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State of Iowa
Board of Pharmacy
400 S.W. Eighth Street, Suite E, Des Moines, IA 50309-4688 https://pharmacy.iowa.gov/
Telephone: (515)281-5944 Facsimile: (515)281-4609
BOARD MEMBERS SHARON MEYER BOARD MEMBERS LADONNA GRATIAS Board Chair JASON HANSEL
EDWARD McKENNA BRETT BARKER
GAYLE MAYER ANDREW FUNK JOAN SKOGSTROM Executive Director
M I N U T E S
September 18-19, 2018
The Iowa Board of Pharmacy met on September 18-19, 2018, in the conference room at 400 S.W.
Eighth Street, Des Moines, Iowa.
TUESDAY, SEPTEMBER 18, 2018
MEMBERS PRESENT
Sharon K. Meyer, Chair
Edward J. McKenna, Vice-Chair
Brett Barker
LaDonna Gratias
Jason Hansel
Gayle Mayer
Joan Skogstrom
STAFF PRESENT
Andrew Funk, Executive Director
Laura Steffensmeier, Esq., Assistant Attorney General
Therese Witkowski, Executive Officer
Amanda Woltz, Administrative Assistant
Christie Carlson, Compliance Officer
Curtis Gerhold, Compliance Officer
Mark Mather, Compliance Officer
Sue Mears, Compliance Officer
Jennifer O’Toole, Compliance Officer
Jean Rhodes, Compliance Officer
Daniel Sedlacek, Compliance Officer
James Wolfe, Compliance Officer
Tessa Register, Assistant Attorney General
Rebecca Seabrooke, IMP3 Case Manager
At 9:05 a.m., Sharon Meyer, Chair, called the meeting of the Iowa Board of Pharmacy to order on
Tuesday, September 18, 2018.
Administrative Hearing
2017-146, Christopher Betts, Pharmacist license No. 19918, Urbandale.
September 18-19, 2018
At 9:06 a.m., Laura Lockard, Administrative Law Judge, Department of Inspections and Appeals
opened the record. Assistant Attorney General Laura Steffensmeier represented the State. Mr.
Betts did appear and was not represented by counsel. The session was conducted in the presence
of the Board and was open to the public.
The Board examined exhibits and heard testimony of two witnesses.
At 10:04 a.m., the record was closed.
At 10:05 a.m., on a motion by Brett Barker, second by Edward McKenna, the Board voted
unanimously by roll call vote to move into closed session in accordance with Iowa Code Section
21.5(1)(f) to discuss the decision to be rendered in a contested case conducted according to the
provisions of Iowa Code Chapter 17A.
Laura Steffensmeier, Tessa Register, Rebecca Seabrooke, and Board compliance officers left the
room.
At 10:29 a.m., while still in closed session, Edward McKenna moved that the Board go into open
session, seconded by LaDonna Gratias. Motion approved unanimously.
Motion by Jason Hansel, second by Gayle Mayer, to direct Administrative Law Judge Lockard to
draft the Order consistent with the Board’s deliberation in the case 2017-146, Christopher Betts.
Motion approved unanimously.
At 10:30 a.m., Laura Steffensmeier, Tessa Register, Rebecca Seabrooke, and compliance officers
returned to the meeting.
At 10:40 a.m., Joan Skogstrom left the meeting.
Closed session
At 10:44 a.m., on a motion by Brett Barker, second by Jason Hansel, the Board voted unanimously
by roll call vote to move into closed session pursuant to Iowa Code Section 21.5(1)(a), to review
or discuss records which are required or authorized by state or federal law to be kept confidential;
pursuant to Iowa Code Section 21.5(1)(d), to discuss whether to initiate licensee disciplinary
investigations or proceedings; and pursuant to Iowa Code Section 21.5(1)(f), to discuss the
decision to be rendered in a contested case conducted according to the provisions of Iowa Code
Chapter 17A.
At 2:41 p.m., while still in closed session, Jason Hansel moved that the Board go into open session,
seconded by Edward McKenna. Motion approved unanimously.
In open session, the following actions were taken:
1. Closed Session Minutes
Motion by Edward McKenna, second by Gayle Mayer, to approve the Closed Session
Minutes of the July 24, 2018, meeting. Motion approved unanimously.
2. Close With No Further Action
Motion by Gayle Mayer, second by LaDonna Gratias, to close with no further action the
following investigative file in complaint number: 2018-22. Motion approved (Hansel
abstained).
September 18-19, 2018
Motion by Jason Hansel, second by Edward McKenna, to close with no further action the
following investigative file in complaint number: 2018-75. Motion approved (Barker
abstained).
Motion by Jason Hansel, second by Edward McKenna, to close with no further action the
following investigative files in complaint numbers: 2017-99, 2018-45, 2018-63, 2018-71,
2018-99, 2018-98, and 2018-59. Motion approved unanimously.
3. Administrative Warning
Motion by Edward McKenna, second by LaDonna Gratias, to issue an administrative
warning to the pharmacy support person and pharmacist in charge in 2018-70; to the
pharmacy and pharmacist in charge in 2018-62; to the pharmacy and pharmacist in charge
in 2018-63; and to the pharmacist in 2018-90. Motion approved unanimously.
4. Request for Termination of Probation
Motion by Edward McKenna, second by LaDonna Gratias, to deny the request to terminate
probation and to modify the terms of probation to reduce the frequency of inventory to
quarterly and the frequency of self-inspections to biannually. Motion approved
unanimously.
5. Notice of Hearing and Statement of Charges
Motion by Gayle Mayer, second by Edward McKenna, to approve the Notice of Hearing
and Statement of Charges in the following case. Motion approved unanimously.
A. 2018-82, Sheila Schleeper, Pharmacist License No. 23200, Burlington. A copy of the
Notice of Hearing and Statement of Charges is attached as Addendum A.
6. Settlement Agreement and Final Order
Motion by Jason Hansel, second by Edward McKenna, to approve the Settlement
Agreement and Final Order in the following cases. Motion approved unanimously.
A. 2018-24, Alan Bollinger, CSA Registration No. 1304787, Des Moines. A copy of the
Settlement Agreement and Final Order is attached as Addendum B.
B. 2018-8, David Sinnwell, Pharmacist License No. 15813, Johnston. A copy of the
Settlement Agreement and Final Order is attached as Addendum C.
7. Combined Statement of Charges, Settlement Agreement, and Final Order
Motion by Gayle Mayer, second by Edward McKenna, to approve the Combined Statement
of Charges, Settlement Agreement, and Final Order in the following case. Motion approved
unanimously.
A. 2018-31, Stacy Cook, Pharmacy Technician Registration No. 23514, Carroll. A copy
of the Combined Statement of Charges, Settlement Agreement, and Final Order is
attached as Addendum D.
At 2:49 p.m., motion by Gayle Mayer, second by Jason Hansel, to adjourn. Motion approved
unanimously.
