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newsletter National Association of Boards of Pharmacy ® aid to government the profession the public 1904 to 2005 In This Issue. . . . Legal Briefs: March 2005 / Volume 34 Number 3 Legendary Coast Guard Captain Larry Brudnicki, to Deliver 101 st Annual Meeting Keynote Address (continued on page 50) 51 52 54 58 No Runs, One Hit, One Error This Month on www.nabp.net: Special Items Download NABP’s 101 st Annual Meeting Registration Form Download NABP’s Updated National Specified List of Susceptible Products Template for Enforcement Guidelines Regarding the Administrative Prosecution of Entities Importing Prescription Drugs into the United States Headlines NABP Releases Criteria for National Specified List of Susceptible Products, Adds One Drug to List Examinations 2005 NAPLEX/MPJE Registration Bulletin Upcoming Meetings Saturday-Tuesday, May 21-24, 2005 NABP’s 101 st Annual Meeting Sheraton New Orleans Hotel New Orleans, LA Sunday-Tuesday, August 7-9, 2005 NABP/AACP District III Meeting Marriott Hotel Knoxville, TN Thursday-Saturday, August 11-13, 2005 NABP/AACP District V Meeting Minneapolis, MN Thursday-Saturday September 29-October 1, 2005 NABP/AACP District I Meeting Storrs, CT NABP Sets Record High for Licensure Transfer Requests in 2004 Association News: Feature News: 101 st Annual Meeting: CMS Releases Final Regulations for MTM The Centers for Medicare & Medicaid Services (CMS) released final regulations for the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) on January 21, 2005. While the recently released regulations include a discussion of e-prescribing, CMS decided that specific standards would be issued through a separate rule making. These detailed regulations were released on January 28, 2005, and have the usual 60-day comment period with final rules scheduled for release in October 2005. NABP strongly encourages the state boards of pharmacy to review the rules and respond to CMS with their comments by the April 5, 2005 deadline. CMS Releases Proposed Regulations for E-Prescribing, Addresses State Preemption State Preemption Of notable interest to the state boards of pharmacy is the section of the proposed rules regarding federal preemption of state regulations. Under the MMA, federal rules will supercede state law or any regulation that (A) is contrary to the standards or restricts the ability to carry out this part; and (B) pertains to the electronic transmission of medication history and of information on eligibility, benefits, and prescription with respect to covered [P]art D drugs under this part. In its proposed regulations, CMS interprets this section of the MMA “. . . as preempting State law provisions that conflict with Federal electronic prescription program drug requirements that are adopted under Part D.” The agency further states that “for a State law or regulation to be preempted under this express preemption provision, the State law or regulation would have to meet the requirements of both paragraphs (A) and (B). Furthermore, there would have to be a Federal standard adopted through [rule making] that creates a conflict for a State law

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Page 1: March 05 Newsletter - NABP · 2016. 3. 7. · March 2005 / Volume 34 Number 3 Legendary Coast Guard Captain Larry Brudnicki, ... on January 21, 2005. While the recently released regulations

newsletterNational Association of Boards of Pharmacy®

aid to governmentthe profession

the public1904 to 2005

In This Issue. . . .Legal Briefs:

M a r c h 2 0 0 5 / Vo l u m e 3 4 N u m b e r 3

Legendary Coast Guard Captain Larry Brudnicki, to Deliver 101st Annual Meeting Keynote Address

(continued on page 50)

51 52 54 58

No Runs, One Hit, One Error

This Month on www.nabp.net:Special ItemsDownload NABP’s 101st Annual Meeting Registration Form

Download NABP’s Updated National Specifi ed List of Susceptible Products

Template for Enforcement Guidelines Regarding the Administrative Prosecution of Entities Importing Prescription Drugs into the United States

HeadlinesNABP Releases Criteria for National Specifi ed List of Susceptible Products, Adds One Drug to List

Examinations2005 NAPLEX/MPJE Registration Bulletin

Upcoming MeetingsSaturday-Tuesday, May 21-24, 2005NABP’s 101st Annual MeetingSheraton New Orleans HotelNew Orleans, LA

Sunday-Tuesday, August 7-9, 2005NABP/AACP District III MeetingMarriott HotelKnoxville, TN

Thursday-Saturday, August 11-13, 2005NABP/AACP District V MeetingMinneapolis, MN

Thursday-SaturdaySeptember 29-October 1, 2005NABP/AACP District I MeetingStorrs, CT

NABP Sets Record High for Licensure Transfer Requests in 2004

Association News:

Feature News: 101st Annual Meeting: CMS Releases

Final Regulationsfor MTM

The Centers for Medicare & Medicaid Services (CMS) released fi nal regulations for the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) on January 21, 2005. While the recently released regulations include a discussion of e-prescribing, CMS decided that specifi c standards would be issued through a separate rule making. These detailed regulations were released on January 28, 2005, and have the usual 60-day comment period with fi nal rules scheduled for release in October 2005. NABP strongly encourages the state boards of pharmacy to review the rules and respond to CMS with their comments by the April 5, 2005 deadline.

CMS Releases Proposed Regulations for E-Prescribing, Addresses State Preemption

State PreemptionOf notable interest to the

state boards of pharmacy is the section of the proposed rules regarding federal preemption of state regulations. Under the MMA, federal rules will supercede state law or any regulation that

(A) is contrary to the standards or restricts the ability to carry out this part; and

(B) pertains to the electronic transmission of medication history and of information on eligibility, benefi ts, and prescription with respect to covered

[P]art D drugs under this part.

In its proposed regulations, CMS interprets this section of the MMA “. . . as preempting State law provisions that confl ict with Federal electronic prescription program drug requirements that are adopted under Part D.”The agency further states that “for a State law or regulation to be preempted under this express preemption provision, the State law or regulation would have to meet the requirements of both paragraphs (A) and (B). Furthermore, there would have to be a Federal standard adopted through [rule making] that creates a confl ict for a State law

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nabp newsletter

50

The NABP Newsletter (ISSN 8756-4483) is published ten times a year by the National

Association of Boards of Pharmacy (NABP) to educate, to inform, and to communicate the objectives and programs of the Association and its 66 member boards of pharmacy to the profession and the public. The opinions and views expressed in

this publication do not necessarily refl ect the offi cial views, opinions, or policies of NABP or any board

unless expressly so stated. The subscription rate is $35 per year.

National Association of Boards of Pharmacy

1600 Feehanville Drive Mount Prospect, IL 60056

847/391-4406www.nabp.net

[email protected] A. Catizone

Executive Director/SecretaryReneeta C. “Rene” Renganathan

Editorial Manager

© 2005 National Association of Boards of Pharmacy. All rights reserved. No part

of this publication may be reproduced in any manner without the written

permission of the executive director/secretary of the National Association of

Boards of Pharmacy.

Executive CommitteeDonna S. Wall Chairperson, District IV

Donna M. HornPresident, District I

Dennis K. McAllisterPresident-elect, District VIII

Lawrence H. MokhiberTreasurer, District II

Charles Curtis BarrMember, District V

Michael A. MonéMember, District III

Richard A. PalomboMember, District II

Oren M. Peacock, JrMember, District VI

Gary A. SchnabelMember, District VII

Charles R. Young

Member, District I

Feature News

(continued from page 49)

(continued on page 57)

E-Prescribing

to be preempted.” The interpretation of preemption in the e-prescribing provision of the MMA is consistent with the United States Department of Health and Human Services’ (HHS) general position of deferring to state laws regulating the practice of pharmacy and the practice of medicine.

