professional competence, or physical or mental health of a licensee, (2) investigative proceedings regarding allegations of misconduct, (3) strategy sessions or negotiations with respect to litigation, (4) discussions regarding personnel matters, or other purposes itemized at La. R.S. 42:17. NOTE: In compliance with Act 655 of the 2018 Louisiana Legislature, the Board gives notice to its licensees and applicants of their opportunity to file a complaint about board actions or board procedures. You may submit such complaints to one or more of the following organizations: (1) Louisiana Board of Pharmacy; 3388 Brentwood Dr.; Baton Rouge, LA 70809; 225.925.6496; [email protected]. (2) Committee on House & Governmental Affairs; La. House of Representatives; PO Box 44486; Baton Rouge, LA 70804; 225.342.2403; h&[email protected]. (3) Committee on Senate & Governmental Affairs; La. Senate; PO Box 94183; Baton Rouge, LA 70804; 225.342.9845; s&[email protected]. NOTE: In compliance with Act 256 of the 2019 Louisiana Legislature, the Board gives public notice that any information submitted to the Board may become public record unless specifically exempted by the Public Records Law, R.S. 44:1 et seq.

Louisiana Board of Pharmacy 3388 Brentwood Drive

Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected]

Board Meeting

August 14, 2019

mailto:[email protected]

mailto:h&[email protected]

mailto:s&[email protected]




Table of Contents

1 – A. Table of Contents 002 1 – B. Meeting Notice & Arrangements 004 1 – C. Acronyms 005 1 – D. Agenda 010 2. Invocation & Pledge of Allegiance 3. Quorum Call 4. Call for Additional Agenda Items & Adoption of Agenda 5. Consideration of Minutes from Previous Meetings ~ May 29, 2019 013 6. Report on Action Items 042 7. Confirmation of Acts 8. Opportunity for Public Comment * Statement of Purpose & Mission of Board 9. Special Orders of the Day 10. Committee Reports

A. Finance – Mr. McKay 055 • Consideration of Final Report for Fiscal Year 2018-2019 056 • Consideration of Budget Amendment No. 1 for Fiscal Year 2019-2020 072

B. Application Review – Mr. Soileau 078 C. Reciprocity – Mr. Cassidy 079

• List of Pharmacists Licensed by Reciprocity 080 D. Violations – Mr. Indovina 081

• Consideration of Proposed Voluntary Consent Agreements 082 • Consideration of Proposed Revision of PPM.I.C.7.c ~ Violations Committee –

CE Audits/Cases 118 E. Impairment – Ms. Hall 123

• Consideration of Committee Recommendations re Applications F. Reinstatement – Mr. Moore 124

• Consideration of Committee Recommendations re Applications G. Tripartite – Mr. Resweber 125 H. Regulation Revision – Mr. McKay 126

• Consideration of Comments & Testimony from June 26 Public Hearing 127 • Consideration of Regulatory Proposal 2019-E ~ Cannabis MDI (Draft #1) 211 • Consideration of USP-800 Subcommittee Recommendations 212

I. Executive Committee – Mr. Aron 224 • Review of Final Legislative Brief 225 • Consideration of Request to Interpret LAC 46:LIII2451.N ~ Sale of CBD Oil

Products in Marijuana Pharmacies 236 • Consideration of Request to Interpret LAC 46:LIII.2457.D.4.b ~ Reporting

of Marijuana Product Dispensing Transactions 237 • Consideration of Request to Interpret La. R.S. 37:1213 + LAC 46:LIII.511 +

703.A.4 + 903.A.3.f + 905.B.5 ~ Reporting Changes of Pharmacy Employment 238

• Consideration of Proposed Revision of LPM.I.Q.2 ~ Transitional Duty Employment Audit Form 241

• Consideration of Proposed Revision of PPM.I.A.26 ~ Sale of CBD Oil (Guidance Document) 242

• Consideration of Proposed Revision of PPM.I.B.6 ~ Board Liaisons to Other Entities 246


Board Meeting August 14, 2019 Page 2 of 2 10. Committee Reports (cont.) I. Executive Committee (cont.)

• Consideration of Requests for Approval of Pharmacy Technician Training Programs: Penn Foster College [Scottsdale, AZ] 248 Medical Education & Training Campus [Joint Base San

Antonio, TX] 249 11. Staff Reports J. Assistant Executive Director – Mr. Fontenot 251

• Quarterly Report from Prescription Monitoring Program (PMP) 252 • Consideration of Requests for Waivers from PMP Reporting Rule 262

K. General Counsel – Mr. Finalet 279 • Consideration of Proposed Voluntary Consent Agreements 280

L. Executive Director – Mr. Broussard 288 • Narrative Report 289 • Internal Reports

Credentials Div. – Census Report 296 Credentials Div. – License Activity Report 299 Credentials Div. – Pending Application Report 300 Credentials Div. – Exceptions Report 301 Compliance Div. – Census Report 303 Compliance Div. – Complaint Investigation Policy Monitor 304 Compliance Div. – Annual Statistical Summary 305

• External Reports Annual Report 311

• Examination Reports Pharmacists – MPJE 325 Pharmacists – NAPLEX 330 Technicians – ExCPT 335 Technicians – PTCE 337

• Hurricane Barry Assessment 343 • Attorney General Civil Law Training – Registration & Schedule 344 • Enhancing Well-being and Resilience Among the Pharmacist Workforce ~

A National Consensus Conference 346 12. Request for Approval of Pilot Project – Automated Medication System in Correctional

Facilities – Mr. Robert Sonnier (Institutional Pharmacies of Louisiana – Scott, LA) 352 13. New Agenda Items Added During Meeting 368 14. Announcements 370 15. Recess

Revised 2018-0101

Acronyms AACP American Association of Colleges of Pharmacy AAPS American Association of Pharmaceutical Scientists AAPT American Association of Pharmacy Technicians ACA American College of Apothecaries ACCME Accreditation Council for Continuing Medical Education ACCP American College of Clinical Pharmacy ACE Advisory Committee on Examinations (NABP) ACHC Accreditation Commission for Health Care ACPE Accreditation Council for Pharmacy Education ADA American Dental Association ADC automated dispensing cabinet ADS automated dispensing system AFDO Association of Food & Drug Officials AFPE American Foundation for Pharmaceutical Education AIHP American Institute of the History of Pharmacy AMA American Medical Association AMCP Academy of Managed Care Pharmacy AMS automated medication system APEC Australian Pharmacy Examining Council APhA American Pharmacists Association APPE advanced pharmacy practice experience ASAE American Society of Association Executives ASAP American Society for Automation in Pharmacy ASCP American Society of Consultant Pharmacists ASHP American Society of Health-System Pharmacists ASPEN American Society of Parenteral & Enteral Nutrition ASPL American Society for Pharmacy Law ATT authorization to test AVMA American Veterinary Medical Association AWARxE NABP consumer protection program BNDD Bureau of Narcotics and Dangerous Drugs BPS Board of Pharmacy Specialties CAC Citizen Advocacy Center CCAPP Canadian Council for Accreditation of Pharmacy Programs CCGP Commission for Certification in Geriatric Pharmacy CDC U.S. Centers for Disease Control and Prevention CDER U.S. Center for Drug Evaluation and Research (FDA) CDTM collaborative drug therapy management CDS controlled dangerous substances CE continuing education CFR Code of Federal Regulations CHPA Consumer Healthcare Products Association CLEAR Council on Licensure, Enforcement and Regulation CMI consumer medication Information CMS U.S. Centers for Medicare and Medicaid Services CPD continuing professional development CPhA Canadian Pharmacists Association CPPA Center for Pharmacy Practice Accreditation CPSC U.S. Consumer Product Safety Commission

Revised 2018-0101

DEA U.S. Drug Enforcement Administration DEQ La. Department of Environmental Quality DME durable medical equipment DMEPOS durable medical equipment, prosthetics, orthotics, and supplies DNV Det Norske Veritas (Norwegian accreditation organization) DOA La. Div. of Administration DOA – FPC La. Div. of Administration – Facility Planning & Control DOA – ORM La. Div. of Administration – Office of Risk Management DOA – OSR La. Div. of Administration – Office of State Register DOA – OSRAP La. Div. of Administration – Office of Statewide Reporting & Accounting Policy DOE La. Dept. of Education DPSC La. Dept. of Public Safety & Corrections DSCS La. Dept. of State Civil Service DSM disease state management EDK emergency drug kit ELTP Electronic Licensure Transfer Program (NABP) EPA U.S. Environmental Protection Agency EPCS Electronic Prescribing of Controlled Substances (DEA) ETS Educational Testing Service EU European Union ExCPT Examination for the Certification of Pharmacy Technicians FARB Federation of Associations of Regulatory Boards FBI Federal Bureau of Investigation FD&C Federal Food, Drug & Cosmetic Act FDA U.S. Food & Drug Administration FEIS Fiscal & Economic Impact Statement FIP Federation Internationale Pharmaceutique FMI Food Marketing Institute FPGEC Foreign Pharmacy Graduate Examination Committee (NABP) FPGEE Foreign Pharmacy Graduate Equivalency Examination (NABP) FSBPT Federation of State Boards of Physical Therapy FSMB Federation of State Medical Boards FRC Foreign Pharmacy Graduate Equivalency Examination Review Committee (NABP) FTC U.S. Federal Trade Commission GOHSEP Governor’s Office of Homeland Security & Emergency Preparedness GPhA Generic Pharmaceutical Association GPO U.S. Government Publishing Office gTLD generic top level domain (Internet addresses) HCFA Health Care Financing Administration HDMA Healthcare Distribution Management Association HIPAA Health Insurance Portability and Accountability Act (of 1996) HIPDB Healthcare Integrity and Protection Data Bank HMO health maintenance organization IACP International Academy of Compounding Pharmacists ICANN Internet Corporation for Assigned Numbers and Names ICPT Institute for the Certification of Pharmacy Technicians IDOI Internet Drug Outlet Identification (NABP) INEOA International Narcotic Enforcement Officers Association IOM Institute of Medicine IPPE introductory pharmacy practice experience IRS U.S. Internal Revenue Service

Revised 2018-0101

ISMP Institute for Safe Medication Practices JCPP Joint Commission of Pharmacy Practitioners JLCB Joint Legislative Committee on the Budget LAC Louisiana Administrative Code LAMP Louisiana Academy of Medical Psychologists LANP Louisiana Association of Nurse Practitioners LAPA Louisiana Academy of Physician Assistants LASERS La. State Employees Retirement System LASIE Louisiana Association of Self-Insured Employers LBDDD La. Board of Drug & Device Distributors LBP La. Board of Pharmacy LDA Louisiana Dental Association LDAF La. Dept. of Agriculture & Forestry LDH La. Dept. of Health LDI La. Dept. of Insurance LDR La. Dept. of Revenue LFO Legislative Fiscal Office LHA Louisiana Hospital Association LIPA Louisiana Independent Pharmacies Association LLA La. Legislative Auditor LPA Louisiana Pharmacists Association LPC Louisiana Pharmacy Congress LPTA Louisiana Physical Therapy Association LPTB Louisiana Physical Therapy Board LSA Louisiana Sheriffs’ Association LSBD La. State Board of Dentistry LSBME La. State Board of Medical Examiners LSBN La. State Board of Nursing LSBOE La. State Board of Optometry Examiners LSBPNE La. State Board of Practical Nurse Examiners LSBVM La. State Board of Veterinary Medicine LSHP Louisiana Society of Health-System Pharmacists LSMS Louisiana State Medical Society LSNA Louisiana State Nurses Association LTC long term care LTCF long term care facility LVMA Louisiana Veterinary Medical Association MPJE Multistate Pharmacy Jurisprudence Examination (NABP) MRC MPJE Review Committee (NABP) NABP National Association of Boards of Pharmacy NABP-F National Association of Boards of Pharmacy Foundation NABPLAW National Association of Boards of Pharmacy – Law Database NACDS National Association of Chain Drug Stores NADDI National Association of Drug Diversion Investigators NAMSDL National Alliance for Model State Drug Laws NAPLEX North American Pharmacist Licensure Examination (NABP) NAPRA National Association of Pharmacy Regulatory Authorities (Canada) NASCSA National Association of State Controlled Substance Authorities NASPA National Alliance of State Pharmacy Associations NASPER National All Schedules Prescription Electronic Reporting Act NCC MERP National Coordinating Council for Medication Error Reporting and Prevention

Revised 2018-0101

NCPA National Community Pharmacists Association NCPDP National Council for Prescription Drug Programs NCPIE National Council on Patient Information and Education NCPO National Conference of Pharmaceutical Organizations NCSBN National Council of State Boards of Nursing NCVHS National Committee on Vital and Health Statistics NDC National Drug Code NDMA Nonprescription Drug Manufacturing Association NIPCO National Institute for Pharmacist Care Outcomes NISPC National Institute for Standards in Pharmacist Credentialing NOCA National Organization for Competency Assurance NPA National Pharmacy Association NPC National Pharmaceutical Council NPDB National Practitioner Data Bank NPTA National Pharmacy Technician Association NRC NAPLEX Review Committee (NABP) Federal Nuclear Regulatory Commission OAL Optometry Association of Louisiana OBRA Omnibus Budget Reconciliation Act OIG Office of Inspector General ONDCP Office of National Drug Control Policy ONDD Office of Narcotics and Dangerous Drugs OPEB other post employment benefits OSHA Occupational Safety and Health Administration PBM pharmacy benefit management PCAB Pharmacy Compounding Accreditation Board PCCA Professional Compounding Centers of America PCMA Pharmaceutical Care Management Association PCOA Pharmacy Curriculum Outcomes Assessment (NABP) PDMA Prescription Drug Marketing Act PEBC Pharmacy Examining Board of Canada PhRMA Pharmaceutical Research and Manufacturers of America PMP Prescription Monitoring Program PMP-i Prescription Monitoring Program Interconnect (NABP) PTAC Pharmacy Technician Accreditation Commission PTCB Pharmacy Technician Certification Board PTCE Pharmacy Technician Certification Examination PTEC Pharmacy Technician Educators Council PTTP pharmacy technician training program RFID/EPC Radio Frequency Identification / Electronic Product Code RS Louisiana Revised Statutes SAMSHA U.S. Substance Abuse & Mental Health Services Administration SEGBP State Employees Group Benefit Program TJC The Joint Commission TOEFL Test of English as a Foreign Language TOEFL iBT Test of English as a Foreign Language Internet-based Test TSE Test of Spoken English URAC Utilization Review Accreditation Commission USP United States Pharmacopeia / United States Pharmacopeial Convention USP DI U.S. Pharmacopeia Dispensing Information USP-NF U.S. Pharmacopeia – National Formulary

Revised 2018-0101

VAWD Verified-Accredited Wholesale Distributors (NABP) Vet-VIPPS Veterinary-Verified Internet Pharmacy Practice Sites (NABP) VIPPS Verified Internet Pharmacy Practice Sites (NABP) VPP Verified Pharmacy Practice (NABP) WHO World Health Organization WHPA World Health Professions Alliance




NOTICE IS HEREBY GIVEN that a meeting of the Board has been ordered and called for 9:00 a.m. on Wednesday, August 14, 2019 at the Board office, for the purpose to wit:

A G E N D A NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official.

Revised 08-08-2019 1. Call to Order 2. Invocation & Pledge of Allegiance 3. Quorum Call 4. Call for Additional Agenda Items & Adoption of Agenda 5. Consideration of Minutes from Previous Meetings – May 29, 2019 6. Report on Action Items 7. Confirmation of Acts 8. Opportunity for Public Comment 9. Special Orders of the Day 10. Committee Reports

A. Finance – Mr. Pitre • Consideration of Final Report for Fiscal Year 2018-2019 • Consideration of Proposed Budget Amendment for Fiscal Year 2019-2020

B. Application Review – Mr. Soileau C. Reciprocity – Mr. Cassidy D. Violations – Mr. Indovina

• Consideration of Proposed Voluntary Consent Agreements (1) Case No. 18-0215 ~ PHY.002662 – MPI, Inc. d/b/a Michel’s Pharmacy

of Bayou Vista f/k/a Medicine Shoppe of Bayou Vista [Morgan City, LA]

(2) + Case No. 18-0216 ~ PST.011999 – Steve Patrick Michel (3) + Case No. 18-0217 ~ CPT.009534 – Tawanna Lynn Thomas (4) Case No. 19-0101 ~ PHY.007127 – Fred’s Stores of Tennessee, Inc. d/b/a Fred’s Pharmacy No. 3079 [Sterlington, LA] (5) + Case No. 19-0133 ~ CPT.005937 – Jenni Lee Anderson (6) Case No. 19-0089 ~ PHY.007430 – Partners Pharmacy of Texas, LLC d/b/a Advanced Pharmacy [Stafford, TX] (7) Case No. 19-0064 ~ PST.017980 – Christopher Brooks Klingman (8) Case No. 19-0104 ~ PHY.003625 – Pharmaceutical Specialties, LLC d/b/a Pharmaceutical Specialties [Baton Rouge, LA] (9) Case No. 19-0054 ~ PHY.007770 – Belleview Pharmacy, LLC d/b/a Belleview Pharmacy [Plaquemine, LA] (10) + Case No. 19-0056 ~ PST.018760 – Darvis Keon Harvey






Board Meeting August 14, 2019 Page 2 of 3 10. Committee Reports (cont.) D. Violations (cont.)

• Consideration of Proposed Revision of PPM.I.C.7.c ~ Violations Committee – CE Audits/Cases

E. Impairment – Ms. Hall • Consideration of Committee Recommendations re Applications

F. Reinstatement – Mr. Moore • Consideration of Committee Recommendations re Applications

G. Tripartite – Mr. Resweber H. Regulation Revision – Mr. McKay

• Consideration of Comments & Testimony from June 26 Public Hearing • Consideration of Renewal of Pilot Project – Automated Medication System in

Unlicensed Medical Clinic Setting (Highgate Apothecary – Covington, LA) • Consideration of Regulatory Proposal 2019-E ~ Cannabis MDI (Draft #1) • Consideration of USP-800 Subcommittee Recommendations

I. Executive – Mr. Aron • Review of Final Legislative Brief • Consideration of Request to Interpret LAC 46:LIII.2451.N ~ Sale of CBD Oil

Products in Marijuana Pharmacies • Consideration of Request to Interpret LAC 46:LIII.2457.D.4.b ~ Reporting of

Marijuana Product Dispensing Transactions • Consideration of Request to Interpret La. R.S. 37:1213 + LAC 46:LIII.511 +

703.A.4 + 903.A.3.f + 905.B.5 ~ Reporting Changes in Pharmacy Employment

• Consideration of Proposed Revision of LPM.I.Q.2 ~ Transitional Duty Employment Audit Form

• Consideration of Proposed Revision of PPM.I.A.26 ~ Sale of CBD Oil (Guidance Document)

• Consideration of Proposed Revision of PPM.I.B.6 ~ Board Liaisons to Other Entities

• Consideration of Approval of Pharmacy Technician Training Programs Penn Foster College (Scottsdale, AZ) Medical Education & Training Campus (Joint Base San Antonio, TX)

11. Staff Reports J. Assistant Executive Director – Mr. Fontenot

• Quarterly Report of Prescription Monitoring Program (PMP) • Consideration of Requests for Waivers from PMP Reporting Requirement

K. General Counsel – Mr. Finalet • Consideration of Proposed Voluntary Consent Agreements & Surrenders

(1) Case No. 19-0167 ~ CPT.013944 – Jasman Carrington Wilton





Board Meeting August 14, 2019 Page 3 of 3 11. Staff Reports (cont.)

K. General Counsel (cont.) (2) Case No. 19-0174 ~ PST.016442 – Marco Bisa Hawkins Moran

(3) Case No. 19-0202 ~ PHY.004331 – Contract Pharmacy Services, Inc. d/b/a Contract Pharmacy Services [Warrington, PA] (4) Case No. 19-0228 ~ PST.020652 – Kelly Leigh Goodson

L. Executive Director – Mr. Broussard • Consideration of Annual Report for Fiscal Year 2018-2019

12. Request for Approval of Pilot Project – Automated Medication Systems in Correctional Facilities – Mr. Robert Sonnier (Institutional Pharmacies of Louisiana – Scott, LA)

13. New Agenda Items Added During Meeting 14. Announcements 15. Recess






Consideration of Minutes from Previous Meetings


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Minutes Regular Meeting Wednesday, May 29, 2019 at 1:00 p.m. & Administrative Hearing Thursday, May 30, 2019 at 8:30 a.m. Location: Louisiana Board of Pharmacy 3388 Brentwood Drive

Baton Rouge, Louisiana 70809-1700


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Table of Contents Agenda Item No. Description Page No. Wednesday, May 29, 2019 1. Call to Order 04 2. Invocation & Pledge of Allegiance 04

3. Quorum Call 04 4. Call for Additional Agenda Items & Adoption of Agenda 05 5. Consideration of Minutes from Previous Meeting 05 6. Report on Action Items 05 7. Confirmation of Acts 05 8. Opportunity for Public Comment 06 * Statement of Purpose 06 9. Special Orders of the Day 06 A. Presentation of Pharmacist Gold Certificates 06 B. Presentation of Distinguished Service Award 06 10. Committee Reports

A. Finance 07 B. Application Review 07 C. Reciprocity 07 D. Violations 08 E. Impairment 10 F. Reinstatement 12 G. Tripartite 12 H. Regulation Revision 13 I. Executive 16

11. Staff Reports J. Assistant Executive Director 20

K. General Counsel 21 L. Executive Director 22

12. Technology Presentation re Real-Time Benefit Check Ms. Kim Diehl-Boyd, CoverMyMeds 07

13. New Agenda Items Added During Meeting A. Regulatory Project 2019-1A ~ Marijuana Pharmacies 23 14. Announcements 23 15. Recess 24

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Agenda Item No. Description Page No. Thursday, May 30, 2019

A. Call to Order 24 B. Invocation & Pledge of Allegiance 24 C. Quorum Call 24 D. Call for Additional Agenda Items & Adoption of Agenda 24 E. Opportunity for Public Comment 24 * Appearances 24 F. Formal Hearings 25 G. Report of Violations Committee 27 H. Report of General Counsel 28 I. Adjourn 28

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A regular meeting of the Louisiana Board of Pharmacy was held on Wednesday, May 29, 2019 at the office of the Louisiana Board of Pharmacy, located at 3388 Brentwood Drive in Baton Rouge, Louisiana 70809-1700. The meeting was held pursuant to public notice, each member received notice, and public notice was properly posted. 1. Call to Order Mr. Carl Aron, President, called the meeting to order at 1:00 p.m. 2. Invocation & Pledge Mr. Aron called upon Mr. Rhonny Valentine for the invocation. Ms. Diane Milano then led the group in the Pledge of Allegiance. 3. Quorum Call Mr. Aron called upon the Secretary, Mr. Richard M. Indovina, Jr., to call the roll to establish a quorum. Members Present:

Mr. Carl W. Aron Mr. Allen W. Cassidy, Jr.

Ms. Jacqueline L. Hall Mr. Richard M. Indovina, Jr. Mr. Kevin LaGrange Mr. Robert C. LeBas Mr. Richard Mannino Mr. Marty R. McKay Ms. Diane G. Milano Mr. Ronald E. Moore

Mr. Don L. Resweber Mr. Douglas E. Robichaux Mr. Richard A. Soileau Dr. Raymond J. Strong Mr. Rhonny K. Valentine Member Absent: Dr. J. Robert Cloud

Mr. Blake P. Pitre Staff Present: Mr. Malcolm J. Broussard, Executive Director Mr. Carlos M. Finalet, III, General Counsel Mr. M. Joseph Fontenot, Assistant Executive Director Mr. Benjamin S. Whaley, Chief Compliance Officer Ms. Alicia P. Harris, Pharmacist Compliance Officer

Ms. Becky C. Parker, Pharmacist Compliance Officer Mr. Huey J. Savoie, Pharmacist Compliance Officer

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Guests: Mr. Alfred Gaudet – Gold Certificate Recipient Ms. Kathleen Gaudet – Gold Certificate Recipient Mr. William Stroud, III – Gold Certificate Recipient Ms. Barbara LeBeouf – Gold Certificate Recipient Mr. Roland Thibodeaux – Gold Certificate Recipient Mr. Bevan Callicott – Cardinal Health Mr. Ben J. Sims – Brookshire Grocery Co. Dr. Alexandre Raymond – Ochsner Medical Center Ms. Kim Diehl-Boyd – CoverMyMeds Dr. Gena Territo-Tynes – Ochsner Medical Center Ms. Patricea Angelle – International Academy of Compounding Pharmacists

Mr. Indovina certified Dr. Cloud and Mr. Pitre were absent; however, the remaining 15 members were present, constituting a quorum for the conduct of official business. 4. Call for Additional Agenda Items & Adoption of Agenda Mr. Aron asked if there were any additional agenda items to be added. Mr. Indovina noted the public hearing for Regulatory Project 2019-1A ~ Marijuana Pharmacies was held earlier that day, that no comments were received, and that it would be appropriate to determine whether to continue the promulgation process that day instead of waiting until the next Board meeting in November. He moved to amend the agenda to add the regulatory project. There were no member questions or public comment. The motion was adopted following a unanimous roll call vote in the affirmative. Mr. Aron added the regulatory project to the agenda, noting the Item Number as 13-A. With no further requests to amend the agenda, and without objection, the members adopted the posted agenda dated May 13, 2019, as amended. Mr. Aron requested authority to re-order the agenda as may become necessary, and there were no objections to that request. 5. Consideration of Minutes Mr. Aron reminded the members they had received the draft minutes from the Regular Board Meeting held on February 19, 2019 in Monroe, Louisiana. With no objections, he waived the reading of the draft minutes. With no requests for amendment or any objection to their approval, Mr. Aron declared the minutes were approved as presented. Mr. Indovina reminded the members to sign the Minute Book. 6. Report on Action Items Mr. Aron called on Mr. Broussard for the report. Mr. Broussard directed the members to a copy of the report in their meeting binder. There were no questions from the members or guests. 7. Confirmation of Acts Pursuant to Mr. Aron’s declaration that the officers, committees, and executive director had attended to the business of the Board since their last meeting in accordance with policies and procedures previously approved by the Board, Mr. Moore moved,

Resolved, that the actions taken and decisions made by the Board officers, Board committees, and Executive Director in the general conduct

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and transactions of Board business since February 19, 2019 are approved, adopted, and ratified by the entire Board.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. 8. Opportunity for Public Comment Mr. Aron reminded the members and guests the Open Meetings Law requires all public bodies to provide an opportunity for public comment at all meetings and for each agenda item upon which a vote is to be taken. He solicited general comments on non-agenda items from the guests present, and none were offered. * Statement of Purpose Mr. Aron reminded the members of the purpose and mission of the Board of Pharmacy by reciting the relevant portion of the Louisiana Pharmacy Practice Act. He urged the members to keep their legislative mandate in mind as they considered all the matters before them. 9. Special Orders of the Day A. Presentation of Pharmacist Gold Certificates

Mr. Aron reminded the members and guests of the Board’s award of a Pharmacist Gold Certificate to a pharmacist completing 50 years of Louisiana pharmacist licensure. He informed the audience the Board issued new licenses to 173 pharmacists in 1969, and of that number the licenses of 50 pharmacists were still in active status. He noted five of those pharmacists were present and had requested to receive their certificates during the Board meeting. Mr. Aron then presented Gold Certificates to the following pharmacists, noting during each presentation a synopsis of the recipient’s professional service: PST.009300 – William Fletcher Stroud, III PST.009422 – Alfred Louis Gaudet PST.009438 – Barbara Ann LeBeouf PST.009544 – Roland James Thibodeaux PST.009633 – Kathleen Vocke Gaudet

The members and guests congratulated each of the recipients with standing ovations.

B. Presentation of Distinguished Service Award

Mr. Aron noted one of the members was nearing the completion of a six year term of service on the Board. He reminded the members and guests that Governor Bobby Jindal had appointed Ms. Diane Milano to the Board on July 1, 2013 and that her term would expire on June 30, 2019. During his presentation of the Distinguished Service Award to Ms. Milano, he noted her service on various Board committees and faithful participation in Board meetings and administrative hearings. Ms. Milano expressed her appreciation for the award and indicated her hope for continued service through another appointment. The members and guests congratulated her with a generous round of applause.

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At this point, Mr. Aron re-ordered the agenda to accommodate a presenter with flight arrangements later that afternoon. 12. Technology Presentation re Real-Time Benefit Check – Ms. Kim Diehl-Boyd, CoverMyMeds. Mr. Aron invited Ms. Diehl-Boyd to the witness table to introduce herself and make her presentation to the members. She directed the members to a copy of her presentation in their electronic meeting binder. She then gave a brief introduction to the company before describing a technology service which allows a prescriber to ascertain a patient’s third party insurance coverage of a medication intended to be prescribed. The service allows the prescriber and the patient to know the approximate price of the medication for the patient at the pharmacy of the patient’s choice prior to the patient leaving the prescriber’s office. The members asked several questions about different aspects of the service. Ms. Diehl-Boyd promised to follow-up after the meeting with information about a question relative to cash prices at pharmacies. Mr. Aron expressed his appreciation for her presentation. At this point, Mr. Aron recognized Ms. Alicia Harris, a pharmacist compliance officer who recently affiliated with the Board and was not present at the previous Board meeting. He introduced her to the members, confirmed her territory, and welcomed her to the Board’s staff. Mr. Aron then returned to the sequence of the posted agenda. 10. Committee Reports

A. Finance Committee In the absence of Mr. Blake Pitre, Chair of the Finance Committee, Mr.

Aron called upon the ranking member, Mr. Marty McKay, for the committee report. Mr. McKay directed the members to the Interim Report for Fiscal Year 2018-2019 in their meeting binder. Mr. McKay summarized the report for the members; there were no questions. He reminded the members no action was necessary for that report. Finally, Mr. McKay closed his report with appreciation to the other committee members for their ongoing efforts.

B. Application Review Committee

Mr. Aron called upon Mr. Soileau for the committee report. Mr. Soileau reported the committee had not met since the previous Board meeting.

Finally, Mr. Soileau closed his report with appreciation to the other committee members for their ongoing efforts.

C. Reciprocity Committee Mr. Aron called upon Mr. Cassidy for the committee report. He reported

the staff had evaluated 86 applications for pharmacist licensure by reciprocity since the last Board meeting and that none of them contained information that warranted a committee level review. In conformance with policies and procedures previously approved by the Board, the staff approved the

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applications and issued the credentials. Finally, he closed his report with appreciation to the other committee

members for their ongoing efforts. D. Violations Committee

Mr. Aron called upon Mr. Indovina for the committee report. Mr. Indovina reported the committee held preliminary hearings on March 20-21, 2019 to consider their posted agenda which included 22 cases: eight pharmacists, six pharmacy technicians, one pharmacy technician candidate, and seven pharmacy permits. Two respondents failed to appear; the committee voted to refer both of them for formal administrative hearings which were held the following day. After interviews and deliberations at the preliminary hearings, the committee continued one case for further investigation; voted to take no action against another respondent; voted to allow one respondent to enter into a private no-practice agreement while that case is continued; and also voted to issue non-disciplinary Letters of Noncompliance to two respondents. The committee then voted to offer proposed voluntary consent agreements to the remaining 15 respondents. Of that number, 12 accepted their proposed consent agreements; the other three were scheduled for a future administrative hearing. He then reported the receipt of a signed consent agreement from a respondent who case had been previously continued. Mr. Indovina then presented the following proposed consent agreements to the members for their consideration. Ja’Faira Romeshia Lajoy Holland (CPT.013935): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand, and further, assessed a fine of $250 plus administrative costs. Destiny Araine Woolfolk (CPT.010453): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board suspended the certificate for one year and stayed the execution of the suspension, then placed the certificate on probation for one year effective May 29, 2019 subject to certain terms enumerated within the consent agreement, and further, assessed administrative costs. Racheal Jordan Flores (PST.021687): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Warning, and further, assessed administrative and investigative costs. Walgreen La. Co., Inc. d/b/a Walgreen Pharmacy No. 110-02995 [Baton Rouge, LA] (PHY.002868): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public

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comments. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $10,000 plus administrative and investigative costs. Prescription Dispensing Laboratories, Inc. d/b/a Prescription Dispensing Laboratories [Cedar Park, TX] (PHY.007538): Mr. Indovina moved to approve the proposed voluntary consent agreement. Mr. Finalet responded to a question from one member; there were no public comments. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand, and further, assessed a fine of $5,000 plus administrative costs. Noah’s Pharmacy, LLC d/b/a Noah’s Pharmacy [Brusly, LA] (PHY.006145 ~ Case No. 18-0364): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board terminated the previously imposed probationary period, suspended the permit for five years and stayed the execution of the suspension, then placed the permit on probation for five years effective May 29, 2019 subject to certain terms enumerated within the consent agreement, and further, assessed administrative and investigative costs. Gaylyn Elizabeth Bellaire (PST.014692): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board restricted the license by prohibiting the acceptance of an appointment as the pharmacist-in-charge of any pharmacy until after May 29, 2020, and further, assessed a fine of $500 plus administrative costs. Kimberly Juanita Murphy (PST.016122): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board terminated the previously imposed probationary period, suspended the license for five years and stayed the execution of the suspension, then placed the license on probation for five years effective May 29, 2019 subject to certain terms enumerated within the consent agreement, and further, assessed a fine of $7,500 plus administrative costs. Noah’s Pharmacy, LLC d/b/a Noah’s Pharmacy [Brusly, LA] (PHY.006145 ~ Case No. 19-0024): Mr. Indovina moved to approve the proposed voluntary consent agreement. He replied to questions from six members; there were no public comments. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $5,000 plus administrative and investigative costs.

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Lato Drug Company, Inc. d/b/a Post Haste Pharmacy [Hollywood, FL] (PHY.006650): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $15,000 plus administrative and investigative costs. Winn Dixie Stores, Inc. d/b/a Pathstone Health Services [Jacksonville, FL] (PHY.007203): Mr. Indovina moved to approve the proposed voluntary consent agreement. He replied to questions from three members; there were no public comments. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $12,500 plus administrative and investigative costs. Leslie Dominique Threatts (CPT.014040): Mr. Indovina moved to accept the voluntary surrender of the credential. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board accepted the voluntary surrender of the credential, resulting in the active suspension of the certificate for an indefinite period of time effective March 21, 2019. Thomas Joseph Walker (PST.015721): Mr. Indovina moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand, and further assessed a fine of $1,000 plus administrative and investigative costs. Mr. Indovina then presented the Complaint Investigation Monitor Report, which demonstrated the opening of 384 new cases and the closure of 349 cases during the current fiscal year. The average number days for staff to complete their case investigation was 51 days. Of the 349 case closures, 15 of them [4.3%] exceeded the policy goal of 180 days for completion of case investigations. Mr. Indovina reported the committee was scheduled to meet on June 11-12 to consider the 24 cases on that docket, which includes 10 pharmacists, seven pharmacy technicians, one pharmacy technician candidate, five pharmacy permits and one DME permit. Finally, he concluded his report with appreciation to the other committee members for their ongoing efforts and to the compliance officers for the quality of their case investigations.

E. Impairment Committee

Mr. Aron called upon Ms. Hall for the committee report. Ms. Hall reported the committee met the previous day to consider four referrals from the staff – two applications for reinstatement of credentials, one appearance for informal conference, and one appearance for guidance. The committee also performed their annual review of the roster of approved addictionists. Following their interviews of the applicants and subsequent deliberations, the

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committee developed recommendations for the applicants. Ms. Hall then presented the following files to the members for their consideration. Michael Wayne Lindsey (PST.015624) Ms. Hall moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board granted the applicant’s request for reinstatement of the previously suspended license contingent upon the completion of certain requirements identified within the consent agreement, to suspend the newly-reinstated license for 15 years and stay the execution of the suspension, and then place the license on probation for 15 years effective on the date of reinstatement subject to certain terms enumerated within the consent agreement. Steve Khai Vu (PST.015586) Ms. Hall moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board granted the applicant’s request for reinstatement of the previously suspended license contingent upon the satisfaction of certain requirements identified within the consent agreement, to suspend the newly-reinstated license for five years and stay the execution of the suspension, then place the license on probation for five years effective on the date of reinstatement subject to certain terms enumerated within the consent agreement. Todd Michael Durham (PST.016962) Ms. Hall moved to accept the voluntary surrender of the credential. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board accepted the voluntary surrender of the credential, resulting in the active suspension of the license for an indefinite period of time effective May 28, 2019. David Evans Collins (PST.014181) Ms. Hall moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board granted the request for reinstatement of the previously suspended license, converted the duration of the suspensive period from an indefinite term to a term of 15 years and stayed the execution of the suspension, then placed the license on probation for 15 years effective May 29, 2019 subject to certain terms enumerated within the consent agreement. Ms. Hall reported the committee had performed its annual review of the roster of approved addictionists, offered no proposed revisions, and voted to recommend the Board’s continuing approval of the current roster. On behalf of the committee, Ms. Hall then moved,

Resolved, to continue the approval of the current Roster of

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Approved Addictionists. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Finally, Ms. Hall closed her report with appreciation to her fellow committee members for their work the previous day.

F. Reinstatement Committee

Mr. Aron called upon Mr. Moore for the committee report. Mr. Moore reported the committee had met the previous day to consider three referrals from the staff. Following their interviews of the applicants and subsequent deliberations, the committee developed recommendations for the applicants. Mr. Moore then presented the following files to the members for their consideration.

Bocage Pharmacy Centre, Inc. d/b/a Bocage Pharmacy Centre (CDS.039257-PHY): Mr. Moore moved to reinstate the previously suspended CDS license without restriction. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board granted the applicant’s request for reinstatement of the previously suspended license and then restored the CDS license to active and unrestricted status. Virginia Kay Alexander (CPT.006750): Mr. Moore moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board granted the request for reinstatement of the lapsed certificate contingent upon the satisfaction of certain requirements identified within the consent agreement. Alicia Williams Lafayette (CPT.006921): Mr. Moore moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board granted the applicant’s request for reinstatement of the lapsed certificate contingent upon the satisfaction of certain requirements identified within the consent agreement.

Mr. Moore closed his report with appreciation to the other committee members for their work the previous day.

G. Tripartite Committee

Mr. Aron called upon Mr. Resweber for the committee report. Mr. Resweber reported the committee had not met since the previous Board meeting.

At this point, Mr. Aron declared a recess. It was noted the members recessed at 2:40 p.m. and then reconvened at 3:05 p.m. Mr. Aron resumed the sequence of the posted agenda.

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H. Regulation Revision Committee

Mr. Aron called upon Mr. McKay for the committee report. Mr. McKay reported the committee met on April 24, 2019 to consider the items on their posted agenda. During that meeting, the committee voted to recommend the approval of four regulatory proposals. He then presented the following proposals to the Board for their consideration. Regulatory Proposal 2018-B ~ Drug Disposal by Pharmacies (Draft #5)

Mr. McKay informed the members of the committee’s deliberations on whether and how a pharmacy could facilitate the disposal of previously dispensed prescription drugs no longer needed or wanted by consumers. The committee considered whether a pharmacy should accept drug

returns from consumers for destruction. They received stakeholder input concerning the potential for diversion within a pharmacy, both for theft as well as return to return to active dispensing stock. They determined it appropriate to allow a pharmacy to accept returns and imposed a quarantine and security requirement in the proposed rule.

The committee considered whether a pharmacy should be required to accept drug returns for prescriptions it dispensed and permitted to accept drugs dispensed by other pharmacies. The committee declined to require pharmacies to accept any drug returns, but determined it appropriate to require pharmacies to inform consumers of their disposal options.

With respect to pharmacies electing to accept drugs for disposal, the committee reviewed existing federal standards for the disposal of certain types of drugs and inserted a requirement to comply with those federal standards.

Mr. McKay noted the regulatory proposal inserts the proposed changes into three different chapters – Chapter 15 for hospital pharmacies, Chapter 25 for all pharmacies, and Chapter 27 for controlled substances. On behalf of the committee, Mr. McKay then moved,

Resolved, to approve Regulatory Proposal 2018-B ~ Drug Disposal by Pharmacies (Draft #5), and further, to authorize the Executive Director to promulgate the proposed rule upon the instruction of the President, and further, to authorize the President to approve acceptable amendments as may become necessary during the promulgation process.

Mr. McKay replied to questions from three members; there were no public comments. The motion was adopted after a unanimous vote in the affirmative.

Regulatory Proposal 2018-N ~ Pharmacy Compounding (Draft #5)

Following the publication of the final FDA Guidance Document relative to the compounding of copies of commercially available products, the committee was asked to review the Board’s rules for pharmacy compounding. The committee recommends amending Subsection F of

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Section 2535 which is the Board’s rule on pharmacy compounding. The proposal removes the reference to the ASHP website as a source of drugs in shortage, leaving the official FDA website for that information. The proposal also amends the allowance to compound copies of commercially available products with only minor changes to the active ingredient profile using the same language in the FDA Guidance Document. On behalf of the committee, Mr. McKay then moved,

Resolved, to approve Regulatory Proposal 2018-N ~ Pharmacy Compounding (Draft #5), and further, to authorize the Executive Director to promulgate the proposed rule upon the instruction of the President, and further, to authorize the President to approve acceptable amendments as may become necessary during the promulgation process.

There were no member questions; there was one public comment. The motion was adopted after a unanimous vote in the affirmative.

Regulatory Proposal 2019-A ~ Pharmacy Records (Draft #3)

Mr. McKay informed the members the proposal originated as a request from long term care pharmacies to implement the provisions of Act 602 of the 2018 Legislature recognizing the use of chart orders. Since chart orders are analogous to prescriptions, the committee’s deliberations revealed the necessity to amend several different chapters and sections of the rules. Draft #2 was the result of those deliberations. While preparing that draft for the Board’s consideration, staff noted several portions of that draft affected the chapter of rules for automated medication systems, which is the subject of another regulatory proposal still under consideration by the committee. Draft #3 is the result of the removal of the portion of Draft #2 relative to automated medication system. That portion of Draft #2 was transferred to a different regulatory proposal relative to automated medication systems still under review by the committee. Mr. McKay also noted that while the proposal contains suggested revisions to pharmacy record rules to include chart orders, it also includes a large number of technical amendments necessary to conform the Board’s rules to the style required by the state register. On behalf of the committee, Mr. McKay then moved,

Resolved, to approve Regulatory Proposal 2019-A ~ Pharmacy Records (Draft #3), and further, to authorize the Executive Director to promulgate the proposed rule upon the instruction of the President, and further, to authorize the President to approve acceptable amendments as may become necessary during the promulgation process.

There were comments from two members and no public comments. The motion was adopted after a unanimous vote in the affirmative. Regulatory Proposal 2019-D ~ Pharmacist Access to PMP (Draft #1) Mr. McKay reminded the members of the legislative mandate to automatically register all prescribers to grant them access to the state prescription monitoring program database. The committee reviewed the

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current law and rule to determine whether such automatic registration could also be offered to pharmacists. Staff determined no statutory amendment was necessary and that such capacity could be accomplished with a change in the rule. The proposal amends registration procedures in the PMP rules. On behalf of the committee, Mr. McKay then moved,

Resolved, to approve Regulatory Proposal 2019-D ~ Pharmacist Access to PMP (Draft #1), and further, to authorize the Executive Director to promulgate the proposed rule upon the instruction of the President, and further, to authorize the President to approve acceptable amendments as may become necessary during the promulgation process.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Mr. McKay reported on other topics assigned to the committee. With respect to the committee agenda item relative to automated

medication systems, the committee requested additional revisions and an updated draft for the next committee meeting.

With respect to the committee agenda item relative to the planned new USP <800> Hazardous Drugs ~ Handling in Healthcare Settings, the USP-800 Subcommittee held their first meeting on April 23. They planned their approach to developing a recommendation for the Regulation Revision Committee and are actively working to develop a document for consideration during their next meeting on June 12. During the April 24 meeting of the full committee, the members determined it appropriate to suggest a delay in the Board’s enforcement of the new USP <800>. On behalf of the committee, Mr. McKay then moved,

Resolved, that the Board delay the enforcement of the provisions of USP <800> Hazardous Drugs ~ Handling in Healthcare Settings until January 1, 2021.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative.

With respect to the committee agenda item relative to petitions for the return of inactive pharmacist licenses to active status, the committee reviewed the current rule in Section 505 and determined an interpretation of that rule via a policy document would be sufficient to achieve the desired outcome. The committee communicated that recommendation to the Executive Committee, which had prepared a proposed policy document for the Board’s consideration later during that meeting. The Regulation Revision Committee returned their assignment to the Board with no further action.

With respect to the committee agenda item relative to compounding in nuclear pharmacies, the committee is aware of the September 2018 final guidance document from the FDA on that topic as well as the anticipated new USP <825> Radiopharmaceuticals chapter. The committee is anticipating the appointment of a USP-825 Subcommittee and requested nominations of interested and qualified pharmacists by the members.

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With respect to the committee agenda item relative to pharmacy technician training programs, the committee members reviewed the current rule and then voted to return the item to the Board with no recommendation. There was substantial discussion but no further guidance or direction to the committee.

Finally, Mr. McKay closed his report by identifying the public members of

the USP-800 Subcommittee: Ms. Patricea Angelle, from Prescription Compounds in Baton Rouge; Ms. Susan Caudle, from Line Avenue Pharmacy in Shreveport; Ms. Angelle Huff, from The Wellness Corner in Prairieville; Dr. Gary LeBlanc, from Heart Hospital in Lafayette; and Dr. Heather Maturin, from Ochsner Medical Center in Baton Rouge.

Mr. McKay expressed his appreciation to those pharmacists as well as the committee members for their ongoing efforts.

I. Executive Committee Mr. Aron reported the committee had met the previous day to consider the

items on their posted agenda. He indicated Mr. McKay was prepared to offer motions on behalf of the committee.

Proposed Revision of PPM.I.C.5.a ~ Reinstatement Committee – Case Management Mr. Aron reported the Regulation Revision Committee had suggested an interpretation of Section 505 of the Board’s rule relative to the process for returning a pharmacist license on inactive status to active status in lieu of a revision of the rule. The committee reviewed the existing policy of the Reinstatement Committee and determined a revision of that policy describing a process for such petitions would be appropriate. On behalf of the committee, Mr. McKay moved,

Resolved, to approve the proposed revision of PPM.I.C.5.a ~ Reinstatement Committee – Case Management for the Board’s Policy & Procedure Manual.

Mr. Aron replied to questions from two members; there were no public comments. The motion was adopted after a unanimous vote in the affirmative. Proposed Revision of Pharmacy Inspection Blueprints Mr. Aron reminded the members of their adoption of the national blueprints for pharmacy inspections in August 2017. He reminded them there were four modules: basic pharmacy services, compounding of nonsterile preparations, compounding of sterile preparations, and nuclear pharmacy services. He informed the members there had been some minor updates to the first three of those blueprints and that it was necessary to update those blueprints in the Board’s Policy & Procedure Manual. On behalf of the committee, Mr. McKay moved,

Resolved, to approve the proposed revision of PPM.IV.B.2.d ~

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Inspection of Basic Pharmacy Services for the Board’s Policy & Procedure Manual.

Mr. Aron replied to questions from multiple members; there was one public comment. The motion was adopted after a unanimous vote in the affirmative. Mr. McKay then moved,

Resolved, to approve the proposed revision of PPM.IV.B.2.e ~ Inspection of Nonsterile Compounding Services for the Board’s Policy & Procedure Manual.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Mr. McKay then moved,

Resolved, to approve the proposed revision of PPM.IV.B.2.f ~ Inspection of Sterile Compounding Services for the Board’s Policy & Procedure Manual.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Proposed New Policy PPM.III.B.03 ~ Application for New Pharmacy Intern Registration Proposed New Policy PPM.III.B.03.a ~ Maintenance of Pharmacy Intern Registration Mr. Aron reported the recent inquiry from a college of pharmacy as to the impact of a pharmacy intern taking a leave of absence on his eligibility to retain his pharmacy intern registration. Although the Board has consistently allowed an intern to be out of school for up to one semester and retain the registration, the Board does not have a formal policy. He requested staff develop policies reflecting current practice, and the committee voted to recommend their approval. On behalf of the committee, Mr. McKay moved,

Resolved, to approve PPM.III.B.03 ~ Application for New Pharmacy Intern Registration and PPM.III.B.03.a ~ Maintenance of Pharmacy Intern Registration for the Board’s Policy & Procedure Manual.

Mr. Aron replied to a question from one member; there were no public comments. The motion was adopted after a unanimous vote in the affirmative. Continuing Approval of Updated Policy & Procedure Manual Mr. Aron reminded the members of the changes they had made to the manual since their last annual review in May 2018. The committee recommended the continuing approval of the updated manual. On behalf of the committee, Mr. McKay moved,

Resolved, to continue the approval of the Board’s updated Policy & Procedure Manual.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Proposed New Policy LPM.I.R ~ Confined Spaces Mr. Aron reported the Division of Administration’s Office of Risk Management

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suggested the implementation of a new policy relative to confined spaces. The committee voted to recommend its approval. On behalf of the committee, Mr. McKay moved,

Resolved, to approve the proposed new policy LPM.I.R ~ Confined Spaces for the Board’s Loss Prevention Manual.

Mr. Aron replied to questions from two members; there were no public comments. The motion was adopted after a unanimous vote in the affirmative. Continuing Approval of Updated Loss Prevention Manual Mr. Aron reported the only change to the manual since the last annual review in May 2018 was the policy just approved. The committee recommended the continuing approval of the updated manual. On behalf of the committee, Mr. McKay moved,

Resolved, to continue the approval of the Board’s updated Loss Prevention Manual.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Annual Review of Roster of Approved Colleges of Pharmacy Mr. Aron reminded the members the only changes to the roster since their last annual review in May 2018 was the addition of one new school in August 2018 and the removal of probationary status for two schools at the same time. The committee recommended the continuing approval of the updated roster. On behalf of the committee, Mr. McKay moved,

Resolved, to continue the approval of the Board’s Roster of Approved Colleges of Pharmacy.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Annual Review of Roster of Approved Pharmacy Technician Training Programs Mr. Aron reminded the members the only change to the roster since their last annual review in May 2018 was the addition of one new program in November 2018 and the removal of three programs in February 2019. Since that meeting, the Board had received a request for approval from two programs. The committee recommended the approval of both new programs as well as the continuing approval of the updated roster. On behalf of the committee, Mr. McKay moved,

Resolved, to approve the request from Health Mart Systems for recognition as an approved pharmacy technician training program.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Mr. McKay then moved,

Resolved, to approve the request from American National University for recognition as an approved pharmacy technician training program.

There were no member questions or public comments. The motion was

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adopted after a unanimous vote in the affirmative. Mr. McKay then moved, Resolved, to continue the approval of the Board’s updated Roster of Approved Pharmacy Technician Training Programs.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Annual Legislative Financial Audit Mr. Aron reminded the members of the upcoming annual financial audit and of the necessity to approve the management representation letter. The committee reviewed the proposed letter and recommended its approval. On behalf of the committee, Mr. McKay moved,

Resolved, to approve the Management Representation Letter for the 2019 Financial Audit.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Interim Procurement for Louisiana Medical Marijuana Tracking System (LMMTS) Mr. Aron reminded the members of the tracking system established for the medical marijuana products. The system contracted for by the state agriculture department did not include a method to uniquely identify marijuana products. Marijuana pharmacies require a unique number for such products to facilitate the reporting of the dispensing transactions to the state prescription monitoring program. Mr. Aron directed staff to work with the vendor for LMMTS to establish a method to assign product identification numbers to the marijuana products to be sold by the producers to the pharmacies. The vendor offered a module of their system which had not been requested by the state agriculture department. So as to not interrupt the progress of the implementation of the statewide program, Mr. Aron authorized the interim procurement of the product identification module which will integrate with the remainder of the tracking system. However, in order to continue the purchase of the module in the next fiscal year, Board approval was necessary. The committee reviewed the procurement and recommended the approval of the purchase for the following fiscal year. On behalf of the committee, Mr. McKay moved,

Resolved, to approve the proposed agreement with Metrc for the product identification module in the Louisiana Medical Marijuana Tracking System, at the stipulated rate, in an amount not to exceed $20,000 for Fiscal Year 2019-2020.

Several members questioned how the module would integrate with the pharmacy information systems and facilitate the reporting of dispensing transactions to the state prescription monitoring program. Some of the members questioned the necessity of the program. Some of the members understood the necessity of the interim procurement and questioned whether it would be necessary every year. Some of the members questioned whether the state agriculture department should include that module in the annual renewal of their contract for the tracking system going forward. There were

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no public comments. The motion was adopted after a unanimous vote in the affirmative.

Finally, Mr. Aron closed his report with appreciation for the other

committee members and their work the previous day. At this point, Mr. Aron declared a brief recess. It was noted the members recessed at 5:20 p.m. and then reconvened at 5:30 p.m. Mr. Aron resumed the sequence of the posted agenda. 11. Staff Reports J. Report of Assistant Executive Director

Mr. Aron called upon Mr. Fontenot for the report. He directed the members to the quarterly report of the prescription monitoring program, detailing the prescription transaction counts as well as queries from prescribers, dispensers, and law enforcement agencies. He answered questions from several members.

Mr. Fontenot then directed the members to the requests from 28 pharmacies seeking a waiver from the duty to report zero prescription transaction reports to the prescription monitoring program. Mr. McKay then moved,

Resolved, to authorize the issuance of full PMP reporting waivers to:

> PHY.007227-NR – A-1 Pharmacy Services (MS); > PHY.007532-NR – Allivet (FL); > PHY.007298-NR – Benzer Pharmacy (FL); > PHY.007727-NR – Bio Tek reMEDys (DE); > PHY.005543-NR – Clinical Solutions (TN); > PHY.007828-NR – Concentrix CVG Corporation (AZ); > PHY.006342-NR – Coram CVS/Specialty Infusion Services (MN); > PHY.006242-NR – Exactus Pharmacy Solutions (FL); > PHY.000381-HOS – Franklin Foundation Hospital Pharmacy (LA) > PHY.006340-HOS – Franklin Medical Center Pharmacy (LA);

> PHY.007826-NR – GoLiveWell Pharmacy (MO); > PHY.007723-NR – Haltom Pharmacy (TX);

> PHY.006754-NR – Hometech Advanced Therapies (PA); > PHY.000501-HOS – Iberia Medical Center Pharmacy (LA); > PHY.007286-SAT – Iberia Medical Center North (LA); > PHY.000471-HOS – Hood Memorial Hospital Pharmacy (LA); > PHY.007885-NR – Kroger Specialty Infusion Therapy (TX); > PHY.007881-NR – Lemonaid Pharmacy (MO); > PHY.007842-NR – MediStar Healthcare Connections (AZ); > PHY.007896-NR – Milton Medical & Drug Co. (FL); > PHY.007872-NRN – NuTech (TX); > PHY.007879-HOS – Ochsner LSU Health Shreveport (LA); > PHY.007877-HOS – Our Lady of Lourdes Women’s & Children’s

Hospital Pharmacy (LA);

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> PHY.007888-HOS – Our Lady of the Lake Ascension Hospital Pharmacy (LA);

> PHY.007860-NR – Pinnacle Medical Solutions (MS); > PHY.007870-NR – Skip’s Pharmacy (FL); > PHY.007857-NR – Soleo Health (IL); and > PHY.007807-NR – Unlimited Pharmacy (TX)

once they have executed the standard consent agreement for that purpose.

Mr. Fontenot replied to questions from two members. There were no public comments. The motion was adopted after a unanimous vote in the affirmative. He then reported on the progress of the program’s collaboration with the Dept. of Health to integrate the PMP into all the electronic health record systems and pharmacy information systems in the state. He noted the grant funding supporting that initiative required completion of the integration by June 30, 2019.

Finally, Mr. Fontenot indicated completion of his report.

K. Report of General Counsel Mr. Aron called upon Mr. Finalet for the report. Mr. Finalet reported the

May 20, 2019 decision of the 19th Judicial District Court in Rx Greenhouse, LLC, et al vs The Louisiana Board of Pharmacy. The judge affirmed the Board’s decision in its award of the marijuana pharmacy permit for Region 1. Mr. Finalet then presented the following proposed voluntary consent agreements to the members for their consideration.

