newsletterNational Association of Boards of Pharmacy®

aid to governmentthe profession

the public1904 to 2004

This Month on www.nabp.net:NABP 2004 Executive Committee Reports under “Special Items.”

NABP 2003-2004 Committee and Task Force Reports under “Special Items.”

NABP 100th Annual Meeting News Releases under “Headlines.”

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

View the revised Model Rules for Licensure of Wholesale Distributors.

NABP News Release under “What’s New”: NABP Addresses the Danger and Ease Involved in Purchasing Prescription Medications via Online Search Engines.

Upcoming MeetingsSunday-Tuesday, August 1-3, 2004NABP/AACP District III MeetingBeau Rivage Resort and Casino Biloxi, MS

Thursday-Saturday, August 12-14, 2004NABP/AACP District V MeetingHilton Garden InnJohnston, IA

Friday, August 27, 2004; Monday, August 30, 2004, Friday, September 10, 2004Board Program Review and TrainingNABP HeadquartersPark Ridge, IL

Monday-Wednesday, September 23-25, 2004NABP/AACP District VI MeetingSan Luis ResortGalveston, TX

In This Issue. . . .

®�

Association News: Two New Executive Committee Members Inaugurated

May - June 2004 / Volume 33 Number 5

Legal Briefs: 100th Annual Meeting Report of Counsel

Feature News: Panelists Discuss Drug Importation During NABP’s 100th Annual Meeting

Association News: PSAM Development Moving Forward

(continued on page 78)

79 80 84 93

The Alabama State Board of Pharmacy and the Alabama Pharmacy Association (APA) recently joined NABP and Food and Drug Administration (FDA) in unveiling the “Looks Can Be Deceiving” campaign, an extensive consumer education operation to warn patients on the dangers of counterfeit drugs.

The Alabama State Board of Pharmacy and the APA decided to join NABP and FDA in response to continuing efforts by several Alabama legislators and the city of Montgomery, AL, to ignore federal laws that are intended to keep unsafe prescription medications from entering the United States drug supply.

NABP, FDA, Alabama Board of Pharmacy, APA Warn Citizens on Dangers Associated with Illegal Drug Importation

According to Jerry Moore, executive director of the Alabama Board, “While some medications may be expensive, we should never gamble with our health by the use of illegally imported drugs.”

On May 5, 2004, at the State Capitol in Montgomery, AL, representatives and offi cials from NABP, the Alabama Board, FDA, and APA unveiled the “Looks Can Be Deceiving” campaign, which includes posters, fl yers, and prescription bag inserts; these informational materials will be distributed to pharmacies throughout Alabama.

There is increasing concern throughout the country by FDA, pharmacists, and pharmacy

regulatory offi cials over the safety risks incurred by individuals who illegaly import prescription drugs from foreign countries. According to FDA examinations conducted in January 2004, the agency found that of 1,982 inspected parcels, 89% contained unapproved drugs; this included so-called “foreign versions” of FDA-approved drugs, recalled drugs, drugs requiring special storage conditions, drugs requiring close physician monitoring, and drugs containing addictive controlled substances.

NABP Executive Director/Secretary Carmen A. Catizone stated, “The dangers of illegally

nabp newsletter

78

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 Pharmacy700 Busse Highway

Park Ridge, IL 60068 847/698-6227www.nabp.net

custserv@nabp.netCarmen A. Catizone

Executive Director/SecretaryReneeta C. “Rene” Renganathan

Editorial Manager

© 2004 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.

(continued from page 77)

Executive CommitteeDonna S. Wall Chairman, 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. YoungMember, District I

®�

Association News

NABP, FDA, APA

NABP recently released the 2003 test administration results for its North American Pharmacist Licensure Examination™ (NAPLEX®), Multistate Pharmacy Jurisprudence Examination® (MPJE®), and Pre-NAPLEX™. The MPJE saw a dramatic increase in the number of candidates sitting for the examination, with 1,532 more candidates in 2003 than in 2002.