Some industry representatives believe that Congress intended a broad application of the preemption provision; for example, these groups interpret that the statute intended to preempt the entire fi eld of e-prescribing through this provision in the MMA. This would require an interpretation that the word “and” between paragraphs (A) and (B) means “or” in this context. If the word “or” were in the statute, as some believe is implied, then the preemption would enable the standards adopted for the Federal electronic prescription drug program to preempt all state laws and regulations that restrict the HHS secretary’s ability to carry out the goals of an e-prescribing program including those outside of Part D covered drugs and individuals. This is not CMS’s interpretation. Furthermore, these industry representatives contend that some states have existing barriers in their statutes or regulations

that could impede the success of e-prescribing. As an example, they refer to laws and regulations that were drafted with only paper prescriptions in mind, but that may not be conducive to e-prescribing applications.

NABP is recognized in the proposed rule for its involvement with the National Committee on Vital and Health Statistics (NCVHS) during this process. NABP’s leadership representing the state boards of pharmacy regarding electronic prescribing was highlighted in the text of the regulation, which reads:

We have consulted with the National Association of Boards of Pharmacy directly and through participation in NCVHS hearings, and we believe that the approach we suggest as to the scope of preemption discussed earlier in the preamble [provides] both States and other affected entities the best possible means of addressing preemption issues. We will consult further with the States before issuing the fi nal rule.

CMS noted that, in particular, it would like to receive comments with respect to state statutes and regulations that should

be preempted, but that would not be under CMS’s proposed interpretation of the scope of preemption. In addition, the agency would like comments on whether or not the preemption provision “applies only to transactions and entities that are part of an electronic prescription drug program under Part D or to a broader set of transactions and entities.” Finally, CMS is seeking comment on “whether this preemption provision applies only to electronic prescription transactions or to paper transactions as well.”

E-PrescribingAlthough detailed

guidelines regarding e-prescribing are still in the public comment phase, the fi nal regulations released on January 21 do state a timeline for fi nalizing e-prescribing rules as set forth in the MMA: Initial standards may be adopted no later than September 1, 2005, and fi nal standards must be published no later than April 1, 2008. The statute also states that the effective dates of these regulations must be no later than one year after the date of the promulgation of fi nal standards.

The areas regarding e-prescribing discussed in these latest proposed rules include (along with preemption), but are not limited to, the current prescribing environment, standards design criteria,

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Legal Briefs

No Runs, One Hit, One ErrorBy Dale J. Atkinson

Attorney Dale J. Atkinson is a partner in the law fi rm of Atkinson & Atkinson, counsel for NABP.

The pharmacist admitted that he was responsible for the error, but did not submit a personal plan for corrective action as requested on a Notice of Investigation issued by the Board. The pharmacy manager and the pharmacy director, however, did advise the Board of steps being taken to avoid a repetition of the mistake.

At the hearing, the dean of the College of Pharmacy at Washington State University, testifying as an expert on behalf of the pharmacist, indicated that the average error rate among pharmacists occurred in approximately 2% of prescriptions fi lled, while the error rate of

Aprescription was submitted by an elderly nursing home resident

to a local pharmacy for Lanoxin® to help slow his heart rate. He received medication labeled Lanoxin, but the vial actually contained levothyroxine, a thyroid medication. As a result, the patient missed 24 doses of Lanoxin until the mistake was discovered by a Florida pharmacist while the patient was on vacation. A complaint was fi led by the Washington State Board of Pharmacy charging the pharmacist who was responsible for fi nal verifi cation of prescriptions dispensed by the local pharmacy with unprofessional conduct.

the pharmacist charged (including an error that occurred in 1998 involving the fi lling of a Lanoxin prescription with levothyroxine) was below average. He opined that the Board should assess the riskiness of the practice, not the actual harm that occurs, in determining appropriate disciplinary action. The pharmacist, testifying on his own behalf, stated that he should not be disciplined for a single error when all pharmacists make mistakes from time to time. The Board introduced no expert testimony.

The Board placed the pharmacist’s license in probationary status for 24

months, allowing him to seek reinstatement in 12 months, provided he met the following:

(i) 20 hours of community service focusing on educating consumers about medication error prevention;

(ii) 10 hours of continuing education credits encompassing ethics; and

(iii) the submission of a plan of correction to prevent recurring medication errors.

The pharmacist appealed to the trial court, which affi rmed the Board’s ruling. He then appealed this matter to the Court of Appeals of Washington.

The pharmacist claimed he was being subjected to discipline partly because he did not fi le a corrective plan as required by the Board’s Notice of Investigation, emphasizing there was no notation in the complaint regarding such plan. The appeals court found that the Board has a duty to regulate the profession of pharmacy and that failure to respond to the request for a corrective plan in the Notice of Investigation could be taken into consideration by the Board

(continued on page 52)

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Association News

in determining discipline, though not included in the complaint fi led by the Board. It concurred that the pharmacist’s failure to submit such a plan demonstrated his apparent failure to appreciate the potential harm his error might have caused.

The pharmacist further argued that the Board improperly substituted its expertise for his expert’s testimony and, in doing so, established a standard of “zero” tolerance for errors. The court upheld the Board’s

right to assess professional conduct based on the harm that could occur as opposed to the argument of the pharmacist and his expert that discipline, if any, should be based upon an error percentage rate. The court confi rmed the right of the Board to rely on the specialized practice knowledge of Board members as experts in establishing standards of practice.

The court found that the Board had met its burden of proof through “. . . clear, cogent and convincing evidence . . .” discounting the fact that the pharmacist’s error rate fell below the average error rate of

pharmacists generally. Both the Board and the court were deeply concerned with the unreasonable risk of harm to the patient created by this error.

Finally, the court upheld the disciplinary action of the Board including the requirements in regard to community service, continuing education, and the submission of a plan of correction. It held that unless a disciplinary action ordered by a Board is arbitrary and capricious, it will be upheld.

This case is quite interesting, particularly when considering the contingencies placed in the disciplinary order imposed

NABP’s Electronic Licensure Transfer Program® reported a record 7,292 licensure transfer requests for 2004. This number easily surpasses last year’s record amount at 881 more requests than the 6,411 requests reported for 2003.

For the third consecutive year, Florida led the states with the most pharmacists requesting licensure transfer into that state. NABP processed 514 licensure transfer requests for Florida, while Arizona

NABP Sets Record High for Licensure Transfer Requests in 2004

had the second most “in” requests with 448. The state receiving the third most license transfer requests was New York, at 332.

“The large increase in licensure transfer requests was caused by the merger of some of the larger chain pharmacies and more states requiring nonresident licensure for pharmacists who work for pharmacies that ship medications into these states,” notes NABP President Donna M. Horn.

“This increase also stems from the high demand for pharmacists and increased recruiting efforts to eliminate the shortage of pharmacists in some areas.”

In 2004, several more states began licensing nonresident pharmacists as a prerequisite to practice pharmacy in their states. This is likely due to the expansion of mail-order and Internet pharmacies in the United States and states wishing to ensure that

out-of-state pharmacists who will be shipping medications into the state are familiar and compliant with the state’s pharmacy practice regulations. In addition, licensing nonresident pharmacists enables states to directly address violations of the state’s practice act and regulations.

The map and chart on page 53 provide an overview of the 2004 licensure transfer request totals.

Legal Briefs(continued from page 51)

upon the pharmacist. It refl ects the continuing quest of boards of pharmacy to take action to educate pharmacists in avoiding recurring errors and to cause the institution of corrective procedures where errors in dispensing have occurred. It is also in full accord with the campaign of NABP to foster greater patient safety through the elimination of dispensing errors.

Dutton v Washington State Board of Pharmacy, 2004 WL 2861777 (Wash AppDiv2)

Opinion is unpublished and was issued on December 14, 2004.

(continued on next page)

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Feature News

CMS Releases Final Regulations for MTM

Coverage for MTM programs under Medicare is a historic event for the practice of pharmacy and the profession took seriously the opportunity to comment on CMS’s proposed regulations, which will go into effect January 1,2006. In its regulations, CMS noted some of the comments that it received and followed these with the agency’s responses. This article provides an overview of the regulations as well as CMS’s response to the pharmacy profession’s comments about the guidelines.