Randolph Adam Baez (PST.018669): Mr. McKay moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand, and further, assessed a fine of $1,000 plus administrative costs. Pharmcore, Inc. d/b/a Hallandale Pharmacy [Fort Lauderdale, FL] (PHY.00.7866): Mr. McKay moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $10,000 plus administrative costs. Robert Brent Clevenger (PST.021999): Mr. McKay moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board suspended the license for four years plus nine months plus twenty days and stayed the execution of the suspension, then placed the license on probation for four years plus nine months plus twenty days effective May 29, 2019 and terminating March 21, 2024 subject to certain terms enumerated within the consent agreement, and further, assessed administrative costs. The Board took note the probationary period

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was scheduled to proceed concurrently with the probationary period imposed by the Alabama Board of Pharmacy on his Alabama pharmacist license. Nguyet Anh Thi Nguyen (CPT.006154): Mr. McKay moved to accept the voluntary surrender of the credential. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board accepted the voluntary surrender of the credential, resulting in the active suspension of the certificate for an indefinite period of time effective April 22, 2019. Pharmaceutical Specialties, Inc. d/b/a Hoye’s Pharmacy [Tampa, FL] (PHY.007496): Mr. Mr. McKay moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board assessed a fine of $5,000 plus administrative costs. Whitney Nicole Cantrelle (PST.021219): Mr. McKay moved to accept the voluntary surrender of the credential. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board accepted the voluntary surrender of the credential, resulting in the active suspension of the license for an indefinite period of time effective April 29, 2019. Tanya Centrell Ann Ventress (CPT.004921): Mr. McKay moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand, and further, assessed a fine of $250 plus administrative costs. Brandee Cecilia Lam (PST.021000): Mr. McKay moved to approve the proposed voluntary consent agreement. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. The Board issued a Letter of Reprimand, and further, assessed a fine of $1,000 plus administrative costs.

Finally, Mr. Finalet indicated the completion of his report. L. Report of Executive Director

Mr. Aron called upon Mr. Broussard for the report. Mr. Broussard directed the members to his report in the meeting binder. He reviewed the following topics:

• Meeting Activity • Reports

Internal Reports Credentials Division Census Report Licensure Activity Report

- 23 –

Application Activity Report Exceptions Report Compliance Division Census Report Complaint Investigation Policy Monitor

External Reports Administrative and Legislative Agency Reports

• Examinations MPJE NAPLEX ExCPT PTCB

• Operations Credentials Division Compliance Division Administrative Division

• State Activities La. Legislature La. State Board of Medical Examiners

• Regional & National Activities National Association of Boards of Pharmacy (NABP) NABP-AACP District 6 MALTAGON

• International Activities International Pharmaceutical Federation (FIP) dotPharmacy Verified Websites Program

Finally, Mr. Broussard indicated the completion of his report. 13. New Agenda Items Added During Meeting A. Regulatory Project 2019-1A ~ Marijuana Pharmacies

Mr. Aron reminded the members of the public hearing earlier that day to receive comments and testimony on the proposed rule. The Board received no comments or testimony either prior to or during the public hearing. He questioned whether they wished to entertain any amendments to the proposed rules. With no requests for any further amendments. Mr. McKay then moved,

Resolved, to make no revisions to the original proposed rule and to direct staff to submit the required reports and continue the promulgation process.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. 14. Announcements Mr. Aron directed the members to the announcements in their meeting binder. He announced the next meeting of the board would be held on August 14 at the Board office in Baton Rouge.

- 24 –

15. Recess Having completed the tasks itemized on the posted agenda, with no further business pending before the Board and without objection, Mr. Aron recessed the meeting at 5:45 p.m. * * * An Administrative Hearing was convened on Thursday, May 30, 2019 in the Boardroom of the Board’s office, located at 3388 Brentwood Drive in Baton Rouge, Louisiana. The hearing was held pursuant to public notice, each member received notice, each respondent received notice (unless specifically stated otherwise in the official transcript), and public notice was properly posted. A. Call to Order Mr. Aron called the hearing to order at 8:35 a.m. B. Invocation & Pledge Mr. Aron called upon Mr. Valentine for the invocation. Dr. Strong then led the group in the Pledge of Allegiance. C. Quorum Call Mr. Aron called upon Secretary Indovina and he called the roll. After doing so, he certified Dr. Cloud, Mr. Mannino, Mr. Moore, and Mr. Pitre were absent; however, the remaining 13 members were present, constituting a quorum for the conduct of official business. D. Call for Additional Agenda Items & Adoption of Agenda Mr. Aron asked if there were any additional agenda items, and none were requested. With no objection, the Board adopted the posted agenda dated May 20, 2019. E. Opportunity for Public Comment Mr. Aron reminded the members and guests the Open Meetings Law requires all public bodies to provide an opportunity for public comment at all meetings and prior to the vote on each agenda item. He solicited general comments on non-agenda items from the guests present, and none were offered. Appearances Mr. Aron indicated he would serve as the Hearing Officer. Mr. Carlos Finalet served as the Prosecuting Attorney. Ms. Susan Erkle served as the Official Recorder, and Mr. Malcolm Broussard served as the Hearing Clerk. Mr. Aron informed the members the cases on the agenda originated with the Violations Committee, and that the members of that committee in attendance at their December 5, 2018 and March 19, 2019 meetings would be recused from the hearings. In particular, Dr. Cloud, Ms. Hall, Mr. Indovina, Mr. Robichaux, and Mr. Valentine were recused. He reminded the other members they should recuse themselves should the need arise.

- 25 –

Without objection, Mr. Aron waived the reading of the posted agenda and instead direction the insertion thereof into these minutes. The posted agenda is re-created here.

A G E N D A NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official.

Revised 05-20-2019 A. Call to Order B. Invocation & Pledge of Allegiance C. Quorum Call D. Call for Additional Agenda Items & Adoption of Agenda E. Opportunity for Public Comment * Appearances F. Formal Hearings

1. Case No. 18-0348 ~ CPT.010443 – Tiffani Lauren Burnaman

2. Case No. 18-0396 ~ CPT.011436 – Christie Elaine Parker

3. Case No. 18-0480 ~ PTC.024692 – Jonnesha D’Shae London G. Report of Violations Committee – Consideration of Proposed Voluntary Consent Agreements H. Report of General Counsel – Consideration of Proposed Voluntary Consent Agreements &

Voluntary Surrenders/Revocations I. Adjourn F. Formal Hearings Mr. Finalet informed the hearing panel the second case listed on the agenda would be continued until a future date due to the delayed arrival of a witness affidavit. With Mr. Aron’s approval, he then began the hearings by calling the first case listed.

Tiffani Lauren Burnaman (CPT.010443) Mr. Finalet appeared for the Board. The respondent, Tiffani Lauren Burnaman, did not appear and was not represented by counsel. Mr. Aron ruled the hearing would proceed as noticed in the form of a default proceeding. Mr. Finalet offered an opening statement, presented no witnesses and six exhibits, and then proffered proposed Findings of Fact, Conclusions of Law, and Board Order. Mr. Finalet tendered the matter to the hearing panel for its consideration. Mr. Soileau moved to enter into executive session for the purpose of deliberating the disciplinary matter and discussing the respondent’s professional competency and fitness for practice. There were no member questions or public comments. The motion was adopted after a unanimous roll call vote in the affirmative.

It was noted the hearing panel entered into executive session at 8:45 a.m. and then

- 26 –

reconvened at 8:55 a.m. Mr. Aron returned the hearing panel to open session; he reported no decision was made during the executive session and questioned the members as to their disposition of the case. Mr. Cassidy then moved,

Resolved, that the hearing panel, having heard the testimony and considered the evidence, accept the Findings of Fact as proposed by the Prosecuting Attorney, adopt them as our own, and then enter them into the hearing record.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Mr. Cassidy then moved,

Resolved, that the hearing panel accept the Conclusions of Law as proposed by the Prosecuting Attorney, adopt them as our own, and then enter them into the hearing record.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Mr. Cassidy then moved,

Resolved, that the hearing panel enter the following order at this time: It is ordered, adjudged, and decreed that Louisiana Pharmacy Technician Certificate No. 10443 held by Tiffani Lauren Burnaman shall be, and is hereby, suspended for an indefinite period of time effective on the entry of this order; and further, the respondent shall pay the following assessments: (1) A fine of $500; (2) The administrative hearing fee of $250; and (3) The investigative and hearing costs, including the costs of

the prosecuting attorney and the official recorder; and It is further ordered, the acceptance of any future application for the reinstatement of the certificate or any application for any other credential issued by the Board shall be conditioned upon the satisfaction of the following terms: (1) Respondent shall have paid all assessments levied herein;

and (2) Respondent shall have no pending legal or disciplinary

matters against her in any jurisdiction. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Jonnesha D’Shae London (PTC.024692) Mr. Finalet appeared for the Board. The respondent, Jonnesha D’Shae London, did not appear and she was not represented by counsel. Mr. Aron ruled the hearing would proceed as noticed in the form of a default proceeding. Mr. Finalet offered an opening statement, presented one witness and six exhibits, and then proffered proposed Findings of Fact, Conclusions of Law, and Board Order. Mr. Finalet tendered the matter to the hearing panel for its consideration. Mr. Cassidy moved to enter into executive session for the purpose of deliberating the disciplinary matter and discussing the respondent’s professional competency and fitness for practice. There were no member questions or public comments. The motion was adopted

- 27 –

after a unanimous roll call vote in the affirmative. It was noted the hearing panel entered into executive session at 9:10 a.m. and then reconvened at 9:15 a.m. Mr. Aron returned the hearing panel to open session; he reported no decision was made during the executive session and questioned the members as to their disposition of the case. Dr. Strong then moved,

Resolved, that the hearing panel, having heard the testimony and considered the evidence, accept the Findings of Fact as proposed by the Prosecuting Attorney, adopt them as our own, and then enter them into the hearing record.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Dr. Strong then moved,

Resolved, that the hearing panel accept the Conclusions of Law as proposed by the Prosecuting Attorney, adopt them as our own, and then enter them into the hearing record.

There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative. Dr. Strong then moved,

Resolved, that the hearing panel enter the following order at this time: It is ordered, adjudged, and decreed that Louisiana Pharmacy Technician Candidate Registration No. 24692 held by Jonnesha D’Shae London shall be, and is hereby, suspended for an indefinite period of time effective on the entry of this order; and further, the respondent shall pay the following assessments: (4) A fine of $500; (5) The administrative hearing fee of $250; and (6) The investigative and hearing costs, including the costs of

the prosecuting attorney and the official recorder; and It is further ordered, the acceptance of any future application for the reinstatement of the certificate or any application for any other credential issued by the Board shall be conditioned upon the satisfaction of the following terms: (3) Respondent shall have paid all assessments levied herein;

and (4) Respondent shall have no pending legal or disciplinary

matters against her in any jurisdiction. There were no member questions or public comments. The motion was adopted after a unanimous vote in the affirmative.

Mr. Finalet indicated completion of the cases scheduled for that day. Mr. Aron expressed his appreciation to Ms. Erkle for her recording services that day. G. Report of Violations Committee Mr. Aron noted the committee presented its proposed consent agreement the previous day and there were no additions to that list.

- 28 –

H. Report of General Counsel Mr. Aron noted Mr. Finalet presented his proposed consent agreements the previous day and there were no addition to that list. I. Adjourn Having completed the tasks itemized on the posted agenda, with no further business pending before the Board, and without objection, Mr. Aron adjourned the hearing at 9:20 a.m. Respectfully submitted, __________________________________ Richard M. Indovina, Jr. Secretary



Report on Action Items




August 14, 2019 Agenda Item 6: Report on Action Items During the reports from the Violations, Impairment and Reinstatement Committees and General Counsel, as well as during the Administrative Hearing, you took disciplinary action against a number of credentials. We entered those decisions in the eLicense system which enables their public access in the credential verification module of the Board’s website. We filed the required reports on those actions to the NABP Disciplinary Clearinghouse and the National Practitioner Data Bank. We also published your actions in the quarterly newsletter, with the exception of those cases exempted from such publication by your policies. During the report from the Regulation Revision Committee, you approved four regulatory proposals, delayed the enforcement of a new Chapter <800> Hazardous Substances – Handling in Healthcare Settings published by USP, and authorized continued progress on a regulatory project. In particular: With respect to Regulatory Proposal 2018-B ~ Drug Disposal by Pharmacies (Draft #5),

we have submitted our required notice to the Occupational Licensing Review Commission (OLRC). We are waiting on their reply as to whether they will require a formal review of the proposed rule or issue a waiver to allow us to proceed without such review.

With respect to Regulatory Proposal 2018-N ~ Pharmacy Compounding (Draft #5), we have submitted our required notice to the OLRC. We are waiting on their reply as to whether they will require a formal review of the proposed rule or issue a waiver to allow us to proceed without such review.

With respect to Regulatory Proposal 2019-A ~ Pharmacy Records (Draft #3), we have submitted our required notice to the OLRC. We are waiting on their reply as to whether they will require a formal review of the proposed rule or issue a waiver to allow us to proceed without such review.

With respect to Regulatory Proposal 2019-D ~ Pharmacist Access to PMP (Draft #1), we have not yet submitted the required notice to the OLRC. The Regulation Revision Committee is considering another PMP-related proposal to implement a new law from the 2019 Legislature. The committee has recommended the filing of several PMP-relative proposals in one single package. The committee anticipates submitting the new PMP proposal, which will incorporate this proposal, to you during your next meeting in November.

With respect to your decision to delay the enforcement of the new USP Chapter <800>, we published an article in your July 2019 edition of the newsletter informing the licensees of your decision.

With respect to Regulatory Project 2019-1A ~ Marijuana Pharmacies, you evaluated the absence of comments at the public hearing and authorized continued progress on that project. We submitted the required notice to the OLRC and requested a waiver from further review. We are waiting for their reply.

During the report from the Executive Committee, you took action on a number of different types of documents. You approved two new policies and revisions of four existing policies in your Policy &


Procedure Manual. You also continued your approval of the manual for the next fiscal year. You also approved one new policy in your Loss Prevention Manual and extended your approval of the manual for the next fiscal year. We have posted the updated manuals and advised staff.

You approved two pharmacy technician training programs. We informed the programs of your requirements, posted the revised roster on our website and alerted the licensing staff.

Finally, copies of the Regulatory Project Promulgation Record as well as the Legislative Action Plan Implementation Report are attached to this report. Respectfully submitted, Malcolm J Broussard Executive Director

Louisiana Board of PharmacyRegulatory Projects - Promulgation Record

Last update: 08-14-2019

Project Public Oversight Final Rule Law Book No. Hearing Hearing Published Published

2019-18 Cannabis MDI

2019-17 Pharmacy Records Waiting for reply from OLRC

2019-16 Pharmacy Compounding Waiting for reply form OLRC

2019-15 Drug Disposal by Pharmacies Waiting for reply from OLRC

454-2019 Comments on Entirety of Rules 6/26/2019

2019-14 Rulemaking ProceduresOLRC issued waiver from Commission review

2019-13 CDS License for 3PL ProvidersOLRC issued waiver from Commission review

2019-12 Partial Fill of C-II PrescriptionsOLRC issued waiver from Commission review

2019-11 Continuing Education RecordsOLRC hearing

2019-10 License Transfer for Pharmacy TechniciansOLRC hearing

2019-9 Delays of Licensure ExaminationsOLRC hearing

2019-8 Dispensing of Prescription RefillsOLRC issued waiver from Commission review

2019-7 Veterinary Hospital PharmacyOLRC issued waiver from Commission review

5/20/2019

4/22/2019

4/22/2019

4/22/2019

Pending

Pending

4/12/2019

4/12/2019

1st Report 2nd Report 3rd ReportProject Name Notice of Intent Hearing Record Completion

Pending




2019-6 Prescription Monitoring ProgramOLRC issued waiver from Commission review

2019-5 Correctional Center PharmaciesOLRC issued waiver from Commission review

2019-4 Telepharmacy Dispensing SitesOLRC hearing

2019-3 Investigational DrugsOLRC issued waiver from Commission review

2019-2 Pharmacy ImmunizationsOLRC issued waiver from Commission review

2019-1B Licensing of Marijuana PharmaciesOLRC hearing

2019-1A Marijuana Pharmacies 5/29/2019 Waiting for reply from OLRCOLRC issued waiver from Commission review

2018-3 Drugs of Concern - Naloxone 10/26/2018 [none] 1/20/2019 2019

2018-2 La. Uniform Prior Authorization 9/28/2018 [none] 12/20/2018 2019Delayed effective date: 1/1/2019

2018-1 Pharmacy Benefit Managers 6/25/2018 10/8/2018 Sen. H&W Cmte rejected proposed rule.

2017-2 Equivalent Drug Product Interchange 5/30/2017 [none] 11/20/2017 11/20/2017

2017-1 Internship Requirements 5/30/2017 [none] 11/20/2017 1/1/2018Delayed effective date: 1/1/2018

5/20/2018 9/11/2018

4/20/2017 9/27/2017 2/6/2018

Pending

4/12/2019

4/12/2019

9/20/2018

10/25/2018

12/3/2018

2/26/2019

2/26/2019

4/20/20193/20/2019

Pending

4/12/2019

4/12/2019

8/20/2018

4/20/2017 9/27/2017 2/6/2018





2016-6 Marijuana Pharmacy 3/2/2017 Comments prompted substantive revision, requiring a second public hearing6/26/2017 [none] 8/20/2017 2017

2016-5 Reinstatement of CDS License Emergency Rule #1 issued; it expired 3/17/2017.Emergency Rule #2 issued; it was cancelled upon publication of the Final Rule.

3/1/2017 [none] 5/20/2017 2017

2016-4 Standing Orders for Distribution of Naloxone Emergency Rule #1 issued; it expired 12/8/2016.Emergency Rule #2 issued; it expired 4/6/2017.Emergency Rule #3 issued; it was cancelled upon publication of the Final Rule.

3/1/2017 [none] 5/20/2017 2017

2016-3 Medication Synchronization 5/25/2016 [none] 9/20/2016 2016

2016-2 Pharmacist-in-Charge of Nonresident Pharma 5/25/2016 [none] 1/20/2017 2017

2016-1 CDS Prescriptions 5/25/2016 [none] 7/20/2016 2016

2015-9 Accreditation of Technician Training Program Emergency Rule #1 issued; it expired 3/28/2016.Emergency Rule #2 issued; it expired 7/22/2016.Emergency Rule #3 issued; it expired 11/18/2016.Revised Emergency Rule issued; it expired 3/17/2017Emergency Rule #5 issued; it expired 7/13/2017Emergency Rule #6 issued; it will expire 11/7/2017Emergency Rule #7 issued; it was cancelled upon publication of the Final Rule.

3/1/2017 Comments prompted substantive revision, requiring a second public hearing

6/26/2017 [none] 12/20/2017 1/1/2018Delayed effective date: 1/1/2018

2015-8 Remote Access to Medical Orders 8/26/2015 [none] 10/20/2015 2016

8/10/2016

1/20/2017

12/7/20164/5/2017

1/20/2017 3/27/2017 2/6/2018

4/20/2016 8/1/2016 2/1/2017

3/15/2017

4/20/2016 11/14/2016 2/6/2018

4/20/2016 6/3/2016 2/1/2017

Project Name Notice of Intent Hearing Record Completion

11/17/20/163/15/2017

1/20/2017 3/27/2017 2/6/2018

2/6/20187/5/2017

11/30/20153/24/20167/21/201611/17/2016

7/20/2015 9/8/2015 2/22/2016

11/6/2017

1/20/201711/6/2017 2/6/2018

7/10/2017

1st Report 2nd Report 3rd Report




2015-7 Remote Processor Pharmacy Permit 8/26/2015 [none] 10/20/2015 2016

2015-6 Telepharmacy Services Permit 8/26/2015 [none] 10/20/2015 2016

2015-5 Electronic Signature on Fax Prescription Emergency Rule; will expire on 09/30/2015Emergency Rule re-issued; will expire on publication of Final Rule.

8/26/2015 [none] 10/20/2015 2016

2015-4 Compounding for Office Use for Veterinarians Emergency Rule; will expire on 09/28/2015Emergency Rule re-issued; will expire on 01/19/2016Emergency Rule re-issued; will expire on 05/14/2016Emergency Rule re-issued; will expire on publication of Final Rule

8/26/2015 Comments prompted substantive revision, requiring a second public hearing4/19/2016 [none] 6/20/2016 2016

2015-3 Electronic Product Verification 6/25/2015 [none] 8/20/2015 2016

2015-2 Expiration Date of Schedule II Prescriptions 1/28/2015 [none] 4/20/2015 2016

2015-1 Dispenser Reporting to PMP 1/28/2015 [none] 4/20/2015 2016

2014-6 Special Event Pharmacy Permit 10/30/2014 [none] 1/20/2015 3/15/2015

2014-5 Prescriptions 7/28/2014 Comments prompted substantive revision, requiring a second public hearing10/30/2014 [none] 1/20/2015 3/15/2015

2014-4 Pharmacy Compounding Emergency Rule - valid for 120 daysEmergency Rule re-issued; expired on publication of Final Rule on 1/20/2015.

10/30/2014 [none] 1/20/2015 3/15/2015

2014-3 Pharmacy Records 4/29/2014 Comments prompted substantive revision, requiring a second public hearing9/30/2014 [none] 11/20/2014 3/15/2015

9/21/2015

7/20/2015 9/8/2015

2/1/2017

4/20/2015 6/29/2015 2/22/2016

9/21/20151/15/20162/24/20167/20/2015

2/22/2016

6/1/2015

6/20/201411/18/2014 2/22/2016

8/8/201412/5/2014

9/20/2014 11/18/2014 2/22/2016

7/20/2015 9/8/2015 2/22/2016

7/20/2015 9/8/2015 2/22/2016


3/20/201410/3/2014 3/13/2015

12/20/2014 3/3/2015 2/22/2016

12/20/2014 3/3/2015 2/22/2016

9/20/2014 11/18/2014 2/22/2016

5/10/2016

6/1/2015




2014-2 Veterinarian Exclusion from PMP 4/29/2014 [none] 6/20/2014 3/15/2015

2014-1 PMP Delegates 4/29/2014 [none] 6/20/2014 3/15/2015

2013-06 Penal Pharmacy Permit Revision 8/27/2013 [none] 11/20/2013 1/15/2014

2013-05 Collaborative Drug Therapy Management 8/27/2013 [none] 12/20/2013 1/15/2014

2013-04 Preferential Licensing for Military Personnel 8/27/2013 [none] 11/20/2013 1/15/2014

2013-03 Technician Training Programs [Chap. 9] 5/30/2013 [none] 7/20/2013 1/15/2014

2013-02 Hospital Off-Site Satellite Pharmacies [Chap. 2/27/2013 [none] 5/20/2013 1/15/2014

2013-01 Compounding for Prescriber Use ~ ER-1 Emergency Rule - valid for 120 days 1/18/2013 Sen H&W Cmte rejected Emergency Rule

Compounding for Prescriber Use ~ ER-2 Replacement Emergency Rule - valid for 120 daysReplacement Emergency Rule re-issued - valid for 120 daysReplacement Emergency Rule re-issued - valid for 120 daysReplacement Emergency Rule re-issued - valid for 120 daysReplacement Emergency Rule re-issued - expired 8/4/2014; see Project 2014-4 abovce for new ER

Compounding for Prescriber Use [Chap 25] 2/27/2013 Comments prompted substantive revision, requiring a second public hearing

5/30/2013 Comments prompted substantive revision; additional hearing requiredTime has expired for the 2013 Notice of Intent - New Project & Notice of Intent required.

2012-11 DME Permit [Chapter 24] 12/27/2012 [none] 3/20/2013 4/15/2013

2012-10 PMP [Chapter 29] 8/27/2012 [none] 2/20/2013 4/15/2013

2012-09 CDS in EDK [§1713, 2743] 8/27/2012 [none] 2/20/2013 4/15/2013

2012-08 CDS Lic. For Non-Resident Distributor [§2705 8/27/2012 [none] 2/20/2013 4/15/2013

3/20/2014 5/8/2014 3/13/2015

7/20/2013 11/8/2013 2/7/2014

7/20/2013 9/23/2013 2/7/2014

3/20/2014 5/8/2014 3/13/2015

7/20/2013 10/3/2013 2/7/2014

12/13/2012

1/31/20135/29/20139/27/20132/6/20144/4/2014

4/20/2013 6/4/2013 2/7/2014

1/20/2013 3/15/2013 2/7/2014

7/20/2012 1/2/2013 3/8/2013

7/20/2012 1/2/2013 3/8/2013

1/20/2013

1/20/2014

11/20/2012 1/5/2013 2/7/2014

7/20/2012 1/2/2013 3/8/2013





2012-07 Security of Rx Dept [§1103] 8/27/2012 [none] 2/20/2013 4/15/2013

2012-06 Interstate Remote Processing [§1139, 1143] 8/27/2012 [none] 2/20/2013 4/15/2013

2012-05 Institutional Pharmacy [§1705, 1727] 8/27/2012 [none] 2/20/2013 4/15/2013

2012-04 Chapter 24 - DME Permits ~ Emergency Rule Emergency Rule - valid for 120 daysEmergency Rule re-issued - valid for 120 daysEmergency Rule re-issued - valid for 120 days

2012-03 Remote Processing [§1143, 1525] 2/28/2012 [none] 5/20/2012 4/15/2013

2012-02 Hospital Pharmacy [§1501, 1512, 1513] 2/28/2012 [none] 5/20/2012 4/15/2013

2012-01 E-Communications [§505, 905, 1203] 2/28/2012 [none] 5/20/2012 4/15/2013

2011-07 Penal Pharmacy [Chapter 18] 2/28/2012 [none] 5/20/2012 4/15/2013

2011-02 Cognitive Services [§525] 2/28/2012 [none] 5/20/2012 4/15/2013

2011-01 PIC Requirements [§1105] 2/28/2012 [none] 5/20/2012 4/15/2013

2009-04 Digital Imaging of Prescriptions [§1123] 1/27/2010 [none] 4/20/2010 1/31/2011

2009-03 Prescription Transfers [§2523] 1/27/2010 [none] 4/20/2010 1/31/2011

2009-02 Pharmacy Interns [§709] 1/27/2010 [none] 4/20/2010 1/31/2011

2009-01 Drugs of Concern [§2901] 1/27/2010 [none] 4/20/2010 1/31/2011

2008-03 CDS [Chapter 27] 7/30/2008 [none] 10/20/2008 1/31/2011

2008-02 Pharmacies [§1107.B + §1727] 5/28/2008 [none] 7/20/2008 1/31/2011

3/8/2013

7/20/2012 1/2/2013 3/8/2013

7/20/2012 1/2/2013 3/8/2013

4/5/2011

1/20/2012 3/19/2012 3/8/2013

1/20/2012 3/19/2012 3/8/2013

1/20/2012 3/19/2012 3/8/2013

1/20/2012 3/19/2012 3/8/2013

2/7/201412/28/2012 2/7/2014

6/20/2008 8/21/2008 3/16/2009

4/20/2008 6/2/2008 3/16/2009

7/20/2012 1/2/2013

12/20/2009 2/26/2010 4/5/2011

12/20/2009 2/26/2010 4/5/2011

12/20/2009 2/26/2010 4/5/2011

12/20/2009 2/26/2010


1/20/2012 3/19/2012 3/8/2013

1/20/2012 3/19/2012 3/8/2013

5/2/2012 2/7/20148/31/2012




2008-01 Pharmacy Interns [ §521.G + §705.C] 5/28/2008 [none] 7/20/2008 1/31/2011

2007-01 Prescription Monitoring Program [Chapter 29] 5/30/2007 [none] 7/20/2007 1/31/2011

2006-03 Pharmacy Practice 12/27/2006 Comments prompted substantive revision, requiring a second public hearing4/20/2007 [none] 6/20/2007 1/31/2011

2006-02 Proposal No. 2006-11 - Certified Preceptors 10/30/2006 [none] 12/20/2006 1/31/2011

2006-01 Proposal No. 2006-11 - Certified Preceptors Emergency Rule - valid for 120 days [none] N/A N/A

2005-03 §705 - Practical Experience for Interns 1/25/2006 [none] 4/20/2006 9/1/2006

2005-02 §705 - Practical Experience for Interns Emergency Rule - valid for 120 days [none] N/A N/A

2005-01 §907 - Scope of Practice for Technicians 7/27/2005 Refiled report due to disruption caused by Hurricanes Katrina & Rita2/14/2006 6/20/2006 9/1/2006

2004-01 Chapter 8 →Chapter 9: Pharmacy Technician 9/27/2004 [none] 11/20/2004 1/1/2005

2003-01 Complete Revision of Board Rules 8/26/2003 [none] 10/20/2003 1/1/2004

2001-01 §1109 - Prescription Forms 10/25/2001 [none] 11/20/2001 1/1/2002

2000-04 Chapter 7 - Pharmacy Interns 7/27/2000 [none] 10/20/2000 12/1/2000

2000-03 Chapter 8 - Pharmacy Technicians 5/30/2000 Comments prompted substantive revisions, requiring a 2nd hearing8/24/2000 [none] 10/20/2000 12/1/2000

2000-02 §3517 - Drug Donations / Charitable Pharmac 5/30/2000 [none] 8/20/2000 10/1/2000

2000-01 §3517 - Drug Donations / Charitable Pharmac Emergency Rule - valid for 120 days [none] N/A N/A

1999-01 Chapter 12 - Automated Medication Systems 11/29/1999 [none] 6/20/2000 6/1/2000

6/20/2005 8/25/20051/30/2006 3/30/2007

8/20/2004 10/5/2004 3/18/2005

3/30/2007

9/20/1999 3/13/2000 N/A

6/20/2000 8/28/2000 N/A

4/20/2000 7/5/20007/20/2000 8/28/2000 N/A

4/20/2000 6/20/2000 N/A

3/20/2000 N/A

7/20/2003 8/28/2003 2/27/2004

9/20/2001 11/5/2001 N/A

12/20/2005 3/30/2007

11/20/20063/30/2007 5/3/2007 2/13/2008

9/20/2006 11/1/2006

4/20/2008 6/2/2008 3/16/2009

4/20/2007 6/5/2007 2/13/2008

1st Report

9/1/2006 3/30/2007

12/20/2005 1/30/2006 3/30/2007

2nd Report 3rd ReportProject Name Notice of Intent Hearing Record Completion

Louisiana Board of PharmacyAction Plans to Implement Legislation

Bill Act Topic Citation(s) Law Book Rules PPM Guidance Forms Operations CompletionHB 138 2019-354 Revised definitions; new drugs in Schedule I 40:961 and 964 8/1/2019 8/1/2019HB 243 2019-423 Reporting of opioid-related overdoses 40:978.2.1 8/1/2019 8/1/2019HB 284 2019-426 Prescriber overrides of 7-day supply 40:978(G)(2) 8/1/2019 8/1/2019HB 358 2019-284 Cannabis metered-dose inhalers 40:1046(A)(1) 8/1/2019 Reg. Proposal 2019-E in CmteHB 375 2019-219 CBC for CDS license applicants 40:973.1 8/1/2019 Assigned to CmteHB 423 2019-227 Repeal of student loan disqualifications 37:2951 repealed 8/1/2019 8/1/2019HB 433 2019-161 Pharmacist may decline to fill prescription 37:1219(D through F) 8/1/2019 Assigned to CmteHB 452 2019-231 Scheduling of mitragynine 40:964 and 40:989.3 8/1/2019 8/1/2019HB 491 2019-164 Hemp-derived CBD oil products 40:961.1 8/1/2019 PendingHB 507 2019-331 7% tax on gross sales of marijuana products 40:1046(H)(8)(a) 8/1/2019 8/1/2019HB 614 2019-256 Public notice for public records 44:33.1(B) 8/1/2019SB 41 2019-124 Licensure and regulation of PBMs 37:1252 et seq; 40:2861 et seq 8/1/2019 Reg. Proposal 2019-G in CmteSB 53 2019-080 Access to PMP by federal jurisdictions 40:1007(G) 8/1/2019 Reg. Proposal 2019-F in CmteSB 99 2019-052 Board member qualifications 37:1174(A)(4) 8/1/2019 Assigned to Cmte

SB 119 2019-351 Palliative Care Advisory Council 40:2018.6 PendingSB 241 2019-204 Revision of APA re small business impact 49:953 et seq Review


Bill Act Topic Citation(s) Law Book Rules PPM Guidance Forms Operations CompletionHB 45 2018-186 CDS license for 3rd party logistics providers 40:961(42); 972(B)(7); 973(A)(1) 8/1/2018 Reg Project 2019-13 in process

HB 150 2018-063 Military spouse renewal fee waiver 37:1208.1 8/1/2018 No rule required PST-MS #12-MS 11/1/2018HB 151 2018-064 Definition of 'approved school of pharmacy' 37:1164(2) 8/1/2018 No rule required 11/1/2018HB 153 2018-119 New substances to Schedules I and II 40:964 8/1/2018 8/1/2018HB 165 2018-677 Penalties for CS violations 40:966; 967 8/1/2018 8/1/2018HB 186 2018-199 Penalties for CS violations 40:979 8/1/2018 8/1/2018HB 188 2018-200 Acceptance of gifts by public servants 42:1115.2 anticipatedHB 189 2018-454 Rulemaking procedures 49:953(C) 8/1/2018 Reg Project 2019-14 in processHB 224 2018-203 Penalties for legend drug violations 40:1060(13); (15) 8/1/2018 8/1/2018HB 326 2018-206 Technical corrections to practice acts 37:1164; 1182; 1226.1; 1226.2 8/1/2018 8/1/2018HB 372 2018-623 Occupational licensing review commission 37:41-47 1/31/2019 1/31/2019HB 579 2018-708 New indications for therapeutic marijuana 40:1046 8/1/2018 8/1/2018HB 627 2018-496 New indications for therapeutic marijuana 40:1046 8/1/2018 8/1/2018HB 748 2018-693 Occupational licensing review by Gov office 49:903 3/14/2019HB 823 2018-715 Delay termination date of marijuana program 40:1046(J) 8/1/2018 8/1/2018HCR 70 Review of military licensing procedures anticipatedSB 27 2018-644 Nominations to Medicaid P&T Cmte 46:153.3(D) 8/15/2018 8/15/2018SB 28 2018-219 Exemptions for veterinarians 37:1251(D); 40:978(F)(3); 978.3(E) 8/1/2018 8/1/2018SB 29 2018-423 Uniform prior authorization form 22:1006.1; 1651(J); 46:460.33 1/20/2018 §1129 & 1130 1/1/2019SB 40 2018-515 Consumer members to licensing boards 37:1172(A); 1174(B) 8/1/2018 8/1/2018SB 75 2018-405 Prescriber licensing boards re PMP access 40:978(F)(2) 8/1/2018 8/1/2018SB 90 2018-028 Voluntary nonopioid directive form 40:1156.1 8/1/2018 LDH 11/1/2018

SB 109 2018-232 Epidemiologist access to PMP 40:1007(E)(8) 8/1/2018 Reg Project 2019-6 in processSB 110 2018-146 PMP definition of 'drugs of concern' 40:1003(10) 8/1/2018 §2901 1/20/2019SB 131 2018-031 Pharmacist licensure by reciprocity 37:1202; 1203 8/1/2018 No rule required 11/1/2018SB 134 2018-032 Partial fills for all Schedule II drugs 40:978(A) 8/1/2018 Reg Project 2019-12 in processSB 241 2018-317 Pharmacist communication with patients 22:1657; 37:1219 8/1/2018 No rule required 11/1/2018SB 260 2018-655 Complaints re board actions or procedures 37:23.1; 23.2 11/1/2018 11/1/2018SB 391 2018-669 Internet filters in state agency offices 8/1/2018 8/1/2018SB 477 2018-602 Chart orders for institutional patients 37:1164(59); 1226.4 8/1/2018 Reg Project 2019-17 in processSCR 83 Military licensing info on website 10/1/2018



Special Orders of the Day




Finance Committee



Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 E-mail: [email protected]

Finance Committee

Final Report for Fiscal Year 2018-2019

August 14, 2019

Blake P. Pitre Chair


Louisiana Board of Pharmacy Finance Committee

Final Report for Fiscal Year 2018-2019

Table of Contents Statement of Net Position 03 Statement of Equity 05 Statement of Cash Flow 06 Statement of Revenue, Expenses, & Budget Performance 07 Statement of Fund Balance Changes 09 Budget Variance Report 10 Summary of Board Actions 12 Iberia Bank – General Reserve Fund Statement 13 Iberia Bank – OPEB Reserve Fund Statement 13 Iberia Bank – Pension Reserve Fund Statement 14 Cumulative Fund Balance Report 15

Louisiana Board of PharmacyFY 2018-2019

Statement of Net Position

FY 17-18 FY 18-19Q4 06/30/2018 Q4 06/30/2019

ASSETS & DEFERRED OUTFLOWS Assets

> Current Assets * Cash

General OperationsHancockWhitney Bank 245,279.77 228,043.77Iberia Bank 932,997.64 1,684,545.02

Investment Accounts - Iberia Bank 107,440.90 268,913.41 * Total Cash & Cash Equivalents 1,285,718.31 2,181,502.20

* Accounts Receivable 17,170.00 24,295.00

* Accrued Interest Receivable 11,355.30 11,671.80

* Prepaid Expenses 8,154.42 53,834.10

* Grant Receivable 0.00 210,667.00Total Current Assets 1,322,398.03 2,481,970.10

> Noncurrent Assets * Investment Accounts

Iberia Bank - General Reserve Fund 1,190,485.88 1,216,051.35Iberia Bank - OPEB Reserve Fund 1,157,538.40 1,084,491.59Iberia Bank - Pension Reserve Fund 1,693,121.81 1,739,912.89

4,041,146.09 4,040,455.83 * Fixed Assets

Land: Lot 5-A, Towne Center Business Park 709,079.90 709,079.90Land: Lot 1-A-2, Leonard Place Subdivision 295,860.00 295,860.00Office Building - 3388 Brentwood Drive 1,065,861.29 1,354,876.72Construction in Progress 181,353.19 0.00Office Equipment 227,265.21 230,345.19Furniture 173,594.14 177,074.08Software: Licensure & Website 408,560.00 408,560.00Accumulated Depreciation (940,172.13) (995,793.19)

2,121,401.60 2,180,002.70

Total Noncurrent Assets 6,162,547.69 6,220,458.53

Total Assets 7,484,945.72 8,702,428.63

Deferred Outflows of ResourcesOPEB Reserve Fund 42,799.00 71,452.00Pension Reserve Fund 1,227,635.00 972,930.00

Total Deferred Outflows of Resources 1,270,434.00 1,044,382.00

TOTAL ASSETS & DEFERRED OUTFLOWS 8,755,379.72 9,746,810.63


Statement of Net Position

FY 17-18 FY 18-19Q4 06/30/2018 Q4 06/30/2019

LIABILITIES, DEFERRED INFLOWS, & EQUITY Liabilities

> Current LiabilitesGrant payable 0.00 1,035,749.00Accrued salaries and benefits 41,335.18 45,716.43Unemployment taxes payable 52.92 184.03State taxes withheld 4,212.00 4,820.00State retirement withheld 0.00 0.00Deferred compensation withheld 0.00 0.00Garnishment payable 0.00 0.00Accounts payable 8,960.31 4,582.35Compensated absences (ST) 65,024.75 44,648.86PES fee payable 100.00 200.00Contract & retainage payable 111,502.03 0.00

Total Current Liabilities 231,187.19 1,135,900.67

> Long Term LiabilitiesCompensated absences (LT) 62,582.46 90,377.73Other Post Employment Benefits (OPEB) Payable 1,934,454.00 1,928,937.00Net Pension Liability 5,455,797.00 5,297,583.00

Total Long Term Liabilities 7,452,833.46 7,316,897.73

Total Liabilities 7,684,020.65 8,452,798.40

Deferred Inflows of ResourcesOPEB Reserve Fund 106,345.00 154,202.00Pension Reserve Fund 144,892.00 80,208.00

Total Deferred Inflows of Resources 251,237.00 234,410.00

Equity 820,122.07 1,059,602.23

TOTAL LIABILITIES, DEFERRED INFLOWS, & EQUITY 8,755,379.72 9,746,810.63

Louisiana Board of PharmacyFiscal Year 2018-2019

Statement of Equity

FY 17-18 FY 18-19Q4 06/30/2018 Q4 06/30/2019

Balance of Equity at Beginning of Year 1,493,402.25 820,122.07

Restatement due to implementation of GASB Statement 75 ~ Accounting &Financial Reporting for OPEB (751,686.00)

741,716.25

Net Income 78,405.82 239,480.16

Balance of Equity at End of Year 820,122.07 1,059,602.23

Components of Equity:Fund Balance at End of Prior Year (1,596,501.35) (1,600,918.63)

Fund Balance - designated 216,816.00 241,038.00

Invested in Fixed Assets 2,121,401.60 2,180,002.70741,716.25 820,122.07


Statement of Cash Flow

Cash flows from operating activitiesCash received from licensees 5,130,322.89Cash payments to suppliers for goods and services (1,524,942.67)Cash payments to employees for services (2,653,003.37)

Net cash provided by operating activities 952,376.85

Cash flows from captial and related financing activitiesPurchase of capital assets (218,772.16)

Net cash used by capital and related financing activities (218,772.16)

Cash flows from investing activitiesProceeds from redemption of investment 99,000.00Interest income 63,179.20

Net cash provided (used) by investing activities 162,179.20

Net increase in cash and cash equivalents 895,783.89

Cash and cash equivalents, beginning of period 1,285,718.31

Cash and cash equivalents, end of period 2,181,502.20

Reconciliation of operating income to net cash provided by operating activities

Cash flows from operating activitiesOperating income 77,674.72

Adjustments to reconcile operating income to net cash provided by operating activities

Depreciation 55,621.06Changes in current assets and liabilities

Increase in accounts receivable (7,125.00)Increase in grant receivable (210,667.00)Increase in prepaid expenses (45,679.68)Decrease in deferred outflows related to pensions 254,705.00Increase in deferred outflows related to OPEB (28,653.00)Decrease in accounts payable and PES fee payable (11,229.99)Increase in grant payable 1,035,749.00Increase in salaies and benefits payable 4,381.25Increase in payroll tax liability 739.11Increase in compensated absences 7,419.38Decrease in net pension liability (158,214.00)Decrease in OPEB payable (5,517.00)Decrease in deferred inflows related to pensions (64,684.00)Increase in deferred inflows related to OPEB 47,857.00

Total adjustments 874,702.13

Net cash provided by operating activities 952,376.85


Statement of Revenue, Expenses, and Budget Performance

FY 17-18 FY 18-19 FY 18-19Q4 06/30/2018 Q4 06/30/2019 Budget (A#2) Notes

Licensing FeesPST License Application Fee 179,100.00 170,400.00 180,000.00 1PST License Reciprocity Application Fee 45,750.00 48,750.00 46,000.00 2PST License Renewal Fee 849,150.00 872,200.00 850,000.00 3PNT Registration Application Fee 2,780.00 3,520.00 3,000.00 4PTC Registration Application Fee 35,075.00 27,125.00 35,000.00 5CPT Certificate Application Fee 53,500.00 55,400.00 55,000.00 6CPT Certificate Renewal Fee 339,100.00 340,500.00 340,000.00 7PHY Permit Application & Renewal Fee 282,005.00 280,925.00 285,000.00 8AMS Registration Application & Renewal Fee 22,800.00 21,750.00 23,000.00 9DME Permit Application & Renewal Fee 86,750.00 85,350.00 87,000.00 10EDK Permit Application & Renewal Fee 12,825.00 11,725.00 13,000.00 11CDS License Application & Renewal Fee 508,855.00 531,170.00 510,000.00 12Credential Reinstatement Fee 28,990.00 25,340.00 30,000.00 13Delinquent Renewal Fee for PST & CPT 13,775.00 14,500.00 13,000.00 14Delinquent Renewal Fee for PHY & CDS 12,117.50 11,647.50 12,000.00 15

Sales of Goods & ServicesProduct Charge for Duplicate Credentials 4,175.00 4,350.00 4,000.00 16Product Charge for PST Original Certificate 6,845.00 5,475.00 7,000.00 17Product Charge for PST Silver Certificate 500.00 500.00 500.00 18Product Charge for Law Book & Supplement 510.00 375.00 500.00 19Product Charge for Official List of Licensees 21,000.00 25,650.00 21,000.00 20Product Charge for Document Copies 862.00 272.00 900.00 21Service Charge for Document Certification 5,100.00 4,240.00 5,000.00 22Service Charge for Inspection Services 0.00 6,000.00 3,000.00 23Service Charge for PNT Practical Experience 530.00 350.00 200.00 24Disposal of Assets 0.00 0.00 0.00

Administrative FeesRecovery of Bank Charges for NSF Fees 375.00 200.00 500.00 25Handling & Mailing Fees 339.00 377.00 500.00 26

Enforcement ActivitiesAdministrative Hearing Fee 31,750.00 22,750.00 32,000.00 27Fines 263,750.00 268,250.00 300,000.00 28Cost Recoveries 17,088.97 25,653.33 17,000.00 29

Prescription Monitoring Program (PMP)PMP Assessments 555,830.00 591,220.00 560,000.00 30

GrantsPrivate Grants 0.00 81,200.00 81,000.00 31Government Grants 0.00 1,810,667.00 1,833,900.00 32

Miscellaneous 1,117.13 283.06 1,000.00 33

TOTAL REVENUE 3,382,344.60 5,348,114.89 5,350,000.00 34

Revenue


Statement of Revenue, Expenses, and Budget Performance


OperationsEquipment Rentals 15,668.28 14,974.91 16,000.00 35Equipment Maintenance 2,307.12 2,201.88 3,000.00 36Telephone 16,668.44 18,034.76 17,000.00 37Printing 25,772.54 18,099.33 28,000.00 38Postage 58,078.09 60,055.00 58,000.00 39Dues & Subscriptions 11,670.64 10,671.61 12,000.00 40Financial Service Charges 60,319.77 52,713.75 61,000.00 41Office Meeting Expenses 14,465.48 5,067.38 15,000.00 42Office Supply Expenses 21,530.38 21,956.05 22,000.00 43Utilities 10,885.75 10,422.52 11,000.00 44Civil Service Assessments (DSCS) 6,663.00 7,966.00 8,000.00 45Office Insurance (ORM) 11,546.00 16,980.00 17,000.00 46Depreciation of Fixed Assets 52,453.82 55,621.06 55,000.00 47Acquisitions 3,049.36 5,676.36 20,000.00 48Miscellaneous Expenses 0.00 0.00 0.00Personal ServicesSalaries for Employees 1,517,733.96 1,669,429.89 1,745,000.00 49Wages for Temporary Labor 19,370.31 12,420.31 20,000.00 50Payroll Taxes (FICA & FUTA) 26,139.00 28,503.45 35,000.00 51Health Insurance Premiums (SEGBP) 165,539.60 170,746.80 192,000.00 52Pension Plan Premiums (LASERS) 741,611.92 655,213.95 698,000.00 53Other Post-Employment Benefits (OPEB) 36,806.00 13,687.00 40,000.00 54Board Member Per Diem 31,425.00 29,850.00 32,000.00 55Professional ServicesAccounting & Expense Reimbursement 28,255.00 28,129.50 30,000.00 56Legal & Expense Reimbursement 29,096.39 47,564.60 60,000.00 57Information Systems 115,230.50 119,075.00 130,000.00 58Prescription Monitoring Program 93,700.00 137,915.04 162,000.00 59PMP Statewide Integration Project 0.00 1,810,667.00 1,833,900.00 60Drug Price Transparency Website 0.00 81,200.00 81,000.00 61Property Management 22,520.67 22,091.28 150,000.00 62Staff ExpensesExecutive Director 3,634.28 4,822.99 5,000.00 63General Counsel 9,616.70 9,868.05 10,000.00 64Assistant Executive Director 2,843.74 4,853.17 5,000.00 65Compliance Officer - Travel 3,734.72 6,995.39 6,000.00 66Compliance Officer - Rental Cars 11,141.71 8,991.96 13,000.00 67Compliance Officer - Fuel for Rental Cars 3,891.75 3,328.07 4,000.00 68Compliance Officer - Conference Travel Expenses 8,158.21 2,710.29 12,000.00 69House Staff Travel & Education 0.00 25.00 100.00 70Mileage 23,111.18 28,049.76 24,000.00 71Board ExpensesBoard Meetings 20,156.24 17,492.94 20,000.00 72Committee Meetings 10,590.77 9,520.15 11,000.00 73Conference Travel Expenses 14,865.86 19,782.78 20,000.00 74President's Expenses 2,271.36 7,233.21 8,000.00 75Mileage - Members & President 17,610.97 19,831.98 18,000.00 76TOTAL EXPENSES 3,270,134.51 5,270,440.17 5,708,000.00 77

Expenses


Summary of Income and Fund Balance Changes


Income Statement

Total Revenue 3,382,344.60 5,348,114.89 5,350,000.00 78

Total Expenses 3,270,134.51 5,270,440.17 5,708,000.00 79

Net Ordinary Income 112,210.09 77,674.72 (358,000.00) 80

Other Income & Expenses

Investments (33,804.27) 161,805.44 0.00 81

Net Income 78,405.82 239,480.16 (358,000.00) 82

FY 17-18 FY 18-19 FY 18-19Q4 06/30/2018 Q4 06/30/2019 Budget (A#2)

Fund Balance

Beginning Fund Balance 1,493,402.25 820,122.07 820,122.07

Total Income 3,348,540.33 5,509,920.33 5,350,000.00

Total Expenses 3,270,134.51 5,270,440.17 5,708,000.00

GASB-75 Restatement (751,686.00) 0.00 0.00

Ending Fund Balance 820,122.07 1,059,602.23 462,122.07

Reservations of Fund Balance 1,750,000.00 1,750,000.00 1,750,000.00

Unreserved Fund Balance (929,877.93) (690,397.77) (1,287,877.93)

Notes on Reservation of Fund BalanceUnfunded Pension Liability 1,000,000.00 1,000,000.00 1,000,000.00Unfunded OPEB Liability 500,000.00 500,000.00 600,000.00Compensated Absences 150,000.00 200,000.00 150,000.00Building Renovation & Repair 100,000.00 50,000.00 0.00

Total 1,750,000.00 1,750,000.00 1,750,000.00

Summary


Budget Variance Notes

Notes % Variance

1 PST License Application Fee (5.33) Overestimated by 32 applicants2 PST Reciprocity Application Fee 5.98 Underestimated by 18 applicants3 PST License Renewal Fee 2.61 Underestimated by 222 applicants4 PNT Registration Fee 17.33 Underestimated by 52 applicants5 PTC Registration Fee (22.50) Overestimated by 315 applicants6 CPT Certificate Application Fee 0.73 Underestimated by 2 applicants7 CPT Certificate Renewal Fee 0.15 Underestimated by 10 applicants8 PHY Application & Renewal Fees 0.32 Underestimated activity9 AMS Application & Renewal Fees (0.54) Overestimated by 8 applicants10 DME Application & Renewal Fees (1.90) Overestimated growth and renewals11 EDK Application & Renewal Fees (9.81) Overestimated by 51 permits12 CDS Application & Renewal Fees 4.15 Underestimated growth and renewals13 Credential Reinstatement Fee (15.53) Overestimated by 23 applicants14 Delinquent Renewal (people) 11.54 Underestimated number of delinquent renewals15 Delinquent Renewal (places) (2.94) Overestimated number of delinquent renewals16 Duplicate credentials 8.75 Underestimated demand17 PST Original Certificate (21.79) Overestimated demand by 20 requests18 PST Silver Certificate 0.00 Lucky guess19 Law Books & Supplements (25.00) Overestimated demand 20 Official Lists of Licensees 222.14 Underestimated demand by 31 requests21 Document Copies (69.78) Overestimated demand22 Document Certification (15.20) Overestimated demand23 Inspection Services 100.00 Timing issue; payment for 2 years in same fiscal year24 PNT Experience Certifications 75.00 Underestimated demand by 15 requests25 NSF Fee Recoveries (60.00) Overestimated incidence of NSF checks26 Handling & Mailing Fees (24.60) Overestimated demand27 Administrative Hearing Fees (28.91) Overestimated caseload by 37 cases28 Fines (10.58) Overestimated assessments29 Cost Recoveries 50.90 Underestimated cost recoveries30 PMP Assessments 5.58 Underestimated growth and renewals of CDS licenses31 Private Grants 0.25 Close estimate32 Government Grants (1.27) Timing issue for LDH; balance rec'd July 201933 Miscellaneous (71.69) Overestimated minor revenue34 Total Revenue (0.04) Overestimated total revenue

Account Name Comment

Revenue


Budget Variance Notes

Notes % Variance

35 Equipment Rentals (6.41) Reduction in use of color printing36 Equipment Maintenance (26.60) Overestimated need37 Telephone 6.09 Underetimated utilization38 Printing (35.36) Deferred some year-end projects39 Postage 3.54 Underestimated demand40 Dues & Subscriptions (11.07) Re-evaluated need for certain subscriptions41 Financial Service Charges (13.58) Overestimated use of online renewals42 Office Meeting Expenses (66.22) Overestimated use of meeting security43 Office Supply Expenses (0.19) Close estimate44 Utilities (5.25) Overestimated use45 Civil Service Assessments (DSCS) (0.43) Premium set by state46 Office Insurance (ORM) (0.12) Premium set by state47 Depreciation of Fixed Assets 1.13 Underestimated amount of depreciation48 Acquisitions (71.62) Deliberate deferrals49 Salaries for Employees (4.33) Personnel turnover contributed to lower salary expense50 Wages for Temporary Labor (37.90) Overestimated need for student labor51 Payroll Taxes (FICA & FUTA) (18.56) Overestimate related to turnover and less students52 Health Insurance (SEGBP) (11.07) Premiums at 10.28% of salary expense53 Pension Plan (LASERS) (6.13) Premium set by state; includes inflows + outflows54 OPEB (65.78) Premium set by state55 Board Member Per Diem (6.72) Overestimated meeting activity56 Accounting Services (6.24) Overestimated cost of services57 Legal Services (20.73) Overestimated cost of services58 Information Systems (8.40) Overestimated need for special support services59 Prescription Monitoring Program (14.87) New features on phased implementation60 PMP Statewide Integration Project (1.27) Timing issue with LDH; balance paid in July61 Drug Price Transparency Website 0.25 Budget was not precise.62 Property Management (85.28) Renovation-related expenses recorded on balance sheet63 Staff - Executive Director (3.54) Overestimated cost of meeting travel64 Staff - General Counsel (1.32) Overestimated cost of meeting travel65 Staff - Asst. Exec. Director (2.94) Overestimated cost of meeting travel66 C.O. - Travel 16.59 Underestimated cost of field travel67 C.O. - Rental Cars (30.83) Overestimated need68 C.O. - Fuel for Rental Cars (16.80) Overestimated cost 69 C.O. - Conference Travel (77.41) Limited to USP 795/797/800 training70 House Staff - Travel & Education (75.00) Limited to CBC-related travel71 Mileage - entire staff 16.87 Underestimated mileage for staff72 Board - Meeting Expenses (12.54) Overestimated meeting travel needs73 Board - Committee Expenses (13.45) Overestimated committee meeting activity74 Board - Conference Travel (1.09) Overestimated conference meeting activity75 Board - President's Expenses (9.58) Overestimated meeting travel76 Mileage - Board & President 10.18 Underestimated mileage for members77 Total Expenses (7.67) Overestimated total expenses

78 Total Revenue 58.2% increase over FY 18, but only 3.95% over w/o federal grant79 Total Expenses 61.2% increase over FY 18; but only 5.79% over w/o federal grant80 Net Ordinary Income 30.78% decrease from FY 1881 Investments Significant difference from FY 18; 39% from proceeds; rest is FMV82 Net Income 205% increase over FY 18

Expenses

Summary

Account Name Comment


Summary of Board Actions

Date Action

11/14/2017 Original Budget - Finance Committee Approval

11/15/2017 Original Budget - Board Approval

8/14/2018 Budget Amendment #1 - Finance Committee Approval

8/15/2018 Budget Amendment #1 - Board Approval

11/13/2018 Budget Amendment #2 - Finance Committee Approval

11/14/2018 Budget Amendment #2 - Board Approval

Acceptance of Final Report

Investment Account ~ Portfolio Snapshots

Reserve Account

OPEB Account

Pension Account

Louisiana Board of Pharmacy

Cumulative Fund Balance Reports

FY 98-99 FY 99-00 FY 00-01 FY 01-02 FY 02-03 FY 03-04 FY 04-05 FY 05-06 FY 06-07 FY 07-08Actual Actual Actual Actual Actual Actual Actual Actual Actual Actual