NAPLEX, Pre-NAPLEXThe number of candidates

who sat for the NAPLEX in 2003 remained consistent with 2002. From January through December 2003, 8,618 candidates sat for the NAPLEX compared to 8,609

2003 NAPLEX, MPJE Results Released; Pre-NAPLEX Numbers Reported

importing and consuming prescription drugs from foreign sources affect all Americans. Consumers need to know that while on the surface importation of drugs through the Internet may look like a reasonable solution to concerns with access, it is actually a danger that could severely impact the health care and medication distribution system of the US.”

William Eley, executive director of the APA, explained, “We understand

that people need access to safe and affordable prescription drugs. This is why we are urging individuals . . . to talk to their pharmacist about [safe]cost drug options.”

NABP, FDA, and the Missouri Pharmacy Association (MPA) also unveiled the “Looks Can Be Deceiving” campaign during a April 20 news conference in St Louis, MO.

The campaign was fi rst launched in Illinois in

February 2004, and has since been expanded to California, Maryland, New York, Virginia, and now Alabama and Missouri.

®�

administrations in 2002. Of those taking the NAPLEX in 2003, 6,817 were fi rst-time candidates. First-time candidates performed better than those retaking the examination, with a 95% passing rate compared to an overall passing rate of 90%.

Since the Pre-NAPLEX was launched in May 2003, more than 2,100 candidates have taken the Pre-NAPLEX. Several organizations and pharmacy schools have shown interest in the Pre-NAPLEX by purchasing quantities of vouchers for interns and students. Three forms of the Pre-NAPLEX are are available; a new form was introduced in late spring 2004.

MPJE Reaches Record Number of Administrations

A total of 13,587 candidates were tested in 2003 compared to 12,055 candidates in 2002; these results represent a record number of exams taken since the implementation of the MPJE in November 1998. The overall passing rate for 2003 was 83.5%. During 2003, the MPJE was offered by 45 jurisdictions, four additional jurisdictions than in 2002 and compared to 26 states that administered the examination when it was fi rst introduced.

Michele Fontaine, vice president of the Coalition for Manitoba Pharmacy, and Kerry Prickett, president-elect of the Alabama Pharmacy Association, address reporters in Montgomery, AL, on May 5, 2004.

may-june 2004

79

Association News

Charles Curtis Barr, vice chairman of the Nebraska Board of Pharmacy (District V), and Richard A. Palombo, member of the New Jersey Board of Pharmacy (District II), were each elected to three-year member terms on the NABP Executive Committee during the Association’s 100th Annual Meeting and Centennial Celebration, held April 24-27, 2004 in Chicago, IL.

Charles Curtis BarrSince the 1997

appointment of Charles Curtis Barr, PharmD, to the Nebraska Board of Pharmacy, he has held various positions including member, secretary, and chairman.

In addition to his acitvities with the Board, Barr’s service to NABP has been extensive. He has served on NABP’s Task Force on Licensing of Pharmacy Benefi t Managers and the Committee on Constitution and Bylaws, and participated in the Multistate Pharmacy Jurisprudence Examination® Item-Writing Workshop on item development for Nebraska’s state-specifi c pool.

A member of the Nebraska Pharmacists Association since 1974, Barr has held several offi ces

Two New Executive Committee Members Inauguratedincluding board member, from 1978 to 1980 and 1989 to 1991; president elect in 1989; president in 1990; and chairman of the board in 1990. Barr has also been a part of many committees and task forces at the Nebraska Pharmacists Association including the Legislative Committee, Strategic Planning Committee on Pharmaceutical Care Research, and Academy of Advanced Patient Care Services. Barr is a member of various professional

organizations including the American Pharmacists Association (APhA) and the National Community Pharmacists Association, and is a full fellow of

the American College of Apothecaries.