September 18-19, 2018
WEDNESDAY, SEPTEMBER 19, 2018
MEMBERS PRESENT
Sharon K. Meyer, Chair
Edward J. McKenna, Vice-Chair
Brett Barker
LaDonna Gratias
Jason Hansel
Gayle Mayer
Joan Skogstrom
SPEAKERS
Jon Fransen, Hy-Vee
Dennis McAllister, Express Scripts
Laura Manatt, Poweshiek County
Trevor White, Poweshiek County
Pamela Wiltfang, NuCara Pharmacy
Heidi Price-Eastman, Primary Health Care
Casey Ficek, IPA
Brian Wegmann, NuCara Pharmacy
Cheri Schmit, GRx Holdings/Medicap
STAFF PRESENT
Andrew Funk, Executive Director
Laura Steffensmeier, Esq., Assistant Attorney General
Therese Witkowski, Executive Officer
Amanda Woltz, Administrative Assistant
Christie Carlson, Compliance Officer
Curtis Gerhold, Compliance Officer
Mark Mather, Compliance Officer
Sue Mears, Compliance Officer
Jean Rhodes, Compliance Officer
Daniel Sedlacek, Compliance Officer
James Wolfe, Compliance Officer
Rebecca Seabrooke, IMP3 Case Manager
Call to Order and Announcements
At 9:01 a.m. on Wednesday, September 19, 2018, Sharon Meyer, Chair, called the meeting of the
Iowa Board of Pharmacy to order.
Public Comments
There were no comments from the public.
Approval of Open Session Minutes
The open session minutes of the July 24, 2018, Open Session Meeting were reviewed.
Motion by Brett Barker, second by Gayle Mayer, to approve the Open Session Minutes of the July
24, 2018, meeting as presented. Motion approved unanimously.
Requests
1. Request for Internship hours – Mariam Amir Fahmy Wanis, Intern License No. 7169,
Coralville.
Motion by Jason Hansel, second by Brett Barker, to allow Ms. Wanis’s life experience to
satisfy 300 hours of the 1,500 hour internship requirement. Motion passed unanimously.
2. Request for Variance of delivery requirements – Primary Health Care Pharmacy, Pharmacy
license No. 1237, Des Moines.
September 18-19, 2018
Motion by Jason Hansel, second by Gayle Mayer, to table the request and ask the pharmacy
to provide additional information in a future request. Motion passed unanimously.
3. Request to approve Telepharmacy application and possible waiver of distance requirement
– NuCara Pharmacy, Telepharmacy applicant.
Motion by Jason Hansel, second by Joan Skogstrom, to approve the waiver request for
distance from the nearest pharmacy that dispenses prescription drugs to outpatients, subject
to mandatory review by Department of Public Health Director Claybaugh. Motion passed
5-1-1 (Barker abstain, McKenna voted no).
Licensure/Registration Application Review
1. Request for license transfer approval – Timothy Schirm, RPh, Fishershville, VA.
Motion by Brett Barker, second by Jason Hansel, to approve Mr. Schirm’s request for
license transfer to Iowa. Motion passed unanimously.
2. Review of Pharmacist in Charge Registration application – Brandon Wayne Blake, Hicare
Pharmacy, Texas.
Motion by Jason Hansel, second by Edward McKenna, to approve the registration. Motion
passed unanimously.
Reports
1. Executive Director’s Report
A. Appointments
The governor’s office is seeking applicants for the open Board member position for a
Certified Pharmacy Technician. To maintain gender and geographical balance on the
board, the governor is seeking a male technician from western/southwestern or northern
Iowa.
Jason Hansel was appointed to represent NABP District V on the NABP Resolution
Committee.
Andrew Funk was appointed to chair the NABP Task Force to Develop Regulations Based
on Standards of Care, a resolution which passed during this year’s Annual Meeting.
B. Staffing
Rebecca Seabrooke has joined Board staff as IMP3 Case Manager.
Two additional temporary clerk specialists will be hired to assist with fall renewals.
The four health boards are considering seeking a full-time human resources professional
to provide on-site human resources support.
C. Licensing.
September 18-19, 2018
Andrew Funk has developed a mechanism to award one hour of non-ACPE continuing
education credit for pharmacists in attendance at the board meetings which will be reported
to the pharmacist’s CPE monitor.
Since implementation of the new licensing database, 3,742 licenses/registrations have been
renewed online, representing 53% of all renewal transactions.
D. Database project
Online renewals for wholesalers, outsourcing facilities, pharmacies, and pharmacy support
persons will be available November 1, 2018.
Online new applications will be implemented in the spring of 2019.
The project’s scope and budget remains constant, while the full implementation has been
extended at least three months.
E. USP
The comment period for proposed revisions to USP General Chapter 797 is between July
27, 2018 and November 30, 2018. The proposed revisions will be reviewed and draft
comments will be reviewed at the Board’s November meeting.
The official / enforceable date for USP General Chapter 800 is currently set for December
1, 2019. Board rules require compliance with USP Chapters 795 and 797, which by
reference will include USP 800, unless the board seeks changes to rules.
USP has two on-demand webinars available for anyone interested.
The Board will be hosting a live training session on USP 800 on October 2, 2018 to be held
at the Johnston-Grimes Fire Department in Johnston, Iowa. The training will be provided
by The Accreditation Commission for Health Care (ACHC). Registration is full and staff
is assessing the need for a second session in early 2019.
F. Implementation of 2018 legislation
Rules to implement the Board’s bill have been published for Notice and have been
presented to the Administrative Rules Review Committee (ARRC). A public hearing is
scheduled for Tuesday, September 25, 2018 to receive additional public comments relating
to the proposed rules for wholesalers, limited distributors, and third-party logistics
providers. Any comments received through the open comment period and hearing will be
reviewed by the rules committee in October and the board in November.
Chapter 37, “Prescription Monitoring Program,” will be completely revised to include the
applicable provisions of House File 2377. The PMP Advisory Council and the rules
committee will review and finalize proposed amendments for the Board’s consideration at
its November meeting.
The rules committee held extensive discussion on rules relating to Technician Product
Verification (TPV) and statewide protocols to implement SF 2322. The committee wishes
to continue discussion on TPV at its October meeting and intends to have proposed rules
for the Board’s consideration at its November meeting. The committee approved proposed
rules relating to statewide protocols which will be presented to the Board later on this
agenda.
September 18-19, 2018
2. Meetings and Travel
A. IMP3 will meet on Friday, September 21, 2018.
B. FDA will hold its seventh Intergovernmental Working Group on Pharmacy
Compounding in Silver Spring, MD on September 25-26, 2018. Sue Mears, Christie
Carlson, and Dr. Caitlin Pedati (IDPH medical director and state epidemiologist) will
attend.
C. The National Opioid Crisis Management Conference will be held in Washington, DC
on September 27-28, 2018. Andrew Funk will be a presenter.
D. ACHC Compliance Workshop (USP 800) will be held in Johnston on October 2, 2018.
Sharon Meyer, Joan Skogstrom, Gayle Mayer, Brett Barker, and all the compliance staff
plan to attend.
E. The NABP Executive Officer Form will be held in Chicago, IL on October 2-3, 2018.
Andrew Funk will attend.