Beginning Fund Balance 910,394 1,127,239 1,267,076 1,351,191 1,521,807 1,588,141 1,478,412 1,587,349 1,677,669 2,077,236

Total Income 984,414 1,030,423 1,168,798 1,200,575 1,223,872 1,274,804 1,524,411 1,627,306 2,228,918 2,657,168

Total Expenses 767,569 890,586 1,084,683 1,029,959 1,170,252 1,384,533 1,415,474 1,536,986 1,829,351 2,184,076

Ending Fund Balance 1,127,239 1,267,076 1,351,191 1,521,807 1,588,141 1,478,412 1,587,349 1,677,669 2,077,236 2,550,328

Reservations of Fund Balance 48,884 102,368 476,000 524,000 1,210,000 1,245,000 1,300,000 1,300,000 1,400,000 2,050,000

Unreserved Fund Balance 1,078,355 1,164,708 763,515 997,807 378,141 233,412 287,349 377,669 677,236 500,328


Beginning Fund Balance 2,550,328 2,607,575 2,715,185 2,810,463 2,936,874 3,225,350 (620,086) 363,796 1,293,857.73 1,493,402.25

Total Income 2,570,282 2,706,829 2,808,468 2,775,418 2,849,249 3,059,394 3,615,033 3,512,690 3,191,751.77 3,348,540.33

Total Expenses 2,513,035 2,599,219 2,713,190 2,649,007 2,560,773 2,764,020 2,631,151 2,582,629 2,992,207.25 3,270,134.51

GASB Restatements (4,140,810) (751,686.00)(GASB-68) (GASB-75)

Ending Fund Balance 2,607,575 2,715,185 2,810,463 2,936,874 3,225,350 (620,086) 363,796 1,293,857 1,493,402.25 820,122.07

Reservations of Fund Balance 1,900,000 1,650,000 1,650,000 500,000 750,000 2,162,000 1,272,000 772,000 1,750,000.00 1,750,000.00

Unreserved Fund Balance 707,575 1,065,185 1,160,463 2,436,874 2,475,350 (2,782,086) (908,204) 521,857 (256,597.75) (929,877.93)


Cumulative Fund Balance Reports


Beginning Fund Balance 820,122.07 1,059,602.23

Total Income 5,509,920.33

Total Expenses 5,270,440.17

GASB Restatements

Ending Fund Balance 1,059,602.23

Reservations of Fund Balance 1,750,000.00

Unreserved Fund Balance (690,397.77)


Beginning Fund Balance

Total Income

Total Expenses

GASB Restatements

Ending Fund Balance

Reservations of Fund Balance

Unreserved Fund Balance



Finance Committee

Proposed Budget Amendment No. 1 Fiscal Year 2019-2020

August 14, 2019

Blake P. Pitre Chair


Louisiana Board of PharmacyFY 2019-2020 Budget Amendment #1

FY 18-19 FY 19-20 FY 19-20Actual Original BA-1 Notes

Licensing FeesPST License Application Fee 170,400.00 180,000.00 170,000.00 1PST License Reciprocity Application Fee 48,750.00 46,000.00 49,000.00 2PST License Renewal Fee 872,200.00 850,000.00 872,000.00 3PNT Registration Application Fee 3,520.00 3,000.00 3,500.00 4PTC Registration Application Fee 27,125.00 35,000.00 28,000.00 5CPT Certificate Application Fee 55,400.00 55,000.00 55,000.00CPT Certificate Renewal Fee 340,500.00 340,000.00 340,000.00PHY Permit Application & Renewal Fee 280,925.00 285,000.00 281,000.00 6AMS Registration Application & Renewal Fee 21,750.00 23,000.00 23,000.00DME Permit Application & Renewal Fee 85,350.00 87,000.00 87,000.00EDK Permit Application & Renewal Fee 11,725.00 13,000.00 13,000.00CDS License Application & Renewal Fee 531,170.00 510,000.00 532,000.00 7Credential Reinstatement Fee 25,340.00 30,000.00 26,000.00 8Delinquent Renewal Fee (people) 14,500.00 14,000.00 14,000.00Delinquent Renewal Fee (places) 11,647.50 12,000.00 12,000.00

Sales of Goods & ServicesProduct Charge for Duplicate Credentials 4,350.00 4,000.00 4,500.00 9Product Charge for PST Original Certificate 5,475.00 7,000.00 6,000.00 10Product Charge for PST Silver Certificate 500.00 500.00 500.00Product Charge for Law Book & Supplement 375.00 500.00 500.00Product Charge for Official List of Licensees 25,650.00 21,000.00 26,000.00 11Product Charge for Document Copies 272.00 500.00 500.00Service Charge for Document Certification 4,240.00 5,000.00 5,000.00Service Charge for Inspection Services 6,000.00 3,000.00 3,000.00Service Charge for PNT Practical Experience 350.00 500.00 500.00Disposal of Assets 0.00 0.00 0.00

Administrative FeesAdministrative Fee for NSF Items 200.00 500.00 500.00Administrative Fee for Handling & Mailing 377.00 500.00 500.00

Enforcement ActivitiesEnforcement: Administrative Hearing Fee 22,750.00 32,000.00 23,000.00 12Enforcement: Fines 268,250.00 300,000.00 265,000.00 13Enforcement: Cost Recoveries 25,653.33 18,000.00 25,000.00 14

Prescription Monitoring Program (PMP)Assessments 591,220.00 560,000.00 591,000.00 15

GrantsPrivate Grants 81,200.00 41,000.00 42,000.00 16Government Grants 1,810,667.00 0.00 0.00

Miscellaneous 283.06 1,000.00 1,000.00

TOTAL REVENUE 5,348,114.89 3,478,000.00 3,500,000.00 17

Revenue


FY 18-19 FY 19-20 FY 19-20Actual Original BA-1 Notes

OperationsEquipment Rentals 14,974.91 16,000.00 15,000.00 18Equipment Maintenance 2,201.88 2,500.00 2,200.00 19Telephone 18,034.76 16,500.00 29,000.00 20Printing 18,099.33 16,000.00 17,000.00 21Postage 60,055.00 58,000.00 60,000.00 22Dues & Subscriptions 10,671.61 12,000.00 12,000.00Financial Service Charges 52,713.75 60,000.00 53,000.00 23Office Meeting Expenses 5,067.38 14,500.00 5,000.00 24Office Supply Expenses 21,956.05 21,500.00 22,000.00 25Utilities 10,422.52 11,000.00 11,000.00Civil Service Assessment (DSCS) 7,966.00 8,000.00 8,400.00 26Office Insurance (ORM) 16,980.00 17,000.00 22,000.00 27Depreciation of Fixed Assets 55,621.06 52,500.00 55,000.00 28Acquisitions 5,676.36 20,000.00 100,000.00 29Miscellaneous 0.00 0.00 0.00

Personal ServicesSalaries for employees 1,669,429.89 1,789,000.00 1,789,000.00Wages for temporary labor 12,420.31 20,000.00 20,000.00Payroll Taxes (FICA + FUTA) 28,503.45 36,000.00 36,000.00Health Insurance Premiums (SEGBP) 170,746.80 197,000.00 197,000.00Pension Plan Premiums (LASERS) 655,213.95 716,000.00 727,000.00 30Other Post Employment Benefits (OPEB) 13,687.00 37,000.00 15,000.00 31Board Member Per Diem 29,850.00 32,000.00 30,000.00 32

Professional ServicesAccounting & Expense Reimbursement 28,129.50 30,000.00 30,000.00Legal & Expense Reimbursement 47,564.60 50,000.00 50,000.00Information Systems 119,075.00 135,000.00 154,000.00 33Prescription Monitoring Program 137,915.04 208,000.00 208,000.00Drug Price Transparency Website 81,200.00 42,000.00 42,000.00Statewide Integration PMP Gateway 1,810,667.00 0.00 0.00Property Management 22,091.28 30,000.00 30,000.00

Staff ExpensesExecutive Director 4,822.99 5,000.00 5,000.00Assistant Executive Director 4,853.17 5,000.00 5,000.00General Counsel 9,868.05 10,000.00 10,000.00Compliance Officer - Travel 6,995.39 6,000.00 7,000.00 34Compliance Officer - Rental Cars 8,991.96 13,000.00 9,000.00 35Compliance Officer - Fuel for Rental Cars 3,328.07 4,000.00 4,000.00Compliance Officer - Conference Travel 2,710.29 14,000.00 14,000.00House Staff Education & Travel 25.00 500.00 400.00 36Mileage - entire staff 28,049.76 24,000.00 30,000.00 37

Board ExpensesBoard Meeting Expenses 17,492.94 20,000.00 18,000.00 38Committee Expenses 9,520.15 11,000.00 10,000.00 39Conference Travel Expenses 19,782.78 20,000.00 20,000.00President's Expenses 7,233.21 8,000.00 8,000.00Mileage - Members & President 19,831.98 18,000.00 20,000.00 40

TOTAL EXPENSES 5,270,440.17 3,806,000.00 3,900,000.00 41

Expenses


FY 18-19 FY 19-20 FY 19-20Q4 06/30/2019 Original BA-1 Notes

Total Revenue 5,348,114.89 3,478,000.00 3,500,000.00 42

Total Expenses 5,270,440.17 3,806,000.00 3,900,000.00 43

Net Ordinary Income 77,674.72 (328,000.00) (400,000.00) 44

Other Income & Expenses

Investments 161,805.44 0.00 0.00

Net Income 239,480.16 (328,000.00) (400,000.00)

FY 18-19 FY 19-20 FY 19-20Q4 06/30/2019 Original BA-1

Beginning Fund Balance 820,122.07 469,074.10 1,059,602.23

Total Income 5,509,920.33 3,478,000.00 3,500,000.00

Total Expenses 5,270,440.17 3,806,000.00 3,900,000.00

State-Imposed Adjustments 0.00 0.00 0.00

Ending Fund Balance 1,059,602.23 141,074.10 659,602.23

Reservations of Fund Balance 1,750,000.00 1,750,000.00 1,750,000.00

Unreserved Fund Balance (690,397.77) (1,608,925.90) (1,090,397.77)

Unfunded Pension Liability 1,000,000.00 1,000,000.00 1,000,000.00Unfunded OPEB Liability 500,000.00 600,000.00 600,000.00Compensated Absences 200,000.00 150,000.00 150,000.00Building Renovation & Repair 50,000.00 0.00 0.00

Total 1,750,000.00 1,750,000.00 1,750,000.00

Summary of Fund Balance


Revenue1 Using historical data, estimate 567 applicants @ $300 each2 Using historical data, estimate 327 reciprocity applicants @ $159 each3 Using historical data, estimate 8,720 pharmacist renewals @ $100 each4 Using historical data, estimate 350 intern applicants @ $10 each5 Using historical data, estimate 1,120 candidate applicants @ $25 each6 Using historical data for pharmacy permits and renewals7 Using historical data for CDS licenses and renewals8 Using historical data for credential reinstatement fees9 Using historical data for sales of duplicate credentials10 Using historical data for sales of pharmacist certificates, 80 @ $75 each11 Using historical data for sales of official lists, 173 @ $150 each12 Using historical data, estimate 92 cases with administrative hearing fees of $250 each13 Using historical data, estimate for fines approximates 7.5% of total anticipated revenue14 Using historical data for recovery of investigative costs.15 Using historical data for PMP assessments, 23,640 @ $25 each16 After initial implementation cost, annual grant should approximate $42,00017 Revised estimate for total revenue reflects 0.6% increase from original budget

Expenses18 Using historical data for equipment rental charges.19 Using historical data for equipment maintenance and repairs20 Using historical data for telephone charges + $14,000 for replacement system21 Using historical data for office printing expenses22 Using historical data for postage expenses23 Using historical data for financial service charges due to online credit card fees24 Using historical data for office meeting expenses include meeting security charges25 Using historical data for office supply expenses26 State increased the premium for State Civil Service participation fees27 State increased the premium for office insurance28 Using historical data for depreciation of fixed assets29 Includes $100,00 for computer replacements due to withdrawal of support for Windows 730 State increased the premium for LASERS; now at 40.7% of salaries31 Using historical data for OPEB estimate32 Using historical data for board member per diem payments33 Includes increase in eLicense maintenance + Metrc product ID module agreement34 Using historical data for compliance officer field travel expenses35 Using historical data for rental car expenses for compliance officers36 Lower estimate for house staff travel expenses37 Using historical data for increased staff mileage expenses38 Using historical data for board meeting expenses39 Using historical data for board committee meeting expenses40 Using historical data for board member mileage expenses41 Revised estimate for total expenses reflects 2.5% increase from original budget

Summary42 Revised estimate reflects 1.1% decrease from FY 19 adjusted by omission of grant43 Revised estimate reflects 12.7% increase from FY adjusted by omission of grant44 Revised estimate reflects 22% increase from original projected deficit

Notes



Application Review Committee




Reciprocity Committee


New Pharmacist Credentials Issued by ReciprocityIssued Since 05/13/2019

Applicant Interviewer Result1 Tawanna Nicole Matthews (MS) Waived PST.022960 issued 05/16/192 Jennifer Michelle-Skinner Chesser (MI) Waived PST.022962 issued 05/16/193 James Matthew Curtis (AR) Waived PST.022963 issued 05/16/194 Lawrence DeMaio (FL) Waived PST.022964 issued 05/16/195 Ryan Kelso Taylor (NJ) Waived PST.022965 issued 05/16/196 Andrew Thienvan Fitzgerald (TX) Waived PST.022968 issued 05/16/197 Mikki Leigh Kline (TX) Waived PST.022969 issued 05/16/198 Kyle Lynddell Coleman (KS) Waived PST.022970 issued 05/16/199 Raya Alice Marie Elizabeth Manship (AZ) Waived PST.022971 issued 05/16/1910 Megan McKenzie Malley (MS) Waived PST.022972 issued 05/16/1911 Joseph Chi Trung Phan (GA) Waived PST.022973 issued 05/16/1912 Ahmad Zaiter (FL) Waived PST.022974 issued 05/16/1913 Clay Douglas Pehrson (AZ) Waived PST.022975 issued 05/16/1914 Rafael Angel Diaz (FL) Waived PST.022976 issued 05/16/1915 Alisa Brown Chamblee (VA) Waived PST.022978 issued 05/16/1916 Anna Marie Baldwin (MS) Waived PST.022979 issued 05/16/1917 Timothy Kyle Riordan (TX) Waived PST.022980 issued 05/16/1918 Alisha Nicole Chamberlain (IN) Waived PST.022982 issued 05/22/1919 Roy Michael Napoli (TX) Waived PST.022983 issued 05/31/1920 Holly Elaine Vandermey (TX) Waived PST.022984 issued 05/31/1921 Paul Anthony Koerner (KS) Waived PST.022985 issued 05/31/1922 Angela Sue Northrop (OH) Waived PST.022986 issued 05/31/1923 Kayla Ann Petty (IN) Waived PST.022987 issued 05/31/1924 William A Bartkowiak (IL) Waived PST.022988 issued 05/31/1925 Douglas Allen Gebhard (PA) Waived PST.022989 issued 05/31/1926 Michael David Green (IO) Waived PST.022992 issued 05/31/1927 Jeffrey Wayne Brooks Jr. (FL) Waived PST.022994 issued 06/10/1928 Lindsey Mae Fovel (NY) Waived PST.022995 issued 06/10/1929 Kayla Shea Douglas (MS) Waived PST.022996 issued 06/17/1930 Diana Sue Tow (TX) Waived PST.022997 issued 06/18/1931 Emily Ann Jensen (IO) Waived PST.022998 issued 06/18/1932 Michelle Nguyen (WA) Waived PST.022999 issued 06/19/1933 Chawn Harris Simon (MS) Waived PST.023000 issued 06/20/1934 Christy Kyounghye Min (VA) Waived PST.023001-M issued 06/20/1935 Roy Christopher Putrino (NY) Waived PST.023002 issued 06/20/1936 Raj Naran Patel (IL) Waived PST.023003 issued 06/20/1937 Dominique Danele Smith (NC) Waived PST.023004 issued 06/20/1938 Manid Lee Pokorney (MO) Waived PST.023005 issued 06/20/1939 Elizabeth Ann Murphy (NY) Waived PST.023007 issued 06/20/1940 Taylor Bret Allen (AZ) Waived PST.023008 issued 06/20/1941 Jordan Rae Burt (FL) Waived PST.023009 issued 06/20/1942 Holly Christine Winn (CA) Waived PST.023010-M issued 06/25/1943 Gregory Joseph France (OH) Waived PST.023011 issued 06/26/1944 Marc Adrian Breneman (MO) Waived PST.023013 issued 06/26/1945 Julie Rebecca Mandel (PA) Waived PST.023016 issued 06/26/1946 Rashmi Shingari (NC) Waived PST.023018 issued 06/26/1947 Rodel Christian Garcia Raymundo (FL) Waived PST.023019 issued 06/26/1948 Tyler Edward Dinkelaker (MO) Waived PST.023020 issued 06/26/1949 Katrina Anne Lancaster (MO) Waived PST.023022 issued 06/26/1950 Dhrumilkumar D. Patel (MS) Waived PST.023026 issued 06/26/1951 Brandon Lee Salke (MO) Waived PST.023027 issued 06/28/1952 Hiba Zuhiar Cheetany (IL) Waived PST.023028 issued 06/28/1953 Graham Benjamin Brown (TX) Waived PST.023031 issued 06/28/1954 Jordan Bowers Cuccia (AL) Waived PST.023036 issued 07/03/1955 Michael George Castellon (FL) Waived PST.023044 issued 07/03/1956 Russell Frederick Whitford (TX) Waived PST.023048 issued 07/11/1957 Timothy James Davis (PA) Waived PST.023049 issued 07/11/1958 Jill Renee Meyer (AL) Waived PST.023060 issued 07/22/1959 Zachary Tyler Tackett (NC) Waived PST.023078 issued 07/23/1960 Desire Ebot Eyong (TX) Waived PST.023079 issued 07/23/1961 James Patrick Demarest (CO) Waived PST.023080 issued 07/23/1962 Jeffrey Scott Lang (NV) Waived PST.023085 issued 07/23/1963 Leanna Elizabeth Barker (AL) Waived PST.023086 issued 07/23/1964 Sarah Allison Jackson (ID) Waived PST.023087 issued 07/23/1965 Parth Kamalnayan Parikh (VA) Waived PST.023088 issued 07/23/1966 Theresa Ann Jacques (FL) Waived PST.023092 issued 07/24/1967 Kristina Babakhanova (NY) Waived PST.023095 issued 07/30/1968 Nathan Allen Hunnell (PA) Waived PST.023097 issued 07/30/1969 Cory Alan Swymer (GA) Waived PST.023100 issued 07/31/1970 Alexandra Blake Ferrante (KY) Waived PST.023108 issued 07/31/1971 Rachel Ann Wiechert (MO) Waived PST.023109 issued 07/31/1972 Alaina Ann Dekerlegand (FL) Waived PST.023111 issued 07/31/19

Total: 72



Violations Committee


Louisiana Board of Pharmacy Policies & Procedures 1 2 Title: Violations Committee – CE Audits/Cases Policy No. I.C.7.c 3 4 Approved: 02-15-2006 Revised: 08-15-2018 5 6

7 1. The statutory authority for continuing education (CE) is RS 37:1210. 8 9 2. The regulatory authority for CE is LAC 46:LIII.507 and 909. 10 11 3. The Board staff will measure compliance with CE requirements by auditing 12

CE records maintained at CPE Monitor. 13 14 4. In an effort to provide guidance to staff as they address situations where they 15

discover noncompliance with relevant CE regulations, the following courses of 16 action shall be followed: 17

18 A. The following charges shall be considered and entered as appropriate: 19

1. R.S. 37:1241(A)(1) – Has practiced or assisted in the practice of 20 pharmacy, or knowingly permitted or has permitted anyone in his employ 21 or under his supervision to practice or assist in the practice of pharmacy, 22 in violation of the provisions of this Chapter and any rules and regulations 23 promulgated thereto in accordance with the Administrative Procedure Act. 24 [This charge shall be applicable to all cases] 25

2. R.S. 37:1241(A)(2) – Attempted to or obtained a license, registration, 26 certificate, permit or any other designation deemed necessary to engage 27 in the practice of pharmacy by fraud or misrepresentation. 28 [This charge shall be applicable when the licensee certified their 29 compliance with CE rules on their renewal application and the subsequent 30 audit revealed they did not comply with CE rules; it shall also be 31 applicable when the licensee falsifies CE transcripts or other documents.] 32

3. R.S. 37:1241(A)(7) – Has failed to report to the board any adverse action 33 taken by another licensing jurisdiction, government agency, law 34 enforcement agency, or court for conduct that would constitute grounds for 35 action as defined in this Section. 36 [This charge shall be applicable when a licensee credentialed in another 37 jurisdiction is disciplined for violation of CE rules in that jurisdiction and 38 then fails to disclose that disciplinary action on their subsequent 39 application for the renewal of their Louisiana license.] 40

4. R.S. 37:1241(A)(22) – Has failed to furnish to the board, its investigators, 41 or representatives any information legally requested by the board. 42 [This charge shall be applicable when a licensee fails to respond 43 appropriately to a board representative in connection with a CE audit.] 44

5. LAC 46:LIII.507.C – A minimum of 1.5 ACPE or board-approved CPE 45 units, or 15 hours, shall be required each year as a prerequisite for 46 pharmacist license renewal. Of this number, no less than 0.3 ACPE or 47 board-approved CPE units, or three hours, shall be acquired through live 48 presentations, as designated by ACPE or the board. Alternatively, should 49

DRAFT

a pharmacist choose to not acquire at least 0.3 ACPE or board-approved 50 CPE units, or three hours, through live presentations, then he shall 51 acquire an additional 0.5 ACPE or board-approved CPE units, or five 52 hours, through any other acceptable method, over and above the 53 minimum requirement, for a total of two ACPE or board-approved CPE 54 units, or 20 hours. 55 [This charge shall be applicable when a pharmacist fails to comply with 56 the CE requirements.] 57

6. LAC 46:LIII.909.A – A minimum of one technician-specific ACPE or 58 board-approved CPE unit, or 10 credit hours, shall be required each year 59 as a prerequisite for annual renewal of a pharmacy technician certificate. 60 Such CPE units shall be credited in the 12-month period prior to the 61 expiration date of the certificate. 62 [This charge shall be applicable when a technician fails to comply with the 63 CE requirements.] 64 65

B. Staff shall prepare a proposed voluntary consent agreement for consideration 66 by the licensee. 67 1. The proposed voluntary consent agreement shall identify the appropriate 68

charges based upon the facts of the case. 69 2. The proposed voluntary consent agreement shall propose the following 70

sanctions: 71 a. For the violation of R.S. 37:1241(A)(2), a Letter of Reprimand, which 72

shall be published in the Board’s newsletter. 73 b. For the violation of R.S. 37:1241(A)(7), a Letter of Reprimand, which 74

shall be published in the Board’s newsletter. 75 c. For the violation of R.S. 37:1241(A)(22), a Letter of Warning. 76 d. For the violation of LAC 46:LIII.507.C, a Letter of Reprimand, which 77

shall be published in the Board’s newsletter. 78 e. For the violation of LAC 46:LIII.909.A, a Letter of Reprimand, which 79

shall be published in the Board’s newsletter. 80 f. Where there are multiple citations, a single sanction shall apply, and 81

the more severe option identified above shall apply. 82 3. The proposed voluntary consent agreement shall propose the following 83

assessments: 84 a. A single administrative hearing fee of $250 shall be assessed on all 85

proposed voluntary consent agreements. 86 b. Staff shall calculate and enter an amount sufficient to recover the cost 87

of staff investigation. 88 c. For the violation of R.S. 37:1241(A)(2), a fine in the range of $250 – 89

$1,000 for pharmacists and $100 - $250 for technicians. 90 d. For the violation of R.S. 37:1241(A)(7), a fine in the range of $250 – 91

$1,000 for pharmacists and $100 - $250 for technicians. 92 e. For the violation of R.S. 37:1241(A)(22), a fine in the range of $250 – 93

$750 for pharmacists and $100 - $250 for technicians. 94 f. For the violation of LAC 46:LIII.507.C, a fine based on the number of 95

credit hours in deficit: 96 i. $250 for 0 – 5 hours; and 97 ii. $50 for each credit hour more than 5. 98

DRAFT

g. For the violation of LAC 46:LIII.909.A, a fine based on the number of 99 credit hours in deficit: 100 i. $50 for 0 – 5 hours; and 101 ii. $25 for each credit hour more than 5. 102

4. When the CE audit identifies a deficiency in the number of CPE units or 103 credit hours, the proposed voluntary consent agreement shall instruct the 104 licensee to remedy the deficiency by: 105 a. acquiring that number of CPE units or credit hours prior to the 106

expiration date of the current renewal; and 107 b. transmitting a copy of the CPE Monitor transcript to the board office as 108

evidence of compliance with that instruction 109 Staff shall instruct the licensee the CE acquired for the remediation shall 110 not be applicable for the CE requirement for the next renewal. 111

5. When the licensee has been the subject of previous disciplinary action by 112 the board for violation of the CE rules, staff shall not propose a voluntary 113 consent agreement, and shall refer the case to the Violations Committee. 114

115 C. Staff shall transmit the proposed voluntary consent agreement to the licensee 116

for his consideration, and shall identify a deadline for the licensee to respond 117 to the proposal. 118 1. In the event the licensee elects to accept the proposed voluntary consent 119

agreement, staff shall present the proposal to the board for its 120 consideration and approval. 121

2. In the event the licensee elects to not accept the proposed voluntary 122 consent agreement, staff shall schedule the case for a preliminary hearing 123 by the Violations Committee. 124

125 B. For an initial violation of the above provisions, staff shall issue the 126

Respondent a Letter of Noncompliance. 127 1. The Letter of Noncompliance shall identify the appropriate allegations 128

based upon the facts of the case. However, the Letter of Noncompliance 129 shall not be considered disciplinary action by the Board. 130

2. When the CE audit identifies a deficiency in the number of CPE units or 131 credit hours, the proposed Letter of Noncompliance shall instruct the 132 licensee to remedy the deficiency by: 133 a. Acquiring that number of CPE units or credit hours; and 134 b. Transmitting a copy of the CPE Monitor transcript to the Board office 135

as evidence of compliance with that instruction; and further, 136 c. Staff shall instruct the licensee the CE acquired for the remediation 137

shall not be applicable for the CE requirement for the next renewal. 138 139

C. For a second violation of the above provisions, staff shall prepare a proposed 140 voluntary consent agreement for consideration by the licensee. 141 1. The proposed voluntary consent agreement shall identify the appropriate 142

charges based upon the facts of the case. 143 2. The proposed voluntary consent agreement shall propose a Letter of 144

Reprimand, which shall be published in the Board’s newsletter. The Letter 145 of Reprimand shall be considered a disciplinary action. 146

DRAFT

3. The proposed voluntary consent agreement shall propose the following 147 assessments: 148 a. A fine of $500 for pharmacists and $100 for technicians. 149 b. A single administrative hearing fee of $250 shall be assessed on all 150

proposed voluntary consent agreements. 151 c. Staff shall calculate and assess an amount sufficient to recover the 152

cost of staff investigation and preparation. 153 4. When the CE audit identifies a deficiency in the number of CPE units or 154

credit hours, the proposed voluntary consent agreement shall instruct the 155 licensee to remedy the deficiency by: 156 a. Acquiring that number of CPE units or credit hours prior to the 157

expiration date of the current renewal; and 158 b. Transmitting a copy of the CPE Monitor transcript to the Board office 159

as evidence of compliance with that instruction; and further, 160 c. Staff shall instruct the licensee the CE acquired for the remediation 161

shall not be applicable for the CE requirement for the next renewal. 162 5. Staff shall transmit the proposed voluntary consent agreement to the 163

licensee for his consideration, and shall identify a deadline for the licensee 164 to respond to the proposal. 165 a. In the event the licensee elects to accept the proposed voluntary 166

consent agreement, staff shall present the proposal to the Board for its 167 consideration and approval. 168

b. In the event the licensee elects to not accept the proposed voluntary 169 consent agreement, staff shall schedule the case for an informal 170 conference before the Violations Committee. 171

172 D. When the licensee has been the subject of previous disciplinary action by the 173

Board for violation of the CE rules, staff shall not propose a voluntary consent 174 agreement, and shall refer the case to the Violations Committee. 175

176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193

194 195

DRAFT

Revision History 196 197 08-14-2019 Re-structured policy to provide for a non-disciplinary Letter of 198

Noncompliance for the first offense, and then the proposed consent 199 agreement for the second offense. Re-structured the disciplinary 200 action within the consent agreement to be a Letter of Reprimand 201 regardless of the nature of the specific violation. Re-structured the 202 fine to be a $500 fine for pharmacists and $100 for technicians. 203

204 08-15-2018 Re-numbered policy. 205 206 05-23-2018 Made the following revisions to the original policy: 207

Amended Paragraph 3 to insert CPE Monitor. 208 Replaced Paragraph 4. 209

DRAFT



Impairment Committee




Reinstatement Committee




Tripartite Committee




Regulation Revision Committee


Department of Health Board of Pharmacy

Notice of Public Hearing

In compliance with the Administrative Procedure Act, more specifically R.S. 49:953(C)(2)(a) as adopted by Act 454 of the 2018 Regular Legislative Session, the Louisiana Board of Pharmacy hereby gives notice of a public hearing to receive comments and testimony concerning the entirety of its rules [LAC 46:LIII.Chapters 1 through 33] as to whether any of them may be contrary to law, outdated, unnecessary, overly complex, or burdensome.

A public hearing on these rules is scheduled for 9:00 am on Wednesday, June 26, 2019 at the Board office, which is located at 3388 Brentwood Drive in Baton Rouge, Louisiana 70809-1700. To request reasonable accommodations for persons with disabilities, please call the Board office at 225.925.6496. During the hearing, all interested persons will be afforded an opportunity to submit data, views, or arguments, either orally or in writing. The deadline for the receipt of all comments is 12:00 noon that same day.

Interested persons may submit written comments, via United States Postal Service or other mail carrier, or in the alternative, by personal delivery to Malcolm J Broussard, Executive Director, at the Board office. While the Board will consider and respond to verbal testimony, only written comments will be included in the Board’s report to the Joint Legislative Oversight Committee on Health and Welfare.



NOTICE IS HEREBY GIVEN that a Public Hearing has been ordered and called for 9:00 a.m. on Wednesday, June 26, 2019 at the Board office, for the purpose to wit:

A G E N D A Revised 05-10-2019

1. Call to Order 2. Appearances 3. Solicitation of comments re Board’s rules [LAC 46:LIII.101 through 3301]

4. Opportunity for Public Comment 5. Adjourn




Summary of Testimony & Public Comments re

Regulatory Project 454-2019 ~ Comprehensive Rule Review at

June 26, 2019 Public Hearing 1. Testimony from C. Bevan Callicott, on behalf of himself Asked how often Act 454 public hearings would be scheduled. Offered no comments or suggestions regarding rule changes. 2. Testimony from Katie Nguyen, on behalf of herself Requested the Board to consider mandatory lunch breaks for pharmacists practicing in pharmacies. Offered no comments or suggestions regarding other rules. 3. June 26, 2019 letter from Mary Staples, on behalf of National Association of Chain Drug Stores (NACDS) Request the Board to consider amendments to the following sections of rules:

• §511, to remove the requirement to notify the Board of employment changes; • §521.B, to eliminate the separate authority to administer document, allowing the

prescription for the medication to indicate that authority, for the life of the prescription; • §709.B, to eliminate the ratios for pharmacy interns; • §901, to amend the definition of a training program to allow the Board to approve

programs that are not nationally-accredited; • §903.A.2.c.i, to change the proof of enrollment to either nationally-accredited or board-

approved, and not to limit programs to being both; • §903.A.3.f, to remove the requirement to notify the Board of employment changes; • §903.B.2, to eliminate the requirement for a training program to notify the Board when

students separate from the training program; • §903.D.1, to remove the board approval of technician examinations and specify the

requirement for accreditation by NCCA (National Commission for Certifying Agencies); • §903.D.2, to remove the time delays on re-examination; • §905.A.3.a, to amend the eligibility for a technician certificate to allow national

accreditation or board approval of training program; • §905.A.3.b, to reduce the experiential requirement from 600 hours to 320 hours (8

weeks), or in the alternative, 440 hours as required by PTCB certification; • §907.A.2, to remove the ratios for pharmacy technicians; • §907.A.3, to re-frame the scope of practice from a list of prohibited tasks to a list of

permitted tasks, citing a list of activities associated with medication dispensing and assisting with clinical activities;

• §1101.C, to remove the requirement for the signature of the PIC on the permit application form and simply require the name of the PIC on the form;

• §1101.C.2, to change the permit renewal cycle from annual to biennial; • §1103, to remove sections for square footage, counter space, and aisle space; • §1103.H.1, to remove the first sentence specifying storage space; • §1103.K, to remove the requirement for a printed law book;


Regulatory Project 454-2019 June 26, 2019 Public Hearing Summary of Comments Page 2 of 2

• §1105.A.1.b, to reduce the amount of practice experience to qualify for a PIC privilege, from two years to either six months or one year;

• §1105.A.2, to remove the minimum number of hours for a PIC to be present; • §1105.I, to change the 10-day notice for PIC changes to 30 days; • §1109, to clarify that a pharmacist assisting a patient in a clinical capacity does not

created a pharmacist absence; • §1111, to insert a similar clarification relative to pharmacist assisting a patient; • §1113, to repeal the prohibition on mechanical drug dispensing devices, or in the

alternative, to allow for such devices when approved by the Board; • §1123, to remove the requirement to store hardcopy prescriptions for one year, in favor

of allowing imaging systems to retain those records for at least two years; • §1131.A.1, to remove the requirement for a PIC signature, in favor of the signature of an

authorize representative; • §1131.A.4, for pharmacy opening procedures, to remove section on DEA registration; • §1201, to amend the definition of ‘final check of work’ to allow for technology solutions in

lieu of mandatory human checks; • §1207.A, to designate the PIC or verifying pharmacist as accountable for the accuracy of

the AMS, with additional clarification that counting machines are not AMS devices; • §2307.A.1.c, to repeal the two year practice requirement for the PIC; • §2425.A.1, to reduce the mileage from 20 miles to 10 miles relative to telepharmacy

dispensing sites; • §2425.A.6, to remove the requirement for a telepharmacy dispensing site to close if a

new community pharmacy opens within 20 miles of the dispensing site; • §2425.E.2.c, to remove staffing parameters as well as references to staffing ratios; • §2425.E.3.g, to require counseling on new prescriptions and an offer to counsel on refills; • §2511.C.1, to remove the minimum size of a prescription form; • §2511.C.5, to allow for the electronic capture of facsimile prescriptions; • §2511.C.5.d, to remove the 2016 expiration date; • §2511.D.1, to allow a technician or intern enter a verbal transcription of a prescription

into the dispensing information system, with the pharmacist held accountable to such prescriptions;

• §2513, to repeal the section on prescription receipt and verification as redundant and unnecessary;

• §2519.B.2, to remove C-V prescriptions, in alignment with 21 CFR 1306.22; • §2521, to extend the 72-hour allowance for emergency refills to a 30-day supply, or in the

alternative, an exception for unit-of-use containers; • §2525.B.2, to remove the 6-month expiration date for C-V prescriptions; • §2733.C.1.a, to remove the annual CDS inventory as unnecessary; and • §2747.B.5, to allow for partial fills as requested by patients.

4. June 26, 2019 letter from John Rocchio, on behalf of CVS Health Requested the Board to consider amendments to the following sections of rules:

• §907, to remove the ratios for pharmacy technicians and technician candidates; • §1109, to clarify a pharmacist is not absent if assisting a patient in a clinical capacity; and • §1111, to insert a similar clarification about a pharmacist absence from the pharmacy.

- END -

NACDS NATIONAL ASSOCIATION OFCHAIN DRUG STORES

June 26, 2019

Mr. Malcolm 1. BroussardExecutive DirectorLouisiana Board of Pharmacy3388 Brentwood DriveBaton Rouge, Louisiana 70809-1700

By Fax: 225-925-6649By Email: infoJpharmac.la.gov

RE: Louisiana Board of Pharmacy Rule Review

Dear Mr. Broussard:

On behalf of our members operating in Louisiana, the National Association of Chain DrugStores (NACDS) appreciates the opportunity to comment on the Board of Pharmacy’s

(Board) review of existing rules related to the practice of pharmacy. We applaud the Board

for accepting comments on its rules as it is critical to keep them current to best serve

patients in the state. NACDS requests the Board to view the rules through the lens of astandard of care approach. Our extensive comments are aimed at reducing prescriptive

rules and in consideration of a standard of care approach, like our medicine and nursing

counterparts. We ask the Board to consider this approach as it applies to the utilization of

technology, scope of practice, supervision, personnel, facility and notification requirements.

COMMENTS AND RECOMMENDED AMENDMENTS

Chapter 5. Pharmacists

Subchapter A. Ucensure Procedures

§511. Employment Change (A)We recommend striking this section as very few states require notification of employment

changes as we believe this is unnecessary and an administrative burden for all licensees.

§521. Prescription Orders to Administer Medications

Subsection (B): We recommend eliminating the properly executed Authority to Administer

and allow the prescriber to authorize administration on the prescription. If a pharmacist

meets the criteria to administer the medication and the prescriber has issued the order, thepharmacist should be allowed to administer such medication. Additionally, we recommend

eliminating the 180 days requirement as this should apply to the life of the prescription.

EXHIBIT

I Page

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Chapter 7. Pharmacy Interns §709. Scope of Practice– (B) We recommend striking section B, eliminating the intern to pharmacist ratio. Limiting the number of assistants that a pharmacist may leverage in the dispensing process has not demonstrated a positive impact on patient safety. The advanced training and education of pharmacy interns should make this a clear rule that is open for change. We believe that interns work better and can learn more with other interns, especially in non-drug dispensing or research rotations/internships. We support eliminating the limitation of pharmacy interns that may assist in the prescription filling process. We recommend allowing the precepting pharmacist to determine the appropriate ratio based on their workplace and job duties.

A. Pharmacy interns may perform any duty of a pharmacist provided he is under the supervision of a pharmacist.

B. The ratio of pharmacy interns to pharmacists shall be 1:1. However, the ratio of pharmacy interns on rotation with a board-approved college of pharmacy to pharmacists shall be no more than 3:1.

C. A pharmacy intern may not: 1. present or identify himself as a pharmacist; 2. sign or initial any document which is required to be signed or initialed by

a pharmacist unless a preceptor cosigns the document; 3. independently supervise pharmacy technicians; or 4. administer immunizations unless properly credentialed as required by the

board.

Chapter 9. Pharmacy Technicians §901. Definitions Employer-based training programs prepare technicians for their practice setting. If an employer can show that the core elements of a program are met, they should be allowed the flexibility to provide their own program. Understanding that employee turnover is a reality of any business, we believe there is a potential resolution to the challenges associated with staffing while technicians work towards achieving national certification. Chain pharmacies have a comprehensive training regimen that covers the pertinent competencies required to fulfill the allowed tasks of a Louisiana technician. We believe Louisiana Statute 37:1212 grants the Board the authority to approve company-based training programs as a method of certification, which will be focused on the actual activities being performed at that practice site. We recommend this amendment.

Training Program—a pharmacy technician training program that is currently nationally-accredited and has been approved by the board. The Board may

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approve an employer-based training program that is not nationally accredited if deemed acceptable by the Board.

§903. Pharmacy Technician Candidates Subsection (A)(2)(c)(i): We believe that the Board should allow for both board-approved or nationally accredited programs. If a program is nationally accredited, there is no purpose in also requiring it to be “board-approved”. Instead, we recommend a process to allows for employer-based programs that are not necessarily nationally accredited. Therefore, we suggest changing “and” to “or” to allow for both board-approved or nationally accredited programs. If the Board wishes to mandate national accreditation, then we recommend striking “and board approved”. We also suggest similar changes throughout the chapter to ensure consistency of all rules pertaining to certification programs and requirement. Subsection (A)(3)(f): We recommend striking the change of employment requirement. We believe this requirement to be administratively burdensome and is overly unnecessary to notify the Board of a change in employment. Under current regulations the candidate is already required to notify the Board regarding mailing address changes. Removal of this requirement would not only lessen the administrative burden on the Board and the candidate, it would also align with current requirements in most states. Subsection (B)(2): We recommend striking this section regarding notification of failure by the technician from a training program. The burden of notifying the Board when a trainee is no longer enrolled in a training program should not be the responsibility of the training program. If a technician candidate attempts to become employed elsewhere, the new place of employment has a responsibility to ensure proper credentialing of the candidate prior to hire and engagement in all technician activities. Additionally, it should be the responsibility of the candidate, not the training program, is to notify the Board of a change in program. This is an unnecessary administrative responsibility that has no significant impact on patient safety. Subsection (D)(1): The Board should amend “board-approved” and instead indicate that any exams conducted by organizations accredited by NCCA (National Commission for Certifying Agencies) are acceptable as these are currently the exams conducted by PTCB or NHA only. This is a general standard across the nation. In addition, it does not require the board to specify exam names in the rule nor create a potential bias towards one exam or another. Subsection (D)(2): We recommend striking time frames for retesting. Currently, both the Pharmacy Technician Certification Board (PTCB) and the National Healthcareer Association (NHA) have minimum time-periods in which a candidate must wait prior to re-taking the exam to ensure the integrity of the exam. Additionally, we believe that a one year waiting period is a lengthy time frame in which it is likely to diminish the candidate’s chances of passing this exam as well as decrease interest in gaining certification.

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§905. Pharmacy Technician Certificate Subsection (A)(3)(a): We recommend striking “and board-approved” or amending it to “or board-approved” for the same reasons provided in section 903. Subsection (A)(3)(b): We recommend reducing the 600-hour requirement to 320 hours, or 8 weeks full time, which we think is enough to appropriately train pharmacy technicians. If the Board is not willing to decrease the required hours to 320, at minimum, we suggest revising the existing language to align with the current PTCB training requirements of 440 hours for entry level pharmacy technicians. §907. Technician Scope of Practice Subsection (A)(2): We recommend that the Board eliminate pharmacy technician ratios. Our experience in states with similar ratio requirements to the current Louisiana rule, staffing issues arise due to the limited number of certified technicians available to meet the high end of the ratio allowance. There is no evidence that limiting the number of technicians promotes the safety of pharmacy practice. Conversely, states that place a cap on the number of technician candidates leave pharmacists with the decision to either staff their location without adequate support or violate ratio regulations. Pharmacists are professionals who can manage their pharmacies. Dictating a technician ratio is an antiquated policy in the present pharmacy practice environment. Arbitrary ratios prevent pharmacies from maximizing use of pharmacy technicians to provide a broader set of patient care services to the public. Many Boards of Pharmacy, recognizing this to be true, have over the years relaxed or removed restrictive ratios to allow for optimal use of pharmacy technicians. Notably, the National Association of Boards of Pharmacy (NABP) has long supported the complete elimination of the pharmacist to technician ratio. Given the growing demand for pharmacist-provided patient care services in community pharmacies, there is a corresponding need to deploy pharmacy technicians for administrative and non-judgmental duties. Furthermore, elimination of technician to pharmacist ratios will enable pharmacists to focus more on counseling patients, performing MTM, providing disease management programs, engaging in other important patient care services, and collaborating with other health care professionals, thus integrating more fully in a patient’s care. These services also help patients better adhere to their medication regimens and ultimately serve to improve patients’ health and wellness and reduce our nation’s health care costs. Therefore, we strongly urge the Board to eliminate technician ratios to maximize the utilization of technicians by pharmacists. Subsection (B): The current rules do not delineate specific tasks pharmacy technicians may perform. Instead, it outlines limitations for the duties performed by pharmacy technicians

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and allow pharmacists to determine what duties may be performed by technicians within those limitations. NACDS strongly supports pharmacists practicing at the top of their profession to allow for optimal patient care and improved health outcomes. When considering an enhanced role for pharmacy technicians in collaborative health settings, several duties can be reasonably delegated from these two categories: (1) medication dispensing support; and (2) technical support for clinical services provided by pharmacists and other health professionals. As such, where appropriate, we recommend that the Board strongly considers adopting changes that would allow pharmacy technician to perform duties in the following areas:

Medication Dispensing: Some pharmacist duties related to medication dispensing can be delegated to pharmacy technicians, thus allowing pharmacists to devote more time to patient care. The following tasks are related to medication dispensing and can be performed by a technician:

• Accepting a verbal prescription: Allows the technician to accept a verbal prescription by phone. Currently, 16 states permit this activity for certified technicians.1

• Transferring a prescription: Allows the technician to transfer a patient’s prescription to another pharmacy. Currently, 13 states permit this activity for certified technicians.2

• Consulting with a prescriber for clarifications: When information on a prescription is incomplete, a pharmacy technician can contact the prescriber and appropriately obtain the needed information. However, if the inquiry regarding the missing information requires the professional judgment of a pharmacist, then the pharmacist would contact the prescriber. Currently, six states permit this activity for certified technicians.3

• Final product verification: A new optimizing care practice model is emerging that allows technicians to verify the accuracy of another technician’s work and eliminate the final verification of a prescription by a pharmacist. Currently, this task is allowed in the community setting in Arizona, Idaho, and North Dakota. Iowa is currently soliciting comments on a proposed rule regarding technician product verification.

o Arizona: Qualified technicians may perform a final technology assisted verification of a product and subsequently type and affix a label for the

1 Currently allowed in ID, IL, IA, LA, MA, MI, MO, NH, NC, ND, OH, PR, RI, SC, TN, and WI. National Association of Boards of Pharmacy; Survey of Pharmacy Law; 2018; pp. 50. 2 Currently allowed in AZ, ID, LA, MA, MI, MO, NC, ND, PR, RI, SC, TN, and WY. Id. at 51. 3 Currently allowed in DE, IL, ID, IA, MI and SD.

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prescription medication. A pharmacist, or graduate or pharmacy intern must verify the accuracy of the label.4

o Idaho: A certified technician may perform final verification on prescription drug orders that have previously undergone prospective drug review by a pharmacist.5

o Iowa: Proposed rule would allow certified technicians provide drug product verification.6

o North Dakota: Allows the preparation of a prescription or order for dispensing or administration to be performed by one registered pharmacy technician and verified by another registered pharmacy technician working in the same licensed pharmacy, under specific conditions.7

• Checking the Prescription Monitoring Program (PMP): Technicians should be allowed to initiate a check of the PMP, but not be allowed to make decisions on whether a medication should be dispensed based on the findings in the PMP report. Technicians are currently allowed to check the PMP in Maine and Idaho.8

Assisting with Clinical Services: The following are potential tasks that may be delegated to a technician with proper training to augment the role of pharmacists in providing direct patient care services. It is important to note that these tasks would not allow technicians to perform clinical services, but to perform steps that are part of a clinical service that do not require professional judgment. Except for Idaho, which now allows technicians to administer vaccines, these tasks are not expressly allowed in any state. However, it has been suggested that pharmacy technicians can be trained to perform the following:

• Perform basic physical assessment: Performing basic assessments such as taking a patient’s temperature or blood pressure can be considered non-judgmental tasks

4 Arizona Admin. Code R4-23-1104(A) and (B), https://apps.azsos.gov/public_services/Title_04/4-23.pdf. 5 Rules of the Idaho State Board of Pharmacy, 27.01.01.410 6 Technician Product Verification Programs, Proposed Rule, Nov 2018, https://pharmacy.iowa.gov/sites/default/files/documents/2018/11/draft_tpv_ch_40_pre-notice.pdf. 7 North Dakota Administrative Code, Section 61-02-07.1-12. Conditions require that: there are policies and procedures outlining pharmacy technician scope of practice, including training for the specific activity and appropriate recordkeeping; the pharmacy has a continuous quality improvement system in place to periodically verify the accuracy of the final product; any error must trigger pharmacist review of the process; the pharmacy has a system in place to review all quality related events and errors recorded and takes corrective action based on the information to reduce quality related events and eliminate errors reaching the patient; and the pharmacist-in-charge and permit holder are jointly responsible for the final product dispensed or released for administration from the pharmacy. 8 Idaho Statute, Title 37, Article III, Section 2726 (12). In Idaho, House Bill 374 was recently signed into law allowing technicians to check the PMP as a delegate of the supervising pharmacist as of July 1, 2016. The law provides practitioners with a new tool to streamline access to the PMP and allows for the designation of up to four delegates to access the PMP on their behalf. The bill amends the existing definition of “delegate” to include a registered pharmacy technician. A delegate may access information to the extent the information relates specifically to a current patient to whom the practitioner is prescribing or considering prescribing any controlled substance. Presently, regulations have not been proposed to implement this change in the law.

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and may be tasks that pharmacists can delegate to pharmacy technicians. Allowing pharmacy technicians to perform such assessments may leverage scarce healthcare resources to improve efficiency in pharmacies that offer point-of-care testing. For example, if a pharmacy technician can check a patient’s temperature and administer a screening for influenza, then the pharmacist may assess the results and initiate treatment if appropriate.9

• Conduct medication reconciliation: Properly trained technicians can compile an initial medication list based on an interview with the patient. Assessing that information and making clinical recommendations would be performed by the pharmacist using his or her professional judgment.

• Administer vaccines: Prescribers routinely delegate vaccine administration to healthcare paraprofessionals. Similarly, there is an opportunity to allow pharmacists to delegate this task to a properly trained and certified pharmacy technician. In Idaho, technicians who are appropriately trained and certified may administer vaccines.10

• Administer CLIA-waived laboratory tests: CLIA-waived tests are “simple and have a low risk for erroneous results”11 with most having diagnostic capabilities. Under federal law, CLIA waived tests can be performed by laypersons. Consequently, performing a CLIA-waived test is a task that may be delegated to a properly trained technician. The decision to order, interpret, and act on the results of the test, however, requires professional judgment and would remain the duty of the pharmacist.

Chapter 11. Pharmacies §1101. Pharmacy Subsection (C)(1): We recommend not requiring the signature of the PIC on the initial application as it is an unnecessary administrative burden for the pharmacy. Instead of the PICs signature, we recommend that the Board accept the name of a PIC on the application. Subsection (C)(2): We recommend changing from annual to biennial renewals for pharmacy permits. §1103. Prescription Department Requirements:

9 Pharmacy Today; The Promise of Point of Care Testing; Volume 22, Issue 2, pp 34-37; February 2016. In Nebraska, a Hy-Vee pharmacist is authorized through a collaborative practice agreement with a local primary care physician to dispense amoxicillin, azithromycin, or oseltamivir to treat influenza. 10 Rules of the Idaho State Board of Pharmacy, 27.01.01.330.02(b)(3) 11 Clinical Laboratory Improvement Amendments, Center for Disease Control, https://wwwn.cdc.gov/clia/resources/waivedtests/, last visited November 22, 2016.

https://wwwn.cdc.gov/clia/resources/waivedtests/

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Pharmacy practice has changed over the years and many requirements in this section are outdated. Some pharmacies today do not even stock medications, but rather only provide pharmacy services. Many of the requirements in this section are overly prescriptive, outdated, and unnecessary. We recommend eliminating these three subsections:

C. Square Footage. A prescription department that is new or remodeled on or after January 1, 2004 shall be not less than three hundred (300) total square feet, and shall be inaccessible to the public.

D. Prescription Counter. A prescription counter on which to compound or dispense medications shall have a working surface of not less than a minimum of twenty-four (24) total square feet. The minimum unobstructed free working surface shall be kept clear at all times for the compounding or dispensing of prescriptions.

E. Prescription Aisle Space. The aisle space behind the prescription counter shall be not less than thirty (30) inches in width.

Subsection H)(1): We recommend striking the first sentence and leaving only: “Drugs that require special storage shall be properly stored.”

H. Drug Inventory. 1. Storage. The pharmacy shall provide sufficient space on-site for proper storage of labels,

prescription containers, and an adequate prescription inventory in order to compound and dispense prescription orders. Drugs that require special storage shall be properly stored.

Subsection (K): References - The requirement to keep hardcopies of the Louisiana Board of Pharmacy Laws and Regulations is outdated and should be eliminated. Electronic copies of the laws and regulations are available and can be updated automatically, whereas paper copies must be manually considering laws/rules constantly change. Therefore, we recommend revising this section to allow electronic copies of Louisiana laws and regulations. §1105. Pharmacist-in-Charge Subsection (A)(1)(b): Under current rule, a licensed pharmacist is not be able to serve as PIC until they have obtained a minimum of two years of experience practicing pharmacy in Louisiana or another state. We believe that this requirement is problematic for community pharmacies. While we recognize the important role of the PIC in the operation of pharmacies and appreciate the Board’s intent for developing standards that serve to protect public health, safety, and welfare in the pharmacy setting, this requirement unfairly disadvantages skilled pharmacists and pharmacies who have to wait until the arbitrary timeline requirements are met. Additionally, it potentially exacerbates staffing issues in areas where pharmacies already have challenges recruiting pharmacists.

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We believe that the designation of a PIC should be made on a case-by-case basis and should be based on the level of knowledge and training that a pharmacist has without regard to the number of years in practice. Pharmacists who are appointed to this position are those who are motivated and dedicated to protecting patient safety while upholding the statutes and rules under which they practice. Careful consideration is made prior to appointing a PIC and we believe each institution should have the right to determine if a pharmacist can perform as their PIC. We recommend the Board amend this provision in the proposed rule to require six months to one year of experience. Subsection (A)(2): We recommend eliminating the minimum hours requirement. The Board rules have made clear that the PIC is accountable for the pharmacy following all laws and regulations, therefore a minimum hours requirement is unnecessary and overly prescriptive. Subsection (I): The current rules require the notification in writing to the Board within 10 days of any discharge or termination of the licensed pharmacist or change of the status of the PIC. Additionally, the current rules require the permit holder to designate a new pharmacist-in-charge within 10 days of the departure of the prior pharmacist-in-charge. We disagree with the current language and recommend for notification of only the PIC. Staffing changes occur on a regular basis as pharmacists acquire new employment within the industry. We believe that this level of notification provides no additional patient protection and instead creates an additional administrative burden on the PIC as well as the Board staff. In addition to making changes to only require notification of changes for the PIC, we also ask the Board to increase the report time from 10 days to 30 days to prevent unintended notification consequences. Currently most states allow the pharmacy license holder 30 days to find an adequate replacement for the PIC. We believe that given the level of responsibility of the PIC, the 10-day requirement is unrealistic and unreasonable. We recommend the Board allow more time for this process to be adequately completed. §1109. Pharmacist Temporary Absence, and §1111. Pharmacist Absence We suggest amending the current rule to enable a pharmacist to assist a patient in a clinical capacity from outside of the pharmacy department without being considered absent. It is important to not obstruct safe pharmaceutical care practice in the evolving world of pharmacy services. §1113. Mechanical Drug Dispensing Devices We recommend striking this rule. This rule prohibiting the dispensing of medications directly to patients by mechanical devices or machines may create confusion and/or potentially limit opportunities for increased access. Furthermore, we believe that this technology has been prohibited without evidence of public safety concern, as well as an

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inhibition of patient access to pharmaceutical care. If the Board will not consider elimination of the rule, instead we recommend that the Board considers incorporating an approval process to enable the expansion of patient access to pharmacy care.

A. Dispensing of prescription drugs directly to a patient or caregiver by mechanical devices or machine is prohibited, unless the device is approved by the Board. This prohibition shall not apply to automated medication systems as defined and provided for in Chapter 12 of these regulations.

§1123. Records We ask the Board to strike the requirement to retain a prescription hard copy for a year. Digital images of prescriptions for legend drugs have enabled pharmacies to utilize their software system to receive faxed prescriptions, without utilizing paper, and to scan written and oral transcribed prescriptions into the system for secure record keeping. The requirement to retain the hard copy for a year creates the unnecessary use of paper and limits the storage space within a pharmacy. We recommend the Board consider adopting these amendments:

K. Filing and Retention of Prescription Forms 1. Written prescription forms not stored in accordance to paragraph J (including transcriptions of verbal prescriptions received in the pharmacy, prescriptions received by facsimile in the pharmacy, as well as written prescription forms presented to the pharmacy) shall be assembled and stored in prescription number sequence. Prescriptions for controlled dangerous substances listed in Schedule II shall be filed separately from all other prescriptions. Where multiple medications are ordered on a single prescription form and includes one or more controlled dangerous substances listed in Schedule II, then such forms shall be filed with other Schedule II prescriptions. These original hard copy prescription forms shall be retained in the prescription department for a minimum of two years following the most recent transaction. 2. For those pharmacies utilizing an electronic imaging system as described in Paragraph J of this Section, written prescription forms may be assembled and stored in prescription number sequence, or in the alternative, a date scanned sequence. Further, these original hard copy prescriptions shall be retained in the prescription department for a minimum of one year following the most recent transaction. 3. Prescription forms stored in an electronic imaging system shall be retained within the system in a readily retrievable manner for a minimum of two years from the last transaction. received as an electronic image or electronic facsimile directly within the pharmacy information system shall be retained within the information system for a minimum of two years following the most recent transaction. Further, the pharmacy

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may produce a hard copy of the prescription form but shall not be required to do so merely for recordkeeping purposes.