Currently, Barr is an associate professor of Pharmacy Practice and assistant dean for Alumni Relations at Creighton University (CU) School of Pharmacy and Allied Health Professions. He began teaching at CU in 1974 as an adjunct professor and in 1998 he became an associate professor. In addition, he is the owner/operator of Barr Pharmacy and Blair Medical Supply in Blair, NE.

Barr has received numerous honors including

the Nebraska Pharmacists Association Committee Award, Innovative Pharmacy Practitioner Award, and Bowl of Hygeia, as well as the National Association of Retail Druggists National Preceptor of the Year (1994).

Barr earned a doctor of pharmacy degree from the University of Nebraska College of Pharmacy in 1981 and a bachelor of science in pharmacy degree from CU School of Pharmacy in 1974.

Richard A. PalomboAs a former president and

current member of the New Jersey Board of Pharmacy, Richard A. Palombo, RPh, has served the Board of Pharmacy since 1996. He also served as liaison to the New Jersey State Legislature and liaison to the Enforcement and Inspections Bureau, and was the committee chair for Continuous Quality Improvement.

Palombo has been an active member of NABP since 2000. He was chair of the Committee on Law Enforcement/Legislation and served on such task forces as the Task Force to Examine the Quality and Standards of Internship Requirements and Task

Force on Privacy and Patient Confi dentiality.

Currently a director with the Pharmacy Professional Practice Group and compliance coordinator for Medco Health Solutions, Inc, Palombo is responsible for assessing and monitoring the effi cacy and profi ciency of the Compliance Program. He also develops self-assessment tools to ensure compliance with all federal, state, and local statutes and regulations relating to patient safety and care.

In addition to his pharmacy services, Palombo is the mayor of Upper

Township, NJ. Before becoming mayor in 1999, he served as councilman of Upper Township from 1997 to 1999.

Palombo is a member of many professional organizations including the

APhA; the New Jersey Pharmacist’s Association, which bestowed upon him the Award of Appreciation for Outstanding Contribution to the Profession of Pharmacy in 2001; the South Jersey Pharmacist Association; and the American Society for Pharmacy Law.

Palombo holds a bachelor of science degree in pharmacy from Temple University College of Pharmacy in Philadelphia, PA.

®�

nabp newsletter

80

Legal Briefs

100th Annual Meeting Report of CounselPresented by John F. Atkinson

Uniformity in regard to licensure transfer rests primarily on the use of the North American Pharmacist Licensure Examination™ (NAPLEX®) by all states and jurisdictions within the US. It is through this uniform, standardized examination coupled with the existing requirement in the states mandating graduation from a program approved by the Accreditation Council for Pharmacy Education (ACPE) that pharmacy enjoys the most effi cient licensure transfer program of all the professions.

Eligibility for the initial licensure of pharmacists is determined by state legislatures, not boards. Boards must abide by the statutory provisions of the practice act. NABP should not and cannot force states to legislate to meet the requirements of NABP’s Constitution and Bylaws.

Rather, NABP’s governing documents must contain the fl exibility to adapt to state statutory edicts where uniformity is not jeopardized and the licensure transfer program remains basically intact.

At its January 2004 meeting, the Executive Committee designated both the California and Florida Boards of Pharmacy as active members of NABP , which gives these boards the full privileges of membership, including the right to vote. The designation was made effective March 1, 2004.

The Executive Committee noted that the Florida and California Boards each use the NAPLEX exclusively and abide by the passing scores established by NABP. Florida also uses the Multistate Pharmacy Jurisprudence Examination® (MPJE®)

and California is presently reviewing the possibility of joining the MPJE program. Each of these boards recognizes as approved educational programs those which are accredited by ACPE. Both the California and Florida Boards can provide mechanisms for uniform standards as provided in the licensure criteria as set forth in the NABP Bylaws that are generally adhered to by other member states. The California licensure process is based on the NAPLEX but is prospective in nature measured from January 1, 2004, forward. Florida restricts licensure transfer to those who have taken the NAPLEX within the previous 12 years. The Executive Committee recognized that these restrictions did not exist in other states, but found that these limitations were set by legislation and not by the Boards. The Executive Committee also found that the restrictions, although limiting, were not insurmountable barriers and, therefore, should not block Active member status. Other states are free to subject the licensure transfer of California and Florida applicants into their jurisdictions with like restrictions. Licensure transfer of eligible candidates to and from California or Florida will still occur under the uniform standards that NABP has worked