F. Andrew Funk will give a presentation on the PMP to dentists/social workers/nurses at
Iowa Western Community College in Council Bluffs on October 5, 2018.
G. Critical Point’s Sterile Compounding Inspector Training Certification will be held in
Totowa, New Jersey on October 7-11, 2018. Christie Carslon, Dan Sedlacek, and Jennifer
O’Toole will attend.
H. The NABP Task Force to Develop Regulations Based on Standards of Care will be held
in Chicago, IL on October 9-10, 2018. Andrew Funk will attend.
I. The PMP Advisory Council will meet in Des Moines, Iowa on October 8, 2018.
J. The National Association of State Controlled Substance Authorities (NASCSA) Annual
Conference will be held in Scottsdale, AZ on October 30-November 2, 2018. Sue Mears
will attend.
K. The American Society for Pharmacy Law Annual Meeting will be held in Hilton Head,
South Carolina on November 1-4, 2018. Andrew Funk will attend and present on Iowa’s
drug repository.
L. The Board will next meet on November 13-14, 2018 in Des Moines.
M. NABP Interactive Member Forum will be held in Chicago, IL on November 28-29,
2018. Jason Hansel will attend.
N. ASHP Clinical Midyear meeting will be held in Anaheim, CA on December 2-6, 2018.
Sharon Meyer will attend.
3. Budget Report - Terry Witkowski.
Terry Witkowski reported that FY18 ended September 17, 2018 with the Board carrying
over approximately $1,220,000 to begin FY19. Carryover amounts for IMP3 and PMP are
approximately $32,600 and $95,500, respectively. As these amounts are not sufficient for
these programs, amounts of approximately $60,550 (IMP3) and $140,000 (PMP) will be
transferred to those accounts, leaving the Board with approximately $1,019,000 to carry
over, which is approximately $10,000 more than anticipated, and will be sufficient to
ensure the Board can meet its obligations until receipts come in from renewals.
September 18-19, 2018
4. PMP and MedDrop Update – Andrew Funk.
PMP administrators continue to work with Appriss on its new platform.
IDPH has been awarded grant funds, part of which will be used to develop a web-based
system for reporting naloxone administration by first responders and emergency
departments.
PMP report cards will be initiated in February, 2019.
The PMP Advisory Council will establish threshold criteria to implement proactive
notifications as authorized in HF 2377.
Mandatory registration with the PMP has been implemented with CSA registration, with
the exception of veterinarians.
The PMP Advisory Council has fulfilled all remaining vacancies and will next meet on
October 8, 2018.
Information on the MedDrop program was provided in Board materials.
5. Iowa Monitoring Program for Pharmacy Professionals (IMP3) – Rebecca Seabrooke.
The IMP3 committee will next meet on September 21, 2018. The program has 11
participants (5 pharmacists, 1 intern, and 5 technicians).
6. Legal update – Laura Steffensmeier.
The Board’s administrative denial of a request for a legislative recommendation related to
marijuana is being appealed to district court for judicial review. AAG Steffensmeier has
filed an order to dismiss.
7. IPA Medication Disposal Report – Quarter 2 – Casey Ficek
Information provided for the Board’s review.
8. Hy-Vee Iowa Error Report – Quarter 1 and 2 – Jon Fransen
Information provided for the Board’s review.
9. FDA Statement – New steps to help ensure the quality of and preserve access to
compounded drugs.
Informational item.
10. Board meeting calendar
Proposed meeting dates for 2019 were provided to the Board. As two Board members have
terms which end April 30, 2019, the meeting scheduled for April 30 – May 1, 2019 may
need to be rescheduled.
Rules and Legislation
1. 2019 Legislative Agenda.
September 18-19, 2018
The Board discussed potential legislative initiatives for consideration during the 2019
legislative session. Proposed draft language will be reviewed by the rules committee and
brought back to the Board at its November meeting.
2. Proposed for Adoption and Filing Amendments to Chapter 15, “Correctional Pharmacy
Practice.”
Motion by Brett Barker, second by Edward McKenna, to adopt. Motion approved
unanimously. A copy is attached as Addendum E.
4. Proposed for Notice of Intended Action to amend Chapter 4, “Pharmacist-Interns.”
Motion by Brett Barker, second by Jason Hansel, to file for Notice of Intended Action.
Motion approved unanimously. A copy is attached as Addendum F.
5. Proposed for Notice of Intended Action to Amend Chapter 8, “Universal Practice
Standards,” and Chapter 13, “Telepharmacy Practice.”
Motion by Jason Hansel, second by Brett Barker, to file for Notice of Intended Action.
Motion approved unanimously. A copy is attached as Addendum G.
6. Proposed for Notice of Intended Action to Amend Chapter 39, “Expanded Practice
Standards.”
Motion by Brett Barker, second by Gayle Mayer, to file for Notice of Intended Action.
Motion approved unanimously. A copy is attached as Addendum H.
The Board recessed at 11:43 a.m. for lunch.
The Board reconvened at 12:49 p.m. in Open Session.
Closed Session
At 12:49 p.m., on a motion by Jason Hansel, second by Brett Barker, the Board voted unanimously
by roll call vote to move into closed session pursuant to Iowa Code Section 21.5(1)(d), to discuss
whether to initiate licensee disciplinary investigations or proceedings.
At 1:40 p.m., while still in closed session, Brett Barker moved that the Board go into open session,
seconded by Gayle Mayer. Motion approved unanimously.
In open session, the following actions were taken:
1. Close with No Further Action
Motion by Brett Barker, second by Gayle Mayer, to close with no further action the following
investigative file in complaint number: 2018-42. Motion approved unanimously.
September 18-19, 2018
The Board adjourned at 1:42 p.m. on September 19, 2018.
_______
Sue Mears
Recording Secretary
Andrew Funk Sharon K. Meyer
Executive Director Board Chair
APPROVED THIS 14th DAY OF NOVEMBER, 2018
ADDENDUM A
NOTICE OF HEARING AND STATEMENT OF CHARGES
SHEILA SCHLEEPER
PHARMACIST LICENSE NO. 23200
BURLINGTON, IOWA
Page 1 of 3
BEFORE THE IOWA BOARD OF PHARMACY
RE: Pharmacist License of SHEILA SCHLEEPER License No. 23200 Respondent
CASE NO. 2018-82 NOTICE OF HEARING AND STATEMENT OF CHARGES
COMES NOW the Iowa Board of Pharmacy (“Board”) and files this Notice of Hearing and Statement of Charges against Sheila Schleeper (“Respondent”), 1704 Parkway Dr, Burlington IA 52601, pursuant to Iowa Code sections 17A.12(2), 17A.18(3), and 272C.3(1)"e", and 657 IAC 35.6 and 35.7. Respondent’s Iowa pharmacist license number 23200 is currently active through June 30, 2019.
A. TIME, PLACE, AND NATURE OF HEARING
Hearing. A disciplinary contested case hearing shall be held on November 13, 2018, before the Board. The hearing shall begin at 1:00 p.m. and shall be located in the Board conference room located at the Iowa Board of Pharmacy Office, 400 SW 8th St, Ste E, Des Moines IA 50309.