§1131. Pharmacy Opening Procedures Subsection (A)(1): We recommend the Board amend this section to allow for the signature of appropriate authorized representative of the pharmacy versus the signature of the PIC on the initial pharmacy permit application and Louisiana Controlled Dangerous Substance License application. As stated previously, staffing changes occur on a regular basis as pharmacists acquire new employment within the industry. When a new PIC is designated, the signature and documents are outdated. Allowing the appropriate authorized representative of the pharmacy to sign the initial permit application removes any inaccuracies with frequent employment changes of the PIC, and allows for more accuracy in the application and records processes. Subsection (A)(4): This requirement is unnecessary in rules as it appears to be advisement to the applicant vs. a mandatory requirement.

Chapter 12. Automated Medication Systems §1201. Definitions, and §1207. Pharmacist Review Technology has enabled the utilization of automated product checks that ensure the correct product on the label is dispensed. This has enabled Boards of Pharmacy to safely enable barcode scanning validation actuated by a technician or automated system to meet the requirements of a final pharmacist check. The dispensing pharmacist would be designated as the responsible pharmacist, with the duty of ensuring the accuracy of the technological verification system utilized. In line with these comments, we recommend the following amendments:

§1201. Definitions Final Checks of Work – the requirement that only a pharmacist supervises and releases the completed product prepared by a pharmacy technician, unless otherwise noted in this Section §1207. Pharmacist Review A. The Pharmacist-in-Charge or verifying pharmacist shall be responsible for the

accuracy of medication produced by the Ssystem shall be used in settings that

ensure medication orders are reviewed by a pharmacist prior to administration

and The system must be maintained in accordance with established policies

and procedures and good pharmacy practice. A policy and procedure protocol

shall be adopted to retrospectively review medications which cannot be

reviewed prior to administration, as provided in LAC 46:LIII.1209.2.

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We also recommend that clarifying language be added to indicate that indicates “counting machines” to not be included as automated dispensing systems.

Chapter 23. Nonresident Pharmacy §2307. Pharmacist-in-Charge Similar to Section 1105 which requires a pharmacist to practice for two years prior to becoming a PIC, creating a determining factor of pharmacy management by time of practice is not a holistic view of who can take the responsibility of a PIC. Time of practice is not a holistic view of who can take the responsibility of a PIC. This requirement forces the selection of an individual based on years of practice rather than their individual capabilities to manage a pharmacy. With respect to mandating this of nonresident PICs, the state is, in some instances, prohibiting the domicile PIC of the nonresident pharmacy from being responsible for the actions of his or her pharmacy. In exchange, the rules seek to assign responsibility to another individual simply on the merits of that individual’s tenure being in excess of two years. Consistent with the suggestion made above for Section 1105, we recommend that the Board delete this provision in the rules.

A. The opportunity to accept an appointment as the pharmacist-in-charge (PIC) of a pharmacy is a professional privilege. The following requirements are attached to a PIC privilege: 1. The acquisition of the PIC privilege shall require: a. Possession of an active Louisiana pharmacist license; b. Possession of an active license in the state in which the pharmacy is located, and further, said license shall not have any restrictions which prohibit the position of pharmacist-in-charge; c. Active practice as a pharmacist for a minimum of two years under the jurisdiction of any board of pharmacy in the United States; and cd. …

Chapter 24. Limited Service Providers §2425. Telepharmacy Dispensing Site Subsection (A)(1): We recommend reducing the mileage requirement to 10 miles. For those patients that lack transportation or have other mobility issues, even a few miles may create an access barrier. As currently written, 20 miles does not resolve the access concerns that these rules are intended to fix. Subsection (A)(6): We recommend striking this section of the rule that requires the closing of a dispensing site if a new community pharmacy opens within 20 miles of the existing telepharmacy dispensing site. This section creates an unnecessary barrier for telepharmacies to open. Telepharmacy continues to grow nationally and will have a significant impact on rural areas. Where primary care physicians may be scarce, 91.7% of

13 | P a g e

the country’s population lives within 5 miles of a pharmacy. We applaud Louisiana for having a telepharmacy platform in the state, however we request that the relevant rule be reevaluated to ensure that telepharmacy allows for flexibility to accommodate the inevitable changes in technology. To reevaluate the rule comprehensively, we suggest looking at actions taken by the Indiana Board of Pharmacy (which has established a subcommittee to develop telepharmacy rules that meet the needs for patient population in Indiana) and the Illinois State Board of Pharmacy (which has developed industry leading rules that are currently used in Illinois). Subsection (E)(2)(c): We recommend eliminating this section of the rule. The economics/business aspects of the pharmacy should dictate the number of personnel required to staff a telepharmacy location. In addition, as stated above, we recommend striking any ratio references in this rule. Subsection (E)(3)(g): We recommend counseling requirements only on new prescriptions and an offer to counsel requirement on all refills. The vast majority of patients do not require nor want counseling on refills.

Chapter 25. Prescriptions, Drugs, and Devices §2511. Prescriptions Subsection (C): We recommend the following changes to align with current electronic technology for transmitting prescriptions as well as to remove provisions that are administratively burdensome and unduly unnecessary.

• Striking the size requirements of a written prescription.

• Expanding the rule to allow for electronic capture of facsimile prescriptions. With increased technology, facsimile prescriptions may now be received and stored electronically without a requirement to be in paper format.

• Striking the expiration date of 12/31/2016 of this section of this rule, thereby allowing for prescriptions received by the pharmacy that bears the electronic signature of a prescriber to be construed as a validly formatted prescription for non-controlled prescriptions.

Subsection (D): We recommend adding language that would allow a pharmacy intern or technician to initial the form or add an identifier in the electronic record keeping system. Additionally, we suggest adding language that states that the verifying pharmacists would assume the responsibility for the accuracy of the order received by the technician or the pharmacy intern. 1. Upon the receipt of an oral prescription from an authorized prescriber, the

pharmacist or pharmacy intern or pharmacy technician shall reduce the order to a

14 | P a g e

written form prior to dispensing the medication. As an alternative to recording such prescriptions on paper forms, a pharmacist they may enter the prescription information directly into the pharmacy’s dispensing information system. In the event a pharmacy intern or pharmacy technician transcribes such a prescription, the intern or technician must initial the form, or add an identifier in the electronic record keeping system. The verifying pharmacists assumes responsibility for the accuracy of the order received by a technician or pharmacy intern. supervising pharmacist shall initial or countersign the prescription form prior to processing the prescription.

§2513. Prescription Receipt and Verification Written, oral and electronic transmission of prescriptions as well as the verification of a prescription are all basic standards of practice and otherwise identified and throughout various Board laws and rules. We recommend the Board delete this section as it is redundant and unnecessary. §2519. Prescription Refills; Medication Synchronization and Refill Consolidation Subsection (B)(2): We recommend that the Board amend this section to align with the §1306.22 of the Federal Code. Currently, under Federal Regulation, the DEA only specifies that C-III and C-IV prescriptions to be refilled up to 5 times. We recommend amending (B)(2) to strike C-V’s from this section of the rule to align with these requirements. §2521. Emergency Refills Continuity of chronic care is essential for patients. Pharmacists should be enabled to assist a patient with demonstrated chronic therapy by providing an ample supply of medications when the prescriber cannot be reached for renewal. The current provision of 72-hours is on the low end of allowable quantities and may not bridge the gap being experienced by the patient. In the pharmacist’s clinical judgment, a patient should be enabled to receive a month supply of their chronic medication. This should follow a reasonable attempt by the pharmacist to reach the prescriber. It is also important to note that medications such as inhalers and oral contraceptives cannot be broken down into a 72-hour supply. Regardless of the Board’s desire to extend the day supply allowed for an emergency refill, a carve out for unit dosed packaging that cannot be separated into a 72-hour increment should be enabled. We recommend the Board adopt this amendment:

A. Using sound professional judgment, a pharmacist may provide a refill adequate of medication for a seventy-two (72) hour regimen when an emergency for medication has been adequately demonstrated and the prescribing practitioner is not available. This refill should not exceed a 30-day supply, or the previously prescribed quantity, whichever is less.

§2525. Prescription Expiration

15 | P a g e

Subsection (B)(2): We recommend that the Board amend this section to align with the §1306.22 of the Federal Code. Currently, under Federal Regulation, the DEA only specifies that C-III and C-IV prescriptions to expire 6 months from the date written. Therefore, we recommend amending (B)(2) to strike C-V’s from this section of the rule to align with these Federal Code requirements. DEA: §1306.22 Refilling of prescriptions.

No prescription for a controlled substance listed in Schedule III or IV shall be filled or

refilled more than six months after the date on which such prescription was issued.

No prescription for a controlled substance listed in Schedule III or IV authorized to

be refilled may be refilled more than five times

DEA FAQ’s: Question: Can controlled substance prescriptions be refilled? Answer: Prescriptions for schedule II-controlled substances cannot be refilled. A new

prescription must be issued. Prescriptions for schedules III and IV controlled

substances may be refilled up to five times in six months. Prescriptions for schedule

V controlled substances may be refilled as authorized by the practitioner.

Chapter 27. Controlled Dangerous Substances §2733. Inventory Requirements Subsection (C)(1)(a): This subsection is unnecessary since annual inventory is required and shall include all stocks of controlled substances medications. §2747. Dispensing Requirements Subsection (B)(5): We recommend that the Board review the current rules and amend as necessary to align with Section 702 (21 U.S.C 829(f)) of the Comprehensive Addiction and Recovery Act (CARA) to allow partial fills at the request of the prescriber or patient.

Conclusion We thank the Board for the opportunity to provide input and proposing changes to your rules. We look forward to working with you to ensure that patients in Louisiana continue to receive optimal healthcare at their community pharmacy. If you have any questions or need additional information, please contact me at [email protected] or 817-442-1155. Sincerely,

Mary Staples Regional Director, State Government Affairs


ecw Health One CVS OdveWoonsocket, RI 02895

LEIT

June 26, 2019

Louisiana Board of PharmacyMalcolm BroussardExecutive Director3388 Brentwood DriveBaton Rouge, LA 70809

Dear Mr. Broussard,

RE: §907. Scope of Practice; Technician Ratio

I am writing to you in my capacity as Sr. Director of Regulatory Affairs for CVS Health and its family ofpharmacies located across the United States.

CVS Health’s mission is to help patients on their path to better health. We are committed to patientsafew. technological and process advances. and expanded pharmacy services that will assist in achievingour stated purpose.

CVS Health supports an increase in the number of technicians provided to assist pharmacists, enablingan increased focus on clinical patient care. Increasing the number of pharmacy technicians provided toassist pharmacists in dispensing medications and supporting patient care services enables the highestorder of clinical patient care, and aligns with the Board’s mission of promoting the interest of the health,safety, and welfare of the citizens of the state of Louisiana.”2

The national landscape reveals an overwhelming safety track record of success and shift towardsremoving ratio, featuring 21 states that have eliminated or never sought to establish a technician topharmacist ratio. As there are states with over a century of success in allowing pharmacists to determineand maintain appropriate supervision over support personnel, the National Association of Boards ofPharmacy (NABP) removed all ratio restrictions from The Model State Pharmacy Act and Model Rulesin l999. It is important to note that of the historicjurisdictions without a ratio, there has never been amove to create a ratio once the ratio was abolished.

Additionally, evidence has not been produced to indicate that limiting the number of techniciancandidates promotes the safety of pharmacy practice. As a response to the need for certified techniciansto staff a pharmacy to the currently enabled maximum, pharmacies are routinely hiring new techniciansto bolster their ‘vorkforce. When a certified technician ends employment for non-work related reasonssuch as higher education or a change in career, the pharmacy is forced to seek and hire a new techniciancandidate. During the time it takes to develop an existing technician candidate to be proficient in theirmandated pursuit of certification, a pharmacy prescription volume that requires the current maximum ofthree assistants now must make due with only one or two. This means the pharmacist would be pulledaway from clinical actions such as prescription drug utilization review, counseling, and order entryverification to assist with these non-clinical duties. In addition, the pharmacy is only be able to providecritical learning experience to one technician candidate training at a time, reducing the future number ofcertified technicians available. Decreasing the number of support personnel available to assist in thedispensing process by assigning an arbitrary limit is far more likely to result in a negative impact to

iJ pharmacy ,‘ caremarK / minute clInc / specialty

patient care and safety than the utilization of a sufficient number of technician candidates. CVS Health recommends striking pharmacy technician ratio limitations under section 907 in its entirety.

Louisiana ADC 46 LIII: 907 Scope of Practice

A. Pharmacy technician candidates and pharmacy technicians may assist the pharmacist by performing those duties and functions assigned by the pharmacist while under his direct and immediate supervision. 1. The ratio of candidates to pharmacists on duty shall not exceed one to one at any given time. 2. The ratio of technicians to pharmacists on duty shall not exceed two to one at any given time. However, the ratio of technicians to pharmacists on duty may be increased to three to one if no technician candidates are on duty at the same time.

RE: Louisiana ADC 46 LIII: 1109 Pharmacist Temporary Absence and §1111. Pharmacist Absence

CVS Health believes clarification is required within section 1109, detailing that a pharmacist outside of the prescription department providing individualized patient care will not be considered an absence of a pharmacist. We suggest amending the current rule to enable a pharmacist to assist a patient in a clinical capacity from outside of the pharmacy department without being considered absent. The following amendments will assist pharmacists in understanding this allowance:

Louisiana ADC 46 LIII: 1109 Pharmacist Temporary Absence

A. A pharmacist shall be considered to be temporarily absent from the prescription department when not within the confines of the prescription department but remains on-site, unless assisting a patient in a clinical capacity. …

Louisiana ADC 46 LIII: 1111. Pharmacist Absence

A. A pharmacist is considered absent from the prescription department when he is not in the prescription department and is off-site.

CVS Health is grateful for the opportunity to comment provided through Act 454 of the Louisiana Legislature. We strive to enable pharmacists to have adequate technician support in the prescription filling process, and we strongly support the individualized patient care that is enabled through the allowance for a pharmacist to engage a patient from outside of the pharmacy department, without impacting the functionality and availability of the pharmacy team in producing prescriptions to the point of pharmacist verification. If you have any questions or need additional information, please contact me directly at 617-599-9091.

Sincerely,

John N. Rocchio PharmD. RPh. Sr. Director, Pharmacy Regulatory Affair

References: 1. Berenbrok et al. Pharmacy Technician Role Expansion. An Evidence-Based Position Paper. 2018.

Available from: https://pages.pharmacy.pitt.edu/epittpharmacy/2018/08/07/pittpharmacy-team-reports-

on-expanded-role-of-pharmacy-technicians/ (Accessed April 8, 2019).

2. Louisiana Board of Pharmacy, About Us, 2019. Available from:

http://www.pharmacy.la.gov/index.cfm?md=pagebuilder&tmp=home&pid=44 (Accessed June 26,

2019).

3. National Association of Boards of Pharmacy. The Model State Pharmacy Act and Model Rules of the

National Association of Boards of Pharmacy (Model Act). 2019. Available from:

https://nabp.pharmacy/publications-reports/resource-documents/model-pharmacy-act-rules/ (Accessed

April 8, 2019).

4. National Association of Boards of Pharmacy. Report of the Task Force on Manpower Shortage. 1999.

Available from: https://nabp.pharmacy/wp-

content/uploads/2016/07/TF_Pharmacy_Manpower_Report_1999.pdf (Accessed April 8, 2019).

https://pages.pharmacy.pitt.edu/epittpharmacy/2018/08/07/pittpharmacy-team-reports-on-expanded-role-of-pharmacy-technicians/

https://pages.pharmacy.pitt.edu/epittpharmacy/2018/08/07/pittpharmacy-team-reports-on-expanded-role-of-pharmacy-technicians/

http://www.pharmacy.la.gov/index.cfm?md=pagebuilder&tmp=home&pid=44

https://nabp.pharmacy/publications-reports/resource-documents/model-pharmacy-act-rules/

https://nabp.pharmacy/wp-content/uploads/2016/07/TF_Pharmacy_Manpower_Report_1999.pdf

https://nabp.pharmacy/wp-content/uploads/2016/07/TF_Pharmacy_Manpower_Report_1999.pdf

Louisiana

Board

ofP

harmacy

PublicH

earingA

ttendanceR

ecordJune

26,2019

Regulatory

Project 454-2019

Com

prehensiveR

uleR

eview

In The Matter Of:STATE OF LOUISIANA PARISH OF EAST BATON ROUGE

LOUISIANA BOARD OF PHARMACY

Public Hearing

June 26, 2019

Associated Reporters, Inc.

2431 South Acadian Thruway

Suite 550

Baton Rouge, La. 70808

Original File PHARM BD 06292019X.TXT

Min-U-Script® with Word Index

1

1 STATE OF LOUISIANA

2 PARISH OF EAST BATON ROUGE

3 LOUISIANA BOARD OF PHARMACY

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7 A Public Hearing was held by the

8 Louisiana Board of Pharmacy, on Wednesday,

9 June 26, 2019, at their office located at

10 3388 Brentwood, Baton Rouge, Louisiana 70809

11 beginning at 9:00 a.m.

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14

15 BEFORE:

16 Susan Erkel

17 Certified Court Reporter

18 In and For the State of

19 Louisiana

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1 A P P E A R A N C E S

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3 MALCOLM BROUSSARD, EXECUTIVE DIRECTOR

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1 I N D E X

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4 APPEARANCE . . . . . . . . . . . . . . . . . . . . . . . .2

5 INDEX. . . . . . . . . . . . . . . . . . . . . . . . . . .3

6 PROCEEDINGS. . . . . . . . . . . . . . . . . . . . . . . .4

7 REPORTER'S CERTIFICATE . . . . . . . . . . . . . . . . . 50

8 REPORTER'S PAGE. . . . . . . . . . . . . . . . . . . . . 52

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1 P R O C E E D I N G S

2 MR. BROUSSARD:

3 Good morning. Today is Wednesday,

4 June 26, 2019. The time is 9:00 a.m. We

5 are assembled in the Boardroom at the

6 Louisiana Board of Pharmacy located at

7 3388 Brentwood Drive in Baton Rouge,

8 Louisiana. My name is Malcolm Broussard,

9 and I serve the Board of Pharmacy as its

10 Executive Director. In his absence,

11 Board President Carl Aron has requested

12 that I moderate this hearing. I now call

13 this public hearing to order. As a

14 courtesy to everyone else in the room,

15 please take this time to silence all

16 pagers, cell phones, and other electronic

17 communications devices. Further, should

18 you find it necessary to take or make a

19 telephone call, please step outside the

20 meeting room to do so.

21 For your safety, the emergency exit

22 path from this room is through the door

23 into the lobby and then through the front

24 door through which entered the building.

25 For your comfort, restrooms are located

5

1 in the lobby -- ladies on the opposite

2 side of the lobby, just past the

3 receptionist's window, and gentlemen,

4 just outside the door to this room. In

5 addition, we have a water cooler in this

6 room. Please help yourself.

7 For your peace of mind, please ensure

8 you did not park in one of the three

9 spaces between this building and the back

10 of the building in front of this one, or

11 in front of the building in front of this

12 one. Those parking spaces do not belong

13 to the Board, and tow trucks are regular

14 visitors to that area. Additional

15 parking is available in the rear of the

16 Perlis clothing store on Jefferson

17 Highway, and there is a stairway

18 connecting that parking lot to the

19 Board's parking area in front of our

20 building.

21 This hearing is held in accordance

22 with the Administrative Procedure Act and

23 the Open Meetings Law. As required by

24 these laws, this hearing is convened

25 pursuant to public notice, and notice has

6

1 been properly posted. The purpose of

2 today's hearing is to receive public

3 comments and testimony on the entirety of

4 the Board's rules, from Section 101

5 through 3301.

6 The Board published its Potpourri

7 Notice in the May 2019 edition of the

8 Louisiana Register. Further, the Board

9 distributed an electronic Notice of

10 Rulemaking Activity on May 20, 2019 to

11 its electronic List of Interested

12 Parties, as well as all pharmacies,

13 pharmacists, pharmacy interns, pharmacy

14 technicians, pharmacy technician

15 candidates, pharmacy technician training

16 programs, and all prescribers with

17 controlled substance licenses. As

18 indicated in the Notice, the Board has

19 convened this public hearing to receive

20 public comments and testimony on the

21 entirety of its rules as to whether any

22 of them may be contrary to law, outdated,

23 unnecessary, overly complex, or

24 burdensome.

25 The Board will consider the comments

7

1 and testimony offered today to determine

2 whether any revisions to the current

3 rules are necessary. We will reply to

4 your comments as soon as possible

5 thereafter. Prior to making any comments

6 today we ask that you sign the guest

7 register for this event.

8 Copies of today's agenda and the

9 notice are available at the registration

10 desk. In addition, we have a copy of the

11 relevant portion of the Table of Contents

12 from the Louisiana Pharmacy Law Book

13 identifying all of the sections in all of

14 the chapters of the Board's rules. Those

15 rules are also available in the Public

16 Library section of the Board's website at

17 www.pharmacy.la.gov, as well as the

18 website of the Louisiana Register.

19 While we may answer questions to

20 clarify language and interpretation, is

21 it not our intent to debate any issues

22 today. Again, the purpose of this

23 hearing is to receive your comments and

24 testimony for the Board's consideration.

25 As indicated in the notice, the deadline

8

1 for all comments and testimony on these

2 rules is 12:00 noon today.

3 We are now prepared to receive your

4 comments and testimony. As you begin

5 your comments, we ask that you identify

6 yourself and any organization you may

7 represent.

8 MR. CALLICOTT:

9 How often do you anticipate these

10 hearings occurring?

11 MR. BROUSSARD:

12 The question was how often we

13 anticipate these hearings? The law that

14 requires this hearing was adopted last

15 year and is Act 454 of the 2018

16 legislature. So you'll hear me refer to

17 this as an Act 454 Hearing. The law

18 requires that every agency with

19 rulemaking authority in Louisiana conduct

20 this kind of hearing prior to January 1,

21 2020 and every six years thereafter. So

22 I guess the next one will be six years

23 from now. Does that answer your

24 question?

25 MR. CALLICOTT:

9

1 Yes. It's just new.

2 MR. BROUSSARD:

3 It is. Mr. Callicott, I guess in

4 further response to your question, the

5 Board could always convene such a hearing

6 before the six year requirement. But the

7 law requires at least once every six

8 years. It might consider the results of

9 this hearing in making a determination

10 whether it should offer such a hearing

11 sooner than the six year requirement.

12 On the other hand, I wouldn't place

13 to much of a significance on the first

14 one because it is the first of its kind.

15 MR. CALLICOTT:

16 I was just always perceived that they

17 were open to feedback and the dialogue.

18 MR. BROUSSARD:

19 It is the Board's rules allow for

20 anyone to make a request for a rule

21 making at any time. So that's always the

22 option, but I think the legislature

23 envisioned that some agencies might not

24 be such -- so open so they required every

25 agency to adopt this pattern of once

10

1 prior to January 1, 2020 and at least

2 every six years thereafter.

3 MR. CALLICOTT:

4 Thank you.

5 MR. BROUSSARD:

6 You're welcome. Seeing no one

7 rushing to the table, I'm going to place

8 the hearing in recess at 9:10 a.m. and if

9 anyone who wishes to make a comment,

10 please speak to either the Reporter or

11 myself and we'll put us back on the

12 record and enter the comment into the

13 record.

14 We are in recess at 9:11.

15 (THE MEETING WAS RECESSED.)

16 MR. BROUSSARD:

17 We will open the record again at

18 10:05.

19 MS. NGUYEN:

20 Hi. My name is Katrina Nguyen. And

21 what other information do you need? Just

22 my name?

23 MR. BROUSSARD:

24 Are you appearing for an organization

25 or just on your own?

11

1 MS. NGUYEN:

2 I appear on my own but I work at

3 Xavier.

4 MR. BROUSSARD:

5 The College of Pharmacy?

6 MS. NGUYEN:

7 Yes, the College of Pharmacy.

8 MR. BROUSSARD:

9 Okay.

10 MS. NGUYEN:

11 But I don't represent the College of

12 Pharmacy. I represent myself today.

13 MR. BROUSSARD:

14 Okay. Good.

15 MS. NGUYEN:

16 And I guess we are open to any rule I

17 would like to see possibly a requirement

18 to give pharmacist like a lunch break

19 because I felt like even though it's

20 salary, but a lot of time it does add to

21 the stress and everything when

22 pharmacists have to work without a

23 required lunch break. They just usually

24 take lunch when it calms down. But you

25 come and work at a store that's busy on a

12

1 day that, you know, with drive-through,

2 and on a day where you constantly

3 running, running, running, sometime it

4 takes a long time for people to start to

5 have their lunch like to 2:00, 3:00 p.m.

6 And like I felt, you know, even

7 minimum-wage worker get a lunch break and

8 so I felt like pharmacists with a higher

9 level of knowledge and the kind of work

10 we do, at least a lunch break should be

11 there. I know other states like

12 California require pharmacists to take a

13 lunch break, a 30 minute lunch break. So

14 I think if we can at least consider that

15 I know it's not there right now in the

16 book, but if that's possible it would

17 make it easier if you have to work on a

18 hunger or empty stomach, you know,

19 sometime you are easy to get upset,

20 you're not thinking straight.

21 I feel like, and especially for

22 people who have conditions, you know,

23 like if they're a diabetic patient and

24 their still working and if they're

25 hypoglycemic because they didn't get a

13

1 lunch break and weren't to eat and we're

2 not supposed to have food next to our

3 workstation, all right, so I felt like a

4 lunch would be a nice thing to have for

5 pharmacist.

6 MR. BROUSSARD:

7 Okay. Did you have any suggestions

8 about the length of the break?

9 MS. NGUYEN:

10 The length, it's up to -- I guess

11 it's open for suggestions, and if

12 possible, I understand it's a business.

13 They still have to run their business.

14 It's hard to close down for a long time.

15 Maximum, I would say an hour. Minimum,

16 half an hour. At least, you know, time

17 to warm it up or they need to go buy

18 something nearby quickly, they'll have

19 time to walk, run quickly, buy them and

20 then eat quickly and go.

21 And I feel like, you know, if you

22 have trusted technicians and trusted

23 intern who work there they can be, you

24 know, out, you know, like go to the back

25 and eat, you know, wherever and stuff,

14

1 you know, without interruption and then

2 -- or within the premise.

3 And then you know, still have a

4 pharmacy open and do everything else that

5 technician in pharma, you know, an intern

6 can do, you know, like selling

7 prescriptions that was already verified

8 and it's already been bagged up, things

9 like that. Still can run. So business

10 is not really losing half an hour of

11 their time, you know. A technician can

12 still always, you know, take in

13 prescriptions and type it in and get it

14 ready for the pharmacist to come back and

15 work on it. So I think that's, you know,

16 I think half an hour minimum should be,

17 you know, I feel like would be good.

18 MR. BROUSSARD:

19 Okay.

20 MS. NGUYEN:

21 I wouldn't think more than one hour

22 because that would be too long. I don't

23 know if employer like retail pharmacy

24 would be okay with that.

25 MR. BROUSSARD:

15

1 Okay.

2 MS. NGUYEN:

3 I also hold a license in California

4 so when I practiced in California, we're

5 a little different because we're, you

6 know, we have unions. And so union

7 required these companies to give us half

8 an hour lunch break.

9 MR. BROUSSARD:

10 Okay.

11 MS. NGUYEN:

12 So I think if we start at half an

13 hour it wouldn't be, you know, too much

14 to ask since already it is present in

15 other states.

16 MR. BROUSSARD:

17 Okay. If I could ask a question

18 about the California -- is it a union

19 rule or a Board rule for the 30 minutes?

20 MS. NGUYEN:

21 That's a good question. I don't

22 remember. It's been a while.

23 MR. BROUSSARD:

24 Okay. And is it only --

25 MS. NGUYEN:

16

1 I want to say more of a union thing

2 because I have to take a lunch break

3 within five hours of my clock-in time.

4 If I take longer than five hours, five

5 hours one minute then the company has to

6 pay me overtime and pay me the lunch

7 premium.

8 MR. BROUSSARD:

9 And that sort of leads to my next

10 question. Does the 30 minute rule apply

11 only to full-time employees? Does it

12 apply to part-time maybe who doesn't work

13 an eight hour or six hour?

14 MS. NGUYEN:

15 I always worked four hour shifts so I

16 never worked half hour, like half day

17 shift. But I would think it makes sense

18 you only extend that to a full-time

19 worker who's there eight hours and needs

20 to eat. But if it's like you work less

21 than four hours, working there for us --

22 union is different than salary. So in

23 union, full-time is ten hours not eight

24 hours then we earn overtime is after ten

25 hours. So if you work at least five

17

1 hours then you should get half an hour

2 lunch break. If you work less than that

3 you shouldn't be getting that. You

4 already have your break, five, ten,

5 fifteen minutes in between then.

6 MR. BROUSSARD:

7 Okay. So for instance, something

8 that Board could consider if an employee,

9 if a pharmacist works four hours or more

10 in single time, they're entitled to a

11 break of "x" minutes duration?

12 MS. NGUYEN:

13 Yeah. I think that would make sense.

14 I feel like with the recent changes most

15 of the company open for 12 hour shift,

16 but now they have changed that. I know

17 CVS do like overlapping shifts and stuff

18 so I think four hours that, you know, a

19 half an hour break with every four hours

20 make sense. But that's just a number we

21 are talking about. The Board still needs

22 to discuss about this.

23 MR. BROUSSARD:

24 And that's the Board's -- it's

25 actually this topic is already on the

18

1 agenda for the Board's Regulation

2 Revision Committee. There's a -- I

3 believe the agenda item is called the

4 Pharmacy Staffing and Patient Safety.

5 The Board has received some letters for

6 pharmacists with the same issues that

7 you've mentioned so the committees

8 looking at it and the difficulty is

9 trying to find something that's

10 reasonable that could apply to every

11 practice state.

12 Most pharmacist think about chain

13 drugstores because that's the most

14 common. But, of course, there are other

15 practice settings.

16 MS. NGUYEN:

17 I used to be an intern at Children's

18 Hospital and I feel like the staff

19 hospital pharmacist they do have their

20 entitled break. It's scheduled into

21 their work time and they can say I'm

22 going to take a lunch break and when they

23 take a lunch break, I believe, I do want

24 to say the wrong number. I want to say

25 they have an hour because, you know, they

19

1 go down and the line is long and by the

2 time you get your food it's time to go

3 back to work so I think again, an hour

4 lunch break and then return.

5 Like someone leave at 11:00. Someone

6 leave at 12:00. Someone leave at 1:00.

7 Someone leave at 2:00. But they take

8 turns and they do have lunch break built

9 in. At least at the hospital that I work

10 at as an intern I observed that. And

11 even myself, all day I get that much

12 break. I want to say an hour.

13 I have no clear memory, I don't know,

14 but most community pharmacy where it's an

15 independent pharmacy, they're usually

16 pretty good about giving you lunch break,

17 I find that retail company are the one

18 that tends to put that aside more and a

19 lot of time for pharmacists, we know it

20 ourselves, we, you know, I'll just say it

21 out loud, you know.

22 A lot of time they're overworked

23 because they're always working with a

24 larger volume of scripts with less people

25 to help and most company only hire

20

1 another pharmacist if you increase your

2 volume to like every 200 prescription for

3 example. So if somebody who is working

4 398 prescription, they still only get one

5 helper. But they're working, if you

6 round it up, it'll be at like 400 volume,

7 but they only get one worker because they

8 didn't make the next 200 mark.

9 So they're actually working overtime

10 but just the thought that somebody who

11 had two helpers, you see, because of

12 that, they felt obligated to skip lunch,

13 skip break, only take bathroom break when

14 they have to take the break and then work

15 around the clock because they have to

16 deliver otherwise, you know, the customer

17 comes, complains and we want our

18 customers and our patients to have trust

19 in us to know that, you know, we have

20 their health at heart and we can't do

21 that if we're constantly worrying about

22 taking things out and forget the human

23 factor.

24 We're worried about the, you know,

25 process, getting it out, getting it out.

21

1 You know a lot a company flag you if you

2 didn't get it out in time and all of

3 that. So working under constant pressure

4 like that sometime when you, you know,

5 it's just like myself and I had to study

6 for an exam or you take a test, sometimes

7 you got tunnel vision. So pharmacist

8 working. They also work in that sense.

9 They also like worry about let me crank

10 it out and not get the customer upset and

11 get a complaint.

12 And, you know, meet the demand of the

13 employer like you got to pick up the

14 phone by how many. We got to finish the

15 prescription by how many minutes. And I

16 know the board don't have any, you know,

17 control over that. That's the company's

18 policy. But I just felt like if we can

19 make it easier for them, at least give

20 them a lunch break, they can at least

21 take a rest.

22 I feel like sometimes 30 minute rest

23 is really good to recharge and go back in

24 because otherwise pharmacist that want to

25 do more for their patients, counsel

22

1 patients which I know we're required to

2 do, but you know, I'll tell you the truth

3 that when I see some pharmacist who

4 doesn't counsel at all because they just

5 so busy just trying to crank it out.

6 And they don't want -- they're more

7 concerned about patient getting upset.

8 And also, we understand in patient treat

9 pharmacy like, I go and grab something

10 and that's it, you know. They don't give

11 the pharmacist the fair amount of time to

12 really put the things out correctly, to

13 make it and to work to process everything

14 correctly, especially drive-through.

15 They're thinking like McDonald's, you

16 know, and we can't blame the consumer,

17 out patients patience when the industry

18 kind of allowed them to, kind of mislead

19 them to think that that's the way it

20 should be.

21 And it's all because of business.

22 It's because of volume. It's all because

23 of the money. And I understand you have

24 to, you know, make revenue to sustain the

25 business. So I feel like and I

23

1 understand that there's a lot that the

2 Board cannot do that because it is a

3 company. They have the right to do that

4 and how to run their own business.

5 But I feel like if we can possibly at

6 least help them lighten the load a little

7 bit by giving them a 30 minute break.

8 They can sit down away from all the

9 volume because a lot of time what I find

10 is even the pharmacist, when it slow down

11 and they take a lunch and they heat their

12 food up to take a lunch, sometime if they

13 have a walk in, they get to stop what

14 they're doing, come back and finish it

15 before they come and finish their food.

16 So it's not really sitting down eating,

17 you know.

18 And so if they can just be away and

19 then be away from the pharmacy, move

20 back, if they want to be at the pharmacy

21 that's their choice but at least we give

22 them a break that they deserve. And, you

23 know, I feel like especially patients

24 with conditions, you know, I mean we're

25 pharmacist. We're still human and we

24

1 have people who aging, who have diabetes

2 and if they have to work, you know, and

3 having a hypoglycemic episodes like

4 headache, it is really hard to make sound

5 decisions and it 's really hard to make

6 things, work things fast.

7 If you have GERD, acid reflux, you

8 dealing with all the time acid coming up,

9 it just, you know, I think it's fair to

10 at least have half an hour for every, you

11 know, if could be four hour, it could be

12 five hours, whichever the number,

13 whichever the Board consider to be a

14 full-time split in half.

15 MR. BROUSSARD:

16 I mean I think the Board conundrum is

17 recognizing that a business has the right

18 to establish its own policies and

19 procedures. However, the business has a

20 permit from the Board to operate a

21 pharmacy in a manner that's to protect

22 the public health and safety. And what

23 you've indicated is that there are times

24 when some of the business policies and

25 procedures may place a pharmacist in such

25

1 a position that public safety might be

2 compromised.

3 MS. NGUYEN:

4 Yes, I feel so. Other company don't

5 say that you don't have a break. They do

6 say you can a break. It's just it's not

7 required within how many timeframe and so

8 pharmacist sometime work, you know, long

9 hours and skip lunch and sometimes after

10 you are hungry then you're not hungry

11 anymore. So when it slow down they can't

12 really eat. They don't have appetite to

13 eat anymore. But I felt like if the head

14 pharmacist health is not be safe, if they

15 have conditions then it will interfere

16 with the work that they will do and then

17 it will affect the patient safety.

18 MR. BROUSSARD:

19 So how would you counter the argument

20 that sometimes comes up in these kinds of

21 conversations -- how would you counter

22 the argument that the Board should not

23 regulate to that level of detail that if

24 the pharmacist doesn't like the working

25 conditions, they should just go find a

26

1 job someplace else?

2 MS. NGUYEN:

3 So I would counter by saying that

4 there's precedent like the Board of

5 Pharmacy -- I mean in California a

6 company works that way so it's possible.

7 And they have the same company over there

8 like over here. So they can consult

9 within their company to see if that hurt

10 their business at all. I don't think it

11 hurt their business at all. In fact,

12 it's actually helped because when

13 pharmacist can work better they can

14 relate with people better and that's how

15 you keep your volume. That's how you

16 keep your patient.

17 You just mentioned it, Mr. Broussard,

18 about the fact that the Board can

19 initiate policy if it concerns public

20 safety. So the Board do have a little, I

21 guess, you know, a little legality way to

22 at least be involved instead of being

23 completely hands off. So when it comes

24 to safety, like my example of diabetic

25 pharmacist. They have the right to take

27

1 care themselves too. And, you know, if

2 they have to eat, you have the pharmacist

3 who are pregnant and who needs to

4 breast-feed and who needs to go pump and

5 they cannot do that when they don't have

6 a break.

7 All of that factor in, breast-feeding

8 mothers, you know, can do that. And as

9 far as why not work at another company?

10 Well, every company functions that way.

11 If I like community and every company,

12 almost every company functions that way,

13 you talk about major retail chains, you

14 know, then it's just not fair for the

15 pharmacist. I also feel that they also

16 make the company looks more humane if

17 they allow pharmacist to have a break.

18 At least they show that they care about

19 the employee and their employee is not

20 just a number that can be replaced.

21 I also feel that it's easy to say

22 that, you know, you don't like it, go

23 somewhere else. But that's just like a

24 way of taking off your responsibility

25 that you're supposed to have. Isn't it

28

1 part of labor law that you supposed to at

2 least provide a working environment for

3 your employee, whether it's, you know,

4 ventilation, air, safety. So shouldn't

5 that be part of the safety about the

6 health. Health is a safety. It's a

7 major safety.

8 What if we have a pharmacist who's

9 hypoglycemic and then hits something.

10 Now that bills going to go up with what

11 do you call that -- worker compensation.

12 And we're not just talking about that.

13 We're talking about the safety of the

14 pharmacist. And if the technician gets

15 breaks but the pharmacist doesn't, you

16 know. It just doesn't make sense.

17 I felt like we work -- we are working

18 at a higher degree level, profession

19 level profession. At a minimum we should

20 get a lunch break just like everyone else

21 and you know you can also say other,

22 every other business provide a lunch

23 break for their worker. I don't see why

24 it's impossible for company to do that

25 for pharmacists. Their manager, front-

29

1 end, get a lunch break. Their cashier

2 get lunch break. Everybody in the

3 company get a lunch break except the

4 pharmacist. You know, it's required.

5 They go punch out and take break.

6 Pharmacist care enough about the patient

7 and the employer to skip lunch break to

8 perform well and they deserve at least

9 recognition that they deserve a break.

10 I feel like it's a basic minimum

11 working condition. You can't expect

12 someone to go hungry for hours and work

13 well and perform well. You know, the

14 basic needs of humans is you know, food,

15 clothing and shelter. So I feel that how

16 I would counter the company. Everybody

17 needs lunch breaks. It's not something

18 new. I know this. It's not a novel idea

19 that nobody ever worked with before.

20 Within their own company, like I say,

21 everyone get lunch break, you know the

22 cashier, the stock person, the front-end

23 manager, you know, everyone get a lunch

24 break, even technician do and just

25 pharmacist is not. I mean they get it,

30

1 the lunch break, but it's never make it

2 to the point where pharmacist are forced

3 to do it. If you don't force them to

4 take it, they feel that they have to -- I

5 mean they want to keep their job so they

6 have to skip it to do it.

7 MR. BROUSSARD:

8 Okay.

9 MS. NGUYEN:

10 And don't think you asking for long

11 hours. Just half an hour, no more than

12 an hour, you know. I think we only get

13 half an hour in California because the

14 Board in California I believe say that

15 the pharmacy can be opened without a

16 pharmacist present for no more than 30

17 minutes. So if the business is located

18 in a shopping center, you know, the

19 pharmacist can go to the next door store,

20 and it's still considered within the

21 premise of entire business structure, not

22 within the retail company itself.

23 And so in California, you can walk

24 next door to a restaurant next door and

25 get food there and then come back within

31

1 30 minutes then the pharmacy is okay to

2 open. If the pharmacist leave more than

3 30 minutes, then the Board require the

4 pharmacy to close down and then put a

5 return time. And usually that's why we

6 don't do that. We only do 30 minutes.

7 MR. BROUSSARD:

8 And that is actually a fairly common

9 rule among the states. Louisiana has the

10 same. It's called a temporary absence

11 and it's 30 minutes. The pharmacy may be

12 open for up to 30 minutes without a

13 pharmacist present.

14 MS. NGUYEN:

15 So I guess it makes sense to make it

16 a 30 minute time frame then. And then

17 they don't have to close the place down

18 and then the business would be more

19 willing to agree with it if they didn't

20 have to close the business down. Because

21 for business, if I'm a customer and I

22 come in during the time the pharmacist

23 take a break then -- and they come twice

24 like that, I will probably figure what

25 kind of business are they running here.

32

1 I won't come back. So I think 30 minute

2 would be a time we should give them that

3 way they can still stay open. In fact,

4 we supposed to put a sign saying the

5 pharmacist will take their break from

6 this time to this time, an announcement

7 like, by the counter and the drop off and

8 pick up counter there's a sign saying

9 that. Our pharmacist will take a lunch

10 from this time to that time frame, but we

11 will still be open for regular

12 transactions, you know, like pick up

13 transaction.

14 So we have a sign to put it back then

15 everyone would understand that and it

16 won't interfere with their business. I

17 hope that will get passed and it will be

18 good for everyone.

19 MR. BROUSSARD:

20 It's a relatively new item on their

21 agenda, only the last two to three months

22 I think. They have had some

23 conversations. But they're struggling

24 with trying to find the right balance.

25 MS. NGUYEN:

33

1 I see.

2 MR. BROUSSARD:

3 So you can find the agenda for the

4 Regulation Revision Committee on the

5 Board's website. Their next meeting I

6 believe is July 24th. It's a long agenda

7 so I don't know if they'll se spend time

8 on that particular topic. But the

9 committee has been assigned that topic by

10 the Board for them to develop a proposal

11 and come to the Board with that for them

12 to consider that.

13 MS. NGUYEN:

14 I see. So I don't know if I can come

15 in July here because, you know, I drive

16 from New Orleans and my son has to be out

17 there waiting, you know. I am the only

18 caretaker and it's summer and he's

19 outgrown the age to go to daycare so I

20 had to drag him with me. But I will keep

21 on looking forward to news from the Board

22 or an e-mail from the Board so I can keep

23 up-to-date with that.

24 MR. BROUSSARD:

25 And when the Board does develop a

34

1 proposal, it would go through the

2 ordinary rulemaking process where we

3 publish a notice of intent and we have a

4 public hearing like this to receive

5 comments and testimony. So even if

6 you're not able to be here personally, we

7 can accept written comments and testimony

8 so you always have that opportunity as

9 well.

10 MS. NGUYEN:

11 Right. That's good to know. My only

12 -- I don't know if this is possible and

13 because I communicate a lot with the

14 student pharmacists, and if it's the way

15 the Board -- the way the law book is

16 organized, a lot of time I hear comments

17 from students pharmacists and maybe they

18 don't know any better. I'm not an expert

19 either. I don't have a JD so I'm not an

20 expert either but they feel that the --

21 you know they always ask me how come if

22 -- and we talk about marijuana

23 regulations and law and procedure rules.

24 How come it's like some of them it's

25 in this section, some of it in the

35

1 chapter, some of it's in that chapter.

2 And they find like how do I look at all

3 the chapter. I mean they're supposed to

4 look at everything when they study

5 anyway. But like when they want to come

6 back and read about it, let's say they

7 get licensing already and then the

8 marijuana law passed and so they wanted

9 to go back and look at it, you now, it's

10 just the way we organize it, it seems

11 like it's a little bit here, a little bit

12 there in different chapter.

13 So I don't know if it's possible if

14 we organize everything in one chapter

15 which I figure probably not. And I

16 explain it to them that the Board

17 organizes that way because certain part

18 of the marijuana law is talking about

19 licensing and then it goes through

20 licensing section, the registration

21 licensing section. And the other part is

22 dispensing. It goes through the

23 pharmacist responsibility who's

24 dispensing.

25 So, you know, I feel like since I'm

36

1 here I should bring it up since that's

2 the comments I get a lot from the

3 student. They find it confusing to

4 navigate the law book, you know, so. And

5 I don't know how they time there, they'll

6 look at it before they give me that

7 comment. They may not only -- they may

8 just look at once, skim it through and

9 just say that.

10 MR. BROUSSARD:

11 And I appreciate the comments about

12 the law book because I'm the editor of

13 it. I put it together at the Board's

14 direction. And it's organized basically

15 into laws which are passed by the

16 legislature are presented first. And

17 then the rules that are adopted by the

18 Board come after the laws.

19 MS. NGUYEN:

20 Okay.

21 MR. BROUSSARD:

22 With respect to marijuana, there is a

23 law from the legislature about marijuana.

24 That's in one section. And there's a

25 chapter -- a subchapter of rules about

37

1 marijuana pharmacies. So relative to

2 marijuana, medical marijuana, there are

3 two places in the book where it appears.

4 MS. NGUYEN:

5 Thank you for that. Now that I

6 understand how it's organized and knowing

7 better, I can just make a comment better

8 for them. And what I explained earlier

9 doesn't, you know.

10 MR. BROUSSARD:

11 I guess a recommendation I would

12 offer is spend just a few moments looking

13 at that Table of Contents in the front of

14 the book and you can see how -- how it's

15 laid out and organized. But the other

16 thing is, it is in Adobe PDF document,

17 electronically searchable so keying a

18 couple of search terms, marijuana, for

19 instance, will give you the places where

20 that appears and marijuana will also

21 appear in the Criminal Section in

22 Schedule I because that's where it's

23 listed. But then you'll see the big

24 section of law that the legislature

25 passed that authorizes that to be

38

1 recommended and dispensed in the section

2 of rules that has all of the details

3 about how all that is done.

4 But the basic structure is the laws

5 are presented and then the rules are

6 presented.

7 MS. NGUYEN:

8 Now that I understand how it's

9 organized better, I can explain that to

10 them better. I'm aware of the sections

11 they are at. I just didn't see it

12 organized in that sense. Like I say, I'm

13 not a JD and so for me --

14 MR. BROUSSARD:

15 I'm not an attorney either. And I

16 don't know if anyone else would want to

17 reorganize it. They're certainly free to

18 do so.

19 MS. NGUYEN:

20 I like the way you have it. It makes

21 sense the way we have it now. It makes

22 sense. I just brought the comment up

23 because students keep asking me about

24 that.

25 MR. BROUSSARD:

39

1 It's good to hear that.

2 MS. NGUYEN:

3 And I don't have a good explanation.

4 Now that I know the way it is organized I

5 have a better explanation for them and I

6 didn't remember or think of like the

7 search functions on Adobe.

8 MR. BROUSSARD:

9 Right.

10 MS. NGUYEN:

11 If I remember that I would have been

12 able to just comment on that.

13 MR. BROUSSARD:

14 We don't attempt to do a manual index

15 because know we know it's electronically

16 searchable with the Adobe product but the

17 Table of Contents is there as well and I

18 think just a few minutes reviewing that,

19 seeing how it's laid out, laws and then

20 rules, and that way if you have a

21 specific question you probably have a

22 pretty good idea of where to begin your

23 search. Or if you don't, you can always

24 use electronic search terms.

25 MS. NGUYEN:

40

1 Yeah. So now I know I will be able

2 to give feedback on that comment from the

3 students now.

4 MR. BROUSSARD:

5 But we're always open as well if they

6 have an idea for reorganization, that's

7 something that they believe would be more

8 functional, we're certainly open to

9 hearing that.

10 MS. NGUYEN:

11 I think their thought processes are

12 that really -- they felt like they don't

13 really have to know which one is

14 legislature and which one is rulemaking,

15 rule. They just know what they need to

16 know to get their license. And when they

17 think that way, you know, it just changes

18 the way how it's organized. But I think,

19 you know, what we have makes more sense.

20 After all, this is a law making entity so

21 it's to be organized that way.

22 MR. BROUSSARD:

23 And the other reality is that we have

24 all kinds of clients, not just our

25 licensees. We have people in the

41

1 industry who are attorneys, some are not

2 attorneys. There are all kinds of

3 clients for the Board's law book. We

4 certainly would hope that our licensees

5 would be able to use the book to find

6 what they need in a reasonable amount of

7 time. But there were other clients

8 beside licensees that we have to be aware

9 of and take care as well.

10 MS. NGUYEN:

11 And I mean the search button should

12 serve the purpose to search in a

13 reasonable time. It's just I didn't

14 think of that. I wasn't thinking, quick

15 thinking enough to think of that function

16 when they ask me those questions. And

17 because I have more than one person who

18 asked me that, that's why I thought,

19 okay, make sure I bring this up.

20 This had nothing to do I guess the

21 other rules and the law book, you know.

22 Just some feedback.

23 MR. BROUSSARD:

24 It's relevant because it's all of the

25 laws rule and they are contained in the

42

1 law book so that's reasonable. I

2 appreciate the comment.

3 MS. NGUYEN:

4 Thank you for being open.

5 MR. BROUSSARD:

6 Your welcome.

7 MS. NGUYEN:

8 I think that's all I have as far as,

9 you know, the rule book. I think I want

10 to close, as least, you know, option for

11 pharmacist. I think the only other thing

12 is -- I mean I know it's like -- it's an

13 issue over and over again. But I don't

14 know where the Board stands on even the

15 law enforcement stands when it come to

16 marijuana regulation since, you know,

17 the federal government still considers it

18 to be Schedule I although they've been

19 open up a little bit more where this can

20 kind of -- dosage form according to the

21 plant.

22 MR. BROUSSARD:

23 And that's part of the law and it's

24 part of the rule so is it just a question

25 or a suggestion?

43

1 MS. NGUYEN:

2 You know what, I think just disregard

3 that one.

4 MR. BROUSSARD:

5 Okay.

6 MS. NGUYEN:

7 Yeah. Disregard it.

8 MR. BROUSSARD:

9 And you're right. Federally it is

10 still a Schedule I substance. Louisiana

11 has adopted a law as have other states

12 that authorizes the use of the marijuana

13 for medical purposes. In fact, in the

14 Board's rule for marijuana pharmacies,

15 the very section, we call it a preamble

16 and a warning, first section, the

17 legislature directed the Board to adopt

18 these rules.

19 The second section marijuana is still

20 a Schedule I substance and if you have a

21 federal registration you are at risk of

22 violating your federal registration

23 because nothing the state does can

24 override a federal law.

25 And the third section is knowing

44

1 this, if you want to move forward this,

2 if you want to move forward in this line

3 of work, consult your legal counsel.

4 MS. NGUYEN:

5 Oh, okay. So what about the

6 consumer, if the consumer get the

7 recommendation from the provider and went

8 to the dispensary and get some and

9 somehow they have a car accident or they

10 have a ticket and then the police officer

11 find, you know, find trace or smell it

12 and then I wonder how that would go if

13 it's within Louisiana are they still

14 going to be processed, prosecuted

15 according to the law?

16 MR. BROUSSARD:

17 No. And that's actually in the --

18 there's a section about that in the

19 controlled substance law and there's

20 immunity from prosecution for patients

21 who have legitimately acquired medical

22 marijuana products. They will not be

23 able to smell it because the law

24 prohibits the use of marijuana in its raw

25 form. It must be a pharmaceutical grade

45

1 product so it will not smell like

2 marijuana. We would certainly caution

3 consumers to keep it in the labeled

4 container that comes from the marijuana

5 pharmacy so that it's obvious that it was

6 dispensed properly. But the law does

7 provide immunity from prosecution to

8 patients who have legitimately acquired

9 product.

10 Now that only applies to Louisiana.

11 It wouldn't apply in any other state.

12 And you raise and interesting question

13 actually not so much in terms of a car

14 accident, but perhaps an employment

15 situation for employees who are using the

16 product if they are a subject to drug

17 testing.

18 MS. NGUYEN:

19 That's true.

20 MR. BROUSSARD:

21 Employment law is federal in origin.

22 Workers' Compensation is federal in

23 origin. Some case law from Colorado

24 suggests that while the consumer in

25 Colorado was protected under state law,

46

1 they did not escape the reach of the

2 federal law. So if it was an employment

3 situation, if the question arose in a

4 court of law, the court was obligated to

5 side with federal because federal law

6 still prohibits the use of marijuana.

7 And I think Louisiana will experience

8 those same kinds of situations where we

9 have an intersection of state and federal

10 law that are not consistent. State law

11 covers but federal laws still prohibits.

12 So there's -- there will be situations

13 coming in the future as patients begin to

14 use the marijuana products and find

15 themselves in situations where federal

16 law still prevails.

17 MS. NGUYEN:

18 So pretty much use it and dispense it

19 at your own risk and consult with an

20 attorney.

21 MR. BROUSSARD:

22 That's the guidance we put in our --

23 the very first section of our marijuana

24 rules is yes, the legislature told us to

25 do these rules but you know, as long as

47

1 marijuana is still Schedule 1, there's

2 this junction here so if you have any

3 exposure to federal authority, either in

4 the form of a DEA registration, your

5 employer accepts federal funds in the

6 school, for instance, of if your employer

7 has federal exposure in terms of

8 employment law, Workers' Compensation,

9 other areas as well, just because the

10 state passes a law doesn't mean it

11 overrides federal law.

12 MS. NGUYEN:

13 I understand. The federal law is

14 stricter so comply with them.

15 MR. BROUSSARD:

16 Yes. Yes.

17 MS. NGUYEN:

18 Thank you for clearing that up.

19 MR. BROUSSARD:

20 You're welcome.

21 MS. NGUYEN:

22 And I have no more comments.

23 MR. BROUSSARD:

24 Okay.

25 MS. NGUYEN:

48

1 Thank you.

2 MR. BROUSSARD:

3 Thank you for coming today.

4 MS. NGUYEN:

5 It was a good experience. It was

6 good to see you.

7 MR. BROUSSARD:

8 Good to see you again.

9 MS. NGUYEN:

10 It was such a great review for the

11 student. I hope they will do well.

12 MR. BROUSSARD:

13 I hope so too.

14 MS. NGUYEN:

15 Yes, yes. And hopefully you come

16 back to us and do it more, every year for

17 us.

18 MR. BROUSSARD:

19 If they ask, I will try.

20 MS. NGUYEN:

21 It would be great.

22 MR. BROUSSARD:

23 Good. Take care. Bye-bye.

24 There are no other commentators in

25 the room. It is 10:35. We are back in

49

1 recess.

2 (THE MEETING WAS RECESSED.)

3 MR. BROUSSARD:

4 We are back in session and on the

5 record. The time is now 12:00 noon.

6 There's no commentator in the room. No

7 one has alerted us as to their pending

8 arrival. This public hearing is now

9 adjourned.

10

11 (THE HEARING ADJOURNED AT 12:00 P.M.)

12

13

14

15

16

17

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20

21

22

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50

1 C E R T I F I C A T E

2 This certification is valid only for a

3 transcript accompanied by my original signature

4 and official seal on this page.