CMS’s fi nal regulations call for “. . . Part D sponsors to establish an MTMP . . . that is designed to optimize therapeutic outcomes for targeted benefi ciaries by improving medication use and reducing adverse drug events, including adverse drug interactions that may be furnished by

The Centers for Medicare & Medicaid Services’ (CMS) fi nal regulations for

the new prescription drug benefi t and improved access to health care services mandated by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) included guidelines for Medication Therapy Management Programs (MTMP). The regulations, which were released on January 21, 2005, were developed after a 60-day public comment period that ended on October 4, 2004.

a pharmacist, and that may distinguish between services in ambulatory and institutional settings.” MTMPs may include elements designed to promote:

� Enhanced enrollee understanding through benefi ciary education counseling and other means that promote the appropriate use of medications and reduce the risk of potentially adverse events associated with the use of medications.

� Increased enrollee adherence to prescription medication regimens; for example, through medication refi ll reminders, special packaging, compliance programs, and other appropriate means.

� Detection of adverse drug events and patterns of overuse and under-use of prescription drugs.

The fi nal regulations leave open the defi nition of MTM programs and allow programs to potentially span a range of services, from simple to complex. CMS notes that MTM programs “. . . could include, but may not be limited to, performing patient health status assessments, formulating prescription drug treatment plans, managing high cost specialty medications, evaluating and monitoring patient response to drug therapy, providing education and training, coordinating medication therapy with other care management services, and participating in State-permitted collaborative drug therapy management.” According to CMS, the fi nal regulations do not provide a defi nitive specifi cation of MTM program services and service-level requirements because, until the recent consensus defi nition of MTM put forth by 11 pharmacy organizations, there has been no widely agreed-upon defi nition of MTM programs or standards and measures for such programs. As a result, CMS is adopting the fl exibility set forth in the proposed rule. CMS also clarifi ed that MTM programs are voluntary for benefi ciaries; therefore, access to prescription drugs must not be

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responded that “unless there is a confl ict with Federal law, [CMS] will defer to State [pharmacy practice] laws and regulations.” The agency further noted that it does not believe that current MTM program requirements confl ict with state laws; therefore, MTM programs should be developed in compliance with state laws and regulations.

A noteworthy aspect of the fi nal MTM regulations is the requirement of Part D sponsors to develop MTM programs in cooperation with United States licensed and practicing pharmacists and physicians. CMS states that no further rules for licensure are necessary beyond that of compliance with state licensure requirements for pharmacy practice.

The MMA describes targeted individuals for MTMPs as those who:

1) have multiple chronic diseases (such as diabetes, asthma, hypertension, hyperlipidemia, and congestive heart failure);

2) are taking multiple covered Part D drugs; and

3) are identifi ed as likely to incur annual costs for covered Part D drugs that exceed a level specifi ed by the secretary [of the US

Feature News

denied due to benefi ciary nonparticipation.

During the comment period for the proposed regulations some in the pharmacy profession recommended that CMS not increase the level of specifi city present in the proposed rule because plans need fl exibility to develop and implement MTM programs that can best meet the needs of their specifi c patient populations in order to achieve the best outcomes. In response to these comments, CMS stated,

Although best practice examples identifi ed some common elements, neither the Booz Allen Hamilton [a global strategy and technology consulting fi rm] report, nor any comments submitted to us, showed that these MTMPs refl ected widely accepted standards of practice. . . .

We continue to believe that MTMPs can and must offer appropriate services for targeted benefi ciaries. However, we are concerned that further premature regulatory requirements at this time might not only fail to improve MTMPs, but could negatively impact their development. Requiring a universal

set of minimum services and service levels, without fully understanding how

they could effectively be implemented on a much larger platform than illustrated in best practice examples, could result in MTMPs becoming perfunctory services offered just to satisfy regulatory requirements as opposed to patient focused services aimed at improving therapeutic outcomes.

Testimony provided by NABP included the Association’s concern for possible confl icts between MTMPs under the MMA and state defi nitions of the practice of pharmacy and the scope of services that pharmacists are legally able to provide patients. CMS

Testimony provided by NABP included the Association’s concern for possible confl icts between MTMPs under the MMA and state defi nitions of the practice of pharmacy and the scope of services that pharmacists are legally able to provide patients.

(continued on page 57)

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Association News

NABP has expanded its National Clearinghouse of Licensure, Certifi cation, and Accreditation information and is now collecting disciplinary information from the states for actions involving the licensure or registration of wholesale distributors. The database for wholesale distributors has been implemented as a component of the Association’s new Verifi ed-Accredited Wholesale Distributors™ (VAWD™) program, which was developed to assist the state boards of pharmacy and the wholesale distribution industry protect the public from the threat of counterfeit drugs affecting the United States’ drug supply.

In December 2004, state boards began submitting to the NABP Clearinghouse records of disciplinary actions regarding wholesale distributors. The NABP Clearinghouse has operated for more than 20 years. Before the expansion, NABP tracked disciplinary actions of pharmacists and pharmacy technicians. Now, the Association is also collecting information concerning wholesale distributor entities as well as designated representatives and other responsible persons at wholesale distributor entities in accordance with the provisions of the NABP Model Rules for the Licensure of Wholesale

NABP Collecting Data for VAWD Clearinghouse

Distributors, which is part of the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy.

“The Clearinghouse is maintained for the benefi t of the state boards of pharmacy and was expanded to provide states with a central clearinghouse of information,” says NABP President Donna M. Horn. “By expanding the database, NABP will be able to ensure that the Association utilizes the most pertinent information regarding wholesale distributor entities and their owners and employees when determining eligibility for VAWD accreditation. The expanded NABP Clearinghouse will also streamline the licensure application and inspection process for wholesale distributors. Through the VAWD program, information collected by NABP can be provided to all states without the expense and resource commitment of applying and providing required information to 50 different states.”

Data that NABP is gathering from the boards and other agencies that regulate wholesale distributors include:

� Name of the wholesale distributor and designated representative, responsible person, or owner;

� Address;� License number(s);� Federal employer

identifi cation number and social security number (if applicable);

� Date of birth; and� Disciplinary action

taken, date of action, and the basis for action.

NABP began developing VAWD after Food and Drug Administration (FDA) requested that NABP update its Model Rules for the Licensure of Wholesale Distributors. Members of NABP’s resulting Task Force on Counterfeit Drugs and Wholesale Distributors, which met in October 2003, revised the Model Rules and proposed the creation of an accreditation program and clearinghouse for wholesale distributors – a plan that was immediately supported by FDA – to further combat counterfeit drugs. Applicants for VAWD accreditation undergo a criteria compliance review, licensure verifi cation, an inspection, and screening through NABP’s Clearinghouse.

For more information about VAWD or to learn more about submitting disciplinary information to NABP’s Clearinghouse, contact the Association’s Customer Service Department at 847/391-4406, or via e-mail at [email protected].

Around the Association

New Board Members

Dominic DeRose, RPh, was appointed a member of the Utah Board of Pharmacy by Governor Olene Walker. He replaces E. Ray Beasley and his term expires June 30, 2008.

Sudhir C. Manek, RPh, was appointed to the Illinois State Board of Pharmacy by Governor Rod R. Blagojevich. He replaces Michael Glen, and his term expires April 1, 2009.

Board Reappointments

Gary Sobocinski, RPh, and Elaina Wolzak, RPh, were reappointed to the Missouri Board of Pharmacy by Governor Matt Blunt. Sobocinski’s new term expires on January 29, 2009, and Wolzak’s term expires on April 6, 2009.

Roger Kaczmarek, RPh, was reappointed to the Nebraska Board of Pharmacy by the Nebraska Board of Health. His term expires November 30, 2009.