The National Association of Boards of Pharmacy Constitution has served

the Association well throughout NABP’s 100-year history. While the amendments to this document have been numerous, substantive changes have been few in number. Like the United States Constitution, NABP’s document has demonstrated the fl exibility and resilience to be adaptable to the ever-changing practice of the profession of pharmacy as this evolution relates to licensure and regulation of the profession.

may-june 2004

81

Legal Briefs

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

throughout its history to establish. Importantly, licensure will still be based on the NAPLEX examination and graduation from an ACPE-accredited program.

California and Florida have long participated in NABP despite the fact that the Boards of each of these states have been unable to vote and the members of the Boards have not been able to participate on the various NABP committees. Florida has been a member of the Association since 1904, while California’s membership began in 1950. The Executive Committee determined that it would be inequitable to deny these states full membership in NABP when their procedures in regard to uniform licensure are based on the NAPLEX examination and do not essentially affect the uniform standards governing such transfers under the NABP Bylaws.

In response to NABP resolutions, ACPE recently issued a statement that found the bachelor’s degree of Canadian graduates to be at least equivalent to the bachelor’s degree in the US. The recognition covers Canadian Council for Accreditation of Pharmacy Programs graduates through June 30, 2004, the date on which standards for the US baccalaureate program will be phased out in favor of

standards for the doctor of pharmacy degree.

This inspired certain border state jurisdictions to pass legislation permitting Canadian graduates to take the NAPLEX without the necessity of being Foreign Pharmacy Graduate Examination Committee™ (FPGEC®) certifi ed. Certain states amended their respective practice acts and are now recognizing Canadian graduates licensed by other states to be eligible for licensure transfer despite the fact that Canadian graduates are not graduates of ACPE-approved programs. While those states that are allowing such a transfer may be in technical violation of the NABP Constitution and Bylaws, the uniformity secured by the Constitution remains basically intact. Pharmacists being transferred are graduates of Canadian programs presently rated as equivalent to US bachelor programs by ACPE and are qualifi ed by passing the NAPLEX. The inequities of attacking the membership status of these states that are relying on ACPE’s fi ndings that resulted from NABP pressure seem quite obvious. Further, states remain free to reject applicants who have not graduated from ACPE programs but remain obligated to take those applicants who

have graduated from such approved programs.

At the direction of the governor, some states are presently inspecting Canadian pharmacies for the purpose of fostering importation of Canadian drugs. Others are contemplating undertaking such inspections. In these instances, the governor may be aiding and abetting violation of federal law and engaging in activities that could endanger public health. By the boards’ own admission, the inspections are not nearly as stringent as inspections of local pharmacies. When inspecting pharmacies within the US, the state inspector knows the drugs in the facility are US Food and Drug Administration approved. When inspecting pharmacies in Canada, how can a state inspector ascertain that the drugs in that facility are pure, of appropriate strength, and not counterfeit without assaying the products? What meaningful assurance can an inspector give under these circumstances?

It is arguable that these states are effectively permitting the practice of pharmacy within their borders by pharmacists who have not taken the NAPLEX, are not graduates of ACPE-approved programs, and are not locally licensed. If the states license these pharmacists without requiring the NAPLEX, are

(continued on page 88)

nabp newsletter

82

Feature News

The Federal Ephedra Ban and the Regulation of Dietary Supplements

However, as of April 12, 2004, the federal ban prohibiting the sale of ephedra containing dietary supplements (ephedrine alkaloids) went into effect and is now fully enforceable by law. In December 2003, Food and Drug Administration (FDA) announced the upcoming fi nal rule of the ephedra ban, urging consumers to discontinue the use of such supplements and warning ephedra dietary supplement manufacturers to halt production. Essentially, FDA concluded from its studies that ephedra-containing supplements “present an

unreasonable risk to the public health.”