5 I, SUSAN ERKEL, Certified Court Reporter, in

6 and for the State of Louisiana, as the officer

7 before whom this hearing was taken, do hereby

8 certify that the foregoing 49 pages

9 were reported by me in the voice-writing method,

10 and was prepared and transcribed by me or under

11 my personal direction and supervision, and is a

12 true and correct transcript to the best of my

13 ability and understanding;

14 That the transcript has been prepared in

15 compliance with transcript format guidelines

16 required by statute or by rules of the board, and

17 that I am informed about the complete

18 arrangement, financial or otherwise, with the

19 person or entity making arrangements for

20 deposition services;

21 That I have acted in compliance with the

22 prohibition on contractual relationships, as

23 defined by Louisiana Code of Civil Procedure

24 Article 1434 and in rules and advisory opinions

25 of the board;

51

1 That I have no actual knowledge of any

2 prohibited employment or contractual

3 relationship, direct or indirect, between a court

4 reporting firm and any party litigant in this

5 matter nor is there any such relationship between

6 myself and a party litigant in this matter; and

7 That I am not related to counsel or to the

8 parties herein, nor am I otherwise interested in

9 the outcome of this matter.

10

11

12 _________________________

13 SUSAN ERKEL

14 CERTIFIED COURT REPORTER

15 LICENSE NO. 24005

16

17

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23

24

25

52

1 R E P O R T E R ' S P A G E

2

3 I, SUSAN ERKEL, Certified Court Reporter

4 in and for the State of Louisiana, before

5 whom this statement was taken, do hereby

6 state on the Record:

7 That due to the interaction in the

8 spontaneous discourse of this proceeding,

9 dashes (--) have been used to indicate

10 pauses, changes in thought, and/or talkovers;

11 That same is the proper method for a

12 Court Reporter's transcription of

13 proceedings, and that the dashes (--) do not

14 indicate that words or phrases have been left

15 out of this transcript;

16 That any words and/or names which could

17 not be verified through reference material

18 have been denoted with the phrase "(spelled

19 phonetically)."

20

21

22 __________________________

23 SUSAN ERKEL

24 CERTIFIED COURT REPORTER

25 LICENSE NO. 24005

STATE OF LOUISIANA PARISH OF EAST BATON ROUGE LOUISIANA BOARD OF PHARMACY

Public HearingJune 26, 2019

A

able (5) 34:6;39:12;40:1; 41:5;44:23absence (2) 4:10;31:10accept (1) 34:7accepts (1) 47:5accident (2) 44:9;45:14accordance (1) 5:21according (2) 42:20;44:15acid (2) 24:7,8acquired (2) 44:21;45:8Act (3) 5:22;8:15,17Activity (1) 6:10actually (6) 17:25;20:9;26:12; 31:8;44:17;45:13add (1) 11:20addition (2) 5:5;7:10Additional (1) 5:14adjourned (2) 49:9,11Administrative (1) 5:22Adobe (3) 37:16;39:7,16adopt (2) 9:25;43:17adopted (3) 8:14;36:17;43:11affect (1) 25:17Again (5) 7:22;10:17;19:3; 42:13;48:8age (1) 33:19agencies (1) 9:23agency (2) 8:18;9:25agenda (6) 7:8;18:1,3;32:21; 33:3,6aging (1) 24:1agree (1) 31:19

air (1) 28:4alerted (1) 49:7allow (2) 9:19;27:17allowed (1) 22:18almost (1) 27:12although (1) 42:18always (10) 9:5,16,21;14:12; 16:15;19:23;34:8,21; 39:23;40:5among (1) 31:9amount (2) 22:11;41:6announcement (1) 32:6anticipate (2) 8:9,13anymore (2) 25:11,13appear (2) 11:2;37:21appearing (1) 10:24appears (2) 37:3,20appetite (1) 25:12applies (1) 45:10apply (4) 16:10,12;18:10; 45:11appreciate (2) 36:11;42:2area (2) 5:14,19areas (1) 47:9argument (2) 25:19,22Aron (1) 4:11arose (1) 46:3around (1) 20:15arrival (1) 49:8aside (1) 19:18assembled (1) 4:5assigned (1) 33:9attempt (1) 39:14

attorney (2) 38:15;46:20attorneys (2) 41:1,2authority (2) 8:19;47:3authorizes (2) 37:25;43:12available (3) 5:15;7:9,15aware (2) 38:10;41:8away (3) 23:8,18,19

B

back (16) 5:9;10:11;13:24; 14:14;19:3;21:23; 23:14,20;30:25;32:1, 14;35:6,9;48:16,25; 49:4bagged (1) 14:8balance (1) 32:24basic (3) 29:10,14;38:4basically (1) 36:14bathroom (1) 20:13Baton (1) 4:7begin (3) 8:4;39:22;46:13belong (1) 5:12beside (1) 41:8better (8) 26:13,14;34:18; 37:7,7;38:9,10;39:5big (1) 37:23bills (1) 28:10bit (4) 23:7;35:11,11; 42:19blame (1) 22:16Board (34) 4:6,9,11;5:13;6:6,8, 18,25;9:5;15:19;17:8, 21;18:5;21:16;23:2; 24:13,16,20;25:22; 26:4,18,20;30:14; 31:3;33:10,11,21,22, 25;34:15;35:16; 36:18;42:14;43:17Boardroom (1)

4:5Board's (12) 5:19;6:4;7:14,16, 24;9:19;17:24;18:1; 33:5;36:13;41:3; 43:14Book (12) 7:12;12:16;34:15; 36:4,12;37:3,14;41:3, 5,21;42:1,9break (44) 11:18,23;12:7,10, 13,13;13:1,8;15:8; 16:2;17:2,4,11,19; 18:20,22,23;19:4,8, 12,16;20:13,13,14; 21:20;23:7,22;25:5,6; 27:6,17;28:20,23; 29:1,2,3,5,7,9,21,24; 30:1;31:23;32:5breaks (2) 28:15;29:17breast-feed (1) 27:4breast-feeding (1) 27:7Brentwood (1) 4:7bring (2) 36:1;41:19brought (1) 38:22BROUSSARD (54) 4:2,8;8:11;9:2,18; 10:5,16,23;11:4,8,13; 13:6;14:18,25;15:9, 16,23;16:8;17:6,23; 24:15;25:18;26:17; 30:7;31:7;32:19;33:2, 24;36:10,21;37:10; 38:14,25;39:8,13; 40:4,22;41:23;42:5, 22;43:4,8;44:16; 45:20;46:21;47:15, 19,23;48:2,7,12,18, 22;49:3building (5) 4:24;5:9,10,11,20built (1) 19:8burdensome (1) 6:24business (19) 13:12,13;14:9; 22:21,25;23:4;24:17, 19,24;26:10,11; 28:22;30:17,21; 31:18,20,21,25;32:16busy (2) 11:25;22:5button (1) 41:11buy (2)

13:17,19Bye-bye (1) 48:23

C

California (8) 12:12;15:3,4,18; 26:5;30:13,14,23call (4) 4:12,19;28:11; 43:15called (2) 18:3;31:10CALLICOTT (5) 8:8,25;9:3,15;10:3calms (1) 11:24can (33) 12:14;13:23;14:6,9, 11;18:21;21:18,20; 23:5,8,18;25:6;26:8, 13,13,18;27:8,20; 28:21;30:15,19,23; 32:3;33:3,14,22;34:7; 37:7,14;38:9;39:23; 42:19;43:23candidates (1) 6:15car (2) 44:9;45:13care (5) 27:1,18;29:6;41:9; 48:23caretaker (1) 33:18Carl (1) 4:11case (1) 45:23cashier (2) 29:1,22caution (1) 45:2cell (1) 4:16center (1) 30:18certain (1) 35:17certainly (4) 38:17;40:8;41:4; 45:2chain (1) 18:12chains (1) 27:13changed (1) 17:16changes (2) 17:14;40:17chapter (6) 35:1,1,3,12,14;

Min-U-Script® Associated Reporters, Inc.225 216 2036

(1) able - chapter



36:25chapters (1) 7:14Children's (1) 18:17choice (1) 23:21clarify (1) 7:20clear (1) 19:13clearing (1) 47:18clients (3) 40:24;41:3,7clock (1) 20:15clock-in (1) 16:3close (5) 13:14;31:4,17,20; 42:10clothing (2) 5:16;29:15College (3) 11:5,7,11Colorado (2) 45:23,25comfort (1) 4:25coming (3) 24:8;46:13;48:3comment (8) 10:9,12;36:7;37:7; 38:22;39:12;40:2; 42:2commentator (1) 49:6commentators (1) 48:24comments (15) 6:3,20,25;7:4,5,23; 8:1,4,5;34:5,7,16; 36:2,11;47:22Committee (3) 18:2;33:4,9committees (1) 18:7common (2) 18:14;31:8communicate (1) 34:13communications (1) 4:17community (2) 19:14;27:11companies (1) 15:7company (20) 16:5;17:15;19:17, 25;21:1;23:3;25:4; 26:6,7,9;27:9,10,11, 12,16;28:24;29:3,16,

20;30:22company's (1) 21:17compensation (3) 28:11;45:22;47:8complains (1) 20:17complaint (1) 21:11completely (1) 26:23complex (1) 6:23comply (1) 47:14compromised (1) 25:2concerned (1) 22:7concerns (1) 26:19condition (1) 29:11conditions (4) 12:22;23:24;25:15, 25conduct (1) 8:19confusing (1) 36:3connecting (1) 5:18consider (6) 6:25;9:8;12:14; 17:8;24:13;33:12consideration (1) 7:24considered (1) 30:20considers (1) 42:17consistent (1) 46:10constant (1) 21:3constantly (2) 12:2;20:21consult (3) 26:8;44:3;46:19consumer (4) 22:16;44:6,6;45:24consumers (1) 45:3contained (1) 41:25container (1) 45:4Contents (3) 7:11;37:13;39:17contrary (1) 6:22control (1) 21:17

controlled (2) 6:17;44:19conundrum (1) 24:16convene (1) 9:5convened (2) 5:24;6:19conversations (2) 25:21;32:23cooler (1) 5:5Copies (1) 7:8copy (1) 7:10correctly (2) 22:12,14counsel (3) 21:25;22:4;44:3counter (6) 25:19,21;26:3; 29:16;32:7,8couple (1) 37:18course (1) 18:14court (2) 46:4,4courtesy (1) 4:14covers (1) 46:11crank (2) 21:9;22:5Criminal (1) 37:21current (1) 7:2customer (3) 20:16;21:10;31:21customers (1) 20:18CVS (1) 17:17

D

day (4) 12:1,2;16:16;19:11daycare (1) 33:19DEA (1) 47:4deadline (1) 7:25dealing (1) 24:8debate (1) 7:21decisions (1) 24:5degree (1)

28:18deliver (1) 20:16demand (1) 21:12deserve (3) 23:22;29:8,9desk (1) 7:10detail (1) 25:23details (1) 38:2determination (1) 9:9determine (1) 7:1develop (2) 33:10,25devices (1) 4:17diabetes (1) 24:1diabetic (2) 12:23;26:24dialogue (1) 9:17different (3) 15:5;16:22;35:12difficulty (1) 18:8directed (1) 43:17direction (1) 36:14Director (1) 4:10discuss (1) 17:22dispensary (1) 44:8dispense (1) 46:18dispensed (2) 38:1;45:6dispensing (2) 35:22,24disregard (2) 43:2,7distributed (1) 6:9document (1) 37:16done (1) 38:3door (6) 4:22,24;5:4;30:19, 24,24dosage (1) 42:20down (10) 11:24;13:14;19:1; 23:8,10,16;25:11;

31:4,17,20drag (1) 33:20Drive (2) 4:7;33:15drive-through (2) 12:1;22:14drop (1) 32:7drug (1) 45:16drugstores (1) 18:13duration (1) 17:11during (1) 31:22

E

earlier (1) 37:8earn (1) 16:24easier (2) 12:17;21:19easy (2) 12:19;27:21eat (7) 13:1,20,25;16:20; 25:12,13;27:2eating (1) 23:16edition (1) 6:7editor (1) 36:12eight (3) 16:13,19,23either (5) 10:10;34:19,20; 38:15;47:3electronic (4) 4:16;6:9,11;39:24electronically (2) 37:17;39:15else (6) 4:14;14:4;26:1; 27:23;28:20;38:16e-mail (1) 33:22emergency (1) 4:21employee (4) 17:8;27:19,19;28:3employees (2) 16:11;45:15employer (5) 14:23;21:13;29:7; 47:5,6employment (4) 45:14,21;46:2;47:8empty (1)


(2) chapters - empty



12:18end (1) 29:1enforcement (1) 42:15enough (2) 29:6;41:15ensure (1) 5:7enter (1) 10:12entered (1) 4:24entire (1) 30:21entirety (2) 6:3,21entitled (2) 17:10;18:20entity (1) 40:20environment (1) 28:2envisioned (1) 9:23episodes (1) 24:3escape (1) 46:1especially (3) 12:21;22:14;23:23establish (1) 24:18even (7) 11:19;12:6;19:11; 23:10;29:24;34:5; 42:14event (1) 7:7Everybody (2) 29:2,16everyone (6) 4:14;28:20;29:21, 23;32:15,18exam (1) 21:6example (2) 20:3;26:24except (1) 29:3Executive (1) 4:10exit (1) 4:21expect (1) 29:11experience (2) 46:7;48:5expert (2) 34:18,20explain (2) 35:16;38:9explained (1)

37:8explanation (2) 39:3,5exposure (2) 47:3,7extend (1) 16:18

F

fact (4) 26:11,18;32:3; 43:13factor (2) 20:23;27:7fair (3) 22:11;24:9;27:14fairly (1) 31:8far (2) 27:9;42:8fast (1) 24:6federal (17) 42:17;43:21,22,24; 45:21,22;46:2,5,5,9, 11,15;47:3,5,7,11,13Federally (1) 43:9feedback (3) 9:17;40:2;41:22feel (17) 12:21;13:21;14:17; 17:14;18:18;21:22; 22:25;23:5,23;25:4; 27:15,21;29:10,15; 30:4;34:20;35:25felt (9) 11:19;12:6,8;13:3; 20:12;21:18;25:13; 28:17;40:12few (2) 37:12;39:18fifteen (1) 17:5figure (2) 31:24;35:15find (13) 4:18;18:9;19:17; 23:9;25:25;32:24; 33:3;35:2;36:3;41:5; 44:11,11;46:14finish (3) 21:14;23:14,15first (5) 9:13,14;36:16; 43:16;46:23five (6) 16:3,4,4,25;17:4; 24:12flag (1) 21:1food (6)

13:2;19:2;23:12,15; 29:14;30:25force (1) 30:3forced (1) 30:2forget (1) 20:22form (3) 42:20;44:25;47:4forward (3) 33:21;44:1,2four (6) 16:15,21;17:9,18, 19;24:11frame (2) 31:16;32:10free (1) 38:17front (6) 4:23;5:10,11,11,19; 37:13front- (1) 28:25front-end (1) 29:22full-time (4) 16:11,18,23;24:14function (1) 41:15functional (1) 40:8functions (3) 27:10,12;39:7funds (1) 47:5Further (3) 4:17;6:8;9:4future (1) 46:13

G

gentlemen (1) 5:3GERD (1) 24:7gets (1) 28:14giving (2) 19:16;23:7goes (2) 35:19,22Good (15) 4:3;11:14;14:17; 15:21;19:16;21:23; 32:18;34:11;39:1,3, 22;48:5,6,8,23government (1) 42:17grab (1) 22:9grade (1)

44:25great (2) 48:10,21guess (8) 8:22;9:3;11:16; 13:10;26:21;31:15; 37:11;41:20guest (1) 7:6guidance (1) 46:22

H

half (13) 13:16;14:10,16; 15:7,12;16:16,16; 17:1,19;24:10,14; 30:11,13hand (1) 9:12hands (1) 26:23hard (3) 13:14;24:4,5head (1) 25:13headache (1) 24:4health (5) 20:20;24:22;25:14; 28:6,6hear (3) 8:16;34:16;39:1hearing (18) 4:12,13;5:21,24; 6:2,19;7:23;8:14,17, 20;9:5,9,10;10:8; 34:4;40:9;49:8,11hearings (2) 8:10,13heart (1) 20:20heat (1) 23:11held (1) 5:21help (3) 5:6;19:25;23:6helped (1) 26:12helper (1) 20:5helpers (1) 20:11Hi (1) 10:20higher (2) 12:8;28:18Highway (1) 5:17hire (1) 19:25

hits (1) 28:9hold (1) 15:3hope (4) 32:17;41:4;48:11, 13hopefully (1) 48:15Hospital (3) 18:18,19;19:9hour (22) 13:15,16;14:10,16, 21;15:8,13;16:13,13, 15,16;17:1,15,19; 18:25;19:3,12;24:10, 11;30:11,12,13hours (16) 16:3,4,5,19,21,23, 24,25;17:1,9,18,19; 24:12;25:9;29:12; 30:11human (2) 20:22;23:25humane (1) 27:16humans (1) 29:14hunger (1) 12:18hungry (3) 25:10,10;29:12hurt (2) 26:9,11hypoglycemic (3) 12:25;24:3;28:9

I

idea (3) 29:18;39:22;40:6identify (1) 8:5identifying (1) 7:13immunity (2) 44:20;45:7impossible (1) 28:24increase (1) 20:1independent (1) 19:15index (1) 39:14indicated (3) 6:18;7:25;24:23industry (2) 22:17;41:1information (1) 10:21initiate (1) 26:19


(3) end - initiate



instance (3) 17:7;37:19;47:6instead (1) 26:22intent (2) 7:21;34:3Interested (1) 6:11interesting (1) 45:12interfere (2) 25:15;32:16intern (4) 13:23;14:5;18:17; 19:10interns (1) 6:13interpretation (1) 7:20interruption (1) 14:1intersection (1) 46:9into (4) 4:23;10:12;18:20; 36:15involved (1) 26:22issue (1) 42:13issues (2) 7:21;18:6item (2) 18:3;32:20

J

January (2) 8:20;10:1JD (2) 34:19;38:13Jefferson (1) 5:16job (2) 26:1;30:5July (2) 33:6,15junction (1) 47:2June (1) 4:4

K

Katrina (1) 10:20keep (7) 26:15,16;30:5; 33:20,22;38:23;45:3keying (1) 37:17kind (7) 8:20;9:14;12:9;

22:18,18;31:25;42:20kinds (4) 25:20;40:24;41:2; 46:8knowing (2) 37:6;43:25knowledge (1) 12:9

L

labeled (1) 45:3labor (1) 28:1ladies (1) 5:1laid (2) 37:15;39:19language (1) 7:20larger (1) 19:24last (2) 8:14;32:21Law (40) 5:23;6:22;7:12; 8:13,17;9:7;28:1; 34:15,23;35:8,18; 36:4,12,23;37:24; 40:20;41:3,21;42:1, 15,23;43:11,24;44:15, 19,23;45:6,21,23,25; 46:2,4,5,10,10,16; 47:8,10,11,13laws (7) 5:24;36:15,18;38:4; 39:19;41:25;46:11leads (1) 16:9least (17) 9:7;10:1;12:10,14; 13:16;16:25;19:9; 21:19,20;23:6,21; 24:10;26:22;27:18; 28:2;29:8;42:10leave (5) 19:5,6,6,7;31:2legal (1) 44:3legality (1) 26:21legislature (8) 8:16;9:22;36:16,23; 37:24;40:14;43:17; 46:24legitimately (2) 44:21;45:8length (2) 13:8,10less (3) 16:20;17:2;19:24letters (1)

18:5level (4) 12:9;25:23;28:18, 19Library (1) 7:16license (2) 15:3;40:16licensees (3) 40:25;41:4,8licenses (1) 6:17licensing (4) 35:7,19,20,21lighten (1) 23:6line (2) 19:1;44:2List (1) 6:11listed (1) 37:23little (7) 15:5;23:6;26:20,21; 35:11,11;42:19load (1) 23:6lobby (3) 4:23;5:1,2located (3) 4:6,25;30:17long (8) 12:4;13:14;14:22; 19:1;25:8;30:10;33:6; 46:25longer (1) 16:4look (5) 35:2,4,9;36:6,8looking (3) 18:8;33:21;37:12looks (1) 27:16losing (1) 14:10lot (10) 5:18;11:20;19:19, 22;21:1;23:1,9;34:13, 16;36:2loud (1) 19:21Louisiana (11) 4:6,8;6:8;7:12,18; 8:19;31:9;43:10; 44:13;45:10;46:7lunch (35) 11:18,23,24;12:5,7, 10,13,13;13:1,4;15:8; 16:2,6;17:2;18:22,23; 19:4,8,16;20:12; 21:20;23:11,12;25:9; 28:20,22;29:1,2,3,7, 17,21,23;30:1;32:9

M

major (2) 27:13;28:7makes (5) 16:17;31:15;38:20, 21;40:19making (4) 7:5;9:9,21;40:20Malcolm (1) 4:8manager (2) 28:25;29:23manner (1) 24:21manual (1) 39:14many (3) 21:14,15;25:7marijuana (22) 34:22;35:8,18; 36:22,23;37:1,2,2,18, 20;42:16;43:12,14, 19;44:22,24;45:2,4; 46:6,14,23;47:1mark (1) 20:8Maximum (1) 13:15May (9) 6:7,10,22;7:19;8:6; 24:25;31:11;36:7,7maybe (2) 16:12;34:17McDonald's (1) 22:15mean (9) 23:24;24:16;26:5; 29:25;30:5;35:3; 41:11;42:12;47:10medical (3) 37:2;43:13;44:21meet (1) 21:12meeting (4) 4:20;10:15;33:5; 49:2Meetings (1) 5:23memory (1) 19:13mentioned (2) 18:7;26:17might (3) 9:8,23;25:1mind (1) 5:7Minimum (4) 13:15;14:16;28:19; 29:10minimum-wage (1) 12:7

minute (7) 12:13;16:5,10; 21:22;23:7;31:16; 32:1minutes (11) 15:19;17:5,11; 21:15;30:17;31:1,3,6, 11,12;39:18mislead (1) 22:18moderate (1) 4:12moments (1) 37:12money (1) 22:23months (1) 32:21more (17) 14:21;16:1;17:9; 19:18;21:25;22:6; 27:16;30:11,16;31:2, 18;40:7,19;41:17; 42:19;47:22;48:16morning (1) 4:3most (5) 17:14;18:12,13; 19:14,25mothers (1) 27:8move (3) 23:19;44:1,2much (5) 9:13;15:13;19:11; 45:13;46:18must (1) 44:25myself (4) 10:11;11:12;19:11; 21:5

N

name (3) 4:8;10:20,22navigate (1) 36:4nearby (1) 13:18necessary (2) 4:18;7:3need (4) 10:21;13:17;40:15; 41:6needs (6) 16:19;17:21;27:3,4; 29:14,17new (4) 9:1;29:18;32:20; 33:16news (1) 33:21


(4) instance - news



next (8) 8:22;13:2;16:9; 20:8;30:19,24,24; 33:5NGUYEN (46) 10:19,20;11:1,6,10, 15;13:9;14:20;15:2, 11,20,25;16:14; 17:12;18:16;25:3; 26:2;30:9;31:14; 32:25;33:13;34:10; 36:19;37:4;38:7,19; 39:2,10,25;40:10; 41:10;42:3,7;43:1,6; 44:4;45:18;46:17; 47:12,17,21,25;48:4, 9,14,20nice (1) 13:4nobody (1) 29:19noon (2) 8:2;49:5notice (8) 5:25,25;6:7,9,18; 7:9,25;34:3novel (1) 29:18number (4) 17:20;18:24;24:12; 27:20

O

obligated (2) 20:12;46:4observed (1) 19:10obvious (1) 45:5occurring (1) 8:10off (3) 26:23;27:24;32:7offer (2) 9:10;37:12offered (1) 7:1officer (1) 44:10often (2) 8:9,12once (3) 9:7,25;36:8one (18) 5:8,10,12;8:22; 9:14;10:6;14:21;16:5; 19:17;20:4,7;35:14; 36:24;40:13,14; 41:17;43:3;49:7only (15) 15:24;16:11,18; 19:25;20:4,7,13;

30:12;31:6;32:21; 33:17;34:11;36:7; 42:11;45:10Open (16) 5:23;9:17,24;10:17; 11:16;13:11;14:4; 17:15;31:2,12;32:3, 11;40:5,8;42:4,19opened (1) 30:15operate (1) 24:20opportunity (1) 34:8opposite (1) 5:1option (2) 9:22;42:10order (1) 4:13ordinary (1) 34:2organization (2) 8:6;10:24organize (2) 35:10,14organized (9) 34:16;36:14;37:6, 15;38:9,12;39:4; 40:18,21organizes (1) 35:17origin (2) 45:21,23Orleans (1) 33:16otherwise (2) 20:16;21:24ourselves (1) 19:20out (14) 13:24;19:21;20:22, 25,25;21:2,10;22:5, 12,17;29:5;33:16; 37:15;39:19outdated (1) 6:22outgrown (1) 33:19outside (2) 4:19;5:4over (5) 21:17;26:7,8;42:13, 13overlapping (1) 17:17overly (1) 6:23override (1) 43:24overrides (1) 47:11overtime (3)

16:6,24;20:9overworked (1) 19:22own (6) 10:25;11:2;23:4; 24:18;29:20;46:19

P

pagers (1) 4:16park (1) 5:8parking (4) 5:12,15,18,19part (6) 28:1,5;35:17,21; 42:23,24particular (1) 33:8Parties (1) 6:12part-time (1) 16:12passed (4) 32:17;35:8;36:15; 37:25passes (1) 47:10past (1) 5:2path (1) 4:22patience (1) 22:17patient (7) 12:23;18:4;22:7,8; 25:17;26:16;29:6patients (8) 20:18;21:25;22:1, 17;23:23;44:20;45:8; 46:13pattern (1) 9:25pay (2) 16:6,6PDF (1) 37:16peace (1) 5:7pending (1) 49:7people (6) 12:4,22;19:24;24:1; 26:14;40:25perceived (1) 9:16perform (2) 29:8,13perhaps (1) 45:14Perlis (1) 5:16

permit (1) 24:20person (2) 29:22;41:17personally (1) 34:6pharma (1) 14:5pharmaceutical (1) 44:25pharmacies (3) 6:12;37:1;43:14pharmacist (38) 11:18;13:5;14:14; 17:9;18:12,19;20:1; 21:7,24;22:3,11; 23:10,25;24:25;25:8, 14,24;26:13,25;27:2, 15,17;28:8,14,15; 29:4,6,25;30:2,16,19; 31:2,13,22;32:5,9; 35:23;42:11pharmacists (9) 6:13;11:22;12:8,12; 18:6;19:19;28:25; 34:14,17Pharmacy (25) 4:6,9;6:13,13,14, 15;7:12;11:5,7,12; 14:4,23;18:4;19:14, 15;22:9;23:19,20; 24:21;26:5;30:15; 31:1,4,11;45:5phone (1) 21:14phones (1) 4:16pick (3) 21:13;32:8,12place (4) 9:12;10:7;24:25; 31:17places (2) 37:3,19plant (1) 42:21please (5) 4:15,19;5:6,7;10:10pm (2) 12:5;49:11point (1) 30:2police (1) 44:10policies (2) 24:18,24policy (2) 21:18;26:19portion (1) 7:11position (1) 25:1possible (6)

7:4;12:16;13:12; 26:6;34:12;35:13possibly (2) 11:17;23:5posted (1) 6:1Potpourri (1) 6:6practice (2) 18:11,15practiced (1) 15:4preamble (1) 43:15precedent (1) 26:4pregnant (1) 27:3premise (2) 14:2;30:21premium (1) 16:7prepared (1) 8:3prescribers (1) 6:16prescription (3) 20:2,4;21:15prescriptions (2) 14:7,13present (3) 15:14;30:16;31:13presented (3) 36:16;38:5,6President (1) 4:11pressure (1) 21:3pretty (3) 19:16;39:22;46:18prevails (1) 46:16Prior (3) 7:5;8:20;10:1probably (3) 31:24;35:15;39:21Procedure (2) 5:22;34:23procedures (2) 24:19,25process (3) 20:25;22:13;34:2processed (1) 44:14processes (1) 40:11product (4) 39:16;45:1,9,16products (2) 44:22;46:14profession (2) 28:18,19programs (1)


(5) next - programs



6:16prohibits (3) 44:24;46:6,11properly (2) 6:1;45:6proposal (2) 33:10;34:1prosecuted (1) 44:14prosecution (2) 44:20;45:7protect (1) 24:21protected (1) 45:25provide (3) 28:2,22;45:7provider (1) 44:7public (11) 4:13;5:25;6:2,19, 20;7:15;24:22;25:1; 26:19;34:4;49:8publish (1) 34:3published (1) 6:6pump (1) 27:4punch (1) 29:5purpose (3) 6:1;7:22;41:12purposes (1) 43:13pursuant (1) 5:25put (8) 10:11;19:18;22:12; 31:4;32:4,14;36:13; 46:22

Q

quick (1) 41:14quickly (3) 13:18,19,20

R

raise (1) 45:12raw (1) 44:24reach (1) 46:1read (1) 35:6ready (1) 14:14reality (1) 40:23

really (9) 14:10;21:23;22:12; 23:16;24:4,5;25:12; 40:12,13rear (1) 5:15reasonable (4) 18:10;41:6,13;42:1receive (5) 6:2,19;7:23;8:3; 34:4received (1) 18:5recent (1) 17:14receptionist's (1) 5:3recess (3) 10:8,14;49:1RECESSED (2) 10:15;49:2recharge (1) 21:23recognition (1) 29:9recognizing (1) 24:17recommendation (2) 37:11;44:7recommended (1) 38:1record (4) 10:12,13,17;49:5refer (1) 8:16reflux (1) 24:7Register (3) 6:8;7:7,18registration (5) 7:9;35:20;43:21,22; 47:4regular (2) 5:13;32:11regulate (1) 25:23Regulation (3) 18:1;33:4;42:16regulations (1) 34:23relate (1) 26:14relative (1) 37:1relatively (1) 32:20relevant (2) 7:11;41:24remember (3) 15:22;39:6,11reorganization (1) 40:6reorganize (1)

38:17replaced (1) 27:20reply (1) 7:3Reporter (1) 10:10represent (3) 8:7;11:11,12request (1) 9:20requested (1) 4:11require (2) 12:12;31:3required (7) 5:23;9:24;11:23; 15:7;22:1;25:7;29:4requirement (3) 9:6,11;11:17requires (3) 8:14,18;9:7respect (1) 36:22response (1) 9:4responsibility (2) 27:24;35:23rest (2) 21:21,22restaurant (1) 30:24restrooms (1) 4:25results (1) 9:8retail (4) 14:23;19:17;27:13; 30:22return (2) 19:4;31:5revenue (1) 22:24review (1) 48:10reviewing (1) 39:18Revision (2) 18:2;33:4revisions (1) 7:2right (9) 12:15;13:3;23:3; 24:17;26:25;32:24; 34:11;39:9;43:9risk (2) 43:21;46:19room (7) 4:14,20,22;5:4,6; 48:25;49:6Rouge (1) 4:7round (1)

20:6rule (11) 9:20;11:16;15:19, 19;16:10;31:9;40:15; 41:25;42:9,24;43:14Rulemaking (4) 6:10;8:19;34:2; 40:14rules (17) 6:4,21;7:3,14,15; 8:2;9:19;34:23;36:17, 25;38:2,5;39:20; 41:21;43:18;46:24,25run (4) 13:13,19;14:9;23:4running (4) 12:3,3,3;31:25rushing (1) 10:7

S

safe (1) 25:14safety (12) 4:21;18:4;24:22; 25:1,17;26:20,24; 28:4,5,6,7,13salary (2) 11:20;16:22same (4) 18:6;26:7;31:10; 46:8saying (3) 26:3;32:4,8Schedule (5) 37:22;42:18;43:10, 20;47:1scheduled (1) 18:20school (1) 47:6scripts (1) 19:24se (1) 33:7search (6) 37:18;39:7,23,24; 41:11,12searchable (2) 37:17;39:16second (1) 43:19Section (15) 6:4;7:16;34:25; 35:20,21;36:24; 37:21,24;38:1;43:15, 16,19,25;44:18;46:23sections (2) 7:13;38:10Seeing (2) 10:6;39:19seems (1)

35:10selling (1) 14:6sense (10) 16:17;17:13,20; 21:8;28:16;31:15; 38:12,21,22;40:19serve (2) 4:9;41:12session (1) 49:4settings (1) 18:15shelter (1) 29:15shift (2) 16:17;17:15shifts (2) 16:15;17:17shopping (1) 30:18show (1) 27:18side (2) 5:2;46:5sign (4) 7:6;32:4,8,14significance (1) 9:13silence (1) 4:15single (1) 17:10sit (1) 23:8sitting (1) 23:16situation (2) 45:15;46:3situations (3) 46:8,12,15six (7) 8:21,22;9:6,7,11; 10:2;16:13skim (1) 36:8skip (5) 20:12,13;25:9;29:7; 30:6slow (2) 23:10;25:11smell (3) 44:11,23;45:1somebody (2) 20:3,10somehow (1) 44:9someone (5) 19:5,5,6,7;29:12someplace (1) 26:1sometime (5) 12:3,19;21:4;23:12;


(6) prohibits - sometime



25:8sometimes (4) 21:6,22;25:9,20somewhere (1) 27:23son (1) 33:16soon (1) 7:4sooner (1) 9:11sort (1) 16:9sound (1) 24:4spaces (2) 5:9,12speak (1) 10:10specific (1) 39:21spend (2) 33:7;37:12split (1) 24:14staff (1) 18:18Staffing (1) 18:4stairway (1) 5:17stands (2) 42:14,15start (2) 12:4;15:12state (7) 18:11;43:23;45:11, 25;46:9,10;47:10states (4) 12:11;15:15;31:9; 43:11stay (1) 32:3step (1) 4:19still (19) 12:24;13:13;14:3,9, 12;17:21;20:4;23:25; 30:20;32:3,11;42:17; 43:10,19;44:13;46:6, 11,16;47:1stock (1) 29:22stomach (1) 12:18stop (1) 23:13store (3) 5:16;11:25;30:19straight (1) 12:20stress (1) 11:21

stricter (1) 47:14structure (2) 30:21;38:4struggling (1) 32:23student (3) 34:14;36:3;48:11students (3) 34:17;38:23;40:3study (2) 21:5;35:4stuff (2) 13:25;17:17subchapter (1) 36:25subject (1) 45:16substance (4) 6:17;43:10,20; 44:19suggestion (1) 42:25suggestions (2) 13:7,11suggests (1) 45:24summer (1) 33:18supposed (5) 13:2;27:25;28:1; 32:4;35:3sure (1) 41:19sustain (1) 22:24

T

Table (4) 7:11;10:7;37:13; 39:17talk (2) 27:13;34:22talking (4) 17:21;28:12,13; 35:18technician (6) 6:14,15;14:5,11; 28:14;29:24technicians (2) 6:14;13:22telephone (1) 4:19temporary (1) 31:10ten (3) 16:23,24;17:4tends (1) 19:18terms (4) 37:18;39:24;45:13; 47:7

test (1) 21:6testimony (8) 6:3,20;7:1,24;8:1,4; 34:5,7testing (1) 45:17thereafter (3) 7:5;8:21;10:2thinking (4) 12:20;22:15;41:14, 15third (1) 43:25though (1) 11:19thought (3) 20:10;40:11;41:18three (2) 5:8;32:21ticket (1) 44:10timeframe (1) 25:7times (1) 24:23Today (7) 4:3;7:1,6,22;8:2; 11:12;48:3today's (2) 6:2;7:8together (1) 36:13told (1) 46:24topic (3) 17:25;33:8,9tow (1) 5:13trace (1) 44:11training (1) 6:15transaction (1) 32:13transactions (1) 32:12treat (1) 22:8trucks (1) 5:13true (1) 45:19trust (1) 20:18trusted (2) 13:22,22truth (1) 22:2try (1) 48:19trying (3) 18:9;22:5;32:24

tunnel (1) 21:7turns (1) 19:8twice (1) 31:23two (3) 20:11;32:21;37:3type (1) 14:13

U

under (2) 21:3;45:25union (5) 15:6,18;16:1,22,23unions (1) 15:6unnecessary (1) 6:23up (17) 13:10,17;14:8;20:6; 21:13;23:12;24:8; 25:20;28:10;31:12; 32:8,12;36:1;38:22; 41:19;42:19;47:18upset (3) 12:19;21:10;22:7up-to-date (1) 33:23use (7) 39:24;41:5;43:12; 44:24;46:6,14,18used (1) 18:17using (1) 45:15usually (3) 11:23;19:15;31:5

V

ventilation (1) 28:4verified (1) 14:7violating (1) 43:22vision (1) 21:7visitors (1) 5:14volume (6) 19:24;20:2,6;22:22; 23:9;26:15

W

waiting (1) 33:17walk (3) 13:19;23:13;30:23

warm (1) 13:17warning (1) 43:16water (1) 5:5way (18) 22:19;26:6,21; 27:10,12,24;32:3; 34:14,15;35:10,17; 38:20,21;39:4,20; 40:17,18,21website (3) 7:16,18;33:5Wednesday (1) 4:3welcome (3) 10:6;42:6;47:20weren't (1) 13:1wherever (1) 13:25whichever (2) 24:12,13who's (3) 16:19;28:8;35:23willing (1) 31:19window (1) 5:3wishes (1) 10:9within (9) 14:2;16:3;25:7; 26:9;29:20;30:20,22, 25;44:13without (4) 11:22;14:1;30:15; 31:12wonder (1) 44:12work (26) 11:2,22,25;12:9,17; 13:23;14:15;16:12, 20,25;17:2;18:21; 19:3,9;20:14;21:8; 22:13;24:2,6;25:8,16; 26:13;27:9;28:17; 29:12;44:3worked (3) 16:15,16;29:19worker (5) 12:7;16:19;20:7; 28:11,23Workers' (2) 45:22;47:8working (12) 12:24;16:21;19:23; 20:3,5,9;21:3,8; 25:24;28:2,17;29:11works (2) 17:9;26:6workstation (1)


(7) sometimes - workstation



13:3worried (1) 20:24worry (1) 21:9worrying (1) 20:21written (1) 34:7wrong (1) 18:24wwwpharmacylagov (1) 7:17

X

Xavier (1) 11:3

Y

year (4) 8:15;9:6,11;48:16years (4) 8:21,22;9:8;10:2

1

1 (3) 8:20;10:1;47:11:00 (1) 19:610:05 (1) 10:1810:35 (1) 48:25101 (1) 6:411:00 (1) 19:512 (1) 17:1512:00 (4) 8:2;19:6;49:5,11

2

2:00 (2) 12:5;19:720 (1) 6:10200 (2) 20:2,82018 (1) 8:152019 (3) 4:4;6:7,102020 (2) 8:21;10:124th (1) 33:626 (1) 4:4

3

3:00 (1) 12:530 (13) 12:13;15:19;16:10; 21:22;23:7;30:16; 31:1,3,6,11,12,16; 32:13301 (1) 6:53388 (1) 4:7398 (1) 20:4

4

400 (1) 20:6454 (2) 8:15,17

9

9:00 (1) 4:49:10 (1) 10:89:11 (1) 10:14


(8) worried - 9:11

Regulatory Proposal 2019-E ~ Cannabis Metered Dose Inhalers Draft #1

Louisiana Administrative Code 1 2

Title 46 – Professional and Occupational Standards 3 4

Part LIII: Pharmacists 5 6 Chapter 24. Limited Service Providers 7 8 Subchapter E. Marijuana Pharmacy 9 10 §2443. Marijuana Products 11 A. – B.8. … 12

C. Product Dosage Forms. 13 1. The producer shall limit their production of pharmaceutical grade marijuana products to the 14

following dosage forms: 15 a. Oils, extracts, tinctures, or sprays; 16 b. Solid oral dosage forms, e.g., capsules or pills; 17 c. Liquid oral dosage forms, e.g., solutions or suspensions; 18 d. Gelatin-based chewables; 19 e. Topical applications, oils or lotions; 20 f. Transdermal patches; or 21 g. Suppositories; or 22 h. Metered-dose inhalers. 23

C.2. – E.4.f. … 24 25 AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1046. 26 HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 43:1540 (August 2017), 27 amended by LR 28 29

DRAFT

Louisiana Board of Pharmacy 1 3388 Brentwood Drive 2

Baton Rouge, Louisiana 70809-1700 3 Telephone 225.925.6496 ~ E-mail: [email protected] 4

5 6

Blueprint for Inspection of Pharmacies 7 8

Module I – Basic Pharmacy Services 9 10

Version 1.3 11 12 … 13 14 Facility and Security 15 16

37.05 Does the pharmacy have a hazardous waste handling and 17 collection system? For example, empty bottles that contained 18 chemotherapy medications or warfarin, or hazardous drug 19 compounding waste? If yes, indicate how often the bin is 20 emptied/collected and the vendor used? 21

22 … 23 24 46.00 Does the pharmacy utilize any automated apparatuses for prescription 25

processing/counting (such as robotics, Baker cells, etc.)? List number 26 and types. 27

28 46.01 If yes, do they have and follow policies and procedures addressing 29

cross-contamination and identification of drug products? 30 31

46.02 There are policy and procedures that address transportation of 32 hazardous drugs (e.g. transport via pneumatic tube). 33

34 … 35 36 Product Receipt and Inventory 37 38 … 39 40 57.00 Is the most recent complete controlled substance inventory available for 41

review? 42 43

57.01 Does the pharmacy maintain other required inventories (such as 44 change in PIC, theft/loss, etc.)? 45

46 57.02 Does the pharmacy handle hazardous drugs based on “NIOSH List 47

of Antineoplastic and Other Hazardous Drugs in Healthcare 48 Settings”? If yes, does facility maintain a current list of hazardous 49

USP-800 S

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drugs handled by facility which is updated and reviewed at least 50 every 12 months? The facility also has policy and procedures for 51 hazardous drugs that may enter the market after the most recent 52 version of the NIOSH List. 53

54 57.03 Does the pharmacy have a designated person responsible for 55

overseeing hazardous drug handling at the facility? 56 57

57.04 There is signage that is prominently displayed which identifies the 58 hazardous drug handling areas. Access to areas where hazardous 59 drugs are handled is restricted to authorized personnel and located 60 away from break rooms and refreshment areas for personnel, 61 patients, or visitors. 62

63 57.05 The facility has policy and procedures that address receipt, 64

handling, and storage of hazardous drugs. 65 66

57.06 Hazardous drugs are stored in a manner that prevents spillage or 67 breakage. 68

69 … 70 71

Module II – Compounding Nonsterile Preparations 72 73

Version 1.2 74 75 General Operations Information 76 77 … 78 79 13.00 Does the pharmacy perform compounding with hazardous drugs? If so, 80

indicate percentage of total compounding activity designated as such. 81 82

13.01 Is the pharmacy aware of the more stringent requirements of the 83 proposed USP Chapter <800>? 84

85 13.01.01 Based on “NIOSH List of Antineoplastic and Other 86

Hazardous Drugs in Healthcare Settings”, does the 87 pharmacy compound with Group 1 drugs? 88

89 1301.02 Based on “NIOSH List of Antineoplastic and Other 90

Hazardous Drugs in Healthcare Settings”, does the 91 pharmacy compound with Group 2 and Group 3 92 drugs? If yes, are there risk assessments for these 93 drugs that include alternative containment strategies 94 and/or work practices? 95

96 97 14.00 Are Safety Data Sheets (SDS) [formerly known as Material Safety Data 98

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Sheets (MSDS)] available to personnel for drugs and chemicals used in 99 the pharmacy (including those for compounding, if applicable)? Verify that 100 personnel can access them and are familiar with the format. 101

102 … 103 Component Selection and Use 104 105 21.00 All bulk drug substances (APIs) used are: 106 (1) Compliant with the standards of an applicable USP or NF monograph, 107 if one exists; or 108 (2) A component of an FDA-approved human drug product; or 109

(3) On the list of bulk drug substances for use in compounding developed 110 by the FDA and issued through regulation. [Note: must comply with (1) 111 or (2) above until the FDA list is issued] 112

113 … 114 115

21.10 Bulk component containers are labeled with appropriate OSHA 116 hazard communication labels and hazardous substances (including 117 hormones) are segregated. 118

119 … 120 121 Environment 122 123 33.00 The nonsterile compounding area is a controlled environment and 124

separate from the general pharmacy. 125 126 33.01 Facility has designated hazardous drug compounding area(s). 127 128

33.02 Are both nonsterile and sterile hazardous drugs being compounded 129 in the same room? 130

131 33.03 Is particle-generating activity being performed when sterile 132

compounding is in process? 133 134

33.04 Is a C-PEC being used for nonsterile compounding also being used 135 for sterile compounding? 136

137 33.05 Is the C-PEC properly deactivated, decontaminated, cleaned, and 138

disinfected prior to resuming sterile compounding? 139 140 33.06 An eyewash station is readily available. 141 142

33.07 All water sources and drains are located at least one meter away 143 from the C-PEC. 144

145 … 146 147

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36.00 Procedures are implemented to prevent cross-contamination, especially 148 when compounding with drugs such as hazardous drugs and known 149 allergens like penicillin that require special precautions. 150

151 37.00 The compounding area is well-lit. 152 153

37.01 For NIOSH List Group 1, surfaces of ceilings, walls, floors, fixtures, 154 shelving, counters, and cabinets in the nonsterile compounding 155 area must be smooth, impervious, free from cracks and crevices 156 and non-shedding. 157

158 37.02 For NISOH List Group 2 and Group 3, configuration of the space 159

utilized for compounding these hazardous drugs is dedicated or 160 properly deactivated, decontaminated, and cleaned if non-161 hazardous drug compounding is done in this containment 162 ventilated enclosure (CVE) at any other time. 163

164 38.00 The pharmacy performs hazardous nonsterile compounding in a 165

ventilated cabinet such as a BSC, CAI, or CACI or CVE (containment 166 ventilated enclosure); however, CAI may not be used for hazardous drugs 167 that may volatilize. {USP Chapter <800> will change hazardous drug 168 compounding requirements.} The C-PECs used for manipulation of 169 nonsterile hazardous drugs must either be externally vented (preferred) or 170 have redundant HEPA filters in series. Does the C-PEC operate 171 continuously? 172

173 38.01 Ventilated cabinets (BSC, CAI, CACI, CVE) used for hazardous 174

compounding are certified or tested periodically. 175 176

38.02 If the hoods or isolators are not located in a closed, controlled room 177 environment, there is documentation from the manufacturer and 178 site testing to verify proper functioning of equipment under dynamic 179 conditions for the safety of personnel. 180

181 38.03 For NIOSH List Group 1, the C-PEC is located in a Containment 182

Secondary Engineering Control (C-SEC) which is externally vented 183 with at least 12 air changes per hour (ACPH) and negative 184 pressure between 0.01 and 0.03” water column relative to adjacent 185 areas. 186

187 39.00 Appropriate protective attire (gowns, gloves, masks, etc.) is available. 188 189 39.01 If hazardous drugs are used, appropriate protective attire is 190

available (gowns, gloves, hair and shoe covers, eye and face 191 protection, etc.). 192

193 40.00 There is a sink in the compounding area with hot and cold potable water, 194

soap or detergent, and air-driers or single-use towels. 195 196

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… 197 198 48.00 Hazardous drugs are appropriately identified and marked, received, 199

handled and stored by appropriately trained personnel (OSHA regulations 200 and NIOSH Alerts). 201

202 48.01 Pharmacy has a designated hazardous drug receiving area that is 203

neutral/normal or negative pressure relative to surrounding areas. 204 205

48.02 NIOSH List Group 1 antineoplastic hazardous drugs requiring 206 manipulation other than counting or repackaging of final dosage 207 forms are segregated and stored in an externally ventilated, 208 negative pressure room (at least 0.01” water column) to adjacent 209 areas with at least 12 ACPH. 210

211 48.03 Refrigerated antineoplastic hazardous drugs are stored in a 212

dedicated refrigerator in a negative pressure area with at least 12 213 air changes per hour. 214

215 48.04 The NIOSH List Group 2 and Group 3 hazardous drugs, including 216

non-antineoplastic, reproductive risk only, and final dosage forms 217 of antineoplastic hazardous drugs may be stored with other 218 inventory if permitted by entity policy. 219

220 49.00 Trash is disposed of in a safe, sanitary, and timely manner. 221 222

49.01 Hazardous waste is disposed of in a safe, sanitary, and timely 223 manner. 224

225 Training 226 227 50.00 All personnel of reproductive capability who handle or compound 228

hazardous drugs or chemicals have confirmed in writing that they 229 understand the risks of handling hazardous drugs, including teratogenicity, 230 carcinogenicity, and reproductive issues? 231

232 51.00 There is documentation that all personnel that perform compounding are 233

appropriately trained including policies and procedures, documentation, 234 hazardous drug handling, and compounding technique and are not 235 allowed to compound or supervise compounding until training is 236 successfully completed. 237

238 … 239 240 54.00 There is documentation available showing employees performing 241

nonsterile compounding are evaluated at least annually. 242 243 54.01 If performing hazardous nonsterile compounding, there is 244

documentation available showing employees are evaluated at least 245

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annually. 246 247 … 248 249 Compounding Equipment 250 251 … 252 253 60.00 The pharmacy uses separate equipment and utensils to compound 254

allergenic, cytotoxic, or hazardous products, or has detailed procedures 255 for meticulous cleaning of equipment and utensils immediately after use to 256 prevent cross contamination or exposure. 257

258 60.01 Do policy and procedures exist for deactivation, decontamination, 259

and cleaning activities for handling hazardous drugs? 260 261 … 262 263 Compounding Procedures 264 265 … 266 267 68.00 Personnel don appropriate protective garb when performing 268

compounding. 269 270 68.01 If hazardous compounding, personnel don appropriate protective 271

garb when compounding. 272 273

68.02 PPE is properly disposed of upon completion of hazardous 274 compounding activities. 275

276 … 277 278 73.00 Personnel are appropriately garbed for protection when cleaning. 279 280 … 281 282 Finished Preparation Release Checks and Tests 283 284 … 285 286 80.00 Labels on immediate patient-specific containers include identifiers for the 287

persons preparing the compound and performing the final verification, 288 BUD, and an indication that this is a compounded preparation, special 289 requirements for storage, and appropriate packaging and labeling of 290 hazardous materials. 291

292 … 293 294

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80.04 If hazardous, labeling contains storage and handling information. 295 296 … 297 298 Patient Counseling and Communication 299 300 85.00 Patient/caregiver training programs or materials contain information and 301

precautions regarding the handling and disposal of products such as 302 fentanyl, hormones, and chemotherapy medications. 303

304 … 305 306

Module III – Compounding Sterile Preparations 307 308

Version 1.2 309 310 … 311 312 General Operations Information 313 314 … 315 316 012.00 Does the pharmacy perform compounding with hazardous drugs? If so, 317

indicate the percentage of sterile compounding activity designated as 318 such. 319

320 012.01 Does the pharmacy have a plan to comply with USP Chapter 321

<800> by the implementation date? Is the pharmacy aware of the 322 more stringent requirements of the USP Chapter <800>? 323


Hazardous Drugs in Healthcare Settings”, does the 326 pharmacy compound with Group 1 drugs? 327


Hazardous Drugs in Healthcare Settings”, does the 330 pharmacy compound with Group 2 and Group 3 331 drugs? If yes, are there risk assessments for these 332 drugs that include alternative containment strategies 333 and/or work practices? 334

335 012.02 Are hazardous drugs segregated and stored in a room that is 336

negative pressure (at least 0.01” water column) to adjacent areas 337 and with at least 12 ACPH (air changes per hour)? Are hazardous 338 drugs in NIOSH List Group 1, antineoplastic hazardous drugs 339 requiring manipulation other than counting or repackaging of final 340 dosage forms segregated and stored in a room that is negative 341 pressure between 0.01 and 0.03” water column relative to adjacent 342 areas, which is externally vented with at least 12 ACPH? 343

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344 012.03 Is hazardous drug waste quarantined in a designated area and 345

disposed of in compliance with local, state, and federal 346 regulations? 347

348 013.00 Are Safety Data Sheets (SDS) [formerly known as Material Safety Data 349

Sheets (MSDS)] available to personnel for drugs and chemicals used in 350 the pharmacy (including those for compounding, if applicable)? Verify that 351 personnel can access them and are familiar with the format. 352

353 … 354 355 Component Selection and Use 356 357 022.00 All bulk drug substances (APIs) used are: 358 (1) Compliant with the standards of an applicable USP or NF monograph, 359 if one exists; or 360 (2) A component of an FDA-approved human drug product; or 361

(3) On the list of bulk drug substances for use in compounding developed 362 by the FDA and issued through regulation. [Note: must comply with (1) 363 or (2) above until the FDA list is issued] 364

365 … 366 367

022.10 Bulk component containers are labeled with appropriate OSHA 368 hazard communication labels and hazardous substances (including 369 hormones) are segregated. 370

371 … 372 373 Environment 374 375 027.00 If the facility performs both sterile and nonsterile compounding, the areas 376

are separated and distinct. 377 378 … 379 380

027.01 Are both nonsterile and sterile hazardous drugs being compounded 381 in the same room? 382

383 027.02 Are the C-PECs being used for nonsterile compounding sufficiently 384

effective that the room can continuously maintain ISO 7 385 classification throughout the compounding activity? 386

387 027.03 Are the C-PECs placed at least one meter apart? 388 389

027.04 Is particle-generating activity being performed when sterile 390 compounding is in process? 391

392

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027.05 Is a C-PEC being used for nonsterile compounding also being used 393 for sterile compounding? 394

395 027.06 Is the C-PEC properly deactivated, decontaminated, cleaned, and 396

disinfected prior to resuming sterile compounding? 397 398 037.00 A working sink, located on the clean side of the line of demarcation, is 399

available that enables pharmacy personnel to wash hands and enter the 400 sterile compounding area without contaminating his/her hands and is 401 away from/not adjacent to any PECs. 402

403 037.01 An eyewash station is readily available. 404 405 … 406 407 040.00 All air ducts controlling air flow into the sterile compounding clean/buffer 408

room and anteroom are equipped with HEPA filters that maintains the 409 clean/buffer room in an ISO Class 7 environment and the anteroom with 410 an ISO Class 7 (when adjacent to hazardous drugs cleanroom) or ISO 411 Class 8 environment. 412

413 040.01 For NIOSH List Group 1, the pharmacy performs hazardous sterile 414

compounding in a ventilated cabinet such as a BSC, CAI, or CACI. 415 The C-PECs used for manipulation of these sterile hazardous 416 drugs must be externally vented and provide ISO Class 5 or better 417 air quality (e.g., Class II or III BSC, CACI, Class II BSC types A2, 418 B1, or B2). Note: CAI may not be used for hazardous drugs that 419 may volatilize. 420

421 040.02 Ventilated cabinets (BSC, CAI, CACI) used for hazardous 422

compounding are certified or tested periodically. 423 424

040.03 Are non-hazardous drug preparation being made in the same C-425 PEC as hazardous preparations? If yes, is the non-hazardous 426 preparation being placed into a protective outer wrapper during 427 removal from the C-PEC and labeled to require PPE handling 428 precautions? 429

430 040.04 Are refrigerated antineoplastic hazardous drugs stored in a 431

dedicated refrigerator in a negative pressure area with at least 12 432 ACPH? 433

434 … 435 436 045.00 Completely enclosed anteroom and clean/buffer room (with a door) are 437

equipped with monitors or gauges to measure differential pressure. 438 439 … 440 441

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045.03 Hazardous compounding room and drug storage area is at least 442 0.01” water column negative pressure to ISO Class 7 anteroom. 443

444 … 445 446 053.00 For BSC or LAFW that is NOT located in an ISO Class 7 clean/buffer 447

room, the BSC or LAFW has been certified to maintain ISO Class 5 during 448 compounding activities. 449

450 … 451 452

053.05 The sink is separated from the immediate area of the ISO Class 5 453 BSC or LAFW (not adjacent). 454

455 054.00 For CAI/CACI that is NOT located in an ISO Class 7 clean/buffer room, 456

the CAI/CACI has been certified to maintain ISO Class 5 under dynamic 457 conditions including transferring of ingredients, components, and devices, 458 and during preparation of compounded sterile preparations. 459

460 … 461 462

054.04 For NIOSH List Group 1 hazardous compounding in a CACI that is 463 NOT located in a clean/buffer room, the CACI is located in a 464 physically separated area that maintains a negative pressure of 465 0.01” water column pressure to adjacent areas and a minimum of 466 12 air changes per hour (ACPH). 467

468 … 469 470 Training 471 472 070.00 There is documentation that compounding personnel are appropriately 473

trained including policies and procedures, documentation, hazardous drug 474 handling, cleaning/disinfection/spills, garbing/gowning/hand hygiene, and 475 aseptic technique. Compounding personnel includes persons performing, 476 supervising, and verifying compounding activities. List number of 477 personnel training files viewed. 478

479 … 480 481 071.00 All personnel of reproductive capacity who handle or compound 482

hazardous drugs or chemicals have confirmed in writing that they 483 understand the risks of handling hazardous drugs. Teratogenicity, 484 carcinogenicity, reproductive issues. 485

486 072.00 There is documentation, such as an observational checklist, that all 487

personnel (including housekeeping or other outside personnel) that 488 perform cleaning activities in the compounding areas including hazardous 489 compounding areas are appropriately trained in garbing, cleaning, and 490

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disinfection. 491 492 … 493 494 075.00 There is documentation that all compounding personnel (including those 495

supervising or performing verifications) have passed an initial written 496 exam, and subsequent annual written exams for the appropriate 497 compounding risk levels and NIOSH hazardous drugs, when applicable. 498 Indicate frequency if testing more than annually. 499

500 076.00 There is documentation that all compounding personnel have passed an 501

initial and subsequent annual competency assessments of aseptic 502 compounding skills using observational audit tools including handling 503 NIOSH hazardous drugs, when applicable. Compounding skills 504 evaluations shall include use of equipment. Indicate frequency, if testing 505 more than annually. 506

507 … 508 509 Garbing 510 511 … 512 513 089.00 Garbing includes head and facial hair covers and masks. There is a 514

mirror available to check that all hair is covered. 515 516

089.01 PPE is properly disposed of upon completion of hazardous 517 compounding activities. 518

519 … 520 521 Environmental Monitoring 522 523 .. 524 525 099.00 The HEPA filtered air changes per hour (ACPH) were measured for the 526

compounding rooms. 527 528 … 529 530

099.03 ISO Class 7 hazardous sterile compounding room is certified as 531 having a minimum of 30 ACPH. Typically all of the air will be from 532 outside. 533

534 … 535 536 100.00 Air pattern analysis using smoke testing was performed under dynamic 537

conditions (people working in the PECs and rooms). The smoke flow is 538 described in the report for the various tests as turbulent, sluggish, smooth, 539

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etc. 540 541 … 542 543

100.02 Air pattern analysis was conducted to confirm positive pressure 544 (and negative pressure into hazardous compounding rooms for 545 NIOSH List Group 1) at all points around all openings, doorways, 546 and pass-throughs. 547

548 … 549 550 101.00 Differential air pressure between rooms was measured. 551 552 … 553 554

101.02 For NIOSH List Group 1, the differential pressure measured was at 555 least 0.01” water column negative from the hazardous clean/buffer 556 room to the anteroom with the doors closed. 557

558 … 559 560 Patient Counseling and Communication 561 562 143.00 Do patient/caregiver training programs or materials contain information 563

and precautions regarding the handling and disposal of hazardous 564 products such as chemotherapy medications? 565

566 … 567 568 569

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Executive Committee


Items in blue print sponsored by Board. Page 1 of 9



Final Legislative Brief

2019-0814

Regular Session of the 2019 Louisiana Legislature

Convened 2019-0408 @ 1200 – Adjourned 2019-0606 @ 1800

Last Items Reviewed

HB 620 HR 320 HCR 122 HSR 3 HCSR 3 SB 243 SR 279 SCR 145 SSR 1 SCSR 0 Acts 448

Total Items Filed = 1,736 Items on Watch List = 70 Watched Items Successful = 39 Successful Items with Action Plans = 16

House of Representatives Bills HB 69 Zeringue Health & Welfare Provides relative to the membership of the Louisiana State Board of Dentistry. 06-11-2019 Signed as Act 324; effective 06-11-2019. This bill amends the dental practice act to temporarily expand the size of the dental board, to facilitate the appointment of an oral and maxillofacial surgeon to the board. We monitored this item to observe the legislative reconstruction of a licensing board. HB 119 Bishop Insurance Provides relative to the denial of a prescription based upon step therapy or fail first protocols or non-formulary status. 06-11-2019 Signed as Act 206; effective 01-01-2020. This bill amends the insurance law to require any insurer which denies a prescription claim based on step therapy, fail first protocols, or non-formulary status to provide the prescriber with a list of acceptable alternative disease-specific drug therapies. We monitored this item for any potential amendments to pharmacy law; there were none. HB 138 Connick Administration of Criminal Justice Provides relative to certain substances in the Uniform Controlled Substance Law. 06-17-2019 Signed as Act 354; effective 08-01-2019. The Board approved this Legislative Proposal 2019-A; it amends the Controlled Substance Law to harmonize the state definition of marijuana and list of controlled substances with the federal definition and list. Action Plan:

Update Controlled Substances Law in Louisiana Pharmacy Law Book.