Answer. Within twenty (20) days of the date you are served this Notice of Hearing and Statement of Charges, you may file an Answer pursuant to 657 IAC 35.16. The Answer should specifically admit, deny, or otherwise answer all allegations contained in sections C and D of this Notice of Hearing and Statement of Charges.
Filing of Pleadings. Pleadings shall be filed with the Board either by e-mail, if done in compliance with 657 IAC 35.17(2), to [email protected], or by mail/delivery to the following address: Iowa Board of Pharmacy, 400 SW 8th St, Ste E, Des Moines IA 50309.
Presiding Officer. The Board shall serve as presiding officer, but the Board may request an Administrative Law Judge from the Department of Inspections and Appeals make initial rulings on prehearing matters, and be present to assist and advise the Board at hearing.
Hearing Procedures. The procedural rules governing the conduct of the contested case hearing, including prehearing matters, are found at 657 IAC chapter 35. At the hearing, you may appear personally or be represented by counsel at your own expense. You will be allowed the opportunity to respond to the charges against you, to produce evidence on your behalf on issues of material fact, cross-examine witnesses present at the hearing, and examine and respond to any documents introduced at the hearing. The hearing may be open to the public or closed to the public at your discretion, pursuant to Iowa Code section 272C.6(1) and 657 IAC 35.25(10).
Page 2 of 3
Prosecution. The Office of Attorney General of Iowa is responsible for representing the public interest (the State) in this proceeding. Counsel for the State in this matter is Assistant Attorney General Laura Steffensmeier. Ms. Steffensmeier can be reached by phone at (515) 281-6690. Copies of pleadings should be provided to counsel for the State either by email to [email protected], or by mail/delivery to the following address:
Laura Steffensmeier Assistant Attorney General Hoover State Office Building—2nd Floor 1305 E Walnut St Des Moines IA 50319
Communications. You may not contact individual Board members in any manner, including by phone, letter, or e-mail, regarding this Notice of Hearing and Statement of Charges. Board members may only receive information about the case when all parties have notice and the opportunity to participate, such as at the hearing or in pleadings you file and serve upon all parties in the case.
B. LEGAL AUTHORITY AND JURISDICTION
Jurisdiction. The Board has jurisdiction in this matter pursuant to Iowa Code chapters 17A, 147, 155A, and 272C (2018).
Legal Authority. If any of the allegations against you are founded, the Board has authority to take disciplinary action against you under Iowa Code chapters 147, 155A, and 272C, and 657 IAC chapter 36.
Default. If you fail to appear at the hearing, the Board may enter a default decision or proceed with the hearing and render a decision in your absence, in accordance with Iowa Code section 17A.12(3) and 657 IAC 35.27.
C. STATEMENT OF CHARGES
COUNT I OUT-OF-STATE DISCIPLINE
Respondent is charged with having a license revoked or suspended or having other disciplinary action taken by a licensing authority of this state or of another state, territory, or country for conduct substantially equivalent to any of the grounds for disciplinary action in Iowa, pursuant to Iowa Code sections 147.55(9) and 155A.12(1) and 657 IAC 36.6(31).
D. FACTUAL CIRCUMSTANCES
On June 27, 2018, the Illinois Department of Financial and Professional Regulation approved a Consent Order that placed Respondent’s Illinois pharmacist license on indefinite probation for filling fraudulent prescriptions for self-use.
Page 3 of 3
E. SETTLEMENT
This matter may be resolved by settlement agreement. The procedural rules governing the Board’s settlement process are found at 657 IAC 35.24. To cancel a scheduled hearing, an executed settlement agreement must be received by the Board at least three (3) business days prior to the scheduled hearing. If you are interested in pursuing settlement in this matter, please contact the Assistant Attorney General identified above.
F. FINDING OF PROBABLE CAUSE
On this 18th day of September, 2018, the Iowa Board of Pharmacy found probable cause to file this Notice of Hearing and Statement of Charges.
_____________________________________
Chairperson Iowa Board of Pharmacy
Copy to: Laura Steffensmeier Assistant Attorney General Hoover State Office Building—2nd Floor 1305 E Walnut St Des Moines IA 50319 ATTORNEY FOR THE STATE
PLEASE NOTE: If you require the assistance of auxiliary aids or services to participate in this matter because of a disability, immediately call 515-281-5944. (If you are hearing impaired, call Relay Iowa TTY at 1-800-735-2942).
ADDENDUM B
SETTLEMENT AGREEMENT AND FINAL ORDER
ALAN BOLLINGER
CSA REGISTRATION NO. 1304787
DES MOINES, IOWA
ADDENDUM C
SETTLEMENT AGREEMENT AND FINAL ORDER
DAVID SINNWELL
PHARMACIST LICENSE NO. 15813
JOHNSTON, IOWA
ADDENDUM D
COMBINED STATEMENT OF CHARGES, SETTLEMENT
AGREEMENT, AND FINAL ORDER
STACY COOK
TECHNICIAN REGISTRATION NO. 23514
CARROLL, IOWA
ADDENDUM E
ADOPTION AND FILING
AMENDING CHAPTER 15, “CORRECTIONAL
PHARMACY PRACTICE”
SEPTEMBER 19, 2018
ARC 3848CPHARMACY BOARD[657]
Notice of Intended Action
Proposing rule making related to review of correctional pharmacy practice rules andproviding an opportunity for public comment
The Board of Pharmacy hereby proposes to amend Chapter 15, “Correctional Pharmacy Practice,”Iowa Administrative Code.
Legal Authority for Rule Making
This rule making is proposed under the authority provided in Iowa Code sections 124.301 and 147.76.
State or Federal Law Implemented
This rule making implements, in whole or in part, Iowa Code sections 124.303, 124.306, 124.308,126.10, 126.11, 155A.6A, 155A.6B, 155A.10, 155A.13, 155A.27, 155A.28, 155A.31 to 155A.36 and155A.41.
Purpose and Summary
Pursuant to Iowa Code section 17.7(2), the Board has completed a review of this chapter ofadministrative rules. The proposed amendments update the required references to be maintained in areference library in order to be consistent with recent Board action for other practice settings, removethe requirement that the policies and procedures identify the hours of operation of the pharmacy, clarifythe record retention requirements for training documentation, and add the option of an electronicsignature on prescription drug orders.
Fiscal Impact
This rule making has no fiscal impact to the State of Iowa.
Jobs Impact
After analysis and review of this rule making, no impact on jobs has been found.
Waivers
Any person who believes that the application of the discretionary provisions of this rule making wouldresult in hardship or injustice to that person may petition the Board for a waiver of the discretionaryprovisions, if any, pursuant to 657—Chapter 34.
Public Comment
Any interested person may submit written comments concerning this proposed rule making. Writtencomments in response to this rule making must be received by the Board no later than 4:30 p.m. on July10, 2018. Comments should be directed to:
Sue MearsBoard of Pharmacy400 S.W. 8th Street, Suite EDes Moines, Iowa 50309Email: [email protected]
1
Public Hearing
No public hearing is scheduled at this time. As provided in Iowa Code section 17A.4(1)“b,” an oralpresentation regarding this rule making may be demanded by 25 interested persons, a governmentalsubdivision, the Administrative Rules Review Committee, an agency, or an association having 25 ormore members.