Mark Watt, RPh, was reappointed to the Oregon State Board of

(continued on page 60)

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accept e-mailed or faxed applications; completed applications must be mailed

to NABP Headquarters at 1600 Feehanville Drive, Mount Prospect, IL 60056.

For additional information on the redesigned electronic application, please contact NABP’s Customer Service Department at 847/391-4406 or [email protected].

Association News

Beginning in early March 2005, a redesigned NABP Electronic Licensure Transfer Program® application will be available for download at www.nabp.net in the Licensure Transfer/Licensure Transfer Application section for convenient access.

NABP updated the application to better assist the state boards of pharmacy – the revised application now collects more comprehensive disciplinary information concerning candidates, enabling the boards to gain a better understanding of an applicant’s licensure history. In addition, boards will no longer be provided printed applications nor be required to mail the applications to

Electronic Version of ELTP Application Introducedcandidates; instead boards may direct candidates to NABP’s Web site, where the application can be downloaded by applicants.

The “Record of Charges, Convictions, and Fines Imposed” section, where the applicants formerly duplicated in their own writing a statement that they had not been convicted, fi ned, disciplined, or had their license revoked, is renamed “Professional History.” This section now consists of six questions addressing such issues as the candidate’s criminal record, license status, and whether or not he or she has participated in a rehabilitation program. Instead of rewriting the

statement as previously required, the electronic application includes “yes” and “no” check boxes for each question that the applicants must complete, thus simplifying the application process.

The revised electronic application, available in both Microsoft Word and Adobe PDF formats, allows applicants to download the fi le to their computer, enter their information directly into the application, and print the application for submission to NABP. Please note that NABP will not

(continued from page 50)E-Prescribing

the role of the National Committee on Vital and Health Statistics, the electronic prescription drug program, and the like. The standards under consideration and development are technical standards that have to do with the actual transmission of the prescription and relevant information such as medication history, drug interactions, medical history, formulary information, etc, in an interoperable environment.

Boards of pharmacy that wish to remark on CMS’s proposed e-prescribing regulations may submit comments electronically at www.cms.hhs.gov/regulations/ecomments; or via mail to: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-0011-P, Baltimore, MD 21244-8014. The proposed regulations are available on the CMS Web site at www.cms.hhs.gov/medicarereform/01-27master.pdf.

Department of Health and Human Services – HHS].

The final regulations do not further define multiple chronic diseases and multiple drug requirements as CMS believes final determinations must be left to the plan operators. The agency will monitor the programs to determine whether or not further guidance is necessary.

Another issue noted by stakeholders was the cost threshold for MTM programs. CMS determined that thresholds will be established in a sub-regulatory guidance for determining targeted benefi ciaries. This is a change from the proposed rule, which call for the plans to determine cost thresholds.

For more information on the MMA and CMS’s fi nal regulations, visit the HHS Web site at www.hhs.gov.

MTM(continued from page 55)

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Being a hero once is no easy feat, and being a hero day after day over a 30-year span takes dedication, judgment, and teamwork. Best known for his two dramatic rescues during the “Perfect Storm” off the coast of New England in October 1991, United States Coast Guard Captain Larry Brudnicki’s skills for assessing risks, making quick decisions, and inspiring teamwork saves lives. As keynote speaker for NABP’s 101st Annual Meeting, May 21-24, 2005, at the Sheraton New Orleans Hotel in New Orleans, LA, Brudnicki will share his ideas on setting goals, being prepared, understanding risks, and working in teams in today’s challenging business environment.

Throughout his career, Captain Brudnicki has seen the importance of leadership, teamwork, and risk management strategies. During his speech, on Sunday, May 22, at 1:15 pm he will give Annual Meeting attendees new ideas and tactics on being an effective leader, succeeding in situations you cannot control, and making diffi cult decisions with confi dence. In addition, he will share his approach on how to take action when you do not like your options, inspire teamwork, and manage risk. One of Captain Brudnicki’s fi rst assignments after graduating

from the US Coast Guard Academy, with a bachelor’s degree in engineering was as commanding offi cer of the

US Coast Guard Cutter (USCGC) Cape Current (1973-1975), Savannah, GA. During this time he was one of the pioneers that helped the Coast Guard begin a long and proud history in counter drug operations.

Later, Captain Brudnicki attended Wesleyan University, where he earned a master’s degree in physical science to prepare for an assignment as a physics instructor at the US Coast Guard Academy in New London, CT. In his spare time, he earned a master’s degree in physics from the University of Connecticut, Storrs, CT.

In October 1991, Captain Brudnicki was the commanding offi cer of the USCGC Tamaroa, New Castle, NH, and it was at this time he encountered the “Perfect Storm.” Three separate storm systems collided off the coast of New England, creating an “eye” that spanned 1,500 miles, and moved in retrograde motion from east to west. Captain Brudnicki and his team braved

101st Annual Meeting

Captain Brudnicki Career Highlights� Led the team of project engineers that converted

almost 90% of all aids to navigation to solar power and was recognized by the US Department of Energy for being the only federal agency that was successful in that type of endeavor.

� Produced the fi rst two Waterways Management Analysis Studies in the Coast Guard.

� Between 1985 and 1989, while deployed from the Great Lakes to the Caribbean, had three drug seizures and assisted with another three drug seizures – netting 100,000 pounds of marijuana.

� Saved the federal government from the $5 billion in liability costs from the clean-up operation of the T/V Exxon Valdez disaster in 1989 with his proactive approach to discrepancy response and Waterway Analysis Management Studies.

� Was one of the pioneers that helped the Coast Guard begin a long and proud history in counter drug operations.

(continued on page 63)

Legendary Coast Guard Captain Larry Brudnicki to Deliver 101st Annual Meeting Keynote Address

80-mph winds and 40-foot swells to save three people from a sinking sailboat and then saved four Air National Guardsmen after their own rescue helicopter ran out of fuel and crashed into the Atlantic Ocean.

After the infamous storm, Captain Brudnicki continued his remarkable career, moving to San Diego, CA, in 1993 to serve as commander of Coast Guard America’s Cup Patrol. Then from July 1995 to August 1997, he served as the Commanding Offi cer of the USCGC Chase. For his fi nal deployment, Chase joined a Navy Destroyer Squadron to conduct training with foreign countries in Southeast Asia. On its return home,

Chase was diverted to seize a Chinese fi shing vessel that had violated the United Nations Moratorium on High Seas Drift Net Fishing.

Captain Brudnicki retired from the US Coast Guard in March 2002. He performed his last assignment as the chief of operations, 11th Coast Guard District, Alameda, CA, in August 1997, supervising more than 15,000 Search & Rescue cases that saved 1,600 lives including the survivors of the Alaska Air Flight #261 tragedy. During this time he also had tactical control of ships and aircraft that seized more than 150 tons of cocaine, including the 10

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101st Annual Meeting

Saturday, May 21, 2005

9 AM - 6 PM Registration Desk Open

1 - 5 PM

Educational Presentation Area Open/Poster Session

1 - 5 PM

Hospitality Suite in Presentation AreaHosted by the Louisiana Board of Pharmacy

1 - 4:45 PM

Optional Spouse/Guest TourLouisiana Swamp Tour

1 - 2:30 PM

District Nominating Procedures Review

2:45 - 5 PM

New Member Seminar

7 - 10 PM

President’s Welcome ReceptionHonoring NABP President Donna M. HornBuffet Dinner will be served.Dress: business casual attire

Sunday, May 22, 2005

6:30 - 7:30 AM

Fun Run/Walk

7:30 AM - 4:30 PM

Registration Desk Open

8 - 9 AM

Continental Breakfast (In Presentation Area.)