HB 169 Hoffmann Health & Welfare Authorizes a data system for the collection of information on health effects and outcomes associated with medical marijuana. 06-11-2019 Signed as Act 207; effective 08-01-2019. This bill amends the medical practice act to authorize the medical board to develop and operate a database containing health effects and outcomes associated with use of medical marijuana. Only reports filed by patients using medical marijuana, physicians recommending medical marijuana, and physicians treating patients using medical marijuana will be accepted. We monitored this item for any potential amendments to include pharmacies or pharmacists as data reporters; there were none. HB 196 Falconer Commerce Exempts the La. Professional Engineering & Land Surveying Board and the State Board of Architectural Examiners from time limitations for disciplinary proceedings by professional and occupational boards and commissions. 06-11-2019 Signed as Act 281; effective 08-01-2019. This bill amends the professional licensing law to exempt these two boards from the requirement to notify the licensee of a complaint filed against them no later than six months after receipt of the complaint. We monitored this item for any amendment to the list of licensing boards not subject to this requirement; there were none. HB 243 Miller Health & Welfare Provides relative to opioid data reporting. 06-20-2019 Signed as Act 423; effective 06-20-2019. This bill amends the state sanitary code to require reporting by emergency departments of certain information concerning opioid-related overdoses (admissions and discharges). The law also amends the vital records law to require coroners to report drug overdose deaths. The law also amends the naloxone section in the controlled substance law to require first responders to report opioid-related overdoses to the Dept. of Health and whether naloxone was administered; the law also amended the public records law to exempt these first responder reports. We monitored this item for any potential amendment to include pharmacies or pharmacists; there were none. Action Plan:

Update the naloxone section in the Controlled Substance Law in Louisiana Pharmacy Law Book. HB 244 Pierre Judiciary Provides relative to vapor products and alternative nicotine products. 06-20-2019 Signed as Act 424; effective 06-20-2019. This bill amends the alcohol and tobacco control law to include vapor products and alternative nicotine products which requires dealers of such products to obtain a permit from the Alcohol & Tobacco Control (ATC) office and be regulated by that office. The bill added E-liquids, which may or may not contain nicotine and which cannot contain CBD or cannabis, to the list of regulated items. We monitored this item for any potential amendments to the therapeutic marijuana law; there were none. HB 250 Davis Health & Welfare Requires residential treatment facilities to provide access to medication-assisted treatment for patients with opioid use disorder. 06-20-2019 Signed as Act 425; effective 01-01-2020. This bill amends the licensing law for residential treatment facilities to require them to offer, no later than January 1, 2021, onsite access to at least one FDA-approved opioid agonist treatment and at least one FDA-approved partial opioid antagonist treatment. The bill specifies that onsite access shall not require the facility to maintain drug stocks but can allow for delivery to the patient at the facility. We monitored this item for any potential amendment affecting pharmacies or pharmacists; there were none.


HB 284 Abraham Health & Welfare Provides relative to prescribing and dispensing of opioid drugs. 06-20-2019 Signed as Act 426; effective 08-01-2019 This bill amends the prescription section of the Controlled Substance Law to require a prescriber electing to override the 7-day limit on prescriptions of opioids to specify on the prescription form that more than a 7-day supply is medically necessary. We monitored this item for any potential amendments affecting pharmacies or pharmacists. There were none. Action Plan:

Update prescription section of Controlled Substances Law in Louisiana Pharmacy Law Book. Notify licensees via the Legislative Bulletin.

HB 358 James Health & Welfare Provides relative to marijuana for therapeutic use. 06-11-2019 Signed as Act 284; effective 08-01-2019. This bill amended the Therapeutic Marijuana Law to remove the requirement that the recommending physician be domiciled in Louisiana (but still must be licensed by the state medical board); and further, authorized the Board of Pharmacy, by rule, to add metered dose inhalers as an allowable dosage form. Action Plan:

Update Therapeutic Marijuana Law in Louisiana Pharmacy Law Book. Revise marijuana rule to add metered-dose inhaler to the list of allowable dosage forms.

HB 375 Turner Health & Welfare Provides relative to criminal history record checks for certain licenses issued by the Louisiana Board of Pharmacy. 06-11-2019 Signed as Act 219; effective 08-01-2019. The Board approved this Legislative Proposal 2019-B; it amends the licensing section of the Controlled Substance Law to authorize the Board to require criminal history record checks for applicants for a CDS license. Action Plan:

Update Controlled Substance Law in Louisiana Pharmacy Law Book. Revise Chapter 27 – Controlled Dangerous Substances to add CBC requirement for CDS license. Update application form and/or instructions to alert applicants of CBC requirement.

HB 378 James Appropriations Provides relative to the creation of digitized credentials. 06-11-2019 Signed as Act 220; effective 06-11-2019. This bill amends the public finance law to authorize the Commissioner of Administration to promulgate rules to authorize the use of digitized credentials in electronic wallets. We monitored this item for potential use with credentials issued by the Board. HB 404 Schexnayder House & Governmental Affairs Abolishes certain boards, commissions, authorities, like entities, and related funds. 06-22-2019 Signed as Act 434; effective 06-30-2019. This bill abolishes four inactive boards and commissions and increases the membership of one board. We monitored this item to ensure neither the Board of Pharmacy nor the PMP Advisory Council were amended into the bill. They were not.


HB 423 Emerson Commerce Provides for the revocation of occupational and professional licenses for failure to pay student loans. 06-11-2019 Signed as Act 227; effective 08-01-2019 This bill amends the professional licensing law to repeal the section of law requiring licensing boards to deny applications for or renewals of licenses for applicants in default of student loans. Action Plan:

Revise application instruction documents to remove reference to this repealed law.

HB 433 LeBas Health & Welfare Authorizes a pharmacist to decline to dispense a covered prescription drug if the coverage provider reimburses the pharmacy in an amount less than the drug’s acquisition cost. 06-06-2019 Signed as Act 161; effective 06-06-2019. This bill amends the insurance law and the pharmacy practice act to authorize a pharmacist or pharmacy to decline to dispense a covered drug if the reimbursement is less than the drug’s acquisition cost. Action Plan:

Update the pharmacy law in the Louisiana Pharmacy Law Book. Notify licensees via the Legislative Bulletin.

HB 452 Turner Administration of Criminal Justice Provides relative to Schedule I controlled dangerous substances. 06-11-2019 Signed as Act 231; see Act for future effective date. This bill amends the controlled substance law to provide for the anticipatory automatic scheduling of mitragynine (Kratom) – at the same time and in the same schedule when the federal government makes that determination. When so scheduled, the existing prohibition on distribution to minors will be automatically repealed. Action Plan:

Update controlled substance law in Louisiana Pharmacy Law Book.

HB 491 Schexnayder Agriculture, Forestry, Aquaculture, & Rural Development Provides for the regulation of industrial hemp. 06-06-2019 Signed as Act 164; effective 06-06-2019 and 01-01-2020. This bill amends the agriculture law to establish a state-sanctioned industrial hemp program regulated by the Dept. of Agriculture. The bill also amends the controlled substance law to exempt industrial hemp from the definitions of Cannabis and Marijuana. The bill establishes a regulatory structure for the retail sale of hemp-derived CBD products, with such products requiring registration by the Dept. of Health, and the sellers requiring registration by the Alcohol & Tobacco Control unit of the Dept. of Revenue. Action Plan:

Update controlled substance law in Louisiana Pharmacy Law Book. Schedule reconsideration of PPM.I.A.26 ~ Sale of CBD Oil (Guidance Document).

HB 507 Abramson Ways & Means Levies a 7% tax on the gross sales of therapeutic marijuana and dedicates the avails into the New Opportunities Waiver Fund.

06-11-2019 Signed as Act 331; effective 07-01-2019. This bill amends the therapeutic marijuana law to revise the disposition of the 7% tax on the gross sales of marijuana products by the product producer. Instead of the Dept. of Agriculture retaining those proceeds


for its own use, the Dept. of Revenue shall receive those proceeds for distribution to the Community and Family Support System Fund (used for support of citizens with developmental disabilities). The bill also prohibits any sales and use taxes on the retail sales of marijuana products to patients. We monitored this amend for any potential amendments to other sections of the medical marijuana law. Action Plan:

Update therapeutic marijuana law in Louisiana Pharmacy Law Book. HB 538 LeBas Health & Welfare Provides relative to pharmacy record audits. 06-06-2019 Signed as Act 167; effective 08-01-2019. This bill amends the insurance law relative to insurance audits of pharmacy records. Different aspects of audits are addressed including a new provision relative to audits involving clinical judgment. The previous law required a licensed pharmacist perform or consult on the audit; the new law requires that pharmacist to be licensed in Louisiana. We monitored this item for potential amendments to pharmacy law; there were none. HB 560 Abramson Ways & Means Authorizes the imposition of tax on hemp and CBD.

06-11-2019 Signed as Act 247; see Act for effective date. This bill amends the tax law to impose a 3% excise tax on the retail sale of hemp-derived CBD products, in addition to any sales and use taxes on the retail sales of such products. Requires the Dept. of Revenue to collect the tax and deposit the proceeds in the Early Childhood Education Fund. The bill conditioned the effective date of this act upon the effective date of the act originating as HB 138 (Board’s CDS update bill), which is 08-01-2019. The taxes are due beginning 01-01-2020. We monitored this item due to its connection with a Board-sponsored bill. HB 614 Miguez House & Governmental Affairs Exempts certain information from the Public Records Law. 06-11-2019 Signed as Act 256; effective 08-01-2019. This bill amends the public records law to exempt the social security number, driver’s license number, financial institution account number, credit or debit card number, or armed forces identification number of a person that is submitted to a public agency, except for such data recorded in mortgage or conveyance records, court records, or marriage records. The bill also exempts personal healthcare data reported to the state by a healthcare provider when required to do so without the patient’s consent. The bill requires a records custodian to inform the public their communications with the agency may become public record. Action Plan:

Update custodian of records notice on website. Update written and electronic communications platforms to provide public notice.

Resolutions HR 254 Jordan Requests the Dept. of Insurance to study and make recommendations regarding the regulation of pharmacy services administrative organizations. 06-05-2019 Passed; Sent to the Secretary of State. Requests the insurance commissioner to submit his report and recommendations to the legislative committees on insurance no later than 02-01-2020. We monitored this item for potential inclusion of the Board; we were not included. HR 257 Hoffmann Requests the Dept. of Health to study the benefits and costs of eliminating prior authorization requests for


medication-assisted treatment for opioid use disorder. 06-05-2019 Passed; Sent to the Secretary of State. Requests the Dept. of Health to make the changes necessary to eliminate prior authorization requirements in the Medicaid program for all formulations of buprenorphine/naloxone and naltrexone. We monitored this item for potential inclusion of the Board; we are not included.

Senate Bills SB 29 Cortez Commerce, Consumer Protection, & International Affairs Provides relative to professional and occupational licensing boards and commissions. 06-11-2019 Signed as Act 179; effective 08-01-2019. This bill amends the professional licensing law to prohibit a professional licensing board from (1) including nondisparagement provisions in their consent agreements or (2) initiate disciplinary proceedings against a licensee for providing testimony or records to a legislative body. We monitored this item for any potential amendment specifically relative to pharmacy; there were none. SB 36 Mills Health & Welfare Provides relative to emergency departments. 06-11-2019 Signed as Act 438; effective 08-01-2019. This bill amends the hospital licensing law to prohibit freestanding emergency departments and requires all emergency departments to be part of a licensed hospital. The bill exempts any facilities with a construction permit issued prior to 04-01-2019. We monitored this item for its potential impact on a new class of a CDS license. Since hospital licenses already include multiple locations under a single license number, this will not require any change in license type configuration. SB 41 Mills Health & Welfare Provides relative to regulation of pharmacy benefit managers.

06-06-2019 Signed as Act 124; effective 08-01-2019 and 07-01-2020. This bill amends the insurance law and pharmacy law and creates a new section of law relative to the licensure and regulation of pharmacy benefit managers. The new law requires those PBMs operating in the state to obtain a registration from the Dept. of Insurance and allows those PBMs to obtain a permit from the Board of Pharmacy. The bill requires the insurance commissioner and the board to promulgate rules. The new PBM law establishes a monitoring advisory council which will assist the insurance commissioner and the board with investigations and compliance audits. The bill requires the insurance commissioner and board to discipline credentials it issues. The bill authorizes the attorney general to prosecute unfair trade practices. The bill requires the board to submit monthly reports to the attorney general containing a cumulative list of complaints submitted to the board. Action Plan:

Update pharmacy law and insert new PBM law in Louisiana Pharmacy Law Book. Notify licensees via Legislative Bulletin. Update PPM.I.B.6 ~ Board Liaisons to Other Entities. Identify board representative to PBM Monitoring Advisory Council. Establish communication links with Dept. of Insurance and Dept. of Justice. Collaborate with Dept. of Insurance for council administration. Develop MOU or CEA to share council expenses with Dept. of Insurance. Task the Regulation Revision Committee to develop regulatory proposal for Board approval and

subsequent promulgation. Develop application form based on rule requirements. Configure new license type in eLicense based on rule requirements.


SB 53 Johns Health & Welfare Provides relative to prescription monitoring information. 06-04-2019 Signed as Act 80; effective 08-01-2019. The Board approved this Legislative Proposal 2019-C; it amends the PMP law to allow the sharing of PMP information with federal jurisdictions. Action Plan:

Update PMP law in Louisiana Pharmacy Law Book. Task the Regulation Revision Committee to develop a regulatory proposal for Board approval and

subsequent promulgation. Implement file-sharing permissions in PMP administrative dashboard.

SB 57 Walsworth Senate & Governmental Affairs Provides for certain records management services. 06-01-2019 Signed as Act 46; effective 08-01-2019. This bill amends the public records law, and more particularly the law for the state archives division within the Dept. of State. The new law removed the preference for microfilming for record preservation by state agencies and establishes that agency as the central document conversion office for the state. We monitored this item in preparation for our own record conversion project. SB 66 Riser Senate & Governmental Affairs Provides relative to open meetings of public bodies. 06-11-2019 Signed as Act 340; effective 08-01-2019. This bill amends the open meetings law and more specifically the enforcement thereof. The bill increased the amount of the fine for any member of a public body who participates in a meeting held in violation of that law, from $100 to $500. We monitored this item due to its potential impact on board operations. SB 99 Boudreaux Health & Welfare Provides relative to board member qualifications. 06-01-2019 Signed as Act 52; effective 08-01-2019. This bill amends the pharmacy practice act, more specifically the qualifications for board members, to lower the amount of time required for licensed practice in Louisiana, from 5 years to 2 years. We monitored this item for any potential amendments; there were none. Action Plan:

Update the pharmacy law in the Louisiana Pharmacy Law Book. SB 119 Colomb Health & Welfare Creates the Palliative Care Interdisciplinary Council. 06-11-2019 Signed as Act 351; effective 08-01-2019. This bill created the Palliative Care Interdisciplinary Advisory Council within the Dept. of Health, for the purpose of assessing the availability of patient-centered and family-focused palliative care in the state and making recommendations to the secretary and the legislature. One of the 17 members shall be a pharmacist appointed by the Board of Pharmacy, who shall have at least two years of experience in providing individual or interdisciplinary palliative care to pediatric, youth, or adult populations in inpatient, outpatient, or community settings. Unless reauthorized by the legislature, the council shall cease to exist on 03-31-2022. We monitored this item for any potential amendment relative to pharmacy; there were none. Action Plan:

Update PPM.I.B.6 ~ Board Liaisons to Other Entities. Identify board liaison to Dept. of Health.


SB 166 Lafleur Health & Welfare Provides relative to physician assistants. 06-11-2019 Signed as Act 276; effective 08-01-2019. This bill amended the medical practice act to change the eligibility requirement for a physician assistant to apply for prescriptive authority, from an active and unrestricted license to a current license. We monitored this item for any potential amendments relative to the scope of their prescriptive authority; there were none. SB 169 Barrow Health & Welfare Provides relative to the state immunization registry. 06-11-2019 Signed as Act 192; effective 06-11-2019. This bill amends the public health law relative to the state immunization registry. The bill changes the reference to children in favor of clients, which allows the receipt of information about adults. We monitored this item for any potential amendment relative to pharmacies or pharmacists; there were none. SB 239 Mills Health & Welfare Provides relative to the Medicaid prescription drug benefit plan. 06-11-2019 Signed as Act 263; effective 08-01-2019. This bill amends the Medicaid law to require the Dept. of Health to establish a single preferred drug list which shall include all drug classes subject to a prior authorization requirement. The bill creates a new section of law which allows the department to remove the Medicaid pharmacy services from managed care and administer the program directly, and further, if the department uses a managed care firm to administer the benefit, then the firm shall be paid a transaction fee only, with no other gains to be retained by the firm. We monitored this item for any potential amendment to pharmacy law or board operations; there were none. SB 240 Boudreaux Health & Welfare Provides relative to the provision of medication-assisted treatment (MAT). 06-20-2019 Signed as Act 414; effective 08-01-2019. This bill amends the medical practice relative to physician assistants and the nursing practice act relative to advanced practice registered nurses, to authorize both types of practitioners to provide medication-assisted treatment (MAT) for opioid dependence in accordance with federal government rules for that activity from the Substance Abuse and Mental Health Services Administration (SAMHSA). We monitored this item for any potential amendment relative to prescriptive authority privileges or other pharmacy-related amendments; there were none. SB 241 Riser Commerce, Consumer Protection, & International Affairs Provides for the Small Business Protection Act. 06-11-2019 Signed as Act 204; effective 02-01-2020. This bill amends the administrative procedure act to enact the Small Business Protection Act as a successor to the Regulatory Flexibility Act. The bill establishes an office within the Secretary of State’s Commercial Division to administer this new law. The bill revises the adoption of rules by agencies by including that new office in the list of entities to receive all notices and reports. The bill requires the addition of a small business impact statement to the list of other impact statements as part of the proposed notice of intent package. Action Plan:

Update rulemaking procedures and templates. Resolutions SR 255 Barrow To request the La. Dept. of Health, La. State Board of Medical Examiners, and La. Board of Pharmacy to


study and make recommendations relative to certain provisions of Louisiana law on medical marijuana. 06-06-2019 Passed; Sent to the Secretary of State. Requests the identified agencies to consider whether pediatric consultations should be required for all pediatric patients receiving recommendations for medical marijuana, not just for autism as presently required. Requests the agencies to consider whether facilities housing physicians recommending medical marijuana should be licensed as such by the Dept. of Health, similar to pain management clinics. Report and recommendations due to the Senate no later than 02-01-2020. Concurrent Resolutions SCR 31 Barrow Health & Welfare Designates a lead agency over the Interagency Heroin and Opioid Coordination Plan. 06-04-2019 Passed; Sent to the Secretary of State. Act 88 of the 2017 Legislature established the Advisory Council on Heroin and Opioid Prevention and Education (AC-HOPE), housed within the Drug Policy Board in the Office of the Governor. That law requires the AC-HOPE to develop and Interagency Heroin and Opioid Coordination Plan; although the law requires the Dept. of Health to staff the council, the law did not identify a lead agency. During the council’s survey of agencies and organizations with opioid-relative initiatives, some organizations were slow to respond with data. The absence of a lead agency with authority to demand data production was identified as a challenge. This resolution seeks to resolve that issue by designating the Dept. of Health as the lead agency for the state plan to address the opioid crisis. SCR 78 Boudreaux Health & Welfare Requests the Louisiana State Board of Nursing and the Louisiana State Board of Medical Examiners to report on the number of advanced practice registered nurses and the number of physician assistants that provide medication-assisted treatment (MAT) in Louisiana. 06-04-2019 Passed; Sent to the Secretary of State. Requests both boards to submit reports beginning 02-01-2020 and annually thereafter.


Bill Act Topic Citation(s) Law Book Rules PPM Guidance Forms Operations CompletionHB 138 2019-354 Revised definitions; new drugs in Schedule I 40:961 and 964 8/1/2019 8/1/2019HB 243 2019-423 Reporting of opioid-related overdoses 40:978.2.1 8/1/2019 8/1/2019HB 284 2019-426 Prescriber overrides of 7-day supply 40:978(G)(2) 8/1/2019 8/1/2019HB 358 2019-284 Cannabis metered-dose inhalers 40:1046(A)(1) 8/1/2019 Reg. Proposal 2019-E in CmteHB 375 2019-219 CBC for CDS license applicants 40:973.1 8/1/2019 Assigned to CmteHB 423 2019-227 Repeal of student loan disqualifications 37:2951 repealed 8/1/2019 8/1/2019HB 433 2019-161 Pharmacist may decline to fill prescription 37:1219(D through F) 8/1/2019 Assigned to CmteHB 452 2019-231 Scheduling of mitragynine 40:964 and 40:989.3 8/1/2019 8/1/2019HB 491 2019-164 Hemp-derived CBD oil products 40:961.1 8/1/2019 PendingHB 507 2019-331 7% tax on gross sales of marijuana products 40:1046(H)(8)(a) 8/1/2019 8/1/2019HB 614 2019-256 Public notice for public records 44:33.1(B) 8/1/2019SB 41 2019-124 Licensure and regulation of PBMs 37:1252 et seq; 40:2861 et seq 8/1/2019 Reg. Proposal 2019-G in CmteSB 53 2019-080 Access to PMP by federal jurisdictions 40:1007(G) 8/1/2019 Reg. Proposal 2019-F in CmteSB 99 2019-052 Board member qualifications 37:1174(A)(4) 8/1/2019 Assigned to Cmte

SB 119 2019-351 Palliative Care Advisory Council 40:2018.6 PendingSB 241 2019-204 Revision of APA re small business impact 49:953 et seq Review


Bill Act Topic Citation(s) Law Book Rules PPM Guidance Forms Operations CompletionHB 45 2018-186 CDS license for 3rd party logistics providers 40:961(42); 972(B)(7); 973(A)(1) 8/1/2018 Reg Project 2019-13 in process

HB 150 2018-063 Military spouse renewal fee waiver 37:1208.1 8/1/2018 No rule required PST-MS #12-MS 11/1/2018HB 151 2018-064 Definition of 'approved school of pharmacy' 37:1164(2) 8/1/2018 No rule required 11/1/2018HB 153 2018-119 New substances to Schedules I and II 40:964 8/1/2018 8/1/2018HB 165 2018-677 Penalties for CS violations 40:966; 967 8/1/2018 8/1/2018HB 186 2018-199 Penalties for CS violations 40:979 8/1/2018 8/1/2018HB 188 2018-200 Acceptance of gifts by public servants 42:1115.2 anticipatedHB 189 2018-454 Rulemaking procedures 49:953(C) 8/1/2018 Reg Project 2019-14 in processHB 224 2018-203 Penalties for legend drug violations 40:1060(13); (15) 8/1/2018 8/1/2018HB 326 2018-206 Technical corrections to practice acts 37:1164; 1182; 1226.1; 1226.2 8/1/2018 8/1/2018HB 372 2018-623 Occupational licensing review commission 37:41-47 1/31/2019 1/31/2019HB 579 2018-708 New indications for therapeutic marijuana 40:1046 8/1/2018 8/1/2018HB 627 2018-496 New indications for therapeutic marijuana 40:1046 8/1/2018 8/1/2018HB 748 2018-693 Occupational licensing review by Gov office 49:903 3/14/2019HB 823 2018-715 Delay termination date of marijuana program 40:1046(J) 8/1/2018 8/1/2018HCR 70 Review of military licensing procedures anticipatedSB 27 2018-644 Nominations to Medicaid P&T Cmte 46:153.3(D) 8/15/2018 8/15/2018SB 28 2018-219 Exemptions for veterinarians 37:1251(D); 40:978(F)(3); 978.3(E) 8/1/2018 8/1/2018SB 29 2018-423 Uniform prior authorization form 22:1006.1; 1651(J); 46:460.33 1/20/2018 §1129 & 1130 1/1/2019SB 40 2018-515 Consumer members to licensing boards 37:1172(A); 1174(B) 8/1/2018 8/1/2018SB 75 2018-405 Prescriber licensing boards re PMP access 40:978(F)(2) 8/1/2018 8/1/2018SB 90 2018-028 Voluntary nonopioid directive form 40:1156.1 8/1/2018 LDH 11/1/2018

SB 109 2018-232 Epidemiologist access to PMP 40:1007(E)(8) 8/1/2018 Reg Project 2019-6 in processSB 110 2018-146 PMP definition of 'drugs of concern' 40:1003(10) 8/1/2018 §2901 1/20/2019SB 131 2018-031 Pharmacist licensure by reciprocity 37:1202; 1203 8/1/2018 No rule required 11/1/2018SB 134 2018-032 Partial fills for all Schedule II drugs 40:978(A) 8/1/2018 Reg Project 2019-12 in processSB 241 2018-317 Pharmacist communication with patients 22:1657; 37:1219 8/1/2018 No rule required 11/1/2018SB 260 2018-655 Complaints re board actions or procedures 37:23.1; 23.2 11/1/2018 11/1/2018SB 391 2018-669 Internet filters in state agency offices 8/1/2018 8/1/2018SB 477 2018-602 Chart orders for institutional patients 37:1164(59); 1226.4 8/1/2018 Reg Project 2019-17 in processSCR 83 Military licensing info on website 10/1/2018

From: Kevin LaGrange Sent: Monday, June 10, 2019 1:08 PM To: [email protected]; [email protected]; [email protected] Cc: Eric Vidrine <[email protected]>; [email protected] Subject: CBD Sales Malcolm, I am starting to see news articles stating the sale of CBD is now legal in Louisiana https://www.theadvocate.com/baton_rouge/news/business/article_628604b4-893a-11e9-9136-3359dc3bd924.html and retailers will need to register with Alcohol and Tabaco Control (ATC). With the current marijuana rules and regulations written by the Board of Pharmacy, 2551.N “No marijuana pharmacy shall sell anything other than marijuana products; however, the pharmacy may elect to sell over-the-counter (OTC) medications, durable medical equipment (DME), and other retail products from the same premises but outside the prescription department”, will the Board allow Therapeutic Marijuana Pharmacies like The Apothecary Shoppe to sell CBD products within our facility since they specifically won’t be produced by LSU or Southern? If we can, will we be required to register with ATC or will there be some other method/process since we currently had the ability to do so if the products were produced by LSU or Southern?

https://www.theadvocate.com/baton_rouge/news/business/article_628604b4-893a-11e9-9136-3359dc3bd924.html

https://www.theadvocate.com/baton_rouge/news/business/article_628604b4-893a-11e9-9136-3359dc3bd924.html

Iouitana Woarb of jarmacp3388 Brentwood Drive

Baton Rouge, Louisiana 70809-1700 (3Telephone 225.925.6496 — E-mail: info(dpharmacv.l&gov

MEMORANDUM

Interested Parties

From: Malcolm Broussard IIBDate: June 13, 2019

Re: Board Interpretation of LAC 46:LIIl.2457.D.4.b

The Louisiana Medical Marijuana Tracking System (LMMTS) is a “seed-to-sale” informationsystem designed to capture and manage data from multiple stakeholders in the production anddistribution of medical marijuana products. The scope of the information system, which hasbeen used in multiple states with dispensary distribution models, extends to the dispensaryacknowledging receipt of product purchases from the producers and the subsequent reporting ofconsumer sales transactions back to the tracking system by dispensaries. In one state, thesystem reports such sales transactions to the state prescription monitoring program using apatient registration number collected by the dispensary.

The question has arisen whether Louisiana’s marijuana pharmacies are required to report theirdispensing transactions to LMMTS and whether LMMTS can satisfy the pharmacies’ obligationsto report such dispensing transactions to the Louisiana PMP. The Board’s rules for marijuanapharmacies require those pharmacies to enter all inventory-related transactions in LMMTS.

Chapter 24. Limited Service ProvidersSubchapter E. Maruuana Pharmacy§2457. Standards of Practice

D. Recordkeeping Requirements4. Inventory of MarU’uana Product

b. The pharmacy shall access the LMMTS and enter all inventory-related transactions in thatsystem.

[LAC 46:Llll.2457.D.4.b]

Marijuana pharmacies are required to establish and maintain a perpetual inventory of allmarUuana products acquired, held, dispensed, and disposed by the pharmacy. The Boardrequires all marijuana pharmacies to have access to LMMTS for the purpose of acknowledgingreceipt of medical marijuana products purchased from a marijuana product producer. Theproduct information from LMMTS will include a product identification number which will serve asa proxy for the National Drug Code (NDC) number in the pharmacy’s dispensing informationsystem. While the dispensing of a product obviously impacts the inventory level of the product inthe pharmacy’s dispensing information system, the Board does not consider the dispensingtransaction to be an inventory-related transaction reportable to LMMTS.

The Board has interpreted its rule such that marijuana pharmacies shall access LMMTSto acknowledge receipt of their purchases from the product producer but they shall not reporttheir dispensing transactions to LMMTS. Further, since there is no patient registration systemfor medical marijuana products in Louisiana, pharmacies shall report their product dispensingtransactions to the Louisiana PMP from their own dispensing information systems.

To:

NOTICE: In compliance with Act 20)8-655 ofthe Louisiana Legislatut-c, the Board gives notice to its licensees and applicants oftheir opponunitelofile aconiplaim about the

Boards actions or procedures. You may suhtnit such complaints to one or more ofthe following: U) Louisiana Board ofPhannacr; 3388 Breniwood Dr.. Baton Rouge. La

70809,- 225.925.6396; infi%i phurn,ac via. va’ (2)Committee on House & Governmental Affairs; La. House oJ’Reprcsentatives; P0 Box 44486; Baton Rouge. LA 70804;

225.342.2403; h&ea keftlatrv t’3,iCommittecon Senate & Governmet,tal Affairs; La. Senate; PG Box 94)83: Baton Rouge, LA 70804,- 115.342.9845; .c&VJkeis.ln.i’oi

From: Crystal CarterTo: Joe Fontenot; Malcolm J. BroussardSubject: Request for Rule ClarificationDate: Thursday, June 06, 2019 5:13:59 PM

Good afternoon! I had a question from a member that I wanted to get further clarification aboutbefore responding. In the January newsletter, there was a reminder about reporting changes in mailing address andpharmacy employment. The question was asked about the section on the Form 090 relative to“Additional Site of Employment.” If a chain pharmacist is working at multiple locations, are they arerequired to report each location as an additional site? And if so, does that apply to a situation wherethey are only working one shift for a special circumstance? I have not had this kind of question before, so I just wanted to reach out directly for thatclarification. I appreciate your time. Crystal Crystal Carter, MPA | Client StrategistLouisiana Pharmacists [email protected] | [email protected](225) 346-6883 | (225) 344-1132 (fax)620 Florida St., Suite 210 | Baton Rouge, LA 70801www.louisianapharmacists.com

Upcoming EventsJuly 18-20, 2019 – Annual Convention & Trade Show – L’Auberge Casino Lake CharlesDecember 8, 2019 – CE Caravan – Northshore LPA Mission: As members of LPA, we have the power to improve lives and improve the healthcare landscape.

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Louisiana Revised Statutes of 1950

Title 37 – Professions and Occupations

Chapter 14 – Pharmacy Practice Act

§1213. Notification of change of business place or employment

A pharmacist, pharmacy technician, pharmacy intern, or pharmacy technician candidate shall notify the board, in writing, of any change of employment within a time frame determined by the board by rule. (Amended by Act 357 of 2012 Legislature, effective August 1, 2012) * * *

Louisiana Administrative Code

Title 46 – Professional and Occupational Standards

Part LIII – Pharmacists §511. Employment Change

A. A licensed pharmacist shall notify the board within ten days, with documentation, attesting to any change in employment. This documented notice shall include the pharmacist’s full name and license number, the name and address of old and new employment, and the permit numbers of those pharmacies involved.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2084 (October 2003), effective January 1, 2004. * * * §703. Registration

A. – A.3. … 4. A pharmacy intern shall notify the board in writing within 10 days of a change in location(s) of

employment. This notice shall include the pharmacy intern’s name and registration number, the name and address of old and new employment, and the permit numbers of those pharmacies involved.

A.5. – A.5.b. … AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1211. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 26:2285 (October 2000), amended LR 29:2086 (October 2003), effective January 1, 2004, amended by the Department of Health, Board of Pharmacy, LR 43:2163 (November 2017), effective January 1, 2018. * * * §903. Pharmacy Technician Candidates

A. – A.3.e. … f. A pharmacy technician candidate shall notify the board, in writing, no later than 10 days following a change in location(s) of employment. The written notice shall include the candidate’s name, registration number, and name, address, and permit numbers for old and new employers.

B. – D.2.b. … AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1212. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 30:2485

(November 2004), effective January 1, 2005, amended LR 39:1777 (July 2013), amended by the Department of Health, Board of Pharmacy, LR 43:2496 (December 2017), effective January 1, 2018, repromulgated LR 44:49 (January 2018). * * * §905. Pharmacy Technician Certificate

A. – B.4. … 5. A pharmacy technician shall notify the board, in writing, no later than 10 days following a change in

location(s) of employment. The written notice shall include the technician’s name, certificate number, and name, address, and permit numbers for old and new employers.

6. … AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1212. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 30:2486 (November 2004), effective January 1, 2005, amended LR 38:1235 (May 2012), LR 39:1777 (July 2013), amended by the Department of Health, Board of Pharmacy, LR 43:2497 (December 2017), effective January 1, 2018.

THIS FORM IS FOR INTERNAL USE ONLY.

FORM DA WC4000

REVISED 07.2019

Month of Report__________________________ Location code________________________

Agency__________________________________ Contact Person________________________

The agency has developed and implemented a Transitional Duty Employment

plan: ______ Yes ______ No

Transitional Duty Employment is monitored at the department level:

______ Yes ______ No

REPORT THE FOLLOWING ACTIVITY:

1. Number of lost time workers’ compensation claims during the past month:

_________. *

2. Number of employees returned to work on transitional duty: ________.

3. Number of employees returned to work full duty: _________.

4. Number of employees on workers’ compensation at month’s end: _________.

5. Number of employees who are separated from the agency and still receiving

workers’ compensation: _____.

6. The RTW committee has met and reviewed all W/C claims eligible for

Transitional Duty Employment: ____ yes ____ no.

*NOTE: Lost time refers to whole days an employee has missed from work due

to a work-related accident for which indemnity benefits would be paid.

TRANSITIONAL DUTY EMPLOYMENT AUDIT FORM – DA WC4000

The purpose of this form is to record an agency’s Transitional Duty activity for the current

month only.

Please keep completed forms on file at the location or department level

that is responsible for Transitional Duty Employment.

Louisiana Board of Pharmacy Policies & Procedures 1 2 Title: Sale of CBD Oil (Guidance Statement) Policy No. I.A.26 3 4 Approved: 11-14-2018 Revised: 02-19-2019 5 6

7 Preamble 8

• During their November 14, 2018 meeting, the Board approved the original Guidance Document re 9 Cannabidiol (CBD) Oil for the benefit of its licensees, particularly those holding state controlled 10 substance (CDS) licenses and federal registrations from the U.S. Drug Enforcement 11 Administration (DEA). On December 20, 2018, the Agriculture Improvement Act of 2018, more 12 commonly known as the 2018 Farm Bill, became effective. The 2018 Farm Bill created federal 13 recognition for hemp as an agricultural commodity and authorized its use in compliance with the 14 provisions of that law. That law also amended the federal controlled substances law to exempt 15 the tetrahydrocannabinol (THC) found in hemp from the listing of THC in Schedule I of the federal 16 list of controlled substances. 17

• During their February 19, 2019 meeting, the Board took note of the recent federal legislation. 18 They also took note that the Louisiana Legislature has not yet adopted state law to recognize 19 hemp, nor has the state legislature created an exemption for the THC found in hemp from the 20 THC which appears in Schedule I of the state list of controlled substances. Further, there is no 21 differentiation in the source of CBD. In the interim, state law is more stringent than federal law. 22 The Board members voted to revise their original guidance document by removing the references 23 to the federal law but left intact the references to the state law. Finally, their ultimate guidance 24 remains the same: the sale of CBD oil by its licensees would constitute a violation of the state 25 controlled substance law and place them at risk for criminal and/or administrative sanctions. The 26 text of the revised guidance document follows. 27

• During their August 14, 2019 meeting, the Board took note of Act 164 of the 2019 Legislature, 28 which established a statewide industrial hemp program. The definition of hemp mirrors the 29 federal definition of hemp in that it excludes up to 0.3% THC found in hemp from the provisions of 30 the controlled substance law. The act also established a regulatory structure for the retail sale of 31 hemp-derived cannabidiol CBD products. 32

33 34

1. The Board continues to receive questions about cannabidiol (CBD) oil, derived 35 from hemp or derived from marijuana. Act 261 of the 2015 Legislature, which 36 established the state medical marijuana program, made no exception for 37 possession or sale of CBD oil. Louisiana’s controlled substance law includes 38 CBD oil in the definition of marijuana. 39

40 2. All marijuana products shall comply with the rules adopted for the state medical 41

marijuana program; they must have a known source as well as known quantities 42 of active ingredients. Further, they may only be dispensed by marijuana 43 pharmacies licensed by the Board of Pharmacy. 44 45

3. Since marijuana is listed in Schedule I of the state’s list of controlled substances, 46 no one, including board licensees, may possess or sell CBD oil. Violations of the 47 Louisiana Revised Statutes or Louisiana Administrative Code can subject a 48 person to criminal or administrative action. 49 50

For its licensees intending to participate in the retail sale of hemp-derived cannabidiol 51 products, the Board encourages compliance with all applicable federal and state laws 52 and rules. 53

DRAFT

Frequently Asked Questions re CBD Oil 54 55

1. Is CBD (cannabidiol) oil legal under Louisiana law? 56 No. The Louisiana Controlled Dangerous Substances Law defines 57 marijuana as: 58

“all parts of plants of the genus Cannabis, whether growing or not; 59 the seeds thereof; the resin extracted from any part of such plant; 60 and every compound, manufacture, salt, derivative, mixture, or 61 preparation of such plant, its seeds or resin, but shall not include 62 the mature stalks of such plant, fiber produced from such stalks, oil, 63 or cake made from the seeds of such plant, any other compound, 64 manufacture, salt, derivative, mixture, or preparation of such 65 mature stalks (except the resin extracted therefrom), fiber, oil, or 66 cake, or the sterilized seed of such plant which is incapable of 67 germination, or cannabidiol when contained in a drug product 68 approved by the United States Food and Drug Administration.” 69

CBD is a compound of marijuana and therefore is considered marijuana 70 under Louisiana law. Marijuana is listed in Schedule I of the state 71 controlled substance list. There is no lawful possession of a substance 72 listed in Schedule I, except for the marijuana products authorized in the 73 state medical marijuana program. [La. R.S. 40:961(26)] 74

75 2. Is CBD extracted from hemp legal under Louisiana law? 76

No. Louisiana law does not make a distinction between CBD extracted 77 from hemp and CBD extracted from marijuana. CBD is a compound of 78 marijuana and therefore is considered marijuana under Louisiana law. 79

80 3. Does the State of Louisiana have a hemp program? 81

At this time, the State of Louisiana does not have a hemp program. 82 83

4. Can I or my business sell CBD oil products? 84 No. CBD oil, whether derived from hemp or marijuana, is listed in 85 Schedule I of the state’s list of controlled substances. There is no lawful 86 possession of a substance listed in Schedule I, except for the marijuana 87 products authorized in the state medical marijuana program. 88

89 5. What are the consequences for selling CBD oil? 90

Violations of the Louisiana Revised Statutes or Louisiana Administrative 91 Code can subject a person to criminal or administrative action. 92

93 6. How does the Board of Pharmacy intend to enforce this guidance statement? 94

The Board’s efforts at this time are educational. In the event licensees 95 continue to sell CBD oil despite having accurate guidance information, the 96 Board may reassess its compliance methodology. 97

98 7. How is a DEA licensee allowed to dispense Marinol and Epidiolex? 99

Marinol and Epidiolex have been approved by the federal Food & Drug 100 Administration (FDA) as prescription drug products, and further, have 101 been scheduled by the DEA in other controlled substance schedules used 102

DRAFT

for prescription drug products [Schedule II for the Marinol product in 103 aqueous formulation, Schedule III for the Marinol product in oil 104 formulation, and Schedule V for the Epidiolex product]. 105

106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151

DRAFT

Revision History 152 153 08-14-2019 Updated preamble, removed three numbered items relative to state 154

law, added single sentence encouraging compliance with 155 applicable laws and rules, and removed FAQ section. 156

157 02-19-2019 Removed references to federal law, consistent with provisions of 158

newly-enacted federal Agriculture Improvement Act of 2018. 159 160

DRAFT

Louisiana Board of Pharmacy Policies & Procedures 1 2 Title: Board Liaisons to Other Entities Policy No. I.B.6 3 4 Approved: 08-15-2018 Revised: 5 6

7 1. The membership of the Drug Policy Board, an agency within the Office of the 8

Governor, is identified at La. R.S. 49:219.2. Within that listing is “a member of 9 the Board of Pharmacy.” That law specifies the member from the Board of 10 Pharmacy serves at the pleasure of the appointing governor and at the expense 11 of the Board of Pharmacy. The President of the Board of Pharmacy shall 12 nominate a member of the Board of Pharmacy to serve as a member of the Drug 13 Policy Board. 14

15 2. The membership of the Prescription Monitoring Program Advisory Council is 16

identified at La. R.S. 40:1005(A). Within that listing is “the President of the 17 Board of Pharmacy or his designee.” That law specifies the member from the 18 Board of Pharmacy serves at the pleasure of the Board and at the expense of 19 the Board of Pharmacy. In the event the President is unable to attend a council 20 meeting, he shall appoint a designee. 21

22 3. The membership of the Medicaid Pharmaceutical and Therapeutics Committee 23

is identified at La. R.S. 46:153.3(D)(2)(a). Within that listing is “two practicing 24 pharmacists nominated by the Louisiana Board of Pharmacy. One pharmacist 25 shall be an independent pharmacist and one pharmacist shall be a pharmacist 26 representing a chain pharmacy.” The law requires the Board of Pharmacy to 27 nominate two pharmacists to the Office of the Governor, and shall certify by 28 affidavit that the practice of each nominee involves either the care of or the 29 supervision of the care of Medicaid recipients. The law requires the 30 gubernatorial appointments be confirmed by the Louisiana Senate. The law 31 further stipulates that a member who misses two consecutive meetings may be 32 replaced. The replacement process requires the Dept. of Health to notify the 33 Board upon the second recorded absence, and if the Board does not nominate a 34 replacement within 30 days, the department may do so. The President of the 35 Board of Pharmacy shall nominate two pharmacists no later than August 1, 36 2018. 37

38 4. The membership of the Collaborative Drug Therapy Management Advisory 39

Committee, constituted as provided in LAC 46:XLV.7417, shall assist the Board 40 of Medical Examiners and the Board of Pharmacy on matters relative to 41 collaborative drug therapy management. The President of the Board shall 42 appoint a pharmacist to serve on the committee, and said pharmacist shall serve 43 at the pleasure of the Board of Pharmacy and without compensation. 44

45 5. The membership of the Pharmacy Benefit Manager Monitoring Advisory Council 46

is specified at La. R.S. 40:2869 and includes the president of the Board of 47 Pharmacy, who may appoint a designee. The president or his appointee serves 48 at the pleasure of the Board of Pharmacy, and is eligible for per diem and travel 49

Draft #

2

expense reimbursements in accordance with Board travel policies 50 51 6. The membership of the Palliative Care Interdisciplinary Advisory Council is 52

identified at La. R.S. 40:2018.6(C). The 17-member council includes one 53 member appointed by the Board of Pharmacy, who shall be a pharmacist with at 54 least two years experience providing individual or interdisciplinary palliative care 55 to pediatric, youth, or adult populations in inpatient, outpatient, or community 56 settings. Members serve at the pleasure of the appointing authority and without 57 compensation. Members missing three consecutive meetings shall be replaced 58 by the appointing authority. The council shall meet at least quarterly. Unless 59 extended by the legislature, the council shall expire on March 31, 2022. 60

61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98

Draft #

2

Revision History 99 100 08-14-2019 Added Items 4, 5 and 6. 101 102 103

Draft #

2

7/17/2019 Online Directory

https://accreditation.ashp.org/directory/#/program/technician/programInfo/AZ-11 1/1

Technician Program Information

Penn Foster Collegehttps://www.pennfoster.edu/programs-and-degrees/medical-and-health-careers/pharmacy-technician-professional-career-

diploma

14300 N. Northsight Blvd, Suite 125

Scottsdale AZ 85260

Code: AZ-11

Accreditation Status: Candidate Category: Technical Training

Sub-Category:

Program Director

Karen Davis CPhT, BHS.

(912) 547-1454

Email: [email protected]

Reporting Administrator

Lisa Rutsky

(570) 961-4133


Program Contact

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Email ASHP

4500 East-West Highway, Suite 900Bethesda, MD 20814

1-866-279-0681

CONNECT WITH ASHP

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Email ASHP4500 East-West Highway, Suite 900

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https://accreditation.ashp.org/directory/#/program/technician/programInfo/TX-33 1/2

Technician Program Information

Medical Education and Training Campus

3018 William Hardee Road, Bldg 895

Joint Base San Antonio TX 78234

Code: TX-33

Accreditation Status: Accredited Category: Technical Training

Sub-Category:

Program Director

Justin Lusk

(210) 808-2200


Reporting Administrator

Christine Edwards LTC, USA, RDN

(210) 808-1365


Program Contact

Certi�cate

Didactic course work: 344/430

Laboratory course work: 134/196

Experiential Training: 120/240

Lecture class size: 20 students/Instructor

Laboratory class size: 6 students/Instructor

Spaces per entering class: 80

Faculty or Sta�

Pharmacists: 4

Technicians: 29

Lab/clerical support: 2

Enrollment

Interview required: No

Flexible scheduling allowed: No

Class Scheduling: Full-Time

Experimental Training Sites

Community pharmacy: 2

Hospital: 2

Home health care: 2

Managed care: 2

Technician Training Demographics

Special Program Features: This is a military /federal only

program designed to prepare students for service in

military/federal pharmacies in the U.S. and overseas. The

program has an advanced phase focused on preparing

students for independent duty in operational settings

within the military. 40-computer-based-training modules

were developed in partnership with the Dept. of Veteran's

A�airs, and are utilized as blended learning throughout

the curriculum. Training facilities were completed in 2010,

incorporating state of the art classrooms and laboratories.

The faculty is comprsed of pharmacists and technicians

respresenting all military services.

http://www.ashp.org/




https://accreditation.ashp.org/directory/#/program/technician/programInfo/TX-33 2/2

Acceptance Requirements: Basic military training and

various other requirements based on service a�liation.

General Location Training Sites: Wilford Hall Medical

Center, Lackland Air Force Base, TXBrooke Army Medical

Center, Ft Sam Houston, TX

Special Requirements : Special Requirements of Training

Site: Students must have successfully completed all

Didactic and Laboratory training.

Academic Degree: Certi�cate of Completion

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Email ASHP

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1-866-279-0681

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Report of Assistant Executive Director


PRESCRIPTION MONITORING PROGRAM (PMP)

1

BOARD MEET ING – AUGUST 14 , 2019

NUMBER OF ELIGIBLE PRESCRIPTION TRANSACTIONS REPORTED TO THE PMP

Total Reported: 134,277,579 (01/01/2008 through 06/30/2019)

2,010 2,011 2,012 2,013 2,014 2,015 2,016 2,017 2,018 2,019RXs 12,124,061 12,584,423 12,989,950 13,032,083 13,020,364 12,350,630 12,288,867 11,967,723 11,307,326 5,437,382

0

2,000,000

4,000,000

6,000,000

8,000,000

10,000,000

12,000,000

14,000,000

2

Opioid Prescriptions* Dispensed to Louisiana Residents

(*Prescription counts based on the following AHFS Drug Classes: Opiate Agonist and Antitussives without DM products. Opiate Partial Agonist not included)

5,222,241 5,161,521

4,887,502

4,356,741

3,800,000

4,000,000

4,200,000

4,400,000

4,600,000

4,800,000

5,000,000

5,200,000

5,400,000

2015 2016 2017 2018

Num

ber

of P

resc

riptio

ns

Year 3

Hydrocodone/APAP Prescriptions Number of Louisiana Patients

818,815 809,635

768,670

692,700

620,000

640,000

660,000

680,000

700,000

720,000

740,000

760,000

780,000

800,000

820,000

840,000

2015 2016 2017 2018

Num

ber

of P

atie

nts

Year 4

Hydrocodone/APAP Prescriptions Number of Prescriptions to Louisiana Patients

2,354,587 2,293,196 2,135,085

1,904,777

0

500,000

1,000,000

1,500,000

2,000,000

2,500,000

2015 2016 2017 2018

Num

ber

of P

resc

riptio

ns

Year 5

Hydrocodone/APAP Prescriptions Number of Doses to Louisiana Patients

141,759,576 135,260,928

122,159,828

104,952,537

0

20,000,000

40,000,000

60,000,000

80,000,000

100,000,000

120,000,000

140,000,000

160,000,000

2015 2016 2017 2018

Num

ber

of d

oses

Year 6

Stimulant Prescriptions* Dispensed to Louisiana Residents

(*Prescription counts based on the following AHFS Drug Classes: Amphetamines, Amphetamine Derivatives, and Respiratory & CNS Stimulants)

1,968,049

2,069,725

2,133,921 2,175,389

1,850,000

1,900,000

1,950,000

2,000,000

2,050,000

2,100,000

2,150,000

2,200,000

2015 2016 2017 2018

Num

ber

of P

resc

riptio

ns

Year

7

PMP User Stats for 2019Q1 (01/01/2019 - 03/31/2019)

PMP Role Title - Healthcare Provider

Number of Providers Eligible

for PMP Access (as of 03/31/2019)

Number of Providers with PMP Active Access Privileges

(as of 03/31/2019)

Number of PMP Requests by Providers

through AWARxE™ During 2019Q1


through GATEWAY™ During 2019Q1

Physician (MD, DO) 13,047 8,748 373,300 1,483,241 Nurse Practitioner (APRN) 3,322 2,575 88,031 60,903 Dentist (DDS) 2,226 1,525 5,479 22 Physician Assistant (PA) 895 668 27,013 7,354 Optometrist (OD) 359 155 15 0 Podiatrist (DPM) 163 112 348 0 Medical Psychologist (MP) 91 81 4,708 0 Medical Intern/Resident 1,157 1,017 2,763 288 Prescriber's Delegate NA 2,239 199,711 NA Pharmacist (PST) 8,894 4,189 504,328 349,849 Pharmacist's Delegate NA 854 38,361 NA Totals 30,154 22,163 1,244,057 1,901,657

PMP User Stats for 2019Q2 (04/01/2019 - 06/30/2019)

PMP Role Title - Healthcare Provider

Number of Providers Eligible

for PMP Access (as of 06/30/2019)

Number of Providers with PMP Active Access Privileges

(as of 06/30/2019)


through AWARxE™ During 2019Q2


through GATEWAY™ During 2019Q2

Physician (MD, DO) 13,149 8,767 401,705 2,023,067 Nurse Practitioner (APRN) 3,435 2,675 94,087 317,520 Dentist (DDS) 2,224 1,531 6,249 657 Physician Assistant (PA) 928 688 30,021 34,675 Optometrist (OD) 360 154 7 0 Podiatrist (DPM) 163 111 520 0 Medical Psychologist (MP) 91 83 5,469 0 Medical Intern/Resident 1,047 1,029 2,790 0 Prescriber's Delegate NA 2,368 204,522 NA Pharmacist (PST) 9,255 4,246 522,828 364,003 Pharmacist's Delegate NA 926 41,913 NA Totals 30,652 22,578 1,310,111 2,739,922

8

Provider Requests for Louisiana PMP Data Through Gateway – All States

9

LAW ENFORCEMENT REQUESTS

Total Number of Law Enforcement Requests Processed: 10,715 01/01/2009 through 6/30/2019

680

889

1,230

845

1,150 1,224

1,011 843 823

1,398

622

0

200

400

600

800

1,000

1,200

1,400

1,600

2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019

RequestsProcessed

10

Requests for Full Exemption from PMP Reporting August 14, 2019

In accordance with LA.R.S:40.4.X-A.1006.C. The board may issue an exemption from the reporting requirement to a dispenser whose practice activities are inconsistent with the intent of the program. The board may rescind any previously issued exemption without the need for an informal or formal hearing.