Review by Administrative Rules Review Committee
The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rulemaking by executive branch agencies, may, on its own motion or on written request by any individual orgroup, review this rule making at its regular monthly meeting or at a special meeting. The Committee’smeetings are open to the public, and interested persons may be heard as provided in Iowa Code section17A.8(6).
The following rule-making actions are proposed:ITEM 1. Amend rule 657—15.4(155A) as follows:
657—15.4(155A) Reference library. References may be printed or computer-accessed. Eachcorrectional pharmacy shall have on site, at a minimum, one current maintain a reference from each ofthe following categories, including access to current periodic updates library, which is either printed orcomputer-accessed and which adequately meets the needs of the services provided and patients served.Examples of references include:
1. A reference including all pertinent Iowa laws, rules, and regulations that impact the pharmacy’spractice.
2. A patient information reference that includes or provides patient information in compliancewith rule 657—6.14(155A).
3. A reference on drug interactions.4. A general drug information reference.5. A drug equivalency reference.6. A reference on natural or herbal medicines.7. The readily accessible telephone number of a poison control center that serves the area.8. Additional references as may be necessary for the pharmacist to adequately meet the needs of
the patients served relating to specific patient populations served.ITEM 2. Amend subrule 15.5(3) as follows:15.5(3) Pharmacist responsibility. Each pharmacist, while on duty, shall be responsible for the
security of the correctional pharmacy. This responsibility includes provisions for effective controlagainst theft of, diversion of, or unauthorized access to prescription drugs or devices, controlledsubstances, records for such drugs and devices, and patient records as provided in 657—Chapter 21and rule 657—8.16(124,155A). Policies and procedures shall identify the days and hours the pharmacyshall be open. A pharmacist shall be on site during all times that the pharmacy is open.
ITEM 3. Amend rule 657—15.7(124,126,155A) as follows:
657—15.7(124,126,155A) Training and utilization of pharmacy technicians or pharmacy supportpersons. Pharmacy technician and pharmacy support person training shall be documented andmaintained by the pharmacy for the duration of at least two years from the last date of employment.Policies and procedures and documentation of pharmacy technician and pharmacy support persontraining shall be available for inspection by the board or an agent of the board.
ITEM 4. Amend subrule 15.8(1) as follows:15.8(1) Required information. Prescription drug orders written in patient health records shall include
the following information:a. Patient name, identification number, and correctional facility location;
2
b. Drug name, strength, dosage form, and quantity or duration;c. Directions for use of the drug;d. Date the prescription drug order is authorized;e. Prescriber’s name, signature or electronic signature, and office address;f. Prescriber’s DEA number for controlled substances.
3
ADDENDUM F
NOTICE OF INTENDED ACTION
AMENDING CHAPTER 4, “PHARMACIST-INTERNS”
SEPTEMBER 19, 2018
1
PHARMACY BOARD [657]
Notice of Intended Action
The Board of Pharmacy hereby proposes to amend Chapter 4, “Pharmacist-Interns,” Iowa
Administrative Code.
Legal Authority for Rule Making
This rule making is proposed under the authority provided in Iowa Code sections 147.76
and 155A.6.
State or Federal Law Implemented
This rule making implements, in whole or in part, Iowa Code section 155A.6.
Purpose and Summary
This proposed amendment removes the limitation of a pharmacist to supervise no more
than two pharmacist-interns concurrently.
Fiscal Impact
This rule making has no fiscal impact to the state of Iowa.
Jobs Impact
After analysis and review of this rule making, no impact on jobs has been found.
Waivers
Any person who believes that the application of the discretionary provisions of this rule
making would result in hardship or injustice to that person may petition the Board for a waiver of
the discretionary provisions, if any, pursuant to 657—Chapter 34.
Public Comment
2
Any interested person may submit comments concerning this proposed rule making.
Written comments in response to this rule making must be received by the Board no later than
4:30 p.m. on ________, 2018. Comments should be directed to:
Sue Mears
Iowa Board of Pharmacy
400 S.W. 8th Street, Suite E
Des Moines, Iowa 50309
E-mail: [email protected]
Public Hearing
No public hearing is scheduled at this time. As provided in Iowa Code section
17A.4(1)“b,” an oral presentation regarding this rule making may be demanded by 25 interested
persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or
an association having 25 or more members.
Review by Administrative Rules Review Committee
The Administrative Rules Review Committee, a bipartisan legislative committee which
oversees rule making by executive branch agencies, may, on its own motion or on written request
by any individual or group, review this rule making at its regular monthly meeting or at a special
meeting. The Committee’s meetings are open to the public, and interested persons may be heard
as provided in Iowa Code section 17A.8(6).
The following rule-making action is proposed:
Amend rule 657—4.9(155A) as follows:
657—4.9 (155A) Preceptor requirements.
4.9(1) to 4.9(2) No change.
3
4.9(3) Number of interns. A preceptor may supervise no more than two pharmacist-
interns concurrently.
4.9(4) Responsibility. A preceptor shall be responsible for all functions performed by a
pharmacist-intern.
ADDENDUM G
NOTICE OF INTENDED ACTION
AMENDING CHAPTER 8, “UNIVERSAL PRACTICE
STANDARDS,” AND CHAPTER 13, “TELEPHARMACY
PRACTICE”
SEPTEMBER 19, 2018
1
PHARMACY BOARD [657]
Notice of Intended Action
The Board of Pharmacy hereby proposes to amend Chapter 8, “Universal Practice
Standards,” and Chapter 13, “Telepharmacy Practice,” Iowa Administrative Code.
Legal Authority for Rule Making
This rule making is proposed under the authority provided in Iowa Code sections 147.76,
147.80, and 155A.13.
State or Federal Law Implemented
This rule making implements, in whole or in part, Iowa Code sections 147.80, 155A.13,
and 155A.26.
Purpose and Summary
These proposed amendments provide more clear language relating to the distance
requirement between a proposed telepharmacy site and a currently licensed pharmacy that
provides prescription drugs to outpatients, consistent with language found in Iowa Code, which
pharmacy may be another licensed telepharmacy; require a pharmacy which intends to change
license type to submit an application and may be subject to an inspection by a board compliance
officer prior to issuance of the new license; implement a late penalty fee for late submission of
license change application; and authorize the board to collect a fee for a written verification of a
pharmacy license.
Fiscal Impact
This rule making is not anticipated to have a fiscal impact to the state of Iowa.
Jobs Impact
After analysis and review of this rule making, no impact on jobs has been found.
2
Waivers
Any person who believes that the application of the discretionary provisions of this rule
making would result in hardship or injustice to that person may petition the Board for a waiver of
the discretionary provisions, if any, pursuant to 657—Chapter 34.
Public Comment
Any interested person may submit comments concerning this proposed rule making.