Ephedrine Alkaloids: Sources, Uses, Pharmacology, and Adverse Effects 2

Most ephedra-containing dietary supplements are composed of alkaloids, which are found in various species of ephedra plants. Ephedrine alkaloids encompass a group of stimulants that primarily includes ephedrine, but also may contain pseudoephedrine, norephedrine, methylephedrine, norpseudoephedrine, or

Sales of dietary supplements reached $15.7 billion in the year 2000 in

the United States, and in 1999 it was estimated that 12 million individuals used ephedra-containing products, which alone1 constituted a billion-dollar industry. The February 2003 death of Baltimore Orioles’ pitcher Steve Bechler, which was attributed to ephedra toxicity, and the subsequent death of 16-year-old Sean Riggins of Lincoln, IL, who died of a heart attack after consuming an ephedra-containing dietary supplement to help him make the high school football team, spawned a statewide ban of ephedra-containing dietary supplements in Illinois, but has probably done little to persuade avid consumers of ephedra products to curb their usage.

methylpseudoephedrine. Naturally occurring ephedrine alkaloids are extracted from various plants such as Ephedra sinica and Ephedra equisetina that are commonly referred to as Ma Huang, Ephedra, or Chinese Ephedra.

Ephedrine alkaloids have reported benefi ts as a weight loss aid, athletic performance enhancer, and energy booster, although scientifi c evidence supporting these uses has been lacking. Due to their sympathomimetic properties and agonist stimulation of the alpha

1-,

, beta

1-, and beta

2-

adrenergic receptors, they have also been used as a bronchodilator and decongestant. Traditionalists in Asian medicine have used ephedrine alkaloids for the alleviation of sweating, bronchial constriction, and water retention.3

Adverse effects of ephedrine alkaloids can range from tachycardia, high blood pressure, and heart palpitations to stroke and myocardial infarction. Other adverse effects include dizziness, anxiety, irritability, insomnia, and headache. “Herbal ecstasy,” which contains ephedrine alkaloids, has been reported to have been used recreationally for its adverse effect profi le.

may-june 2004

83

Feature News

Ephedra-containing Dietary Supplements: History of FDA’s Regulatory Actions 4

In 1997, FDA published a proposed rule on ephedra-containing dietary supplements in response to reports of serious injuries and deaths that were attributed to the use of the supplement. The proposed rule included a number of recommendations including limiting the supplement to 8 mg of ephedrine alkaloid per serving and amending labeling that would warn consumers not to exceed a daily dosage amount of 24 mg of ephedrine alkaloid. The proposed rule also prohibited the inclusion of other ingredients with a stimulant effect such as caffeine and would also instruct consumers to contact their health care professional before using ephedra-containing dietary supplements if they were taking certain medications or had certain health conditions or diseases.

While FDA was receiving comments on the proposed rule, the Commission on Dietary Supplement Labels, an independent commission established pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA) to review and provide recommendations regarding dietary

supplements’ label claims and statements, issued its fi nal report and urged FDA to take “swift action within its regulatory authority to protect the public health from potentially unsafe dietary supplement.” About a year after the release of the Commission’s report, the US General Accounting Offi ce began a study and subsequently issued its fi ndings in July 1999. The Offi ce concluded that ephedra-containing dietary supplements could result in serious health problems and criticized FDA’s use of voluntary adverse event reports as a guide to formulating restrictions on dosage, frequency, and duration of use. In response to these reports, FDA issued an amended proposed rule on ephedra containing dietary supplements in April 2000. Essentially, FDA rescinded its previous per-serving limit of 8 mg (daily dose of 24 mg) and other labeling requirements but retained other aspects of the June 1997 proposal. FDA would continue to monitor the effects of ephedra-containing dietary supplements through the voluntary adverse event reporting system, allowing more time for the agency to collect information and evidence about the health risks of ephedra-containing dietary supplements. In

fact, on the same day that the revised proposed rule was issued, FDA released documents that detailed approximately 270 adverse event reports received between February and September 1997.