8 AM - noonEducational Presentation Area Open/Poster Session

8:30 AM - noonMeeting of the Committee on Resolutions

1 - 1:15 PM

Welcome RemarksCarmen A. Catizone, NABP Executive Director/Secretary

1:15 - 2 PM

Keynote Address

2 - 2:15 PM

Refreshment Break

2:15 - 4:45 PM

First Business Session

May 21-24, 2005 Sheraton New Orleans Hotel New Orleans, LA

NABP and the NABP Foundation are approved by the Accreditation Council for Pharmacy Education (ACPE) as providers of continuing pharmacy education. ACPE Provider Number: 205. Participants may earn up to fi ve hours of ACPE-approved continuing education credit from NABP. Participants in continuing

pharmacy education programs will receive credit by completing a “Statement of Continuing Pharmacy Education Participation” and submitting it to the NABP offi ce. A validated Statement will be sent as proof of participation within approximately six weeks. Full attendance and completion of a program evaluation form for each session are required to receive continuing pharmacy education credit and a Statement of Participation.

Monday, May 23, 2005

7 AM - 4 PM

Registration Desk Open

7 - 8 AM

NABP/USP Breakfast Sponsored by the United States Pharmacopeia, Inc

8 - 11 AM

Meeting of the Committee on Resolutions

8:15 - 10:15 AM

CE Programming

10:15 - 10:30 AM

Refreshment Break

10:30 AM - noon CE Programming

12:15 - 12:30 PM

Second Business Session

12:30 - 12:45 PM Refreshment Break

12:45 - 2:45 PM

Meet the Candidates Session(Lunch provided.)

2:45 - 3 PM

Break

3 - 4:15 PM

Third Business Session

4:15 - 5:30 PM

ACPE Open Hearing on PharmD Standards Revision

Tuesday, May 24, 2005

7:30 AM - 4 PM

Registration Desk Open

8 - 9 AM

Continental Breakfast

8 - 9 AM

Past Presidents’ Breakfast (By invitation only.)

9 - 10:30 AM

CE Programming

10:45 - 11:45 AM

Open Mike Session

11:45 AM - 1 PM

Lunch Break (On your own.)

1 - 4 PM

Final Business Session

2:30 - 2:45 PM Refreshment Break

7 - 10:30 PM

Annual Awards Dinner

Dress: semiformal attire

*Please note that the 101st Annual Meeting Program is subject to change.

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Professional Affairs

Around the Association

(continued on page 62)

DEA Announces Hotline to Report Illegal Prescription Sales and Suspicious Internet Pharmacies

On December 15, 2004, United States Drug Enforcement Administration (DEA) launched 1-877-RxAbuse (1-877/792-2873), a toll-free international hotline that allows the US and Mexican public to anonymously report illegal sales and abuse of pharmaceutical medications by individuals and entities. Callers will be able to report these suspect activities confi dentially anytime of the day, 365 days per year. The reporting of such information may also be submitted via DEA’s Web site at www.usdoj.gov/dea/. This information will assist the Agency in bringing drug dealers to justice and preventing the tragedies that come from prescription drug abuse.

In March 2004, DEA along with the Offi ce of National Drug Control Policy, Food and Drug Administration (FDA), and the Offi ce of the Surgeon General developed a collaborative initiative to address the problem of prescription drug abuse, which is a component of a broader initiative of President George Bush’s 2004 National Drug Control Strategy. This hotline is a direct result of this initiative. The abuse of certain prescription drugs,

particularly controlled substances and performance-enhancing steroids, has become an increasingly widespread problem in the US, leading to dangerous abuse, addiction, and sometimes fatalities. The 2003 National Survey on Drug Use and Health reports that 6.3 million persons currently use prescription medications that have not been prescribed under a health professional’s care. According to the Drug Abuse Warning Network, data collected since 1995 indicates that the number of drug abuse-related emergency room visits involving pain relievers such as Vicodin®, Percocet®, OxyContin®, and Darvon® has increased 153%. One out of every 10 high school seniors now reports abusing powerful prescription pain killers. Also, preliminary data from the Partnership for a Drug-Free America’s Attitude Tracking Study suggests that many adolescents do not consider pharmaceutical drug abuse risky.

HHS Provides Relief for Infl uenza Vaccine Shortage

To alleviate the infl uenza vaccine shortage, outgoing US Department of Health and Human Services (HHS) Secretary Tommy G.Thompson announced on December 7, 2004, that HHS purchased infl uenza vaccine (Fluarix®) from a German GlaxoSmithKline (GSK) facility under

an Investigational New Drug (IND) application authorized by FDA.

In addition to conducting an inspection of the German GSK facility, FDA has reviewed extensive manufacturing and clinical information to determine and ensure the integrity of the vaccine and that it would be effective against the infl uenza strains dominant in the US during this fl u season. With the IND, patients, prior to inoculation with the Fluarix vaccine, must sign an informed consent form that provides important information and an acknowledgement of the potential adverse effects associated with Fluarix. Sponsors of INDs are required to adhere to certain requirements such as maintaining adequate records, assuring that informed consent is obtained from individuals prior to vaccine administration, and providing periodic reports to FDA regarding safety and other issues.

In early October 2004, Chiron Corporation, one of two major pharmaceutical manufacturers of infl uenza vaccine, informed the Centers for Disease Control and Prevention (CDC) that it would be unable to distribute its estimated 48 million doses of Fluvirin® in time for the 2004-2005 fl u season. The United Kingdom’s Medicines and Healthcare products Regulatory Agency temporarily suspended

Pharmacy by Governor Ted Kulongoski. His new term expires June 30, 2008.

Marty Hall, consumer member, was reappointedto the Utah Board of Pharmacy by Governor Olene Walker. His new term expires on June 30, 2008.

New Board Offi cers

The following boards of pharmacy recently elected new offi cers.

Louisiana Board of Pharmacy:

� T. Morris Rabb, RPh –First Vice President

� Marty R. McKay, RPh – Second Vice President

� Joseph L. Adams, RPh – Third Vice President

Massachusetts Board of Registration in Pharmacy:

� Karen Ryle, RPh, MS – President

� George Cayer, RPh –President-elect (new position)

� Sophia Pasedis, PharmD – Secretary

� James T. Devita, RPh – Past President (new position)

(continued from page 56)

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Professional Affairs

exposure to the medication. All of the manufacturers of isotretionin have entered into an agreement with Covance, a drug development services company that currently coordinates the registry for Celgene’s thalidomide. Covance’s task is to develop and operate a universal enhanced RMP by mid-2005; this program will require patients, dispensing pharmacists, and prescribers to register in a single, centralized clearinghouse. The program will also mandate that a pregnancy test be performed at certifi ed laboratories instead of home or in-offi ce testing. According to the Accutane RMP, System to Manage Accutane Related Teratogenicity, when the registry denies an authorization to fi ll the prescription, the prescribing physician must explain the reason for denial to the patient; FDA specifi cally states that the physician is responsible for informing a woman if a pregnancy test result comes back positive.Palladone

Due to Palladone’s (hydromorphone hydrochloride) high potential for abuse, addiction and respiratory depression, the drug’s manufacturer, Purdue Pharma LP, in conjunction with FDA, developed an RMP for this new extended release analgesic. Introduced to the market in January 2005, Palladone is approved for the management of

persistent, moderate to severe pain in patients requiring continuous, around-the-clock analgesia with a high potency opioid for an extended period of time (weeks to months) or longer. Palladone is to be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a minimum daily dose of opiate medication equivalent to 12 mg of oral hydromorphone.

The analgesic’s RMP was devised with four goals:

1. Facilitation of proper use (patient selection, dosing)

2. Avoidance of pediatric exposure

3. Minimization of abuse, and

4. Reduction of diversion Palladone’s RMP

includes provisions for understandable and appropriate labeling, and

proper education of health care professionals, patients, and caregivers. In addition, the manufacturer has offered training sessions to its sales representatives. The RMP provides for the observation and surveillance of abuse and, if abuse, misuse, and/or diversion occur, this program includes an array of interventions. A medication guide will be distributed to patients prescribed Palladone.