Written comments in response to this rule making must be received by the Board no later than
4:30 p.m. on ________, 2018. Comments should be directed to:
Sue Mears
Iowa Board of Pharmacy
400 S.W. 8th Street, Suite E
Des Moines, Iowa 50309
E-mail: [email protected]
Public Hearing
No public hearing is scheduled at this time. As provided in Iowa Code section
17A.4(1)“b,” an oral presentation regarding this rule making may be demanded by 25 interested
persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or
an association having 25 or more members.
Review by Administrative Rules Review Committee
The Administrative Rules Review Committee, a bipartisan legislative committee which
oversees rule making by executive branch agencies, may, on its own motion or on written request
by any individual or group, review this rule making at its regular monthly meeting or at a special
3
meeting. The Committee’s meetings are open to the public, and interested persons may be heard
as provided in Iowa Code section 17A.8(6).
The following rule-making action is proposed:
ITEM 1. Amend subrule 8.35(4) as follows:
8.35(4) Inspection of new pharmacy location.
a. A new pharmacy location in Iowa shall require an on-site inspection by an authorized
agent of the board. Application for a pharmacy license and other required registrations shall be
submitted to the board at least 14 days prior to the anticipated inspection. Any deficiencies
identified during the inspection shall be corrected and verified by an authorized agent of the
board prior to the issuance of the pharmacy license. Prescription drugs, including controlled
substances, may not be delivered to a new pharmacy location prior to the delivery of the
pharmacy license and registration certificates.
b. A pharmacy location in Iowa which is applying for a different license type than
previously held may be subject to an inspection prior to the issuance of the new license.
ITEM 2. Amend subrule 8.35(6) as follows:
8.35(6) Pharmacy license changes. When a pharmacy changes its name, location,
ownership, or pharmacist in charge, or license type, a completed pharmacy license application
with a nonrefundable $135 fee shall be submitted to the board pursuant to subrule 8.35(2). Upon
receipt of the completed application and fee, the board shall issue an updated pharmacy license
certificate, pending any necessary inspection pursuant to subrule 8.35(4), paragraph “b”, unless
the board identifies any ground for denial of the license. Any restrictions or disciplinary history
associated with the previous pharmacy shall remain unchanged. A pharmacy wishing to
disassociate itself from the previously licensed pharmacy restrictions or disciplinary history may
4
petition the board for such disassociation. The burden is on the pharmacy to demonstrate that the
current pharmacy is not associated with or responsible for the pharmacy as it previously existed.
The old license certificate shall be returned to the board within ten days of receiving the updated
license certificate.
a. through d. No change.
e. License type. A change in pharmacy license type shall require submission of a
pharmacy license application and appropriate fee prior to the change. A pharmacy changing
licensure type shall notify the pharmacist in charge and patients of the change in accordance with
subrule 8.35(7).
f. License change application submission. Applications for license changes shall be
timely submitted pursuant to this subrule. A licensed pharmacy that has timely submitted a
license change application and fee may continue to service Iowa patients while the license
change is pending final approval. An applicant that has submitted an application for license
changes after the required date of submission pursuant to this subrule but within 30 days of the
required date of submission shall be assessed a nonrefundable late penalty fee of $135 in
addition to the license fee. An applicant that has submitted an application for license changes 31
days or later following the required date of submission pursuant to this subrule shall be assessed
a nonrefundable late penalty fee of $540.
ITEM 3. Adopt the following new subrule 8.35(9):
8.35(9) License verification fee. The board may require a nonrefundable fee of $15 to
complete a request for written license verification of any pharmacy license.
ITEM 4. Amend rule 657—13.16(124,155A) as follows:
657—13.16(124,155A) Telepharmacy site—initial application.
5
13.16(1) License application. A telepharmacy site shall complete and submit to the board
a limited use/telepharmacy license application and nonrefundable fee as provided in rule 657—
8.35(155A). In addition to the application and fee, the telepharmacy site shall include the
additional information identified in this rule.
13.16(2) CSA registration application. If controlled substances will be dispensed from
the telepharmacy site, the telepharmacy site shall complete and submit, with the limited
use/telepharmacy license application and fee, the CSA registration application and
nonrefundable fee as provided in rule 657—10.1(124) 657—10.5(124).
13.16(3) No change.
13.16(4) Distance to nearest general pharmacy that dispenses prescription drugs to
outpatients. The telepharmacy site application shall identify the nearest licensed pharmacy that
dispenses prescription drugs to outpatients and shall provide evidence identifying the total
driving distance between the proposed telepharmacy site and the nearest currently licensed
general pharmacy that dispenses prescription drugs to outpatients.
a. If the distance between the proposed telepharmacy site and the nearest currently
licensed general pharmacy that dispenses prescription drugs to outpatients is less than ten miles,
the telepharmacy site shall submit a request for waiver of the distance requirement. The process
and requirements for a request for waiver are identified in subrule 13.16(8).
b. No change.
13.16(5) through 13.16(7) No change.
13.16(8) Request for distance waiver. The board shall consider a request for waiver of the
distance requirement between the proposed telepharmacy site and the nearest currently licensed
pharmacy that dispenses prescription drugs to outpatients if the petitioner can demonstrate to the
6
board that the proposed telepharmacy site is located in an area where there is limited access to
pharmacy services and that there exist compelling circumstances that justify waiving the distance
requirement.
a. No change.
b. In addition to the requirements of 657—Chapter 34, the request for waiver shall
include evidence and specific information regarding each of the following, if applicable. If an
item identified below does not apply to the proposed telepharmacy site, the request for waiver
shall specifically state that the item does not apply.
(1) to (2) No change.
(3) That access to the nearest currently licensed general pharmacy that dispenses
prescription drugs to outpatients is limited. A description of how the proposed telepharmacy site
will improve patient access to pharmacy services shall be included.
(4) to (7) No change.
c. The board shall consider a request for waiver of the distance requirement during any
open session of a meeting of the board. One or more representatives of the parties to the waiver
request, including representatives of the proposed telepharmacy site, the managing pharmacy,
and the nearest currently licensed general pharmacy that dispenses prescription drugs to
outpatients, shall be invited and encouraged to attend the meeting at which the waiver request is
scheduled for consideration to be available to respond to any questions.
d. No change.
ADDENDUM H
NOTICE OF INTENDED ACTION
AMENDING CHAPTER 39, “EXPANDED PRACTICE
STANDARDS”
SEPTEMBER 19, 2018
1
PHARMACY BOARD [657]
Notice of Intended Action
The Board of Pharmacy hereby proposes to amend Chapter 39, “Expanded Practice
Standards,” Iowa Administrative Code.
Legal Authority for Rule Making
This rule making is proposed under the authority provided in Iowa Code 147.76 and 2018
Iowa Acts, Senate File 2322.
State or Federal Law Implemented
This rule making implements, in whole or in part, Iowa Code 155A.44 and 2018 Iowa
Acts, Senate File 2322.