Nearly three years after its previous proposed rule, FDA published another notice in March 2003, making available all of the new information it had been collecting over the previous years, and solicited public comment concerning if dietary supplements containing ephedrine alkaloids are adulterated because they present a signifi cant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling or under ordinary conditions. New information included additional adverse event reports and also the study conducted by the Southern California Evidence-Based Practice Center, the RAND Report.5 The RAND study found that ephedra-containing dietary supplements were associated with higher incidences of heart palpitations, psychiatric effects, upper gastrointestinal effects, tremor, and insomnia, especially when they

(continued on page 86 )

nabp newsletter

84

Feature News

Effects of Importation on Patient Safety

One of the paramount concerns of those opposed to drug importation has been patient safety. Drugs that are imported from other countries bypass regulatory mechanisms that ensure the safety, quality, and effectiveness of drugs.

Joseph L. Bast, president and Chief Executive Offi cer of The Heartland Institute, suggested that alternatives to importation exist and discussed four effects of illegal drug importation.

1. Importation undermines valuable laws and legal precedents.

Panelists Discuss Drug Importation During NABP’s 100th Annual Meeting

During the continuing education session “Drug Importation: A Public

Policy Discussion,” held April 26, 2004, at NABP’s 100th Annual Meeting and Centennial Celebration in Chicago, IL, seven panelists discussed the effects of drug importation on public policy. The panel consisted of Joseph L. Bast, president and chief executive offi cer of The Heartland Institute; Michael J. Albano, former mayor of Springfi eld, MA; Ronald Guse, registrar of the Man itoba Pharmaceutical Association; Senator Chris Lauzen (R-Illinois, 25th District); Ram Kamath and Scott McKibbin, special advocates for Prescription Drugs for Illinois; and Rebecca H. Deschamps, executive director of the Montana Board of Pharmacy.

2. Any savings would only be short term.

3. Importation leads to social injustice.

4. Importation reduces investment in research, development, and testing new drugs.According to Bast,

the number one reason Americans travel to Canada, or other foreign countries, to purchase prescription drugs is price. In discussing alternatives, Bast stated, “If the goal is lower prices, a shorter route to get there is to continue recent steps to streamline the approval process for new and generic drugs and limit lawsuit abuse, thereby lowering drug costs.”

Bast continued to explain that if consumers called at least three pharmacies to compare prices they could save as much or more money than they would by going online – without the safety risks.

Concerning the undermining of valuable laws and legal precedents, Bast noted that it is appropriate for free trade governments to restrict the importation of products when the exporters are violating patents and contractual agreements forbidding resale.

He also remarked that drug importation has been illegal since 1987, but due to advances in technology (ie, the Internet and other telecom advances), changes in exchange rates, rising health care costs, and the fact that state-elected offi cials have become vocal advocates of importation, it has taken 17 years for the issue of drug importation to gain attention.

Ronald Guse, registrar of the Manitoba Pharmaceutical Association, noted that drug importation is more of a burden on the exporting country than the importing country and is resulting in rising drug prices for Canadians.

Guse further explained that drug importation is not “Internet pharmacy.” In reality, according to Guse, drug importation is increasing drug prices

may-june 2004

85

Deschamps also called for cross-border regulation because there is “no clear line of authority in cases of patient injury and currently foreign countries are not responsible for enforcing the United States’ laws.

Being in a border state, the Montana Board and Deschamps have had fi rsthand experience with cross-border pharmacies. She shared her thoughts and experiences in dealing with two storefront business operations that assisted US citizens in obtaining medications from foreign countries, such as Canada. The fi rst, Club Medz, took only a month to close its doors once the Board took action against the pharmacy. The second, Rx Depot, was a more diffi cult company to legally battle. The pharmacy was issued several warning letters, but the owner refused to comply and eventually a temporary injunction had to be obtained against Rx Depot. (For more information on Rx Depot see page 109 of the September 2003 NABP Newsletter). Recently, another Canadian pharmacy has appeared in Montana, Canadian Connection, which is operated by the same individuals who operated Rx Depot.