During the initial 18 months of Palladone’s release to the market, the manufacturer will only promote Palladone to a limited number of medical practitioners experienced in prescribing opioid analgesics and will closely monitor and gather data on Palladone’s use and any incidences of abuse or diversion, and report this information to FDAon a regular basis.

Chiron’s license for its Liverpool facility that was scheduled to produce Fluvirin for distribution throughout the US. Before Chiron’s announcement, it was expected that 100 million doses would be available during this season, with Aventis, the other major infl uenza vaccine (Fluzone®) producer, contributing 54 million doses.

Individuals who are having diffi culty fi nding the vaccine or who want additional information on infl uenza can call the CDC’s hotline at 1-800/CDC-INFO.

Accutane, Palladone RMPs Revised

Risk Management Programs (RMPs) are developed by drug manufacturers to meet the requirements of FDA’s drug approval process, in conjunction with FDA, to minimize risk associate with specifi c drug products. To date, several specifi c drug products have formal risk management programs beyond labeling alone, to further ensure patient safety. Two relevant examples are Accutane® (Roche Pharmaceuticals) and Palladone capsules (Purdue Pharma LP). Accutane

On November 23, 2004, FDA announced changes to the RMP for isotretinoin (Accutane) that will be implemented in mid-2005 in order to reduce the risk of birth defects associated with fetal

Links to Sources and More Information DEA Hotline:Source: www.usdoj.gov/dea/pubs/pressrel/pr121504.htmlInfl uenza Vaccine:Source: www.hhs.gov/news/press/2004pres/20041207.htmlFDA Flu Information: www.fda.gov/oc/opacom/

hottopics/fl u.htmlCDC Infl uenza Information (including vaccination

information and antiviral medication usage guidelines): www.cdc.gov/fl u/

PalladoneProfessional prescribing information and the Medication

Guide for Palladone Capsules can be found online at www.purduepharma.com/html/Our_products/Our_products.htm#Prescription_products

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Around the Association(continued from page 60)

State Board News

New Oklahoma Pseudoephedrine Law Causes Decrease in Illegal ‘Meth’ Labs

In its January 2005 Newsletter, the Oklahoma State Board of Pharmacy reported that since a new state law was passed in April 2004 restricting the sale of the pseudoephedrine tablet form, there has been a signifi cant decrease in the number of illegal methamphetamine “meth” labs.

The success of the new regulation was also highlighted in a January 17, 2005 article in The Oklahoman entitled “Offi cials Praise Anti-meth Law,” where it was reported that since the law has been implemented, the number of “meth” labs has decreased by 50-70% and there have been 581 fewer meth lab arrests.

“Because of this law, the ingredients to ‘cook’ ‘meth’ are no longer available over the counter, which has caused a decrease in the number of ‘meth’ labs,” explains Bryan Potter, executive director of the Oklahoma State Board of Pharmacy. “Unfortunately, because the drug isn’t available over the counter in Oklahoma anymore, consumers are traveling to our border states like Arkansas and Kansas. Many of these states are looking into similar legislation [regarding the restriction of pseudoephedrine].”

Reprinted in its entirety with the permission of the Oklahoma Board, the following article provides suggestions to pharmacists on how to process the sale and tracking of pseudoephedrine products.

Implementation of New Pseudoephedrine Law

The Oklahoma Bureau of Narcotics has indicated that the new law has signifi cantly reduced the number of “meth” labs in Oklahoma. The Bureau appreciates the effort that pharmacies and pharmacists have made to initiate this new program. In reviewing the program, the Bureau has found [that] a number of pharmacies are failing to obtain the data required by law and in some cases are selling in excess of the nine grams/30 days limit. Pharmacists are responsible for the sale of a Schedule Vproduct. A pharmacist or a pharmacy technician must make the sale of PSE [pseudoephedrine]. Please review your process on these sales. The Oklahoma Bureau of Narcotics is working on an electronic process for tracking sales. Until that is available the pharmacist and pharmacy are responsible for the sale of this Schedule V product. Because the exempt narcotic book does not seem to accommodate the required data very well, the Board [of Pharmacy] has the following suggestions:

1. Prepare a loose-leaf notebook using the guideline on the Board

[of Pharmacy’s] Web site [www.pharmacy.state.ok.us/].

2. Keep purchasers’ names alphabetical – it will make it easier to check the number of grams purchased in the past 30 days.

3. Keep the total in grams (make a chart converting mgs to g/number of tablets).

4. Make sure all employees understand the importance of following the law.

If we continue to see a disregard for compliance with this law and the record keeping requirements, it could be changed back to requiring that pharmacists only make the sales.

The Board of Pharmacy provided these suggestions to better assist Oklahoma pharmacists on how to process the sale and tracking of pseudoephedrine products.

Enforcement of the Bureau’s law falls under jurisdiction of the Oklahoma State Board of Pharmacy. Because pseudoephedrine has been declared a Schedule V drug, Oklahoma’s compliance offi cers have incorporated the rule into their routine inspections to ensure that pharmacists and pharmacies are in accordance with the new regulation.

“It’s just a matter of getting the information out there and keeping the pharmacists and pharmacies up to date,” Potter states about the new law.

Missouri Board of Pharmacy:

� Douglas Lang, RPh –President

� Timothy Koch, RPh –Vice President

New York Board of Pharmacy:

� David Flashover, RPh – Chairperson

North Carolina Board of Pharmacy:

� Robert Crocker, RPh – President

� Betty Dennis, RPh –Vice President

Tennessee Board of Pharmacy:

� Reginald Dilliard, RPh – President

� Julie Frazier, RPh – Vice President

Massachusetts Now Under Division of Professional Licensure

The Massachusetts Board of Registration in Pharmacy now falls under the Division of Professional Licensure. The Board’s address is 239 Causeway St, Suite 500, Boston, MA 02114. The Board’s Web site is www.mass.gov/dpl/boards/ph/index.htm.

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(continued from page 58)

Brudnicki

On Saturday, December 4,2004, 1,870 candidates sat for NABP’s administration of the Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®). The examination was administered in three United States locations: San Mateo (San Francisco), CA; Northlake (Chicago), IL; and New York, NY. Candidates who sat for the December 4 administration received their scores in January 2005. The next FPGEE is scheduled for Saturday, June 25, 2005. Testing sites will be in San Mateo, CA; Northlake (Chicago), IL, and New York, NY.

December 2004 FPGEE Scores Released; June 2005 Administration Date and Locations Announced

NABP provides the Foreign Pharmacy Graduate Examination Committee™ (FPGEC®) Certifi cation Program as a means of documenting the educational equivalency of a candidate’s foreign pharmacy education, as well as his or her license and/or registration. During the FPGEC certifi cation process, candidates are required to submit documents or have certain documents submitted directly to NABP from educational or licensure institutions that present their educational backgrounds and licensure and/or registration to practice pharmacy. Candidates are also required

to pass the FPGEE, the Test of English as a Foreign Language, and the Test of Spoken English. The FPGEC Certifi cate allows foreign graduates to partially fulfi ll eligibility requirements for licensure in the states that recognize the certifi cation. NABP continuously alerts candidates that the FPGEC Certifi cate is not a license to practice pharmacy. Applicants who receive the FPGEC Certifi cate are qualifi ed by the state boards of pharmacy that accept the FPGEC Certifi cate to continue through the licensure process and take the pharmacist licensing examination (North

American Pharmacist Licensure Examination™) and other required examinations in those jurisdictions that accept this certifi cation. To date, 50 states recognize the FPGEC Certifi cate.