Permit Permit Type Name Scope of Practice DEA City State

7533 NR AMOP Pharmacy Specialty Pharmacy Yes Warren MI

7923 NR ARx Patient Solutions Pharmacy

Mail Order Pharmacy No Overland

Park KS

7928 NR BriovaRx Specialty Non Dispensing Pharmacy No Shavano

Park TX

7906 NR Coastline Pharmacy, LLC

Mail Order Yes Jupiter FL

5704 NR DaVita Rx Medication Therapy Management

No Irving TX

7909 NR Dermrx Pharmacy Dermatology Yes Dallas TX

7910 NR Factor One Source Pharmacy LLC

Specialty Pharmacy Yes Cumberland MD

7873 NR Lake Worth Pharmacy

Community Pharmacy Yes Lake Worth FL

7460 IR LHC Group Pharmaceutical Services II

Sterile Compounding Only No Lafayette LA

7468 NR Nufactor Home Infusion/Specialty/Mail Order

Yes Kernersville NC

7934 NR PharmaScript, Inc. Home Infusion/Specialty Pharmacy

Yes Chicago IL

7925 NR Premier Specialty Infusion LLC

Specialty Pharmacy Yes Hoffman Estates

IL

7751 NR Quaker Community Pharmacy, LLC

Specialty Pharmacy Yes Easton PA

7901 NR Solara Medical Supplies, LLC

Specialty Pharmacy Yes Chula Vista CA



Report of General Counsel




Report of Executive Director


Page 1 of 7



August 14, 2019 Agenda Item 11-L: Report of Executive Director 1. Meeting Activity 2. Reports 3. Examinations 4. Operations 5. State Activities 6. Regional & National Activities 7. International Activities 1. Meeting Activity

In addition to Board and committee meetings, I have also participated in or attended the following meetings since the last Board meeting.

June 3 Metrc Implementation Status Conference [via conference call] June 6 dotPharmacy Applicant Appeal Conference [via conference call] June 10 Pharmacy Site Visit June 11 Metrc Implementation Status Conference [via conference call] June 14 Louisiana Medical Marijuana Project Team June 18 Metrc Training Session June 21 Licensing Board Executive Officers July 17 dotPharmacy Executive Board [via webinar] August 6 La. Pharmacy Congress

2. Reports A. Internal Reports (posted in the Library)

1. Credentials Division a. Census Report b. Licensure Activity Report c. Pending Applications Report d. Exceptions Report 2. Compliance Division a. Census Report – Practitioner Recovery Program & Disciplinary Status

b. Complaint Investigation Policy Monitor c. Annual Statistical Summary

B. External Reports Since the last Board meeting, we have filed the following reports on your behalf:

1. La. Office of the Governor – Boards & Commissions a. Annual Report

2. La. Office of the Governor – Drug Policy Board / HOPE Advisory Council a. Naloxone Dispensing Report

3. La. Div. of Administration – Office of the Commissioner a. Annual Report for Sexual Harassment Complaints [Act 2018-270]

4. La. Div. of Administration – Boards & Commissions a. Annual LaTrac Report of Board Activity [Act 2009-12] b. Quarterly Report of Member Expense Reimbursements c. Ad hoc reports of personnel salaries, meeting notices, and budgets


Page 2 of 7

5. La. Div. of Administration – Facility Planning & Control a. Semiannual Report of Leased Office Space [Act 2016-66]

6. La. Div. of Administration – Property Assistance Agency a. Annual Inventory of Property & Equipment b. Annual Asset Certification Report

c. Monthly Agency Fleet Mileage Report 7. La. Div. of Administration – Office of Group Benefits a. Annual Designations of Master User & Agency Coordinator b. Ad hoc reports of non-discrimination testing 8. La. Div. of Administration – Office of Risk Management

a. Annual Agency Driver Authorization Report b. Annual Loss Prevention Compliance Audit

c. Semiannual Property Exposure Report d. Quarterly Risk Exposure Report e. Quarterly Property Safety & Maintenance Inspections

f. Monthly Loss Claims Report g. Monthly Report re Transitional Return to Work 9. La. Div. of Administration – Office of State Procurement a. Monthly Report on Status of Professional Contracts [Act 2015-87] b. Ad hoc reports on contractor performance review 10. La. Div. of Administration – Office of State Register a. Ad hoc notices for rulemaking projects

11. La. Div. of Administration – Office of Statewide Reporting & Accounting Policy a. Comprehensive Annual Financial Report b. Annual Report of Taxable Compensation

c. Quarterly Report of Accounts Receivable [Act 1995-745] 12. La. Dept. of Children & Family Services a. Ad hoc rosters for credential renewals for pharmacists and technicians

13. La. Dept. of Culture, Recreation, & Tourism – State Library of Louisiana a. Annual Publications Report Form b. Semiannual Roster & Agency Inventory of Agency Publications c. Ad hoc document publication reports 14. La. Dept. of Economic Development a. Ad hoc rulemaking notices 15. La. Dept. of Health – Bureau of Health Services Financing

a. Monthly Report of Pharmacy Openings & Closures 16. La. Dept. of Health – Office of Public Health a. Semi-annual Report of Active MA Registrations 17. La. Dept. of Insurance a. Annual Report of Investigation Referrals [Act 2009-251]

18. La. Dept. of Justice – Office of the Attorney General a. Quarterly Report of Private Legal Fees Paid [Act 2006-611] b. Ad hoc notices for emergency rules 19. La. Dept. of Revenue a. Quarterly Employer’s Return of State Withholding Tax b. Ad hoc rosters for credential renewals for pharmacists and technicians

20. La. Dept. of State – Division of Archives a. Annual Report of Records Officer Designation 21. La. Dept. of State Civil Service a. Annual Confirmation of Agency EEO Policy b. Annual Report of Performance Evaluations c. Ad hoc Payroll Comparison Report 22. La. Dept. of Treasury – Cash Management Review Board a. Quarterly Report of Agency Bank Accounts [Act 2016-587] 23. La. Board of Regents – ULM College of Pharmacy a. Annual Report of Pharmacy Education Support Fees Collected

24. La. State Employees Retirement System a. Monthly Report of Employer & Employee Contributions 25. La. Workforce Commission a. Quarterly Report of Employer’s Unemployment Tax

Page 3 of 7

26. La. House of Representatives – Office of the Speaker a. Annual Report of Rulemaking Activity b. Ad hoc notices for rulemaking projects

27. La. House of Representatives – Poynter Legislative Research Library a. Annual Filing of Legislative Reports 28. La. House of Representatives – Committee on Commerce a. Annual Report of Licensed Ex-Offenders [Act 2017-262] 29. La. House of Representatives – Committee on House & Governmental Affairs a. Quarterly Report of Board Complaints [Act 2018-655]

30. La. House of Representatives – Committee on Health & Welfare a. Annual LaTrac Report on Board Activity [Act 2009-12] b. Annual Report on Rulemaking Activity c. Annual Notice of Budget Adoption d. Comprehensive Annual Financial Report

e. Ad hoc notices for rulemaking projects 31. La. Senate – Office of the President a. Annual Report on Rulemaking Activity b. Ad hoc notices for rulemaking projects

32. La. Senate – Committee on Health & Welfare a. Annual LaTrac Report on Board Activity [Act 2009-12] b. Annual Report on Rulemaking Activity c. Annual Notice of Budget Adoption

d. Comprehensive Annual Financial Report e. Ad hoc notices for rulemaking projects

33. La. Senate – Committee on Senate & Governmental Affairs a. Annual Report on Boards & Commissions b. Quarterly Report of Board Complaints [Act 2018-655]

34. La. Legislature – Legislative Auditor a. Comprehensive Annual Financial Statement b. Annual Inventory of Property & Equipment c. Annual Asset Certification Report d. Annual Notice of Budget Adoption

35. La. Legislature – Legislative Fiscal Office a. Annual Notice of Budget Adoption b. Annual LaTrac Report of Board Activity [Act 2009-12]

c. Ad hoc impact statements for rulemaking projects 36. La. Legislature – Joint Legislative Committee on the Budget a. Annual Notice of Budget Adoption b. Annual LaTrac Report of Board Activity [Act 2009-12] 37. U.S. Dept. of Commerce – Census Bureau a. Annual Survey of Public Employment & Payroll

38. U.S. Dept. of Health & Human Services – Office of Public Health a. Quarterly Report to ESAR-VHP 39. U.S. Dept. of Labor – Bureau of Labor Statistics a. Monthly Survey of Current Employment Statistics 40. U. S. Dept. of Treasury – Internal Revenue Service a. Annual Filings (Forms 1094, 1095-C, 1096, 1099, W-2, & W-3)

b. Quarterly Report of Form 941 – Employer’s Federal Tax Return 3. Examinations

A. Pharmacists 1. MPJE – the results for the first trimester of 2019 are available.

2. NAPLEX – the results for the first trimester of 2019 are available.

Page 4 of 7

B. Technicians

1. NHA – the results for the first half of 2019 are available.

2. PTCB – the results for the first half of 2019 are available. 4. Operations A. Credentials Division

As of June 30, 2019, we had 69,943 active credentials under management by the Board. That number reflects a 7.8% increase from the beginning of this fiscal year on July 1, 2018. About 65% of the credentials (45,174) reside in the Pharmacy Program with the balance in the CDS Program.

We opened the renewal cycle for DME permits on July 1; it will close on August 31. We sent renewal reminder notices to 642 permits. By July 31, 433 had renewed, and of that number, 90.3% did so online.

B. Compliance Division

Our 7 pharmacist compliance officers are responsible for inspecting all the pharmacies and other facilities holding controlled substances (CDS). The census reports available for this meeting reflect 1,431 pharmacies within the state, as well as 339 DME permits, and an additional 521 various types of facilities and persons for CDS visits, including hospitals, researchers, animal euthanasia technicians, etc.

In addition to their routine site visits, the compliance officers are also responsible for investigating complaints filed with the Board. We began this fiscal year with 180 cases pending from the prior fiscal year. We entered 433 new cases and closed 434, leaving 179 cases still open for this fiscal year. Of the 434 cases closed, 63% were disposed of through staff activities and the balance through committee and Board action.

C. Administrative Division

We have a personnel change to report. Ms. Erica Brown, who was a licensing assistant taking care of technician credentials, resigned to take a position with Southern University. We have transferred Ms. Arielle Shelton from the Administrative Division to the Credentials Division to manage the technician credentials.

Hurricane Barry arrived in Louisiana on July 15. The state commissioner of administration ordered the closure of all state offices, including the Board, on the previous Friday, July 12. Although there was flooding and power outages, none of those events affected the Board’s office.

The compliance officers contacted or visited the pharmacies in their territories to assess the impact of the storm. Most pharmacies suffered temporary power losses, although some pharmacies found it necessary to quarantine some previously refrigerated stock. We are aware of two pharmacies which suffered physical damage from flood waters. Both locations have remediated the damage, but one of them was a sterile compounding pharmacy which has not yet resumed compounding operations. Chief Compliance Officer Ben Whaley prepared an assessment for your review, and it is posted in the Boardroom Library.

5. State Activities

A. La. Legislature The Regular Session of the 2019 Legislature adjourned on June 6. A total of 1, 736 items were filed for consideration. The legislature adopted 454 bills; the governor vetoed 8 of them and signed the remaining 448 items into law. All three of the Board’s legislative proposals were successful. We issued Bulletin 19-01 on July 1 to notify our clients of all new legislation affecting pharmacy practice. A copy of the Final Legislative Brief was posted in the Boardroom Library.

Page 5 of 7

B. La. Dept. of Agriculture & Forestry The agency published in the July 2019 edition of the Louisiana Register a list of

pesticides authorized for use on cannabis plants by producers of medical marijuana products.

C. La. Dept. of Health – Office of Public Health

The agency published an Emergency Rule on July 10 to enable the registration of hemp-derived cannabidiol products as authorized by Act 164 of the 2019 Legislature.

D. La. Dept. of Revenue – Office of Alcohol & Tobacco Control

The agency published an Emergency Rule on June 27 to enable the registration of distributors and retailers of hemp-derived cannabidiol products as authorized by Act 164 of the 2019 Legislature.

E. La. Attorney General

The agency has resumed its continuation of the Civil Law Training for members and staff of boards and commissions. The topics covered include laws relative to open meetings, public records, and administrative hearing procedures. The sessions are conducted once per month at the Attorney General’s office building near the state capitol. The announcement containing the schedule of events and registration information was posted in the Boardroom Library.

6. Regional & National Activities A. National Association of Boards of Pharmacy (NABP)

The annual meeting of this association is one of the three meetings for which certain of your travel expenses are eligible for reimbursement, subject to the limitations itemized in the Board’s travel policy as well as the state’s travel policy in PPM-49.

For your planning purposes, the association will hold its 116th Annual Meeting on May 14-16, 2020 in Baltimore, MD. Registration details will be provided when they are available.

B. NABP-AACP District 6


For your planning purposes, Districts 6, 7, and 8 will meet together again on October 6-9, 2019 at The Grove Hotel in Boise, ID. Registration details will be provided when they are available.

C. MALTAGON


The Mississippi Board of Pharmacy is hosting the 2019 conference at the Beau Rivage Resort & Casino in Biloxi, MS on Oct. 27-30. We distributed the information necessary to secure your hotel accommodations and register for the conference. Please take note of the deadline dates in the registration materials. If you have questions or need additional information, please let us know. As a gentle reminder, the Louisiana Board is scheduled to host the conference in 2021.

D. Enhancing Well-being and Resilience Among the Pharmacist Workforce ~ A National

Consensus Conference Louisiana Board Member Jackie Hall participated in the conference, which was a

collaborative effort of the American Pharmacists Association (APhA), Accreditation Council for Pharmacy Education (ACPE), American Association of Colleges of Pharmacy (AACP), National Association of Boards of Pharmacy (NABP), and the National Association of State Pharmacy Association Executives (NASPA). The objectives of the consensus conference were to:

Page 6 of 7

• Evaluate factors that contribute to well-being and resilience at the individual, organizational, and profession levels.

• Develop strategies that could improve pharmacist well-being and resilience and decrease moral distress within individuals, managers, organizations, and the procession.

• Identify and prioritize strategies that will drive change and fuel improvements in well-being and resilience.

• Develop actionable recommendations that guide organizations and individuals in implementing positive change.

The conference was held July 17-19 in Chicago, IL. Complete conference proceedings and outcomes will be formally published in the Fall of 2019. In the interim, we have posted a copy of the 50 consensus recommendations in the Boardroom Library.

7. International Activities

A. International Pharmaceutical Federation (FIP) The Emirates Pharmacy Society will host the FIP World Congress on Sep. 22-26

in Abu Dhabi, UAE. The educational offerings include plenary sessions, platform presentations and poster sessions, all within the four primary topics for the congress:

Topic A – New trends in science, practice, and education These topics focus on technology, digitalization, robotics, individualization, virtual classroom, communication, patient-centered care, and ethical challenges.

Topic B – New roles, opportunities, and responsibilities These topics focus on pharmacists’ roles, roles of individuals, new services, collaboration and education.

Topic C – Health now! Responding to the challenges of today, these topics recognizes that challenges can be faced by looking at new research, ethical considerations, new values, access to health, health systems, environmental sustainability, non-communicable diseases, empowerment of patients, and quality assessment.

Topic D – Targeting special interests These topics will target special interests in the different fields of pharmacy and pharmaceutical sciences.

FIP has announced the 2020 congress will be held Sep. 13-17 in Seville, Spain. The 2021 congress will be held on Aug. 29 – Sept. 2 in Brisbane, Australia.

B. dotPharmacy Verified Websites Program

dotPharmacy is a generic top level domain (gTLD) on the Internet. Although it is owned by NABP, the dotPharmacy domain is governed by a global collaboration including the International Pharmaceutical Federation (FIP) and the National Association of Pharmacy Regulatory Authorities (NAPRA – Canada) and endorsed by multiple global partners, including the World Health Organization (WHO), Interpol, and the Pharmaceutical Group of the European Union (PGEU). dotPharmacy is different from most TLDs in that authority to host a website on dotPharmacy is restricted to applicants whose legitimacy has been verified by NABP or one of its global partners. The vision for dotPharmacy is to create an online pharmacy community where patients can go to safely order prescription drugs, knowing the sites have already been verified as legitimate pharmacies that are licensed by the appropriate pharmacy regulatory authority. In addition to pharmacies, the plan is to create a presence for a number of related organizations, including professional membership organizations, colleges of pharmacy, boards of pharmacy, drug manufacturers, and consumer-oriented drug information organizations. dotPharmacy began accepting applications for website registrations in June 2015.

By July 2019, there were 641 registered domains held by pharmacy organizations representing approximately 60% of the physical pharmacy locations in the U.S. Although most of the domains are based in the U.S., 62 domains are based in other countries around the world, including Canada, the Netherlands, Germany, Malta, and the United Kingdom. Discussions and negotiations are underway with pharmacy regulatory

Page 7 of 7

authorities in Australia, Brazil, China, India, New Zealand, Scotland, South Africa, and Turkey. More information, including a list of registered domains, is available at www.safe.pharmacy.

The Louisiana Board has two website addresses in the dotPharmacy domain: www.laboard.pharmacy and www.la.pharmacy. The domain name fees for these websites have been waived by NABP. For now, visitors to these sites are automatically re-directed to the Board’s website at www.pharmacy.la.gov.

Respectfully submitted, Malcolm J Broussard Executive Director

http://www.safe.pharmacy/

http://www.laboard.pharmacy/

http://www.la.pharmacy/

http://www.pharmacy.la.gov/

Louisiana Board of PharmacyPharmacy Program - Census Report

6/30/2018 11/1/2018 2/6/2019 5/13/2019 6/30/2019

PST.VI LA 14 15 18 26 9NR 20 20 30 2 17Total 34 35 48 28 26

PST-GVI LA 24 24 30 19 20NR 8 8 10 4 6Total 32 32 40 23 26

PST-M LA 0 0 0 6 0NR 8 8 8 2 8Total 8 8 8 8 8

PST-MS LA 0 1 3 3NR 2 2 0 2Total 2 3 3 5

PST-G LA 194 222 178 159 186NR 27 36 28 48 31Total 221 258 206 207 217

PST LA 5,690 5,644 5,584 5,594 5,795NR 3,090 3,153 3,026 3,136 3,230Total 8,780 8,797 8,610 8,730 9,025

9,009 9,065 8,915 8,948 9,255

PNT LA 910 869 914 897 892NR 158 147 205 195 200Total 1,068 1,016 1,119 1,092 1,092

PNT-FPG Total 2 2 1 2 2PNT 1,070 1,018 1,120 1,094 1,094

CPT LA 6,433 6,801 6,917 7,057 6,452NR 152 174 175 178 147Total 6,585 6,975 7,092 7,235 6,599

CPT-M Total 1 2 2 2 1

CPT-MS Total 0 0 0 16,586 6,977 7,094 7,237 6,601

PTC LA 1,931 1,794 1,675 1,555 1,544NR 69 57 58 49 51PTC 2,000 1,851 1,733 1,604 1,595

Active PST

Active CPT

Louisiana Board of PharmacyPharmacy Program - Census Report

6/30/2018 11/1/2018 2/6/2019 5/13/2019 6/30/2019

PHY CH 10 10 10 9 9HOS 163 162 162 162 161HOX 6 7 5 5 5IN 11 11 11 11 11INX 11 11 11 11 11IR 584 586 588 594 597IRX 6 6 7 8 8NR 534 560 543 553 561NRN 8 8 9 10 10NRP 2 2 1 1 1NU 13 13 13 13 13PE 0 0 0 0 0PEN 0 0 0 0 0PEX 3 4 4 4 4RC 630 613 593 595 596RPP 1 1 1 1 2SAT 6 6 6 6 6SPL 0 0 0 0 0TDS 0 0 0 0 0TM 1 3 7 8PHY 1,988 2,001 1,967 1,990 2,003

AMS AMS 498 128 129 136 116AMS-X 372 359 360 357 345AMS 870 487 489 493 461

EDK EDK 435 128 445 449 374EDK-X 11 359 8 8 6EDK 446 487 453 457 380

DME LA 205 322 332 340 339NR 437 278 289 300 301DME 642 600 621 640 640

CDTM 69 75 75 77 78

MAR 3,073 3,121 3,167 3,180 3,161

PMP 15,835 18,166 19,051 19,858 19,686

SWP 45 48 45 43 41

TMD 71 100 96 120 127

TOTAL 41,770 44,063 44,914 45,792 45,174

Louisiana Board of PharmacyCDS Program - Census Report

6/30/2018 6/30/2019

ACS Animal Control Shelter 0 0AMS Automated Medication System 35 40AMX Automated Medication System - Exempt 2 2APN Advanced Practice Registered Nurse 2,975 3,434ASC Ambulatory Surgical Center 0 0CRX Correctional Center 0 0DDS Dentist 2,174 2,224DET Drug Detection Canine - Private Agency 0 6DEX Drug Detection Canine - Law Enforcement 8 0DIS Distributor 290 285DPM Podiatrist 158 163DVM Veterinarian 1,188 1,216DYS Dialysis Center 0 0EMC Emergency Center 0 0EMS Emergency Medical Service 0 0ETC Animal Euthanasia Tech - Cert 3 3ETL Animal Euthanasia Tech - Lead 26 25HOS Hospital 301 297HOX Hospital - Exempt 5 5INT Intern or Resident 318 1,047LAB Analytical Laboratory 8 8LAX Analytical Laboratory - Exempt 4 4MD Physician 12,824 13,138

MDT Physician via Telemedicine 2 11MED Medical Clinic 0 0MFR Manufacturer 45 47MP Medical Psychologist 91 91OD Optometrist 349 360PA Physician's Assistant 783 928

PHX Pharmacy - Exempt 22 24PHY Pharmacy 1,313 1,279REP Sales Representative 0 0RES Researcher 104 106RHC Rural Health Clinic 0 0RNT APRN via Telehealth 5 1ROF Registered Outsourcing Facility 19 19SAC Substance Abuse Clinic 6 6SAX Substance Abuse Clinic - Exempt 0 0MIS Other 0 0

TOTAL 23,058 24,769

Highlighted credentials subject to inspection

Pharmacy Program 41,770 45,174CDS Program 23,058 24,769TOTAL 64,828 69,943

Classification

Total Credentials Under Board Management

Prefix Subcategory CredentialType TotalAMS Automated Medication System 11AMS X Automated Medication System - Exempt 15

26CDS AMS CDS License - Automated Medication System 4CDS APN CDS License - APRN 146CDS DDS CDS License - Dentist 55CDS DIS CDS License - Distributor 3CDS DPM CDS License - Podiatrist 1CDS DVM CDS License - Veterinarian 40CDS ETL CDS License - Animal Euthanasia Technician, Lead (AET-L) 2CDS HOS CDS License - Hospital 8CDS INT CDS License - Medical Intern or Resident 16CDS MD CDS License - Physician 190CDS MDT CDS License - Physician via Telemedicine 1CDS PA CDS License - Physician Assistant 32CDS PHY CDS License - Pharmacy 18CDS RES CDS License - Researcher 4CDS ROF CDS License - Registered Outsourcing Facility 1CDS TM CDS License - Therapeutic Marijuana 3

524

CDTM Collaborative Drug Therapy Management (V) 1

CPT Certified Pharmacy Technician 83

DME Durable Medical Equipment (DME) Provider 18

EDK Emergency Drug Kit 9

MA Medication Administration (V) 46

PHY HOS Pharmacy - Hospital Inpatient 3PHY IR Pharmacy - Community ~ Independent 13PHY NR Pharmacy - Nonresident 29PHY RC Pharmacy - Community ~ Chain 5PHY RPP Pharmacy - Remote Processor 1PHY TM Pharmacy - Therapeutic Marijuana 3

54

PIC Pharmacist-in-Charge (V) 27

PMP CDS PMP - CDS Credential (V) 175PMP PHY PMP - PHY Dispenser Account (V) 92PMP PST PMP - Pharmacist (V) 8

275

PNT Pharmacy Intern 38PNT FPG Pharmacy Intern - Foreign Pharmacy Graduate 1

39

PST Pharmacist 119PST MS Pharmacist - Military Spouse 3

122

PTC Pharmacy Technician Candidate 253

SWP Special Work Permit 9

TM CPT Therapeutic Marijuana Designation - CPT 7TM PST Therapeutic Marijuana Designation - PST 11

18

1504

Prefix Totals

Prefix Totals

New Credentials IssuedFYE 2019 ~ 4rd Quarter

April 1, 2019 - June 30, 2019

Prefix Totals

Grand Totals

Prefix Totals

Prefix Totals

Prefix Totals

Prefix Totals

Prefix Subcat. CredentialType 2/12/2018 5/9/2018 8/2/2018 11/2/2018 2/6/2019 5/13/2019 8/1/2019AMS Automated Medication System 5 7 5 5 8 9 7CPT Certified Pharmacy Technician 44 64 29 29 33 58 46DME Durable Medical Equipment 20 22 17 18 20 12 14EDK Emergency Drug Kit 4 4 4 5 7 2PHY CH Pharmacy - Charitable 1 1 1PHY HOS Pharmacy - Hospital Inpatient 4 1 1 5 6 6 9PHY IN Pharmacy - Institutional 1 1 1 1PHY IR Pharmacy - Community ~ Independent 32 26 21 20 22 18 21PHY NR Pharmacy - Nonresident 84 70 74 73 60 67 61PHY NRN Pharmacy - Nonresident Nuclear 2 2 1PHY NU Pharmacy - NuclearPHY PEN Pharmacy - Penal 3 3 3 1PHY RC Pharmacy - Community ~ Chain 176 2 4 3 2 1PHY RPP Pharmavy - Remote Processor 2 1 1PHY SAT Pharmacy - Hospital Off-Site Satellite 1 1 1 1PHY SPL Pharmacy - Special Event 1 1PHY TM Pharmacy - Therapeutic Marijuana 34 9 9 8 6 2 95PIC Pharmacist-in-ChargePNT FPG Pharmacy Intern - Foreign Graduate 1 1 1 1PNT Pharmacy Intern 44 40 31 173 74 35 57PST Pharmacist 297 381 480 278 272 348 305PTC Pharmacy Technician Candidate 338 320 286 289 223 235 245

1087 952 967 913 731 802 865

Prefix Subcat. CredentialType 2/12/2018 5/9/2018 8/2/2018 11/2/2018 2/6/2019 5/13/2019 8/1/2019CDS AMS CDS - Automated Medication System 2 3 4 1 1 1CDS APN CDS - APRN 12 17 17 14 14 11 10CDS DDS CDS - Dentist 1 9 4 3 2 1CDS DET CDS - Drug Detection / Canine 4 1 3 1CDS DIS CDS - Distributor 6 5 6 17 15 14 13CDS DPM CDS - Podiatrist 1CDS DVM CDS - Veterinarian 3 2 5 4 1CDS ETC CDS - Animal Euthanasia Tech, Certified 1CDS ETL CDS - Animal Euthanasia Tech, Lead 1 1 3 1CDS HOS CDS - Hospital 10 8 9 8 12 13 13CDS INT CDS - Medical Intern or Resident 18 14 7 7 8CDS MD CDS - Physician 17 33 27 34 24 18 20CDS MFR CDS - Manufacturer 4 6 4 4CDS MP CDS - Medical PsychologistCDS OD CDS - Optometrist 1CDS PA CDS - Physician Assistant 4 5 10 11 8 11 14CDS PHY CDS - Pharmacy 85 26 22 27 24 21 20CDS PHX CDS - Pharmacy - Exempt 2 2 1 1CDS RES CDS - Researcher 9 5 5 2 2 3 5CDS RNT CDS - APRN via Telehealth 1CDS ROF CDS - Registered Outsourcing Facility 1 2 2 1 3 2 1CDS SAC CDS - Substance Abuse Clinic 4 4 1 5 1 1CDS TM CDS - Therapeutic Marijuana 34 9 8 6 2 1

192 128 155 149 127 110 107

Prefix Subcat. CredentialType 2/12/2018 5/9/2018 8/2/2018 11/2/2018 2/6/2019 5/13/2019 8/1/2019CDTM Collaborative Drug Therapy ManagementLB Law BookMA Medication Administration 3 3 3 10 10 10 8PMP PMP - CDS Credential 207 221 206 143 342 310 310PMP PMP - MIS CredentialPMP PMP - PHY Credential 2 1PMP PMP - PST Credential 4 225 210 5 345 2 2SWP Special Work Permit 10 10 10 10 10 10 10TM CPT Therapeutic Marijuana Designation - CPT 7 4 18 17 26 26TM OMO Therapeutic Marijuana Designation - OMO 2 6 2TM PST Therapeutic Marijuana Designation - PST 3 14 4 2 7 10 11

229 486 439 190 732 368 367

TOTAL 1508 1566 1561 1252 1590 1280 1339

Pending Applications

Subtotal

OTHER CREDENTIALS

PHARMACY CREDENTIALS

CDS CREDENTIALS

Subtotal

Subtotal

Page 1 of 2



August 14, 2019 Agenda Item 11-L: Report of Executive Director Section 2 – A – 1 – d ~ Exceptions Report 1. PIC at Multiple Pharmacies

Board Policy I.A.4 permits the Executive Director to approve requests from pharmacists wishing to serve as the Pharmacist-in-Charge (PIC) of more than one pharmacy at the same time. The decision to approve such a request requires the concurrence of the President, as well as notice to the Board at its next meeting. As authorized by the President, the Executive Director has delegated this authority to the General Counsel and the Assistant Executive Director.

• On May 20, 2019 Mr. Aron and Mr. Fontenot concurred to grant a request from Charles Edward Maier (PST.015447) for temporary dual PIC privileges at Lakeside Pharmacy (PHY.007013-IR) in Monterey and Island Pharmacy (PHY.007660-IR) in Sicily Island for a limited period of time ending August 31, 2019.

• On May 22, 2019 Mr. Aron and Mr. Fontenot concurred to grant a request from Glenn Joseph Green, Jr. (PST.017753) for temporary dual PIC privileges at Priority Health Care Pharmacy (PHY.007348-IR) in Marrero and Priority Health Care Pharmacy - Gretna (Application – Pending) in Gretna for a limited period of time ending 6 months after first issuance of the pharmacy permit for the Gretna location.

• On June 6, 2019 Mr. Aron and Mr. Fontenot concurred to grant a request from Eugene Irvine Dreher, IV (PST.014527) for temporary dual PIC privileges at M. C. Clinic Pharmacy (PHY.000689-IR) in Morgan City and HPC Specialty Pharmacy (PHY.00739-IR) also in Morgan City for a limited period of time ending November 25, 2019.

• On July 22, 2019, Mr. Aron and Mr. Broussard concurred to grant a request from Jamie J. Stocker (PST.022212) for temporary dual PIC privileges at PAM Specialty Hospital of Covington (PHY.006380) as well as PAM Specialty Hospital of Hammond (PHY.006716), for up to six months.

2. Special Work Permits for military-trained applicants and their spouses

LAC Title 46: LIII §904 authorizes the Board to provide preferential licensing procedures for military-trained applicants and their spouses. As authorized by the President, the Executive Director has delegated this authority to the General Counsel and the Assistant Executive Director.

• On May 20, 2019, Mr. Finalet granted a request of Daniel Richard Hess. He has been issued SWP.00840 to practice for up to 120 days while his application to become a PTC is in process. The SWP will expire on September 30, 2019.

3, Special Work Permits

Board Policy I.A.7 permits the Executive Director to issue Special Work Permits to document the resurrection of expired non-renewable credentials and for other purposes as authorized by the Board. The decision to approve such a request requires the concurrence of the President, as well as notice to the Board at its next meeting. As authorized by the President, the Executive Director has delegated this authority to the General Counsel and the Assistant Executive Director.

• On May 28, 2019, Mr. Aron and Mr. Finalet concurred to grant a request of Jasmine Shawyne Antoine. She had previously obtained PTC.020009 which expired on November 9, 2014. She is PTCB-certified and was issued a Special Work Permit for two years to earn her remaining hours of practical experience.

• On May 28, 2019, Mr. Aron and Mr. Finalet concurred to grant a request of Teri-Lynne


Page 2 of 2

Pushee. She had previously obtained PTC.024509 which expired on March 30, 2018. She is PTCB-certified and was issued a Special Work Permit for two years to earn her remaining hours of practical experience.

• On June 6, 2019, Mr. Aron and Mr. Finalet concurred to grant a request of Amber Courville. She had previously obtained PTC.021225 which expired on September 30, 2015. She is PTCB-certified and was issued a Special Work Permit for two years to earn her remaining hours of practical experience.

• On June 13, 2019, Mr. Aron and Mr. Finalet concurred to grant a request of Lanisha Dillon. She had previously obtained PTC.024512 which expired on April 3, 2018. She is PTCB-certified and was issued a Special Work Permit for two years to earn her remaining hours of practical experience.

• On July 1, 2019, Mr. Aron and Mr. Finalet concurred to grant a request of Valerie Jaye Hildestad. She had previously obtained PTC.009430 which expired on October 7, 2004. She is PTCB-certified and was issued a Special Work Permit for two years to earn her remaining hours of practical experience.

• On July 18, 2019, Mr. Aron and Mr. Finalet concurred to grant a request of Alesia Willett Roman. She had previously obtained PTC.023444 which expired on June 8, 2017. She is PTCB-certified and was issued a Special Work Permit for two years to earn her remaining hours of practical experience.

• On July 18, 2019, Mr. Aron and Mr. Finalet concurred to grant a request of Brittany Rochele Alford. She had previously obtained PTC.025675 which expired on June 27, 2019. She is ExCPT-certified and was issued a Special Work Permit for two years to earn her remaining hours of practical experience.



Compliance Division Census Report

August 14, 2019 Practitioner Recovery Program • Probation Completion Report

[none since May 2019 Board meeting]

• Active Probation 42 Pharmacist 1 Pharmacy intern

7 Technician • Active Suspension 39 Pharmacist

2 Pharmacy intern 17 Technician 4 Technician candidate

Disciplinary Restrictions • Probation Completion Report

06-23-2019 PST.018721 Lee Eric Ori 08-15-2019 PST.013189 Stuart Hall Burgess

• Active Probation 15 Pharmacist 1 Pharmacy intern 2 Technician 1 Technician candidate

4 Pharmacy permit 1 CDS-PHY license • Active Suspension/ 53 Pharmacist

Inactivation 1 Pharmacy intern 80 Technician 20 Technician candidate 1 Special work permit 12 Pharmacy permit 7 CDS-PHY license 97 CDS license for practitioners


Louisiana Board of PharmacyCompliance Division

FY 17-18 FY 18-19 FY 19-20 FY 20-216/30/2018 6/30/2019

Pending at Beginning of Fiscal Year 160 180

New Cases Added 500 433

Cases Closed 480 434

Cases Remaining 180 179

Average No. Days to Close Investigation 52

No. Investigations Closed > 180 Days 19

% Investigations Beyond Policy Limit 4.4%

% Cases Closed by Board Action 27%

Complaint Investigation Completion Policy Monitor

Louisiana Board of Pharmacy - Compliance DivisionStatistical Summary for Fiscal Year 2018-2019

Individual Performance DataCases Audits Reports

CDS PHY/DME Total Assigned Completed Submitted> Compliance Officers

Aaron, Cary D.1st Qtr. 20 60 80 7 1 32nd Qtr. 3 77 80 19 1 133rd Qtr. 12 37 49 18 0 94th Qtr. 20 46 66 5 0 24

Total 55 220 275 49 2 49Completion Rate:

Dennis, Daniel M.1st Qtr 14 66 80 16 0 102nd Qtr 10 60 70 5 0 103rd Qtr 8 71 79 10 0 74th Qtr 5 59 64 10 0 11


Gross, Nicole L.1st Qtr 12 40 52 4 0 112nd Qtr 22 37 59 6 0 63rd Qtr 16 43 59 4 0 44th Qtr 12 51 63 10 0 4


Harris, Alicia P. (hired 2-4-2019)1st Qtr N/A N/A N/A N/A N/A N/A2nd Qtr N/A N/A N/A N/A N/A N/A3rd Qtr 2 26 28 4 0 04th Qtr 17 32 49 10 0 5


Parker, Becky (hired 2-4-2019)1st Qtr N/A N/A N/A N/A N/A N/A2nd Qtr N/A N/A N/A N/A N/A N/A3rd Qtr 6 21 27 5 0 14th Qtr 11 60 71 9 0 8


Savoie, Huey J.1st Qtr 9 52 61 9 1 112nd Qtr 6 56 62 3 0 33rd Qtr 17 57 74 3 0 14th Qtr 8 66 74 9 0 6


InvestigationsInspections


Cases Audits ReportsCDS PHY/DME Total Assigned Completed Submitted

> Compliance Officers

Trisler, Rayland M. (retired 4-1-2019)1st Qtr 8 43 51 12 1 92nd Qtr 7 24 31 5 0 143rd Qtr 0 1 1 0 0 14th Qtr N/A N/A N/A N/A N/A N/A


Whaley, Benjamin S.1st Qtr 5 22 27 7 0 42nd Qtr 4 18 22 3 0 43rd Qtr 11 17 28 5 0 44th Qtr 4 15 19 8 0 5


TOTAL 269 1157 1426Completion Rate

> Administrative OfficersFontenot, M. Joseph

1st Qtr 0 0 0 1 0 02nd Qtr 0 0 0 3 0 23rd Qtr 0 0 0 4 0 34th Qtr 0 0 0 1 0 3

Total 0 0 0 9 0 8

Finalet, Carlos M.1st Qtr 0 0 0 62 0 332nd Qtr 0 0 0 64 0 633rd Qtr 0 0 0 40 0 444th Qtr 0 0 0 52 0 39

Total 0 0 0 218 0 179

Broussard, Malcolm J.1st Qtr 0 0 0 0 0 02nd Qtr 0 0 0 0 0 03rd Qtr 0 0 0 0 0 04th Qtr 0 0 0 0 0 0

Total 0 0 0 0 0 0

Agency Summary1st Qtr 68 283 351 118 3 812nd Qtr 52 272 324 108 1 1153rd Qtr 72 273 345 93 0 744th Qtr 77 329 406 114 0 105

TOTAL 269 1157 1426 433 4 375

InvestigationsInspections


Summary of Investigations and Adjudications

Number of Cases Pending from Prior Fiscal Year(s) 180

Number of Complaints Received during Current Fiscal Year: 433

Number of Complaints Closed during Current Fiscal Year: 434

Number of Complaints Pending at End of Fiscal Year: 179

Disposition of Closed Complaints:

Withdrawn 5

No violations found 88

Administrative/Field corrections 122

Referred to another agency 26

Administrative sanction 19

Termination of previously imposed probationary periods 11

Referred to appropriate Board Committee 163434 Total

Committee Action on Referrals

12 Case dismissed

146 Voluntary Consent Agreement2 Denial / Refusal to Issue17 Reinstatement6 Modifications of Previous Orders16 Assessment3 Letter of Warning29 Letter of Reprimand13 Voluntary Surrender19 Probation4 Suspension7 Revocation30 Other decisions

5 Formal Hearing1 Denial of Reinstatement2 Suspension2 Revocation

163 Total


Analysis of Adjudications by Type of Credential

PST PNT CPT PTC PHY/DME CDS TOTAL

Denial / Refusal to Issue 1 0 1 1 0 0 3

Reinstatement 6 0 8 0 0 3 17

Modification of Previous Orders 6 0 0 0 0 0 6

Assessment 1 0 0 0 15 0 16

Letter of Warning 1 0 0 0 2 0 3

Letter of Reprimand 12 0 12 0 5 0 29

Voluntary Surrender 7 0 3 1 0 2 13

Probation 14 1 2 0 2 0 19

Suspension 4 0 1 1 0 0 6

Revocation 0 0 5 2 2 0 9

Other Decisions 20 0 2 1 7 0 30

TOTAL 72 1 34 6 33 5 151

Louisiana Board of Pharmacy - Compliance DivisionStatistical Summary - Cumulative Data


FY FY FY FY FY FY FY FY FY FY02-03 03-04 04-05 05-06 06-07 07-08 08-09 09-10 10-11 11-12

Summary of Complaint Investigations

Complaints Pending from Prior Year(s) 46 96 132 124 98 82 112 140 127 197

Complaints Received During Year 355 315 273 250 239 280 519 356 432 349

Complaints Closed During Year 305 279 281 276 255 250 491 369 362 389

Complaints Pending at Year End 96 132 124 98 82 112 140 127 197 157

Disposition of Closed Complaints

Withdrawn 20 11 7 4 10 3 23 16 26 23

No violations found 36 46 31 36 30 39 49 41 58 51

Field/administrative corrections 25 34 47 70 40 73 65 76 54 83

Referred to another agency 1 1 3 7 11 2 6 7 5 6

Administrative sanction 89 78 73 37 34 38 255 72 42 46

Termination of probationary period

Referred for Board action 134 109 120 122 130 95 93 157 177 180Total 305 279 281 276 255 250 491 369 362 389


Cases Dismissed 43 17 16 25 20 19 38 24 39 20

Voluntary Consent Agreements 79 80 91 90 97 67 47 124 132 150

Assessment only 11 11 7 2 4 38 25 18 10 12

Denial / Refusal to Issue 1 9 1

Letter of Noncompliance 0 0 0 0 0 0 0 0 0 0

Letter of Warning 20 14 12 26 18 7 3 5 6 3

Letter of Reprimand 13 5 19 12 18 13 13 30 35 17

Voluntary Surrender 9 10 23 25 17 6 8 34 23 21

Probation 9 17 10 13 16 20 5 17 21 31

Suspension 6 10 4 1 5 10 5 2 2 10

Revocation 11 13 16 11 19 9 4 17 11 28

Other decisions 15 27

Formal Hearings 12 12 13 7 13 9 8 9 6 10

Assessment only 0 0 0 0 1 3 0 0 0 0

Denial / Refusal to Issue 0 0 0 0 0 0 0 0 0 0

Letter of Warning 0 2 0 0 0 0 0 0 0 0

Letter of Reprimand 0 0 1 0 0 0 0 0 0 0

Probation 0 1 0 2 2 0 0 0 1 0

Suspension 4 2 2 0 3 3 0 3 2 2

Revocation 8 7 10 5 7 4 8 6 3 8

Interlocutory Hearings 0 2 3 0 1 0 0 0 0 0

Summary Suspension 0 0 2 0 1 0 0 0 0 0

Louisiana Board of Pharmacy - Compliance DivisionStatistical Summary - Cumulative Data


FY FY FY FY FY FY FY FY12-13 13-14 14-15 15-16 16-17 17-18 18-19 19-20 Totals

Summary of Complaint Investigations

Complaints Pending from Prior Year(s) 218 255 252 214 224 160 180 179 2,317

Complaints Received During Year 392 479 404 411 391 500 433 5,445

Complaints Closed During Year 355 482 442 401 468 480 434 5,405

Complaints Pending at Year End 255 252 214 224 147 180 179 2,357

Disposition of Closed Complaints

Withdrawn 25 13 18 18 10 12 5 227

No violations found 32 86 83 48 76 70 88 742

Field/administrative corrections 67 107 113 80 118 63 122 1,052

Referred to another agency 3 11 7 7 16 79 26 93

Administrative sanction 24 15 21 13 4 37 19 841

Termination of probationary period 24 27 15 23 27 14 11 116

Referred for Board action 180 223 185 212 217 205 163 2,334Total 355 482 442 401 468 480 434 5,405


Cases Dismissed 21 41 31 37 26 55 12 417

Voluntary Consent Agreements 157 155 125 163 159 144 146 1,716

Assessment only 9 18 28 18 12 12 16 223

Denial / Refusal to Issue 5 5 2 6 4 17 2 33

Letter of Noncompliance 0 0 0 0 9 6 17 9

Letter of Warning 3 13 5 2 5 3 3 142

Letter of Reprimand 19 7 14 35 29 20 29 279

Voluntary Surrender 21 25 15 13 12 18 13 262

Probation 29 31 16 21 17 28 19 273

Suspension 22 6 2 13 4 4 4 102

Revocation 19 5 14 6 10 4 7 193

Other decisions 30 46 29 49 57 32 36 253

Formal Hearings 2 27 29 12 32 6 5 201

Assessment only 0 0 0 0 0 0 0 4

Denial / Refusal to Issue 0 3 2 0 1 0 1 6

Letter of Warning 0 0 0 0 0 0 0 2

Letter of Reprimand 0 0 0 0 0 0 0 1

Probation 0 0 1 1 1 1 0 9

Suspension 1 20 23 1 1 5 2 67

Revocation 1 4 3 10 10 0 2 94

Interlocutory Hearings 0 0 0 0 0 0 0 6

Summary Suspension 0 0 0 0 0 0 0 3



Annual Report

Fiscal Year 2018-2019

July 1, 2019


Mission Created by the Louisiana Legislature in 1888, the mission of the Louisiana Board of Pharmacy remains unchanged over a century later: to regulate the practice of pharmacy in such a manner as to protect the public health, safety, and welfare of the citizens of Louisiana. Toward that goal, the Louisiana Pharmacy Practice Act specifically authorizes the Board to restrict the practice of pharmacy to qualified persons, as well as to control and regulate all persons and sites that sell prescription drugs or devices or provide pharmacy care services to consumers in this state. Licensure In order to facilitate the restriction of practice to qualified persons, the Board has established educational, experiential, and examination requirements for pharmacist licensure. As authorized by the legislature, the Board has contracted its high-stakes examination procedures with professional testing services. A. Examinations for Pharmacists The North American Pharmacist Licensure Examination (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination (MPJE) are administered by the National Association of Boards of Pharmacy (NABP). These computer adaptive tests are administered in continuous window opportunities at multiple sites throughout the state. A minimum scaled score of 75 is required on each test to qualify for pharmacist licensure; the maximum scaled score is 150 for the NAPLEX and 100 for the MPJE. NABP publishes summary data for the examinations on a trimester basis. The results for all Louisiana-based NAPLEX and MPJE candidates in Calendar Year 2018 are summarized here: NAPLEX Jan – Apr May – Aug Sept – Dec No. of Louisiana Candidates 17 215 50 State Mean Scaled Score 72.88 93.10 76.24 Louisiana Pass Rate 35.29% 86.98% 50% No. of National Candidates 1,349 13,152 3,582 National Mean Scaled Score 77.61 96.25 82 National Pass Rate 56.56% 89.57% 69.24% MPJE Jan – Apr May – Aug Sept – Dec No. of Louisiana Candidates 111 370 211 State Mean Scaled Score 78 77.47 76.64 Louisiana Pass Rate 82.79% 78.82% 69.19% No. of National Candidates 5,845 18,851 9,201 National Mean Scaled Score 77.49 78.21 76.94 National Pass Rate 76.46% 83.07% 72.86%

B. Examinations for Technicians The Board has approved two pharmacy technician certification examinations – the Pharmacy Technician Certification Examination (PTCE) administered by the Pharmacy Technician Certification Board and the Examination for Certified Pharmacy Technicians (ExCPT) administered by National Healthcareer Association (NHA). Both examinations are computer adaptive tests which are administered in continuous window opportunities at multiple sites throughout the state. The results for all Louisiana-based PTCE and ExCPT candidates for Calendar Year 2018 are summarized here: PTCE ExCPT Jan. – June July – Dec. Jan. – June July – Dec. No. of Louisiana Candidates 657 572 57 66 Louisiana Pass Rate 40.9% 44.1% 46.2% 63.6% No. of National Candidates 27,331 21,512 National Pass Rate 57% 58% 64% 70% C. Census Data At the close of the fiscal year on June 30, 2019, a review of our records yielded the following census information: 2019 2018 2017

• Pharmacy Program 1. Pharmacists

> Number of active licenses 9,255 9,009 8,577 > Number of licensees within the state 5,795 5,690 5,588

2. Pharmacy Interns > Number of active registrations 1,094 1,070 1,094

3. Pharmacy technicians > Number of active certificates 6,601 6,586 6,561 4. Pharmacy technician candidates

> Number of active registrations 1,595 2,000 2,052 5 Pharmacies

> Number of active permits 2,033 1,988 1,983 - Community – Independent 605 590 583 - Community – Chain 596 630 651 - Hospital 172 175 175 - Institutional 22 22 23 - Marijuana 8 0 0 - Nuclear 13 13 14 - Charitable 9 10 11 - Penal 4 3 2 - Remote processor 2 1 0 - Nonresident 572 544 524

6. Equipment Permits > Emergency drug kit (EDK) 380 446 411 > Automated medication systems (AMS) 461 870 439 > Durable medical equipment (DME) 640 642 637

7. Special Activity Credentials > CDTM Registration 78 69 66 > Med. Administration Registration 3,161 3,073 2,820 > Special Work Permits 41 45 48 > Marijuana Pharmacy Designations 127 71 0 > PMP Access Registrations 19,686 15,835 (new) Subtotal of Credentials in Pharmacy Program 45,174 41,770 24,688 2018 2018 2017

• CDS Program 1. Automated Medication System (AMS) 42 37 28 2. Advanced Practice RN (APRN) 3,435 2,980 2,343 3. Dentist 2,224 2,174 1.929 4. Drug Detection / Canine 6 8 8 5. Distributor 285 290 284 6. Podiatrist 163 158 136 7. Veterinarian 1,216 1,188 1,007 8. Animal Euthanasia Technician 28 29 25 9. Hospital 302 306 283 10. Laboratory 12 12 11 11. Physicians & Interns/Residents 14,196 13,144 11,575 12. Manufacturer 47 45 38 13. Medical Psychologist 91 91 84 14. Optometrist 360 349 297 15. Pharmacies 1,303 1,335 1,359 16. Physician Assistant 928 783 667 17. Registered Outsourcing Facility 19 19 13 18. Researcher 106 104 100 19. Substance Abuse Clinic 6 6 6

Subtotal of Credentials in CDS Program 24,769 23,058 20,193 Total Active Credentials under Management 69,943 64,828 44,881 D. New Credentials During the past fiscal year, the Board issued 5,864 new credentials in the Pharmacy Program and 2,929 new credentials in the CDS Program. Of note within the Pharmacy Program, we issued 523 new pharmacist licenses, 527 new pharmacy technician certificates, and 1,034 new pharmacy technician candidate registrations during the past fiscal year. Of note within the CDS Program, we issued new CDS licenses to 1,720 physicians, interns and residents, as well as 577 advanced practice registered nurses, and 163 dentists. E. License Transfer (Reciprocity) Persons already licensed as a pharmacist by any other state who wish to obtain a license in Louisiana must successfully complete the MPJE as well as the application and criminal background check. Of the 523 new pharmacist licenses issued this past fiscal year, 295 were issued subsequent to completion of the reciprocity process.

Compliance A. Enforcement

In order to control and regulate the practice of pharmacy in Louisiana, the Board employs five pharmacist compliance officers to perform routine inspections and special investigations throughout the year in all places under the Board’s jurisdiction. In addition to pharmacies, the compliance officers also inspect healthcare facilities to monitor compliance with controlled substance requirements. The compliance officers visited 1,426 pharmacies and other facilities during the year to perform routine inspections, site visits for permit changes and other calls for assistance. The compliance and administrative officers began the fiscal year with 180 cases from the previous fiscal year, received 433 new cases, and closed 434 cases, leaving 179 cases for the next fiscal year. Of the 434 cases closed during the fiscal year: 5 of the original complaints were withdrawn, 11 resulted from termination of previously imposed probationary periods, 88 were determined to be without violation, 26 cases were referred to other agencies, 122 resulted in field/administrative corrections, 19 resulted in administrative sanctions, and 163 cases were referred to the Board’s committees. The committees took no action in 12 of their cases, issued approvals for 30 non-disciplinary petitions, and recommended voluntary consent agreements for 121 cases. Of that number, all but five accepted the proposed discipline; those five respondents were referred for formal administrative hearings. The decisions from the formal hearings resulted in one denial of reinstatement, two suspensions, and two revocations.

Compliance officers coordinate other investigative activities with a wide range of agencies, including local police departments, parish sheriff departments, other state regulatory and law enforcement agencies, and federal agencies such as the Drug Enforcement Administration, the Food and Drug Administration, and the Consumer Product Safety Commission. Though the compliance officers utilize the educational approach as the fundamental mechanism to achieve compliance, certain circumstances warrant formal board action.

B. Adjudications During the past fiscal year, the Board conducted two administrative hearings and levied formal disciplinary action against several credentials. A summary of that activity is presented here: Pharmacist Intern Technician Candidate Permit CDS Sanction Denial / Refusal 1 0 1 1 0 0 Reinstatement 6 0 8 0 0 3 Change Previous Orders 6 0 0 0 0 0 Assessment 1 0 0 0 15 0 Letter of Warning 1 0 0 0 2 0 Letter of Reprimand 12 0 12 0 5 0 Voluntary Surrender 7 0 3 1 0 2 Probation 14 1 2 0 2 0 Suspension 4 0 1 1 0 0 Revocation 0 0 5 2 2 0 Other Decisions 20 0 2 1 7 0

C. Practitioner Recovery Program The Board established its program in 1988 to assist practitioners obtain treatment for their impairment, maintain their recovery, and assist their re-entry into professional practice. As of July 1, 2019 there were 42 pharmacists, one pharmacy intern, and seven pharmacy technicians actively engaged in the recovery program. They surrendered their credentials while in treatment; following treatment and upon favorable recommendation by board-certified addiction medicine specialists, they applied for the reinstatement of their credentials. The Board reinstated their credentials on probation, and the licensees practice under various restrictions designed to monitor their re-entry to professional practice. In addition, the credentials for 39 pharmacists, two interns, 17 technicians, and four technician candidates were still on active suspension for impairment reasons. Board Activity A. Regulatory

The Board’s Regulation Revision Committee is tasked with the continuous review of the Board’s rules and their recommendation for revision as appropriate. The Board initiated and completed two regulatory projects during the fiscal year.

Louisiana Prescription Drug Uniform Prior Authorization Form, amending LAC 46:LIII.1129 and 1130, in collaboration with the La. State Board of Medical Examiners, as directed by Act 423 of the 2018 Legislature; and

Naloxone as Drug of Concern, amending LAC 46:LIII.2901, as directed by Act 146 of the 2018Legislature.

As directed by other legislative acts and by the Board’s own initiative, the Board initiated 17 additional regulatory projects; these are pending review by the Occupational Licensing Review Commission for approval to initiate the formal promulgation process. B. Legislative During the 2019 regular session, the Board sponsored three bills, all of which were successful.

Act 80 amended the prescription monitoring program law to enable the sharing of prescription monitoring information with federal agencies and jurisdictions.

Act 219 amended the licensing section of the controlled dangerous substance law to authorize the Board to require criminal history record checks for certain applicants for the state controlled dangerous substance license.

Act 354 amended the state’s list of controlled dangerous substances to harmonize the state list with recent federal scheduling actions.

C. Prescription Monitoring Program

Finally, the Board continued its operation of Louisiana’s Prescription Monitoring Program (PMP). The vendor contract to operate the program is held by Appriss, Inc., based in Louisville, KY. As reported previously, Appriss acquired the previous vendor (Optimum Technology) in 2016 and transitioned the program to its operating platform, Aware Rx. The number of prescribers and dispensers authorized to access the program’s database continues to increase, as has the average number of queries per

day. Since the program is required to file an annual report to the legislature, we have appended that report to this one to facilitate its separation.