Feature News

(continued on page 89)

in Canada and impeding Canadians’ access to new and existing products and exacerbating the shortage of health care professionals and medications.

Guse explained that if drug importation is to continue, “there needs to be a cross-border agreement whereby pharmacies licensed in a province are recognized to meet or exceed standards for patient care and the shipment of medications into another country for the citizens of that country.”

Rebecca H. Deschamps, executive director of the Montana Board of Pharmacy, offered her comments on importation from the board of pharmacy perspective. Deschamps explained that like all boards of pharmacy, the Montana Board exists to protect the public health. Deschamps pointed out several factors that affect safety when patients import their medications:

! ! Patients are being pushed into a system with no pharmacist-patient relationship.

! ! Patients potentially patronize multiple pharmacies and multiple physicians with little or no oversight.

! ! Potential unauthorized drug substitution could cause confusion and/or adverse drug reactions.

She also remarked that, globally, there have been spotty attempts to address importation problems, but the inability to regulate across borders, and insuffi cient collaboration between countries has hampered efforts to quash importation. On a positive note, Deschamps remarked that there has been an increasing discussion at all levels, an exchange of ideas, and a search for possible solutions. She also noted the collaboration between NABP and FDA against importation and counterfeit drugs.

Benefi ts of Importation

Proponents of the legalization of drug importation convey that the cost of medications in the US has urged consumers to purchase medications from foreign sources. Former Springfi eld, MA Mayor Michael J. Albano offered his opinions and experiences in developing a prescription drug program for Springfi eld employees and retirees.

Albano discussed how Massachusetts had to cut costs while revenues were dropping and state and federal aid was dwindling. Due to Governor Milt Romney imposing cuts necessary to balance the budget, Springfi eld lost $4 million in previously

nabp newsletter

86

Ephedra Ban

were taken with other stimulants. The Report also identifi ed sentinel events such as stroke, heart attack, and even death. Moreover, the Report illustrated that the scientifi c literature did not support a clinically signifi cant fi nding on enhanced athletic performance with the use of ephedra alone and that there was limited scientifi c evidence of ephedra’s benefi ts in weight loss.

In all, FDA has received more than 48,000 comments in response to its proposed rule making notices from individual consumers, independent distributors of ephedra products, medical professionals, scientists, medical and scientifi c associations, state and local heath departments, government agencies, consumer groups, and dietary supplement trade associations. Consequently, in December 2003, FDA determined that the risks of dietary supplements containing ephedrine alkaloids, when used for their labeled indications or under ordinary conditions of use, outweigh the benefi ts of these products and that these risks cannot be adequately mitigated through regulatory measures available to FDA for dietary supplements, such as warnings in labeling.

Highlights of the Final Rule

Essentially all dietary supplements containing ephedra are considered “adulterated” under the federal Food, Drug, and Cosmetic Act, section 402(f)(1)(A), because the use of these dietary supplements presents an “unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use.” The fi nal rule gives FDA a powerful enforcement tool to prosecute violators; grant injunctions; and implement seizures of products from individuals, manufacturers, and distributors of such products.

Over-the-counter medications, such as Broncholate Syrup® and Primatene Tablets®, which contain ephedrine, are not subject to the ruling. The fi nal ruling also does not apply to the use of ephedra preparations in the practice of traditional Asian medicine because, according to FDA, traditionalists usually do not use ephedra products that are marketed as dietary supplements.

The Dietary Supplement Health and Education Act

The DSHEA established a new regulatory frame-work for dietary supplements, which, prior to the DSHEA, had been regulated as a food. Overall, the DSHEA defined dietary supplements, delegated authority to FDA to regulate dietary supplements, and addressed labeling requirements and health claims.