Candidates with questions about the FPGEE or Pre-FPGEE®, the practice examination for the FPGEE, may visit NABP’s Web site at www.nabp.net for updated information or e-mail the Customer Service Department at [email protected]. Individuals without Internet access may contact NABP’s Customer Service Department at 847/391-4406.

Explore “A Medley for Patient Safety: Accreditation, Self Assessment, Quality Care” at NABP’s 101st Annual Meeting, May 21-24, 2005, at the Sheraton New Orleans Hotel in New Orleans, LA.

The program, featuring business sessions, timely and relevant continuing education programming, the annual “Meet the Candidates” session, the Welcome Reception, and Annual Awards Dinner, appears on page 59 of this NABP Newsletter. Please indicate on the inserted registration form if you plan to participate in the Fun Run/Walk and/or the optional spouse/guest Louisiana Swamp Tour.

Register Now for the 101st Annual MeetingNABP has arranged a

special meeting rate of $179 with the Sheraton New Orleans Hotel for single/double occupancy plus applicable taxes. To guarantee your accommodations, contact the Sheraton New Orleans Hotel directly at 504/525-2500, through their central reservation system at 1-888/627-7033, or via fax at 504/561-0178. All major credit cards are accepted. All reservations must be received by April 22, 2005. Be sure to mention that you are attending NABP’s 101st Annual Meeting.

Air travel and rental car rates are available through NABP’s designated travel

agency, Options Travel, at 1-800/544-8785. When calling Options Travel, identify yourself as a registrant of NABP’s 101st Annual Meeting and mention our special code, NABP101.

Register before April 15, 2005, for a savings on your registration fees. Individuals registering after this date or on site will be billed an additional $25.

For more information about the 101st Annual Meeting program, contact the NABP Meetings Desk at 847/391-4406 or e-mail [email protected].

largest cocaine seizures in 2000 and 2001.

Captain Brudnicki holds a Merchant Marine Master’s License. His awards include the Legion of Merit, the Coast Guard Medal (for heroism), the Defense Meritorious Service Medal, the Meritorious Service Medal (two awards), the Coast Guard Commendation Medal (four awards), the Air Force Commendation Medal, the Coast Guard Achievement Medal, and the Humanitarian Service Medal (two awards).

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On December 10, 2004, NABP’s Task Force to Develop Recommendations to Best Reduce Medication Errors in Community Pharmacy Practice convened at the Hyatt Hotel in Rosemont, IL. The Task Force was charged with examining information related to medication errors that occur in community practice and provide recommendations to the Executive Committee on what NABP and the state boards of pharmacy can do to reduce the incidence of medication errors in community practice.

Members of the Task Force include: Karen Ryle, president, Massachusetts Board of Registration in Pharmacy (chair); Philip P. Burgess, member, Illinois Department of Financial and Professional Regulation, Division of Professional Regulation – State Board of Pharmacy; Susan M. DelMonico, member, Rhode Island Board of Pharmacy; Reginald B. Dilliard, member, Tennessee Board of Pharmacy; David Fong, member, California State Board of Pharmacy; Edward G. McGinley, member, New Jersey Board of Pharmacy; and Linda K. McCoy, member, Arizona State Board of Pharmacy. Ex-offi cio members

NABP Convenes Task Force on Reduction in Medication Errors

include Michael Jarema, Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and Alan Vaida, Institute for Safe Medication Practices (ISMP).

Key Task Force Findings

A synopsis of the recommendations follows.

The Task Force recommends that the Executive Committee consider the appointment of a task force that would be charged with analyzing the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act) to refl ect NABP’s continued initiative to promote regulating for outcomes. It further proposes that applicable patient safety standards from organizations such as ISMP and JCAHO be evaluated and considered for incorporation in the Model Act.

NABP should continue to work with the state boards of pharmacy to assess, develop, and implement Best Practice/non-punitive regulations and enforcement actions aimed to promote patient safety and medication error reduction, the Task Force urged. The Task

Force maintains that NABP should also persist with promoting best practices recommendations to the pharmacy profession

to encourage the maximum provision of pharmaceutical care. It is further recommended that the Association continue to collaborate with the states to enact peer review programs and freedom from discovery protection regulation and legislation to encourage the reporting, data collection, and analysis of medication errors.

The Task Force suggests that NABP encourage Food and Drug Administration to prevent the use of product nomenclature, packaging, and labeling that may signifi cantly

contribute to medication errors. If warranted, NABP should commission a task force to identify such high-risk error-prone products and develop specifi c recommendations for reducing the risk of medication errors associated with such products. Furthermore, the Task Force agrees that strategies like separating similar sounding and/or looking products within the pharmacy are helpful in reducing medication errors associated with these products.

The Task Force advises that NABP explore the feasibility of incorporating specifi c competency statements regarding patient safety from a systems perspective into the North American Pharmacist Licensure Examination™ (NAPLEX®). Currently, the NAPLEX contains competency statements addressing:

1. safe and effective pharmacotherapy and the optimization of therapeutic outcomes; and

2. the safe and accurate preparation and dispensing of medications. It is further recommended

that NABP submit a similar request to the Pharmacy Technician Certifi cation

NABP should continue to work with the state boards of pharmacy to assess, develop, and implement Best Practice/non-punitive regulations and enforcement actions aimed to promote patient safety and medication error reduction. . . .

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Association News

New Orleans FactsSite of NABP’s

101st Annual MeetingMay 21-24, 2005

Sheraton New Orleans HotelNew Orleans, LA

The Port of South Louisiana: The US’s Busiest Port by Volume

Founded in 1718 by French settlers, the Port of South Louisiana is the busiest port by volume in the US and third busiest in the world, according to the American Association of Port Authorities. The port imports such items as

coffee and natural rubber. The only US seaport served by six class one rail lines, the port’s main commodities are steel and rubber; more than fi ve million tons of steel were imported in 2000. More than 50,000 barges and 4,000 ocean-going vessels call at the port each year, making it the top-ranked port in the country for export tonnage and total tonnage. The port also boasts the world’s longest wharf, which is 2.01

miles; its cargo handling area is 22 million square feet and the storage area is 6 million square feet.

Board (PTCB) regarding its National Pharmacy Technician Certifi cation Examination.

To improve awareness and knowledge of patient safety and reduce medication errors, the Task Force advocates that NABP encourage the state boards and PTCB to incorporate patient safety and medication error continuing education requirements for licensure renewal and recertifi cation for pharmacists and technicians, respectively.

State boards are encouraged to require pharmacies to document and report medication error incidences to the United States Pharmacopeia Medication Errors Reporting Program. The Task Force also suggests that community pharmacies under common control or ownership be encouraged to periodically submit such information in aggregate as opposed to each and every separate occurrence.

Collaboration between NABP and the Centers for Medicare & Medicaid Services and the National Committee on Vital and Health Statistics on the standardization of electronic prescribing prescription formatting should continue. Development and consensus of a solution is important because a large

percentage of medication errors are attributed to written miscommunication with prescriptions and prescription orders. Furthermore, the Task Force urges NABP to continue encouraging collaboration between the state boards and their medical boards regarding the adoption and incorporation of patient safety efforts, as the successes of patient safety initiatives are signifi cantly dependent upon joint efforts between the state boards of pharmacy and the medical boards.

The Task Force suggests that a stakeholders meeting be held

between NABP, national pharmacy professional organizations, and other applicable organizations to explore ways to decrease medication errors in community practice settings through the creation and implementation of national patient safety goals targeted specifi cally for community pharmacy practice.

Finally, the Task Force advocates that NABP work with the American Association of Colleges of Pharmacy, the American Association of Colleges of Nursing, and the Association of American Medical Colleges to incorporate patient safety

and quality into the respective curricula of pharmacy, nursing, and medical schools.

At the conclusion of the meeting, the Task Force submitted its recommendations to the NABP Executive Committee for its approval. The offi cial report of the Task Force will be available on NABP’s Web site, www.nabp.net, at the end of March 2005.