Purpose and Summary
These proposed amendments establish that a pharmacist may participate in a statewide
protocol developed by the board in consultation with the department of public health; establish
the minimum requirements for participation in statewide protocols, including required
pharmacist training and education and required notification to the patient’s primary care provider
of the product dispensed pursuant to the statewide protocol; require the required continuing
education be approved by the Accreditation Council for Pharmacy Education (ACPE) with the
specific topic designator of “06” for pharmacists; and identify a repeal date for vaccine
administration by pharmacists via a physician-signed protocol in compliance with Senate File
2322, section 8.
Fiscal Impact
This rule making has no fiscal impact to the state of Iowa.
Jobs Impact
2
After analysis and review of this rule making, no impact on jobs has been found.
Waivers
Any person who believes that the application of the discretionary provisions of this rule
making would result in hardship or injustice to that person may petition the Board for a waiver of
the discretionary provisions, if any, pursuant to 657—Chapter 34.
Public Comment
Any interested person may submit comments concerning this proposed rule making.
Written comments in response to this rule making must be received by the Board no later than
4:30 p.m. on ________, 2018. Comments should be directed to:
Sue Mears
Board of Pharmacy
400 S.W. 8th Street, Suite E
Des Moines, Iowa 50309
E-mail: [email protected]
Public Hearing
No public hearing is scheduled at this time. As provided in Iowa Code section
17A.4(1)“b,” an oral presentation regarding this rule making may be demanded by 25 interested
persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or
an association having 25 or more members.
Review by Administrative Rules Review Committee
The Administrative Rules Review Committee, a bipartisan legislative committee which
oversees rule making by executive branch agencies, may, on its own motion or on written request
by any individual or group, review this rule making at its regular monthly meeting or at a special
3
meeting. The Committee’s meetings are open to the public, and interested persons may be heard
as provided in Iowa Code section 17A.8(6).
The following rule-making action is proposed:
ITEM 1. Adopt the following new rule 657—39.6(155A):
657—39.6(155A) Statewide protocols. A pharmacist may, pursuant to statewide protocols
developed by the board in consultation with the department of public health and available on the
board’s website at pharmacy.iowa.gov, prescribe and dispense medications pursuant to rule
657—39.8(155A), rule 657—39.9(155A), and rule 657—39.11(155A).
This rule is intended to implement 2018 Iowa Acts, Senate File 2322.
ITEM 2. Adopt the following new rule 657—39.8(155A):
657—39.8(155A) Statewide protocol – naloxone. An authorized pharmacist may prescribe and
dispense naloxone to patients eighteen years and older pursuant to a statewide protocol
developed pursuant to rule 657—39.6(155A) and in compliance with this rule. An authorized
pharmacist may only delegate the dispensing of naloxone to an authorized pharmacist-intern
under the direct supervision of an authorized pharmacist.
39.8(1) Definitions. For the purposes of this rule, the following definitions shall apply:
“ACPE” means the Accreditation Council for Pharmacy Education.
“Authorized pharmacist” means an Iowa-licensed pharmacist who has completed the
training requirements of this rule. “Authorized pharmacist” also includes an Iowa-registered
pharmacist-intern who has completed the training requirements of this rule and is working under
the direct supervision of an authorized pharmacist.
“Authorized pharmacist-intern” means an Iowa-registered pharmacist-intern who has
completed the training requirements for an authorized pharmacist pursuant to this rule.
4
“Board” means the Iowa board of pharmacy.
“Patient” means an individual consulting with a pharmacist for drug therapy and may
include an individual in a position to assist someone at risk of an opioid-related overdose.
39.8(2) Authorized pharmacist training. An authorized pharmacist shall document
successful completion of an ACPE-approved continuing education program of at least one-hour
duration related to naloxone utilization prior to dispensing naloxone pursuant to the statewide
protocol.
39.8(3) Assessment. An authorized pharmacist shall assess a patient for eligibility to
receive naloxone using criteria identified in the statewide protocol.
39.8(4) Patient education. Upon assessment and determination that a patient is eligible to
receive and possess naloxone pursuant to the statewide protocol, an authorized pharmacist shall,
prior to dispensing naloxone pursuant to the statewide protocol, provide training and education to
the patient including, but not limited to, the information identified in this subrule. An authorized
pharmacist may provide to the patient written materials that include, but may not be limited to,
the information identified in this subrule, but the written materials shall not be in lieu of direct
pharmacist consultation with the patient.
a. The signs and symptoms of opioid-related overdose as described in the statewide
protocol.
b. The importance of calling 911 as soon as possible and the potential need for rescue
breathing.
c. The appropriate use and directions for administration of the naloxone to be dispensed
pursuant to the statewide protocol.
5
d. Adverse reactions of naloxone as well as reactions resulting from opioid withdrawal
following administration.
e. The proper storage conditions, including temperature excursions, of the naloxone
product being dispensed.
f. The expiration date of the naloxone product being dispensed and the appropriate
disposal of the naloxone product upon expiration.
g. Information about substance abuse or behavioral health treatment programs, if
applicable.
39.8(5) Labeling. Naloxone dispensed pursuant to this rule shall be labeled in accordance
with rule 657—6.10(126,155A) and the labeling shall not render the expiration date of the
product illegible.
39.8(6) Reporting. As soon as reasonably possible, the authorized pharmacist shall notify
the patient’s primary health care provider of the naloxone product provided to the patient. If the
patient does not have a primary health care provider, the authorized pharmacist shall provide the
patient with a written record of the naloxone product provided to the patient and shall advise the
patient to consult a physician.
39.8(7) Records. An authorized pharmacist shall maintain records of naloxone prescribed
and dispensed pursuant to the statewide protocol.
This rule is intended to implement 2018 Iowa Acts, Senate File 2322.
ITEM 3. Adopt the following new rule 657—39.9(155A):
657—39.9(155A) Statewide protocol – nicotine replacement tobacco cessation products. An
authorized pharmacist may prescribe and dispense nicotine replacement tobacco cessation
products to patients eighteen years and older pursuant to a statewide protocol developed pursuant
6
to rule 657—39.6(155A) and in compliance with this rule. An authorized pharmacist may only
delegate the dispensing of a nicotine replacement tobacco cessation product to an authorized
pharmacist-intern under the direct supervision of an authorized pharmacist.
39.9(1) Definitions. For the purposes of this rule, the following definitions shall apply:
“ACPE” means the Accreditation Council for Pharmacy Education.
“Authorized pharmacist” means an Iowa-licensed pharmacist who has completed the
training requirements of this rule. “Authorized pharmacist” also includes an Iowa-registered
pharmacist-intern who has completed the training requirements of this rule and is working under
the direct supervision of an authorized pharmacist.
“Authorized pharmacist-intern” means an Iowa-registered pharmacist-intern who has
completed the training requirements for an authorized pharmacist pursuant to this rule.
“Board” means the Iowa board of pharmacy.
39.9(2) Authorized pharmacist training. An authorized pharmacist shall document
successful completion of an ACPE-approved continuing education program of at least one-hour
duration related to nicotine replacement tobacco cessation product utilization prior to dispensing
such products under the statewide protocol.
39.9(3) Assessment. An authorized pharmacist shall assess a patient for appropriateness
of receiving a nicotine replacement tobacco cessation product pursuant to the statewide protocol.