Board Office The Board currently employs 22 people on a full-time basis in a variety of professional, technical, and clerical roles; the Board also supports the local Cooperative Office Education (COE) program in Baton Rouge area high schools by hiring high school senior students on a temporary basis. The physical and mailing address of the board office is: Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, LA 70809-1700 Telephone (225) 925-6496 The board’s website address is www.pharmacy.la.gov and general email is received at [email protected]. Conclusion The board has had an active year on several fronts, and all of these activities have contributed to the overall mission of the board. The officers and members of the board, as well as the entire office staff, are committed to achieving our goal of protecting the public’s health, safety and welfare through appropriate regulation of the practice of pharmacy in this state. We understand that public service is a privilege, and we endeavor to render that service honorably. Respectfully submitted, Malcolm J Broussard Executive Director

http://www.pharmacy.la.gov/




Prescription Monitoring Program Annual Report

Fiscal Year 2018-2019

July 1, 2019


Introduction The Louisiana Prescription Monitoring Program (PMP) is an electronic database used to collect and monitor prescription data for all Schedule II, III, IV, and V controlled substances, as well as certain drugs of concern, dispensed by a pharmacy in Louisiana or to a Louisiana resident from a pharmacy located in another state. The PMP also provides a venue for monitoring patient prescription history for practitioners. Act 676 of the 2006 Louisiana Legislature authorized the development, implementation, operation, and evaluation of an electronic system for the monitoring of controlled substances and other drugs of concern that are dispensed within the state or to state residents by pharmacies located in other states. The goal of the program is to improve the state’s ability to identify and inhibit the diversion of controlled substances and drugs of concern in an efficient and cost-effective manner and in a manner that shall not impede the appropriate utilization of these drugs for legitimate medical purposes. The PMP was implemented in August 2008. Pharmacies and dispensing prescribers were instructed how and when to transmit their dispensing transactions to the program vendor for assimilation into the PMP database. Prescribers, dispensers, and other persons authorized to access PMP information were instructed how to secure their access privileges. The web portal to the PMP database was opened to queries on January 1, 2009, and the program remains fully operational. Advisory Council The enabling legislation created the PMP Advisory Council to assist the Board in the development and operation of the program. The council consists of the following members, each of whom may appoint a designee:

1. The president of the Louisiana State Board of Medical Examiners; 2. The president of the Louisiana State Board of Dentistry; 3. The president of the Louisiana State Board of Nursing; 4. The president of the Louisiana State Board of Optometry Examiners; 5. The president of the Louisiana Academy of Physician Assistants; 6. The president of the Louisiana Board of Pharmacy; 7. The superintendent of the Louisiana State Police; 8. The administrator of the United States Drug Enforcement Administration; 9. The speaker of the Louisiana House of Representatives; 10. The president of the Louisiana Senate; 11. The chairman of the House Committee on Health and Welfare; 12. The chairman of the Senate Committee on Health and Welfare; 13. The secretary of the Department of Health; 14. The president of the Louisiana State Medical Society; 15. The president of the Louisiana Dental Association; 16. The president of the Louisiana Association of Nurse Practitioners; 17. The president of the Optometry Association of Louisiana; 18. The president of the Louisiana Pharmacists Association; 19. The president of the Louisiana Independent Pharmacies Association; 20. The president of the National Association of Chain Drug Stores; 21. The president of the Louisiana Sheriffs’ Association; 22. The president of the Louisiana District Attorneys Association; 23. The president of the Pharmaceutical Research and Manufacturers of America; and 24. The president of the Louisiana Academy of Medical Psychologists.

During Fiscal Year 2018-2019, the council convened all four of their regularly-scheduled quarterly meetings. Representatives from six of the 24 organizations attended 100% of the meetings; ten entities attended 75%; two attended 50%; two attended 25%, and four entities had no representation at any of the meetings. During each of the meetings, program staff presented data concerning the number of prescription transactions reported to the program database as well as the number of queries to the database by prescribers, dispensers, law enforcement, and regulatory agencies. The staff also reported on the addition of new states available through the PMP InterConnect interstate network, as well as the increased utilization by the private sector of the PMP Gateway service, which integrates the PMP access portal into existing practice information systems in a variety of settings, including hospitals, clinics, practitioner offices, and pharmacies. The council reviewed new legislation adopted during the 2018 legislative session, and staff provided updates on the operational implementation of the legislative mandates. Vendor Contract With the 2013 contract expiring at the end of 2018, the Board solicited public bids for an expanded list of improvements and technical specifications. The La. Office of State Procurement awarded the new contract in January 2019 to Appriss, which was the sole bidder. Program Highlights

• August 1, 2018 – established access for an epidemiologist with the La. Dept. of Health for public health surveillance purposes, as authorized by 232 of the 2018 Legislature.

• December 21, 2018 – Louisiana Office of State Procurement awarded the PMP vendor contract to Appriss, Inc. with an effective date of January 1, 2019.

• April 3, 2019 – through participation with the PMP InterConnect™ sponsored by the National Association of Boards of Pharmacy, achieved connection with the United States Military Health System and 26 states, including Alabama, Alaska, Arizona, Arkansas, Connecticut, Delaware, Florida, Georgia, Idaho, Kansas, Massachusetts, Minnesota, Mississippi, Montana, Nevada, New Mexico, North Carolina, North Dakota, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, and West Virginia.

• May 6, 2019 – first distribution of Prescriber Report Cards. The Prescriber Report Card is intended to give prescribers insight into their opioid prescribing patterns. Reports are provided quarterly to all registered PMP prescriber users with an active account and a defined role and specialty who have written at least one opioid prescription during the prior six-month period.

Louisiana PMP Statewide Integration Project On January 1, 2019, the Board partnered with the Louisiana Dept. of Health’s Office of Public Health, Bureau of Community Preparedness (LDH-OPH-BCP) and Appriss Health to provide a statewide PMP integration option to all healthcare providers in Louisiana utilizing a service called PMP Gateway®. Gateway offers healthcare providers an option to integrate PMP data within the provider’s electronic health record (EHR) or pharmacy information system to provide a streamlined clinical workflow for providers. The integration eliminates the need for providers to log in separately to the PMP web portal; instead, the EHR automatically initiates a patient query and returns the patient’s PMP information directly within the provider’s EHR or pharmacy information system. Included as part of the integration, users now have access to an advanced analytics and patient

support tool called NarxCare®. In addition to the existing Louisiana PMP functionality, NarxCare aggregates and analyzes prescription information from pharmacies and presents visual interactive information, as well as advanced analytic insights, machine learning risk scores and more to help prescribers and pharmacists provide better patient safety and outcomes for every patient. NarxCare also provides tools and resources that support patients’ needs and assists a healthcare provider to connect their patient to treatment when appropriate. This statewide initiative is funded by a Centers for Disease Control and Prevention (CDC) grant awarded to LDH-OPH-BCP and covers the costs of the licensing fees associated with the integration and NarxCare service. As of June 30, 2019, the Louisiana PMP was interoperable with 80 licensees (EHR and pharmacy information systems) across the state. There were an additional 179 licensee applicants (EHRs and pharmacy information systems) which had applied for integration and were in process to complete the necessary requirements to obtain access. It is important to note that several licensees have numerous facilities across the state. Ochsner Health System, for example, is one licensee with multiple facilities across the state from New Orleans to Shreveport. Other such licensees include Franciscan Missionaries of Our Lady Health System, Lafayette General Health System, Wal-Mart Pharmacies, and Kroger Pharmacies. Program Metrics The data on the following pages provide summary data for the operational aspects of the program for Calendar Year 2018. The first graphic presents information about the use of the information by the authorized users as identified in the governing legislation. Data for the different categories of prescribers are presented, including the number of prescribers authorized to obtain PMP access privileges, the number with active access privileges and the number of queries to the PMP database by those prescribers. Other authorized users include law enforcement and regulatory agencies; information concerning the number of queries originating from those entities is also presented. The second graphic presents information concerning the numbers of controlled substance prescriptions dispense in the state, including summary data for different types of drugs like opioids and benzodiazepines. Just over 11 million prescriptions were dispensed in the state during Calendar Year 2018, with an average of 2.424 prescriptions per Louisiana resident. Outlook for Next Fiscal Year The program is implementing several new features this year, including monitoring for mandatory use compliance as well as the initiation of clinical alerts.

• The controlled substance law contains some mandatory use provisions for certain prescribers in certain situations, and there are some exceptions to those requirements. The monitor can alert staff when prescribers appear to deviate from the mandatory use requirements. Staff will relay the information to the prescriber’s licensing authority which can then determine whether an exception applies or compliance was not achieved.

• The program will offer prescribers multiple types of clinical alerts. These electronic alerts are delivered directly to a prescriber’s dashboard and his email if desired to alert the prescriber that patient has Exceeded a set prescriber/dispenser threshold; Exceeded a daily active MME threshold; Exceeded a daily active MME threshold for methadone; Exceeded a days count threshold for opioid prescriptions; or Been prescribed opioids and benzodiazepines concurrently.

Louisiana Board of PharmacyPrescription Monitoring Program

Number of Providers Eligible for PMP Access

Number of Providers with Active PMP Access Privileges

Number of PMP Requests through AWARxE™

Number of PMP Requests through GATEWAY™

(as of 12/31/2018) (as of 12/31/2018)Healthcare Provider RolesPhysician (MD, DO) 13,000 8,605 1,393,029 3,543,306Nurse Practitioner (APRN) 3,226 2,473 300,383 109,849Dentist (DDS) 2,225 1,509 21,658 0Physician Assistant (PA) 880 624 65,442 10,435Optometrist (OD) 360 148 35 0Podiatrist (DPM) 161 109 879 0Medical Psychologist (MP) 89 83 19,786 0Medical Intern/Resident 1,076 937 3,354 0Prescriber's Delegate NA 2,127 793,101 NAPharmacist (PST) 9,069 4,156 1,289,904 720,124Pharmacist's Delegate NA 812 140,533 NATotals 30,086 21,583 4,028,104 4,383,714

Law Enforcement, Prosecutorial Officicals, & Specialty CourtsDEA (patient requests) 521Specialty Courts 102FBI 335Homeland Security 3Local Law Enforcement 366HHS - OIG 12State Attorney General 1State Police 40Total 1380

Regulatory AgenciesLA State Board of Medical Examiners 1,149LA State Board of Dentistry 38LA State Board of Nursing 918LA State Board of Pharmacy 1,744DEA (licensee requests) 808Total 4,657

Other RolesMedical Examiner / Cororner 262Louisiana Medicaid 726Total 988

Authorized User Statistics for Calendar Year 2018

Quick Slicers:

2018

0M

5M

10M

YoY Prescriptions (#)

Opioid 2018

Benzo 2018

Anxiolytic, Hypnotics, Se..2018

Other 2018

4,786,754

2,498,343

998,486

3,023,486

YoY Prescriptions (#) by Drug Classes

Schedule 2 2018

Schedule 3 2018

Schedule 4 2018

Schedule 5 2018

Unscheduled 2018

Unspecified 2018

5,139,558

725,533

4,579,843

539,681

321,288

1,166

YoY Prescriptions (#) by Drug Schedule

Prescriptions

11,307,069Days Supply

265,983,525

State Rx per Capita

2.424

DISPENSATION DASHBOARD

Opioids vs. Non Opioids (%)

2019201720162015 2018

New vs. Refill PrescriptionsPrescriptions >= 90 MME vs. All Rx by Patient Demographic Environment

RURAL

SUPER RURAL

URBAN 77%

4%

19%Non-Opioid

Opioid 42%

58%Refill

New 79.7%

20.3%GTE 90

LT 90 97.1%

2.9%

A high level overview of reported dispensation activity.

Last Updated @7/29/2019 112040 AM

EACH (TABLETS, KITS, ETC..

GRAMS (SOLIDS)

MILLILITERS (LIQUIDS)

UNSPECIFIED 118K

81,609K

3,256K

513,932K

Quantity

Dispensed

Conclusion The program has completed approximately ten years of operation. Based on feedback from authorized users, it appears to represent an efficient and cost-effective use of resources. Data from the program suggests we have made some progress in the reduction of diversion of controlled substances. Our interstate collaborations have yielded high marks for our program design and operation. We look forward to fully developing the potential of our program to identify and inhibit the diversion of controlled substances in Louisiana. We appreciate the contributions from and collaboration with our partners on the Prescription Monitoring Program Advisory Council. We also acknowledge the contributions from our administrative coordinators, Ms. Danielle Hartzog and Ms. Nerissa Montgomery, and the program manager, Mr. Joseph Fontenot, for their assistance with the development of this report and administrative oversight of the program. Respectfully submitted, Malcolm J. Broussard Executive Director



Multistate Pharmacy Jurisprudence Examination (MPJE™)

January 1 – April 30, 2019

State & National Summary Data Frequency Distribution of Scaled Scores

August 14, 2019


MPJE-LA-2019 Trimester 1

Multistate Pharmacy Jurisprudence Examination® (MPJE®) State Summary

Report

Louisiana

Test Window:

Table 1 First-Time Candidates, ACPE-Accredited Programs Only

Candidates Pass Rate %Total Scaled

Score Mean

Standard

Deviation

January 1, 2019 - April 30, 2019

State 118 86.44% 79.25 3.72

National 4648 81.95% 78.09 4.11

Table 2 All Candidates


Score Mean

Standard

Deviation

State 157 79.62% 78.26 3.97

58 96

All Candidates 58 96

Scale Score Range 0 100

National 6583 76.77% 77.38 4.11

Table 3 contains information on the range of

scaled scores achieved by FT ACPE (First-Time,

ACPE-Accredited) candidates as well as the

pool of all candidates. It also shows the

boundaries of the Scaled Score Range.

Table 3 Total Scaled Score Min/Max

Min Max

FT ACPE

Candidates who did not answer enough questions to receive a score are reflected in pass

rate data as a fail but are not included in mean scaled score data.

Page 1 of 3

[0,4] 0

[5,9] 0

[10,14] 0

[15,19] 0

[20,24] 0

[25,29] 0

[30,34] 0

[35,39] 0

[40,44] 0

[45,49] 0

[50,54] 0

[55,59] 0

[60,64] 0

[65,69] 3

[70,74] 29

[75,79] 60

[80,84] 60

[85,89] 5

[90,94] 0

[95,100] 0

[0,4] 0 0%

[5,9] 0 0%

The following tables and graphs are scaled score frequency distributions for MPJE candidates. Candidates who did not

answer enough questions to receive a score are not reflected in the frequency distributions.

Table 4 & Graph 1 State Frequency Distribution of Scaled Scores

Based on Total Tests Administered N = 157

Scaled Score Range Frequency

Cumulative Percent of

the Upper Limit of the

Interval

[20,24] 0 0%

[25,29] 0 0%

[10,14] 0 0%

[15,19] 0 0%

[40,44] 0 0%

[45,49] 0 0%

[30,34] 0 0%

[35,39] 0 0%

[60,64] 0 0%

[65,69] 3 2%

[50,54] 0 0%

[55,59] 0 0%

[80,84] 60 97%

[85,89] 5 100%

[70,74] 29 20%

[75,79] 60 59%

[90,94] 0 100%

[95,100] 0 100%

0

10

20

30

40

50

60

70

Freq

ue

ncy

Scaled Score Interval

Page 2 of 3

[0,4] 0

[5,9] 0

[10,14] 0

[15,19] 0

[20,24] 0

[25,29] 0

[30,34] 0

[35,39] 0

[40,44] 0

[45,49] 0

[50,54] 0

[55,59] 4

[60,64] 6

[65,69]162

[70,74]###

[75,79]###

[80,84]###

[85,89]276

[90,94] 23

[95,100] 1

Table 5 & Graph 2 National Frequency Distribution of Scaled Scores

6580




Interval

Based on Total Tests Administered N =

[10,14] 0 0%

[15,19] 0 0%

[0,4] 0 0%

[5,9] 0 0%

[30,34] 0 0%

[35,39] 0 0%

[20,24] 0 0%

[25,29] 0 0%

[50,54] 0 0%

[55,59] 4 0%

[40,44] 0 0%

[45,49] 0 0%

[70,74] 1354 23%

[75,79] 3158 71%

[60,64] 6 0%

[65,69] 162 3%

[90,94] 23 100%

[95,100] 1 100%

[80,84] 1596 95%

[85,89] 276 100%

0

500

1000

1500

2000

2500

3000

3500

Freq

ue

ncy


Page 3 of 3

Multistate Pharmacy Jurisprudence Examination (MPJE)for


Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec

First-Time Candidates, ACPE-Accredited Programs Only

No. of State Candidates 76 329 131 118

State Pass Rate 90.53% 78.37% 71.76% 86.44%

State Scaled Score Mean 79.02 77.56 77.19 79.25

No. of National Candidates 4,113 16,502 5,987 4,648

National Pass Rate 82.37% 85.00% 76.03% 81.95%

National Scaled Score Mean 78.26 78.50 77.46 78.09

All Candidates


State Pass Rate 82.79% 78.82% 69.19% 79.62%





2018 2019 2020 2021



North American Pharmacist Licensure Examination (NAPLEX™)

January 1 – April 30, 2019

State & National Summary Data Frequency Distribution of Scaled Scores

August 14, 2019


NAPLEX-LA-2019 Trimester 1

1 135

Scale Score Range 0 150

11.70 1.23

Table 3 contains information on the range of scaled

scores achieved by FT ACPE (First-Time, ACPE-

Accredited) candidates as well as the pool of all

candidates. It also shows the boundaries of the Scaled

Score Range.

Table 3 Total Scaled Score Min/Max

Min Max

FT ACPE 17 135

All Candidates

0.83 11.67 1.17

National 1344 61.24% 77.80 17.60 11.48 1.07

State 24 70.83% 76.50 15.53 11.42

Table 2 All Candidates


Score Mean

Standard

Deviation

Area 1 Scaled

Score Mean

Standard

Deviation

Area 2 Scaled

Score Mean

Standard

Deviation

National 374 67.11% 82.00 20.14 11.79 1.20 11.87 1.41

State 3 66.67% 71.33 26.65 11.00 1.00 11.33 2.08

North American Pharmacist Licensure Examination® (NAPLEX®) State

Summary Report

Louisiana

Test Window:

Table 1 First-Time Candidates, ACPE-Accredited Programs Only


Score Mean

Standard

Deviation

Area 1 Scaled

Score Mean

Standard

Deviation

Area 2 Scaled

Score Mean

Standard

Deviation

January 1, 2019 - April 30, 2019

Page 1 of 3

[0,4] 0

[5,9] 0

[10,14] 0

[15,19] 0

[20,24] 0

[25,29] 0

[30,34] 0

[35,39] 0

[40,44] 1

[45,49] 0

[50,54] 2

[55,59] 1

[60,64] 1

[65,69] 1

[70,74] 1

[75,79] 6

[80,84] 4

[85,89] 3

[90,94] 2

[95,99] 0

[100,104]1

[105,109]1

[110,114]0

[115,119]0

[120,124]0

[125,129]0

[130,134]0

[135,139]0

[140,144]0

[145,150]0

[140,144] 0 100%

[145,150] 0 100%

[130,134] 0 100%

[135,139] 0 100%

[120,124] 0 100%

[125,129] 0 100%

[110,114] 0 100%

[115,119] 0 100%

[100,104] 1 96%

[105,109] 1 100%

[90,94] 2 92%

[95,99] 0 92%

[80,84] 4 71%

[85,89] 3 83%

[70,74] 1 29%

[75,79] 6 54%

[60,64] 1 21%

[65,69] 1 25%

[50,54] 2 13%

[55,59] 1 17%

[40,44] 1 4%

[45,49] 0 4%

[30,34] 0 0%

[35,39] 0 0%

[20,24] 0 0%

[25,29] 0 0%

[10,14] 0 0%

[15,19] 0 0%

[0,4] 0 0%

[5,9] 0 0%

The following tables and graphs are scaled score frequency distributions for NAPLEX candidates.

Table 4 & Graph 1 State Frequency Distribution of Scaled Scores





Interval

0

1

2

3

4

5

6

7

Freq

ue

ncy


Page 2 of 3

[0,4] 2

[5,9] 0

[10,14] 0

[15,19] 3

[20,24] 2

[25,29] 3

[30,34] 11

[35,39] 12

[40,44] 26

[45,49] 21

[50,54] 43

[55,59] 60

[60,64] 83

[65,69]119

[70,74]136

[75,79]184

[80,84]176

[85,89]141

[90,94] 96

[95,99] 96

[100,104]50

[105,109]41

[110,114]20

[115,119]9

[120,124]6

[125,129]2

[130,134]1

[135,139]1

[140,144]0

[145,150]0

[140,144] 0 100%

[145,150] 0 100%

[130,134] 1 100%

[135,139] 1 100%

[120,124] 6 100%

[125,129] 2 100%

[110,114] 20 99%

[115,119] 9 99%

[100,104] 50 94%

[105,109] 41 97%

[90,94] 96 83%

[95,99] 96 90%

[80,84] 176 66%

[85,89] 141 76%

[70,74] 136 39%

[75,79] 184 52%

[60,64] 83 20%

[65,69] 119 29%

[50,54] 43 9%

[55,59] 60 14%

[40,44] 26 4%

[45,49] 21 6%

[30,34] 11 2%

[35,39] 12 2%

[20,24] 2 1%

[25,29] 3 1%

[10,14] 0 0%

[15,19] 3 0%

[0,4] 2 0%

[5,9] 0 0%

Table 5 & Graph 2 National Frequency Distribution of Scaled Scores





Interval

0

20

40

60

80

100

120

140

160

180

200

Freq

uen

cy


Page 3 of 3

North American Pharmacist Licensure Examination (NAPLEX)for


Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec Jan - Apr May - Aug Sept - Dec

First-Time Candidates, ACPE-Accredited Programs Only


State Pass Rate 0.00% 89.22% 45.83% 66.67%


No. of National Candidates 290 12,271 2,019 374

National Pass Rate 64.48% 91.64% 72.76% 67.11%72.20

National Scaled Score Mean 97.54 84.56 82.00

All Candidates


State Pass Rate 35.29% 86.98% 50.00% 70.83%





2018 2019 2020 2021



Examination for the Certification of Pharmacy Technicians (ExCPT™)

April – June 2019

Cumulative Record (since January 2018)

August 14, 2019


National Healthcareer AssociationExCPT

1st Qtr 2nd Qtr 3rd Qtr 4th Qtr 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr

First-Time Candidate GroupNo. of LA Candidates 7 32 34 32 48 71

No. of LA Candidates who passed 2 16 20 22 41 127

State Pass Rate 29% 50% 59% 69% 85% 56%

No of National Candidates 1835 3942

No. of National Candidates who passed 1356 2503

National Pass Rate 66% 61% 70% 70% 74% 63%

Multiple Attempts GroupNo. of LA Candidates 2 6 2 5 1 1

No. of LA Candidates who passed 1 3 2 2 1 1

State Pass Rate 50% 50% 100% 40% 100% 100%

No. of National Caniddates 172 194

No. of National Candidates who passed 94 95

National Pass Rate 62% 47% 40% 55% 55% 49%

Calendar Year 2018 Calendar Year 2019



Pharmacy Technician Certification Examination (PTCE™)

January – June 2019

Cumulative Record (since January 2000)

August 14, 2019



Pharmacy Technician Certification Examination (PTCB) Data

2000-2018 2000-2019National Data Totals Data Totals Data

First AttemptNo. of Candidates Attempting 39,794No. of Candidates Passing 24,049Pass Rate 60.0%

RepeatersNo. of Candidates Attempting 9,049No. of Candidates Passing 4,114Pass Rate 45.0%

TotalsNo. Candidates Attempting 48,843 895,313No. Candidates Passing 28,056 625,288Pass Rate 57.0% 70%

Louisiana DataFirst AttemptNo. of Candidates Attempting 852No. of Candidates Passing 383Pass Rate 44.9%

RepeatersNo. of Candidates Attempting 377No. of Candidates Passing 145Pass Rate 38.5%

TotalsNo. Candidates Attempting 1,229 17,062No. Candidates Passing 521 10,191Pass Rate 42.4% 59.7%

51

25,63614,783

48.0%

57%57% 58%

657269

40.9%252

44.1%

572

36.1% 41.3%

44.0%

20574

60%

24345.0%

45% 47%

21,512

452 400 402

27,33112,47715,579

4,2351,94846%

1/1/2018 to 6/30/2018 7/1/2018 to 12/31/2018 1/1/2019 to 6/30/2019 7/1/2019 to 12/31/2019

199

17271

46.0%184

540

37.0%

193

138

2,166 2,167

13,510 10,539

4,814 4,610

22,517 17,277 21,02612,616

60% 61%



2000-2013 2000-2014 2000-2015

National Data Data Data Data

No. of Candidates Attempting 628,957 682,465 740,829No. of Candidates Passing 470,680 501,038 535,961

Pass Rate 74.8% 73.4% 72.3%

Louisiana Data

No. of Candidates Attempting 11,002 12,200 13,314No. of Candidates Passing 7,451 8,003 8,562

Pass Rate 67.7% 65.6% 64.3%

2000-2016 2000-2017National Data Data Data

First AttemptNo. of Candidates Attempting 794,159 846,470No. of Candidates Passing 566,892 597,232Pass Rate 71% 71%

RepeatersNo. of Candidates AttemptingNo. of Candidates PassingPass Rate

Louisiana DataFirst Attempt 14,612 15,833No. of Candidates Attempting 9,133 9,670No. of Candidates Passing 62.50% 61%Pass Rate

RepeatersNo. of Candidates AttemptingNo. of Candidates PassingPass Rate

12934%

48%

52,31130,340

58%

1,22153744%

43,18025,908

9,1314,20046%

843405

53,33030,931

58%

43,9582681461%

9,372

45%4,217

60%

840

458

49%412

15634%

378

1,29857144%

45.6% 46.7% 53.1% 48.1%

1/1/2016 to 12/31/2016 Total Candidates 1/1/2017 to 12/31/2017 Total Candidates

287 265 255 304

57.7% 55.8% 59.8% 59.8%

630 568 480 632

15,233 15,125 13,280 21,643

1/1/2014 to 6/30/2014 7/1/2014 to 12/31/2014 1/1/2015 to 06/30/2015 7/1/2015 to 12/31/2015

26,423 27,085 22,197 36,167



2000-2009 1/1/2010 4/1/2010 7/1/2010 10/1/2010 2000-2010 1/1/2011 4/1/2011 7/1/2011 10/1/2011National Data Data 3/31/2010 6/30/2010 9/30/2010 12/31/2010 Data 3/31/2011 6/30/2011 9/30/2011 12/31/2011

No. of Candidates Attempting 415,875 11,611 15,033 16,025 12,774 471,318 11,219 14,026 12,356 14,031No. of Candidates Passing 309,035 8,521 11,216 12,349 9,275 350,396 8,366 10,472 9,565 10,826

Pass Rate 74% 73% 75% 77% 73% 74% 75% 75% 77% 77%

Louisiana Data

No. of Candidates Attempting 9,843 217 421 320 268 11,069 247 437 268 257No. of Candidates Passing 6,688 121 287 219 166 7,481 161 306 182 168

Pass Rate 68% 56% 68% 68% 62% 68% 65% 70% 68% 65%

2000-2011 1/1/2012 4/1/2012 7/1/2012 10/1/2012 2000-2012National Data Data 3/31/2012 6/30/2012 9/30/2012 12/31/2012 Data

No. of Candidates Attempting 522,950 11,851 14,356 14,375 11,180 574,712No. of Candidates Passing 389,625 9,232 11,044 10,982 8,471 429,354

Pass Rate 75% 78% 77% 76% 76% 75%

Louisiana Data

No. of Candidates Attempting 12,278 246 368 329 239 13,460No. of Candidates Passing 8,298 158 269 226 168 9,119

Pass Rate 68% 64% 73% 69% 70% 68% 66% 65%

Changed to semi-annual reports

622 537412 351

19,581 21,745

77% 76%

1/1/2013 to 6/30/2013 7/1/2013 to 12/31/2013

25,448 28,797



2000-2005 2000-2006 2/5/2007 4/24/2007 8/27/2007 11/26/2007National Data Data 3/11/2006 7/22/2006 9/9/2006 11/18/2006 Data 3/9/2007 5/25/2007 9/28/2007 12/31/2007


Pass Rate 79% 69% 66% 66% 60% 76% 69% 70% 72% 69%

Louisiana Data


Pass Rate 73% 63% 57% 63% 44% 70% 62% 64% 67% 58%

2000-2007 2/4/2008 4/28/2008 8/18/2008 11/10/2008 2000-2008 1/1/2009 4/1/2009 7/1/2009 10/1/2009National Data Data 3/14/2008 6/20/2008 10/10/2008 12/19/2008 Data 3/31/2009 6/30/2009 9/30/2009 12/31/2009


Pass Rate 75% 68% 72% 72% 66% 75% 70% 76% 73% 72%

Louisiana Data


Pass Rate 69% 56% 59% 60% 55% 68% 61% 75% 70% 63%



1995-1999National Data Data 3/25/2000 7/22/2000 11/18/2000 3/10/2001 7/14/2001 11/10/2001 3/16/2002 7/27/2002 11/16/2002


Pass Rate 82% 77% 81% 74% 72% 81% 79% 80% 80% 80%

Louisiana Data

No. of Candidates Attempting 514 141 346 327 187 310 324 269 383 308No. of Candidates Passing 390 92 271 221 125 227 228 184 269 213

Pass Rate 76% 65% 78% 68% 67% 73% 70% 68% 70% 69%

2000-2002National Data Data 3/29/2003 7/26/2003 11/15/2003 3/20/2004 7/17/2004 11/13/2004 3/19/2005 7/23/2005 11/19/2005


Pass Rate 78% 78% 83% 82% 79% 77% 78% 81% 78% 75%

Louisiana Data

No. of Candidates Attempting 2,595 385 384 351 285 382 290 337 488 216No. of Candidates Passing 1,830 294 286 271 211 281 214 274 351 167

Pass Rate 71% 76% 74% 77% 74% 74% 74% 81% 72% 77%


Baton Rouge, Louisiana 70809 www.pharmacy.la.gov

_________________ Interoffice_Memo___________________ To: Malcolm Broussard Date: August 08, 2019 Executive Director From: Benjamin S. Whaley, R.Ph., Chief Compliance Officer Subject: Hurricane Barry Assessment The impact of Hurricane Barry on Louisiana pharmacies was limited. In order to determine this, the compliance officers called or visited various pharmacies in each of their respective territories and inquired whether they were impacted or if they knew of other pharmacies that were impacted. The Board also received formal notifications from the corporate offices of multiple chain pharmacies and healthcare organizations. While most of the affected pharmacies only temporarily lost power, there were a small number of pharmacies in which management determined the outage could have compromised the refrigerated stock. For these pharmacies, the Board office was notified accordingly, and the drugs were quarantined for reverse distribution. With the exception of two pharmacies, we are not aware of any physical damage caused by the storm. A Walgreens in New Orleans took on a small amount of water, and their management addressed it accordingly. Option Care, a sterile compounding pharmacy in Elmwood, also had water intrusion which entered the cleanroom. Compounding was immediately discontinued, and the services were outsourced to their Texas and Alabama locations. Both out-of-state locations possess valid NR permits. The PIC stated that the cleanroom has been remediated, but they currently have no plans to resume compounding at this location. Because the impact is very limited, the pharmacies that had issues were able to resolve them quickly. It does not appear there will be any long-term effects from Hurricane Barry. ___________________________________ Benjamin Whaley, R.Ph. Chief Compliance Officer Louisiana Board of Pharmacy

http://www.pahrmacy.la.gov/

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18333-22x8_Sign_.indd 2 6/7/2019 9:48:44 AM

Enhancing Well-being and Resilience Among the Pharmacist Workforce:

A National Consensus Conference

IntroductionNearly a half-century of research has described the issues and concerns associated with job stress,

moral distress, work overload, burnout, and level of control within the pharmacy profession. After

decades of discussion and engagement in diverse strategies by pharmacy stakeholders combined

with rapid changes in the practice models of pharmacy and an ever-changing, evolving health care

system, it is clear that the pharmacist workforce is currently at a critical juncture. The well-being

and resilience of the pharmacist workforce must be effectively and efficiently addressed by all

pharmacy stakeholders.

To address this important issue, a collaboration was formed between the American Association of

Colleges of Pharmacy (AACP), the Accreditation Council for Pharmacist Education (ACPE), the

American Pharmacists Association (APhA), the National Association of Boards of Pharmacy (NABP),

and the National Alliance of State Pharmacy Associations (NASPA) and the Enhancing Well-being and Resilience Among the Pharmacist Workforce: A National Consensus Conference was planned

and conducted.

The objectives of the consensus conference were to:

• Evaluate factors that contribute to well-being and resilience at the individual, organizational,

and profession levels.

• Develop strategies that could improve pharmacist well-being and resilience and decrease

moral distress within individuals, managers, organizations, and the profession.

• Identify and prioritize strategies that will drive change and fuel improvements in well-being

and resilience.

• Develop actionable recommendations that guide organizations and individuals in implementing

positive change.

Diverse stakeholders within the profession—representing pharmacists and employers from across

practice settings, schools and colleges of pharmacy, and professional organizations—came together

in Chicago from July 17–19, 2019, and engaged in a thoughtful and intentional process to discuss

issues and concerns associated with well-being, moral distress, work overload, and burnout. The goal

of the conference was the development and approval of meaningful and actionable recommendations

that can be effectively implemented broadly to address this important issue.

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Enhancing Well-being and Resilience Among the Pharmacist Workforce: A National Consensus Conference

Consensus Recommendations A total of 50 recommendations were developed

and approved by consensus to provide

immediate, viable, and sustainable solutions to

create improvements in critical areas related

to well-being and resilience for pharmacy

professionals at the societal level, at the

organizational level, and the individual level. The

intent of these recommendations is broad, with

opportunities for action by any individual or

organization within the pharmacy profession to

effect change within their spheres of influence.

The accepted consensus recommendations

reflect opportunities to support meaningful and

actionable change by addressing improvement of:

• Pharmacist work conditions and patient

safety

• Payment models

• Relations between pharmacists and

employers

• Pharmacist and student pharmacist

well-being

• Well-being education and training

• Communications

• Data, information, and research on

pharmacist well-being

It is anticipated that accepted recommendations

will be broadly implemented across the

profession to effect meaningful change. It is

anticipated that additional insights and action

plans will be developed by organizations,

individuals, and other stakeholders to contribute

to improving the well-being and resilience of the

pharmacist workforce.

Recommendations Related to the Improvement of Pharmacist Work Conditions and Patient Safety

• Employers must prioritize patient safety,

quality of care, and pharmacist well-being

when setting workload expectations and

ensure the pharmacy workforce is adequately

staffed, trained, and utilized to complete the

expected work volume.

• Employers, payers, accreditors, and

regulators should assess the relevance,

frequency, and need for required

administrative tasks in order to reduce

burdens that detract from quality patient

care and compromise pharmacists’

well-being.

• Employers should promote professional

autonomy, seek pharmacy team input,

and encourage open communication to

effectively establish and meet patient care

and business objectives (e.g., quotas/metrics/

goals) and achieve shared success.

• Employers should provide pharmacists with

mandatory, scheduled, uninterrupted meal

breaks away from the pharmacy workflow to

promote pharmacist well-being and improve

patient safety.

• Employers and boards of pharmacy

should adopt a Just Culture approach to

management of medication errors that

focuses on system improvement within a

learning culture.

• Employers should implement workflow and

technology solutions that facilitate effective

and efficient provision of patient-centered

care, decrease pharmacist burden, and

alleviate moral distress.

18333-22x8_Sign_.indd 2 6/7/2019 9:48:44 AM

18333-22x8_Sign_.indd 2 6/7/2019 9:48:44 AM


• Employers should support staffing and

scheduling models that allow pharmacists

flexibility to establish and maintain

relationships with their pharmacy team, their

patients, and their local communities.

• The National Association of Boards of

Pharmacy should work with its membership

and stakeholders to craft model language

related to meal breaks and other working

conditions that prioritize the delivery of safe

and effective patient care.

• State boards of pharmacy should evaluate

legislative and regulatory requirements to

streamline and remove unnecessary burden

on pharmacists and their ability to safely

provide patient care.

• Professional associations should work with

boards of pharmacy to disseminate informa-

tion about state statutes and rules related to

well-being, working conditions, and burnout.

• Employers and pharmacist managers should

advocate for expanded roles for pharmacy

technicians and support technician career

advancement to enhance the pharmacist’s

ability to provide patient care.

Recommendations Related to the Improvement of Payment Models

• The pharmacy profession should actively

engage and partner with other health

professional organizations, patient advocacy

groups, regulators, and pharmacy benefit

managers/payers that represent top

market share to (1) drive transparency and

expose PBM/health plan payment models

that create patient safety issues, and (2)

eliminate the erosion in reimbursement that

compromises sustainability of and investment

disincentivizes organizations from investing

in pharmacist-provided patient care services.

• Professional associations should collaborate

with other stakeholders to advocate for

legislative changes in payment models

focused on fair compensation for pharmacist

professional services by medical and

pharmacy payers independent of medication

products, devices, or supplies.

Recommendations Related to the Improvement of Relations Between Pharmacists and Employers

• Employers and pharmacist managers

should create a culture that facilitates open

communication and trust, which empowers

the pharmacy workforce to identify and

actively participate in creating solutions to

address burnout.

• Pharmacists should establish and

communicate mutually agreeable boundaries

with managers, supervisors, patients, and

other health professionals without fear of

retribution.


conduct root cause analyses to understand

pharmacist burnout and moral distress

within their workforce, create viable solutions

to address identified issues, and routinely

conduct follow-up assessments.

• Employers should hold forums to hear the

concerns of frontline pharmacists, implement

solutions, and communicate actions made

toward addressing the identified issues.

• Pharmacists should actively engage in

productive dialogue with employers—without

fear of retribution—to improve awareness

of issues that negatively affect well-being

and resilience and identify and implement

solutions.

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18333-22x8_Sign_.indd 2 6/7/2019 9:48:44 AM


• Employers should train and sensitize non-

pharmacist managers and supervisors

about the professional requirements and

expectations of pharmacists as health care

providers, including strategies to support a

positive and safe work environment.

• Employers, pharmacist managers, and

practicing pharmacists should work to ensure

job fit by being mutually transparent and

authentic about requirements, expectations,

responsibilities, and anticipated challenges

for specific pharmacy positions.

Recommendations Related to the Improvement of Pharmacist and Student Pharmacist Well-being

• Pharmacists should assume their professional

responsibility to proactively identify personal

stressors, learn self-care techniques, and

consistently apply strategies that address

well-being and help prevent burnout.

• Employers and schools and colleges of

pharmacy should establish trauma and

second victim support programs and

resources, including access to respite time to

help pharmacists and student pharmacists

recover and cope with situations (e.g., armed

robberies, suicides, natural disasters, tragic

medication errors, and terroristic threats)

that affect their safety, well-being, and

professional confidence.

• Pharmacist managers should prioritize and

model well-being and resilience for their

workforce.

• State boards of pharmacy should consider

the relationship between pharmacist well-

being and patient safety when promulgating

rules and regulations that govern the practice

of pharmacy.


allow flexibility for pharmacists to engage

in a variety of professional opportunities

and practice responsibilities to reduce

redundancy that leads to burnout.

• Employers should reward and incentivize

employees to engage in well-being activities.

• Pharmacist managers should engage in

ongoing leadership training that includes

communications, team building, staff

development, advocacy, pharmacist burnout,

moral distress, and workism and implement

these skills to effectively lead their workforce.


pharmacy should establish strategic plan

priorities that facilitate the development of a

culture of well-being and resilience.

• The Accreditation Council for Pharmacy

Education should require the inclusion of

annual well-being assessments for students,

faculty, and staff to facilitate regular dialogue,

destigmatize behavioral health, and guide

organizational initiatives within schools and

colleges of pharmacy.

• The Accreditation Council for Pharmacy

Education should integrate concepts related

to well-being and resilience into accreditation

standards and guidance.

• The American Society of Health-System

Pharmacists should revise residency

accreditation standards to include well-being

of residents and preceptors as a critical

factor.

• Professional associations should adopt and

prioritize the findings from the Enhancing Well-being and Resilience Among the Pharmacist Workforce: A National Consensus Conference.

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18333-22x8_Sign_.indd 2 6/7/2019 9:48:44 AM


Recommendations Related to the Improvement of Well-being Education and Training

• Employers, pharmacy associations, and

schools and colleges of pharmacy should

provide education and training on how

to effectively manage angry and abusive

individuals and address situations in which

personal safety may be compromised.

• Employers, pharmacist managers, and

pharmacists should apply a change-

management approach to prepare and

support the pharmacy workforce in

responding and adapting to changes in

pharmacy practice.

• Schools and colleges of pharmacy should

incorporate ongoing education, self-

evaluation, and reflection for student

pharmacists, faculty, staff, preceptors, and

graduate students on topics of well-being,

resilience and behavioral health.

• All faculty, staff, student pharmacists, and

preceptors should complete formal training

that addresses behavioral health awareness

(e.g., Mental Health First Aid and Question.

Persuade. and Refer.).

• The pharmacy profession should leverage

existing programs (e.g., the APhA Institute on

Substance Use Disorders and state pharmacy

recovery networks) in order to address the

consequences of burnout.

• Professional associations should develop

and deliver training, tools, and resources that

teach strategies and skills related to personal

well-being and professional resilience, and

address behavioral health issues.

• Professional associations and schools of

pharmacy should develop and deliver training

that teaches strategies and skill sets to

effectively manage personal financial issues

that affect well-being.

Recommendations Related to the Improvement of Communications

• Professional associations should support

the Pharmacists for Healthier Lives outreach

campaign to enhance public perceptions

of the pharmacist’s role in improving health

outcomes.

• Accreditors should utilize standard

assessment processes and solicit user

feedback to continuously improve the clarity

and value of guidance documents.

• Professional associations should develop a

unified communications approach that is

accessible to all pharmacists and consolidates

relevant information to reduce professional

isolation and communication overload.

• Conference proceedings and

recommendations should be widely

disseminated by pharmacy organizations,

including using the subscriber data from CPE

Monitor® to reach all relevant stakeholders.

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Recommendations Related to the Improvement of Data, Information, and Research on Pharmacist Well-being

• Professional associations and schools and

colleges of pharmacy should conduct

research to establish national standards

related to pharmacy metrics that promote

patient safety and pharmacist well-being.

• Professional associations and state boards

of pharmacy should support dissemination

of profession-wide surveys that assess well-

being and patient safety and advocate for

pharmacists to complete them.

• The American Association of Colleges of

Pharmacy should collect and disseminate

well-being and resilience best practice tools

and approaches being used in schools and

colleges of pharmacy.

• Professional associations should advocate for

research of pharmacist work environments

to evaluate aspects that lead to burnout and

identify best practices, and pursue funding

sources to support these efforts.

Recommendations Related to the Improvement of Pharmacist Professional Development

• Employers should partner with professional

associations and schools and colleges of

pharmacy to provide and encourage access

to mentors, role models, career options,

and relatable stories to help pharmacists

and student pharmacists improve their

competence and confidence throughout their

careers.


pharmacy should provide training and

resources to support pharmacists and

student pharmacists in all settings and

roles to enhance business and people-

management skills.

• Employers should support networking and

engagement opportunities that promote

professional collegiality between pharmacists

and other health care team members.



Agenda Item 12

Request for Approval of Pilot Project

Automated Medication System in Correctional Facility

Mr. Robert Sonnier Institutional Pharmacies of Louisiana

Scott, LA


wIPIJINSTITUTIONAl. II IARMACIES OF LOUISIANA

August 1, 2019

MalcolmJ. BroussardExecutive DirectorLouisiana Board of Pharmacy3388 Brentwood DriveBaton Rouge, Louisiana 70809

Re: Request for Approval of Pilot Project: Use of Automated Medication System (AMS) inA Correctional Setting

Dear Mr. Broussard,

Thank you for obliging my request to be included on the docket for the August 14t[1 Board ofPharmacy meeting. In response to your email, please find the enclosed information whichincludes a copy of the letter I sent to you via e-mail concerning our request and a copy of thePower Point presentation slides that would be used at your direction.

Please feel free to distribute this information to Board members at your discretion. A companyrepresentative from Omnicell®, William C. Maguire, RPh, will accompany us for the meeting. Heis a pharmacist who deals with regulatory affairs for Omnicell® and will be present to answerany technical questions that may arise.

Again, a sincere thanks for allowing us valuable meeting time to make this request. If there isanything you need prior to the August 141h meeting please feel free to contact me at any time.

Yours Very Truly,

Institutional Pharmacies of Louisiana, LLCRobert M. Sonnier, Jr., RPhManaging Partner

RM S/cl

Enclosed: Copy of Request Letter! Copy of Presentation Slides 106 Abigayle’s Row

Scott, LA 70583

Phone: 3372684023

Toll Free: 866.9910211

Fax: 337.2689390

‘VINSTITU11ONAL II IARfIAC lbS OF LOUISIANA

August 1, 2019

VIA E-MAIL: mbroussardpharmacvJa.gov

MalcoImJ. BroussardExecutive DirectorLouisiana Board of Pharmacy3388 Brentwood DriveBaton Rouge, Louisiana 70809

Re: Request for Approval of Pilot Project: Use of Automated Medication System(AMS) in a Correctional Setting

Dear Mr. Broussard,

I am writing on behalf of Institutional Pharmacies of Louisiana, to request approval fromthe board, allowing our pharmacy to utilize an automated medication system in a correctionalfacility. Louisiana pharmacy law currently does not allow the use of such automation in thistype of setting due to the correctional facility not having a license from the Health StandardsSection of the Louisiana Department of Health and Hospitals (LDH). We are asking for approvalof a pilot that would allow for this AMS implementation in order to provide for the unit-doseadministration of medications to inmates in a correctional setting.

The automated system we would like to utilize is manufactured by the Omnicell®company. This type of automation is currently used in many hospital systems across thecountry. The Omnicell® AMS would allow our pharmacy to directly interface, bi-directionally,using patient-specific profile-driven technology and allow real-time, unit dose, medicationadministration.

Request for Approval

Institutional Pharmacies of Louisiana respectfully requests consideration for a pilotprogram to allow the use of an automated medication system, the Omnicell®, in a correctionalfacility. We are explicitly asking for this type of system to only be utilized in a correctionalfacility that provides twenty-four (24) hour, around the clock nursing care. This is an importantspecification. We would not intend for any future rules, laws and regulations to allow this typeof automation in a correctional facility where there is not a registered nurse or other licensedcare giver physically on-site in a twenty-four (24) hour capacity. 106 Abigayie’s Row

Scott, LA 70583

Phone: 337.268.4023

Toll Free: 866.991.0211

Fax: 337.268.9390

Malcolm J. Broussard, Executive DirectorJuly 31, 2019Page 2

We look forward to the Board’s review and consideration of this request, and arehoping for approval at the August meeting to allow implementation before the end of the thirdquarter of 2019.

Description of Proposed Drug Logistics

Institutional Pharmacies of Louisiana will be responsible for the prescription orderprofiling and review of all medications prior to administration as well as medication inventorystored within the AMS. All drug logistics including proper barcoding, delivery and stocking ofmedications into the system will be the responsibility of the pharmacy. The pharmacy willmaintain the physical inventory, establish appropriate par levels and replenish the AMS whenneeded, while maintaining all pharmacy records of medications removed and administeredfrom its inventory.

Description of Work Flow

Each unit-dose medication within the AMS inventory will contain the manufacturer’sNDC barcode, lot and expiration date. Medications will be ordered from registered wholesalers.In some instances, a few items may be unit-dose packaged and bar coded by InstitutionalPharmacies of Louisiana. All unit-dosed medications will be loaded or re-stocked into the AMSby a pharmacist or licensed pharmacy technician using a barcode scanning process (SafetyStock®).

Nursing or facility staff will send all medication orders to pharmacy via phone, secure fax,HL7, orNCPDPSCRIPTstandards. Upon receipt of the physician medication orders, a pharmacistwill review for clinical appropriateness and then input the order into the pharmacy informationsystem. Once the order has been reviewed and Drug Utilization Review completed and keyedinto the pharmacy information system, the real time patient profiling technology will allow theorder to appear in the specific inmate’s profile on the AMS, allowing the nurse to administerone individual’s intended dose at a time.

All medications within the AMS will have a set par level which will be determined by thepharmacy. Automated daily reporting will allow pharmacy to monitor all par levels andgenerate appropriate stock replenishment for the AMS. The AMS will be replenished as often asnecessary to maintain appropriate stock levels. AMS replenishment or restocking of inventorywill be performed using a bar coded safety scanning process.

i06 Abigayles Row • Scott, LA 70583 • Phone; 337.268.4023 • Toll Free; 866.99i.0211 • Fax: 337.237.1634

Malcolm J. Broussard, Executive DirectorJuly 31, 2019Page 3

Description of System Security

The media (hard drive) on Omnicell XT cabinets is encrypted using Microsoft BitLocker

Drive encryption. BitLocker is pre-configured by Omnicell before shipping to a customer facility.

Both Microsoft Windows 10 and Microsoft BitLocker use FIPS 140-2 validatedcryptographic modules, which maintain a very high level of confidentiality and integrity of the

information on XT cabinets. Omnicell encryption renders data unreadable to unauthorized

agents using sophisticated technology. Any data in transit is also rendered unreadable via the

same strong encryption technology.

Omnicell also incorporates biometric fingerprint scanning technology which allows two

fingerprints to be registered for each user and will identify and log all healthcare professionals

accessing the AMS. This technology is FIPS Certified (Federal Information Processing Standards

Publication 201).

Basis for Approval

Automated Medication Systems, such as Omnicell®, have been utilized for medicationadministration in various healthcare facilities across the country for more than twenty years.

These systems render an effective way to administer medications, in a unit dose form, safely

and efficiently and offer an alternative to bulky and costly blister card dispensing commonly

seen in correctional settings. Although the blister card method works well for most Long Term

Care (Nursing Home) settings, we feel it may not always be the best alternative for the

correctional setting. We have found through most of our interviews and site surveys in these

correctional institutions, that inmates receive their medications usually by FedEx® or UPS mail

service that sometimes may take up to twenty-four to forty-eight hours to arrive. This means

that the “turn-around” time for medication delivery may be one to two days, delaying inmates

from starting medications such as antibiotics or antihypertensives. Another common problem

we discovered is the amount of waste that accumulates due to short-stay visits or inmate

transfers that often occur within these correctional facilities. The problem of unutilized or

wasted medications seems to be a priority focus of the Louisiana Parish jails we visited. AMS

technology can be utilized to eliminate the over dispensing of oral medications, decrease waste

of unused tablets and capsules and therefore, decrease the cost associated with such waste.

With overall pharmacy monitoring and management of the AMS in this type of setting,the pilot project will prove the value, safety and efficiency of utilizing this technology.

106 Ahigayles Row • Scott, LA 70583 • Phone: 337.268.4023 • Toll Free: 866.991.0211 • Fax: 337.2371634

Malcolm i. Broussard, Executive DirectorJuly 31, 2019Page 4

Approval of the Pilot is Within the Discretion of the Board of Pharmacy

Current Louisiana pharmacy regulations do not allow for the placement of an Automated

Medication System (AMS) in a correctional setting due to the absence of proper facility

licensure by the Louisiana Department of Health (LDH). We are asking that the Board use its

authority to approve a pilot to allow AMS technology in correctional settings, controlled,

monitored and accessed by licensed pharmacists, pharmacy technicians and licensed nursing

personnel, in a manner that will serve and protect Louisiana inmates.

Duration of Pilot

We request that the pilot, if approved, remain in place until such time that rules can be

promulgated to allow for this technology in this type of setting. We will commit to return to the

Board, as frequently as may be required, to update them on the success, as well as any

challenges, of AMS implementation in the correctional setting.

Conclusion

We plan to be present at the Louisiana Board of Pharmacy’s August 14th meeting to

answer any questions that any of its members may have regarding this request. We thank you

in advance for the opportunity to present this request.

Respectfully with Appreciation,

Robert M. Sonnier, Jr., RPh.Managing PartnerInstitutional Pharmacies of Louisiana, LLC106 Abigayle’s RowScott, LA 70583Ph: 337-268-4023

106 Abigayle’s Row • Scott, LA 70583 • Phone: 337.268.4023 • Toll Free: 866.991.0211 • Fax: 337.237.1634

Malcolm J. Broussard, Executive Director

July 31, 2019Page 5

Contact Information for Implementation Partner

William C. Maguire, RPh / Pharmacy Consultant / Regulatory Affairs

rS s red by Care

Omnicell, Inc.2003 Candy Blvd. North

St. Petersburg, FL 33702

Office: 800-845-0053

Mobile: 404-422-2718wiPIiam,maouire1,omniceJI.comhtb:tlm’w,onmicaII comlmts

106 Abigavle’s Row • Scott, LA 70583 • Phone: 337268.4023 • Toll Free: 866.991.0211 • Fax: 337.237.1633

INSTITUTIONAL PHARMACIES of LOUISIANA SCOTT, LOUISIANA

REQUEST FOR APPROVAL OF PILOT PROJECT: Use of Automated Medication System (AMS) in a

Correctional Setting


August 14, 2019

Agenda

Introduction of Automation (Omnicell®) Restocking and Barcoding Safety Stock® Technology Drawer and Bin Configuration (Locking Lids) Biometric I.D. Reporting

Omnicell XT Series Automated Dispensing Cabinets

One-Cell

Two-Cell Three-Cell

Half-Height Cell Quarter-Height Cell

Restocking with Barcoding Bar code technology is the first layer for security and accuracy. This technology directs the pharmacist or pharmacy technician to the correct location during the restock process. The software also directs the nurse to the correct drug while administering medication to patients.

SafetyStock® software SafetyStock® software provides an additional layer of safety, using bar code scanning

and light-lid technology to ensure that medication items are restocked accurately and that the correct medication is issued from the AMS cabinet.

SafetyStock bar code confirmation includes three primary elements: 1. Labeling and scanning confirmation of the correct drug in the correct bin using light lid technology 2. Labeling and scanning for restock confirmation of the correct drug in the correct bin by using light-lid

technology 3. Labeling and scanning for bin location confirmation for the correct drug by using light-lid technology

Both the drawer and the bin light up to

help guide technician to the proper drug

location

Drawer and Bin Configuration All drawers and bins specified for the AMS in the correctional setting will be “HIGH” security type with individual locking lids. These drawers and bins are made of steel and cannot open unless the correct drug is barcoded and SafetyStock® is used to guide the operator to the correct bin. • IF the user attempts to open another bin, a sensor alarm will sound, and an email immediately

notifies both the DON and PIC.

Biometric I.D. • All healthcare professionals accessing the Omnicell drug cabinet (AMS) will use a fingerprint scanner

(biometrics) to enter the cabinet. • Allows two fingerprints to be registered for each user. • FIPS Certified – NIST (National Institute of Standards and Technology) FIPS 201 (Federal Information

Processing Standards Publication 201)

Extensive Reporting

More than 100 standard reports are available through the Omnicell® OmniCenter®server.

Reporting Categories • Financial • Operational • Pharmacy Examples of Pharmacy Reports • Safety Stock Reports • Waste Transaction Reports • Transaction by User Report • Transaction by Inmate Report • Restock Reports • Item Expiration Tracking Report

Question Time



Agenda Item 15

New Agenda Items Added During Meeting




Announcements




August 14, 2019 Agenda Item 14: Announcements Aug. 15 ULM College of Pharmacy ~ P-1 Orientation Aug. 19 Louisiana Medical Marijuana Project Team Aug. 30 Xavier College of Pharmacy ~ P-1 Orientation Sept. 2 Labor Day – Board office closed Sept. 4-5 NABP Work Group on Development of Interstate Endorsement

Credential – Rosemont, IL Sept. 12-13 MPJE Item Review Conference – Mt. Prospect, IL Sept. 18-19 Violations Committee Informal Conference Sept. 22-26 FIP World Congress – Abu Dhabi, UAE Sept. 26-27 Tri-Regulator Symposium – Frisco, TX Oct. 1-2 NABP Executive Officer Forum – Mt. Prospect, IL Oct. 3 dotPharmacy Executive Board – Mt. Prospect, IL Oct. 6-9 NABP-AACP Districts 6-7-8 Annual Meeting – Boise, ID Oct. 10 Drug Policy Board Oct. 16 La. Pharmacy Congress Prescription Monitoring Program Advisory Council Oct. 21-22 Practitioner Diversion Awareness Conference – New Orleans, LA Oct. 21-24 National Association of State Controlled Substance Authorities (NASCSA) Annual Meeting – Richmond, VA Oct. 26-29 NCPA Annual Meeting – San Diego, CA Oct. 27-30 MALTAGON Conference – Biloxi, MS Nov. 11 Veterans Day – Board office closed Nov. 12 Reinstatement, Impairment, Finance, & Executive Committees Nov. 13 Board Meeting Nov. 14 Administrative Hearing


End of Meeting Binder

Documents

Board Meeting - Louisiana...Louisiana Board of Pharmacy 3388 Brentwood Drive Baton Rouge, Louisiana 70809-1700 Telephone 225.925.6496 ~ E-mail: [email protected] Table of Contents