For more information on NABP’s Task Force to Develop Recommendations to Best Reduce Medication Errors in Community Pharmacy Practice e-mail the Association at [email protected].

Source: www.neworleansonline.com/pr/releases/prsall/pr_facts.html

Photo courtesy of World Trade Center of New Orleans.

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Association News

Every year, dedicated volunteers convene to review NABP’s competency assessment programs and safeguard the integrity and validity of the Association’s examinations. NABP appreciates the assistance of these committee members as they evaluate examination content and ensure that it meets the specifi ed competency assessment statements. Among these committees is NABP’s Advisory Committee on Examinations (ACE), which oversees the development and administration of all examination programs, considers policy matters, develops long-range

NABP Values Examination Committeesplanning strategies, and recommends action on specifi c issues to NABP’s Executive Committee.

The listed individuals currently serve on NABP’s examination committees. Members of the North American Pharmacist Licensure Examination™ (NAPLEX®), Multistate Pharmacy Jurisprudence Examination® (MPJE®), Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®), and Disease State Management (DSM) examination review committees start their terms at the beginning of the year, while members of ACE begin their terms in the summer.

Advisory Committee on ExaminationsChair ...................................................................Carl W. Aron

Louisiana Board of Pharmacy Member .................................................... Rebecca W. Chater

North Carolina Board of PharmacyMember ..................................................... Stephen M. Gross

Brooklyn, NYMember ....................................................................Jeff Lurey

Atlanta, GAMember ..................................................... Kendall M. Lynch

Tennessee Board of Pharmacy Member .................................. Richard K. “Mick” Markuson

Idaho Board of Pharmacy Member ............................................................... Jerry Moore

Indian Springs, ALExecutive Committee Liaison .................... Michael A. Moné

Versailles, KY

DSM Examination Review CommitteeMember .............................................................George Alexis

Marshfi eld, MAMember ...............................................................Mary Coffey

Lumberton, NJMember ............................................................ Susan Cornell

Orland Park, ILMember ....................................................Mark C. Granberry

Edinburg, TXMember .............................................Karen Gunning-Leavitt

University of UtahMember ............................................................ Jill T. Johnson

Little Rock, ARMember ........................................................ JaCinda L. Jones

Jerseyville, ILMember .......................................................... W. Greg Leader

University of Louisiana at MonroeMember .................................................... Deborah J. Randall

Decatur, GA

Member ........................................................Eric F. SchneiderCharlotte, NC

Member .................................................. Susan Spivey-MillerGainesville, FL

Member .............................................................. David YoungUniversity of Utah

FPGEE Review CommitteeMember ..........................................................Louis N. Ace, Jr

Fairview, PAMember .......................................................Barbara Adamcik

Idaho State University Member ............................................................ John H. Block

Oregon State University Member ............................................................ Robin Bogner

University of ConnecticutMember ......................................................... Stephen L. Dahl

Kanab, UTMember .............................................................Brian Hodges

University of West VirginiaMember ........................................................ Sheldon Holstad

St Louis College of PharmacyMember .......................................................... James Karboski

University of TexasMember ......................................................... William Kolling

University of Louisiana at Monroe Member ........................................................... Monina Lahoz

Massachusetts College of Pharmacy and Health Sciences Member .......................................................... Holly L. Mason

Purdue University Member ............................................................... Karen Nagel

Midwestern University Member ............................................................. Ralph Raasch

University of North Carolina – Chapel HillMember ....................................................... Timothy J. Smith

University of the Pacifi c

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Association News

Member ................................................... Sr Margaret WrightArlington Heights, IL

Member ..................................................Dale Eric Wurster, JrUniversity of Iowa

Member .......................................................... David ZgarrickMidwestern University

MPJE Review CommitteeMember ........................................................Vance Alexander

Birmingham, ALMember ................................................... Cynthia A. Benning

Wisconsin Pharmacy Examining BoardMember ..............................................James D. “J. D.” Coffey

Massachusetts Board of Registration in PharmacyMember ....................................................... Michael A. Moné

Versailles, KYMember ................................................ Richard D. Morrison

Washington State Board of PharmacyMember ............................................................... Steve Morse

Pfl ugerville, TXMember .........................................................Denise Peterson

Princeton, MNMember ........................................................Melvin N. Rubin

Maryland Board of PharmacyMember ....................................................... Charles W. Sauer

Sycamore, ILMember ........................................................ Alan M. Shepley

Mount Vernon, IAMember ........................................................... John D. Taylor

Tallahassee, FL Ex-offi cio Member ................................ Thomas J. McGinnis

US Food and Drug Administration, Rockland, MDEx-offi cio Member .............................................Vickie Seeger

US Drug Enforcement Administration, Arlington, VA

NAPLEX Review CommitteeMember ...........................................................Marie A. Abate

West Virginia University Member .........................................................Loyd V. Allen, Jr

Edmond, OKMember ...................................................... Dyke F. Anderson

Lincoln, NEMember ............................................................Christi Capers

Hermitage, TNMember .....................................................Rebecca W. Chater

North Carolina Board of PharmacyMember ..............................................Michael B. Cockerham

Shreveport, LA

Member .................................................................Betty DongUniversity of California – San Francisco

Member ...................................................... Thomas S. FosterUniversity of Kentucky

Member ............................................................... Darla GalloElkins Park, PA

Member ................................................ W. Franklin GilmoreMontana Tech of The University of Montana

Member ................................................ Robert P. HendersonSamford University

Member .............................................William A. Hopkins, JrBig Canoe, GA

Member .....................................................Tom M. HouchensLondon, KY

Member ................................................. Arthur I. JacknowitzWest Virginia University

Member ...........................................................William KehoeUniversity of the Pacifi c

Member ....................................................................Jeff LureyAtlanta, GA

Member ............................................................. Susan C. LutzAltoona, IA

Member .............................................................. Gene MartinPensacola, FL

Member ...................................................... David W. NewtonShenandoah University School of Pharmacy

Member ................................................ Stephen M. OuelletteOakland, ME

Member ............................................................. Roy C. ParishSavannah, GA

Member ..............................................................David B. RollRockville, MD

Member ...........................................................Pamela P. RushIndependence, MO

Member ....................................................... Eric F. SchneiderCharlotte, NC

Member ...................................................... James A. SeaboldtThornton, CO

Member ........................................................... John L. SzarekRoss University School of Medicine

Member ......................................................... Andrea TassoneChicago, IL

Member ........................................................... Neal F. WalkerHibbing, MN

Member ........................................................... Siu-Fun WongWestern University of Health Sciences

Page 20: March 05 Newsletter - NABP · 2016. 3. 7. · March 2005 / Volume 34 Number 3 Legendary Coast Guard Captain Larry Brudnicki, ... on January 21, 2005. While the recently released regulations

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Association Highlights

Reminder

National Association of Boards of Pharmacy

1600 Feehanville Drive

Mount Prospect, IL 60056

nabp newsletter

Visit NABP’s Web site at www.nabp.net for the

101st Annual Meeting Registration Form and program information.

march 2005

NABP’s Committee on Law Enforcement/Legislation met on January 28, 2005, at NABP Headquarters in Mount Prospect, IL. Members include (front row, from left): Joshua Bolin, director, Indiana Board of Pharmacy; Monica K. Franklin, consumer member, Tennessee Board of Pharmacy; Gay Dodson (chair), executive director, Texas State Board of Pharmacy; Kathryn H. Craven, member, Nevada State Board of Pharmacy; (back row, from left) Stephen R. Statz, member, South Dakota State Board of Pharmacy; Charles R. Young (Executive Committee liaison), executive director, Massachusetts Board of Registration in Pharmacy; Anthony W. Alexander, member, New Jersey Board of Pharmacy; and George L. Bowersox, member, New Hampshire Board of Pharmacy.

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