39.9(4) Patient counseling and instructions. Upon assessment and determination that
provision of the nicotine replacement tobacco cessation product is appropriate pursuant to the
statewide protocol, an authorized pharmacist shall, prior to dispensing such product, provide
counseling and instructions to the patient pursuant to rule 657—6.14(155A).
7
39.9(5) Labeling. Nicotine replacement tobacco cessation products dispensed pursuant to
this rule shall be labeled in accordance with rule 657—6.10(126,155A) and the labeling shall not
render the expiration date of the product illegible.
39.9(6) Reporting. As soon as reasonably possible, the authorized pharmacist shall notify
the patient’s primary health care provider of the nicotine replacement tobacco cessation product
provided to the patient. If the patient does not have a primary health care provider, the authorized
pharmacist shall provide the patient with a written record of the nicotine replacement tobacco
cessation product provided to the patient and shall advise the patient to consult a physician.
39.9(7) Records. An authorized pharmacist shall maintain records of nicotine
replacement tobacco cessation products prescribed and dispensed pursuant to the statewide
protocol.
This rule is intended to implement 2018 Iowa Acts, Senate File 2322.
ITEM 4. Amend rule 657—39.10(155A) as follows:
657—39.10(155A) Vaccine administration by pharmacists – physician approved protocol.
An Through June 30, 2019, an authorized pharmacist may administer vaccines pursuant to
protocols established by the CDC in compliance with the requirements of this rule. An
authorized pharmacist may only delegate the administration of a vaccine to an authorized
pharmacist-intern under the direct supervision of the authorized pharmacist.
39.10(1) No change.
39.10(2) Authorized pharmacist training and continuing education. An authorized
pharmacist shall document successful completion of the requirements in paragraph 39.10(2)“a”
and shall maintain competency by completing and maintaining documentation of the continuing
education requirements in paragraph 39.10(2)“b.”
8
a. No change.
b. Continuing education. During any pharmacist license renewal period, an authorized
pharmacist who engages in the administration of vaccines shall complete and document at least
one hour of ACPE-approved continuing education related to vaccines with the ACPE topic
designator “06” followed by the letter “P”.
c. No change.
39.10(3) through 39.10(6) No change.
39.10(7) Verification and reporting. The requirements of this subrule do not apply to
influenza and other emergency vaccines administered via protocol pursuant to subrule 39.10(4).
An authorized pharmacist shall:
a. No change.
b. Within 30 days As soon as reasonably possible following administration of a
vaccine identified in subrule 39.10(5) or 39.10(6), report the vaccine administration to the
statewide immunization registry or health information network and to the patient’s primary
health care provider, if known.
ITEM 5. Adopt the following new rule 657—39.11(155A):
657—39.11(155A) Vaccine administration by pharmacists – statewide protocol. An
authorized pharmacist may prescribe and administer vaccines and immunizations pursuant to a
statewide protocol developed pursuant to rule 657—39.6(155A) and in compliance with this rule.
An authorized pharmacist may only delegate the prescribing and administration of a vaccine to
an authorized pharmacist-intern under the direct supervision of an authorized pharmacist.
39.11(1) Definitions. For the purposes of this rule, the following definitions shall apply:
“ACIP” means the CDC Advisory Committee on Immunization Practices.
9
“ACPE” means the Accreditation Council for Pharmacy Education.
“Authorized pharmacist” means an Iowa-licensed pharmacist who has met the
requirements identified in subrule 39.11(3).
“Authorized pharmacist-intern” means an Iowa-registered pharmacist-intern who has met
the requirements for an authorized pharmacist identified in subrule 39.11(3).
“Board” means the Iowa board of pharmacy.
“CDC” means the United States Centers for Disease Control and Prevention.
“Immunization” shall have the same meaning as, and shall be interchangeable with, the
term “vaccine.”
“Vaccine” means a specially prepared antigen administered to a person for the purpose of
providing immunity.
39.11(2) Vaccines authorized by statewide protocol. The vaccines authorized to be
prescribed and administered pursuant to the statewide protocol shall include:
a. To patients ages eighteen years and older:
(1) An immunization or vaccination recommended by ACIP in its approved vaccination
schedule for adults.
(2) An immunization or vaccination recommended by CDC for international travel.
(3) A Tdap (tetanus, diphtheria, acellular pertussis) vaccination in a booster application.
(4) Other emergency immunizations or vaccinations in response to a public health
emergency.
b. To patients ages six months and older:
(1) A vaccine or immunization for influenza.
10
(2) Other emergency immunizations or vaccines in response to a public health
emergency.
c. To patients ages eleven years and older:
(1) The final two doses in a course of vaccinations for HPV.
39.11(3) Authorized pharmacist training and continuing education. An authorized
pharmacist shall document successful completion of the requirements in paragraph 39.11(3)”a”
and shall maintain competency by completing and maintaining documentation of the continuing
education requirements in paragraph 39.11(3)”b.”
a. Initial qualification. An authorized pharmacist shall have successfully completed an
organized course of study in a college or school of pharmacy or an ACPE-accredited continuing
education program on vaccine administration that:
(1) Requires documentation by the pharmacist of current certification in the American
Heart Association or the Red Cross Basic Cardiac Life Support Protocol for health care
providers.
(2) Is an evidence-based course that includes study material and hands-on training and
techniques for administering vaccines, requires testing with a passing score, complies with
current CDC guidelines, and provides instruction and experiential training in the following
content areas:
1. Standards for immunization practices;
2. Basic immunology and vaccine protection;
3. Vaccine-preventable diseases;
4. Recommended immunization schedules;
5. Vaccine storage and management;
11
6. Informed consent;
7. Physiology and techniques for vaccine administration;
8. Pre- and post-vaccine assessment, counseling, and identification of contraindications to
the vaccine;
9. Immunization record management; and
10. Management of adverse events, including identification, appropriate response,
documentation, and reporting.
b. Continuing education. During any pharmacist license renewal period, an authorized
pharmacist who engages in the administration of vaccines shall complete and document at least
one hour of ACPE-approved continuing education with the ACPE topic designator “06”
followed by the letter “P.”
c. Certification maintained. During any period within which the pharmacist may engage
in the administration of vaccines, the pharmacist shall maintain current certification in the
American Heart Association or the Red Cross Basic Cardiac Life Support Protocol for health
care providers.
39.11(4) Assessment. An authorized pharmacist shall assess a patient for appropriateness
of receiving a vaccine pursuant to the statewide protocol.
39.11(5) Verification and reporting. Prior to the prescribing and administration of an
immunization pursuant to the statewide protocol, the authorized pharmacist shall consult and
review the statewide immunization registry or health information network. As soon as
reasonably possible following administration of a vaccine, the pharmacist shall report such
administration to the patient’s primary health care provider, primary physician, and a statewide
immunization registry or health information network. If the patient does not have a primary
12
health care provider, the pharmacist shall provide the patient with a written record of the vaccine
administered to the patient and shall advise the patient to consult a physician.
This rule is intended to implement 2018 Iowa Acts, Senate File 2322.