According to the DSHEA, a dietary supplement is a product taken by mouth “intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, mineral, herb or other botanical, amino acid, a dietary substance for use by man [/woman] to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any ingredient above.”

Perhaps one of the biggest criticisms of the DSHEA is that the onus of proving a dietary supplement unsafe resides with the federal government and, under the DSHEA, dietary supplement manufacturers do not have to provide safety information or report adverse events associated with their products to

FDA. Unlike prescription drug manufacturers, proof of safety and effi cacy are not required of dietary supplements prior to marketing or distribution. In fact, research has revealed that some dietary supplements may be contaminated with toxic substances like arsenic and may also have signifi cant discrepancies between the actual and listed amount of the active ingredient.6,7 Instances where the use of dietary supplements has resulted in signifi cant public harm (ie, kava [piper methysticum]-induced hepatotoxicity and aristolochic acid-induced urothelial carcinoma) have led some to advocate that dietary supplements should meet similar rigorous safety and effi cacy testing like that of prescription drugs. In March 2003, FDA accepted comments on its proposed rule that, if adopted, would establish current Good Manufacturing Practices for dietary supplement fi rms.

Labeling of dietary supplements must include the name of the product, the manufacturer’s name and address, a complete list of ingredients, and the net contents of the product. Additionally, most dietary supplements’ labeling must contain a “Supplement Facts” panel that serves to identify each dietary ingredient contained in the product.

(continued from page 83)

Feature News

may-june 2004

87

®�

Dietary claims, which are regulated by FDA and the Federal Trade Commission (FTC), should not be false or misleading. Claims made by dietary supplements generally fall into three categories: health claims, structure/function claims, and nutrient content claims. The DSHEA requires the inclusion of a “disclaimer” statement when a dietary supplement manufacturer makes a structure/function claim: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease.” However, FDA may approve certain health claims that have been validated by scientifi c evidence or based upon an authoritative statement by a scientifi c body recognized by FDA. Examples include

calcium supplementation to reduce the risk of osteoporosis and the use of folic acid in reducing neural tube birth defects.

FDA and the FTC have long partnered to protect the public against dietary supplement scams that have purported to treat or cure serious diseases such as cancer, HIV/AIDS, and diabetes. False and unsubstantiated claims that FDA and the FTC have confronted include the use of St John’s Wort as a safe and effective treatment for HIV/AIDS, herpes simplex, and other infectious diseases. In February 2000, FDA published a public health advisory warning health care professionals and consumers that a National Institutes of Health study showed that St John’s Wort may interact with

certain prescription medications, including the HIV-1 protease inhibitor, indinavir, possibly resulting in decreased effectiveness. However, despite efforts on behalf of FDA and the FTC, factors such as increasing consumer Internet savvy and the vulnerability of desperate patients who seek a cure for terminal diseases may make it even more diffi cult to regulate such activity.

The Pharmacist’s Role Pharmacists can advise

patients on using reputable dietary supplement brands and inform them on how to notice false or misleading claims. In December 2003, FDA’s Offi ce of Nutritional Products, Labeling, and Dietary Supplements issued a consumer guide, Tips for Older Dietary Supplement Users, which advises

Feature News

References: The Federal Ephedra Ban and the Regulation of Dietary Supplements1. Gugliotta G, Health

concerns grow over herbal aids. Washington Post. 2000; March 19.

2. Hume AL, Strong KM. Herbal Products. In: Berardi RR, DeSimone EM, Newton GD, et al, eds. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 13th ed. Washington, DC: American Pharmacists Association; 2002: 1085-1086.

3. Lavelle JB, Krinsky DL Hawkins EB, et al. Natural Therapeutics Pocket Guide. Hudson: Lexi-Comp, Inc; 2000-2001.

4. 21 CFR 119 Final Ruling Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Final Rule. Washington, DC: US Department of Health and Human Services, Food and Drug Administration, February

consumers on how to use dietary supplements safely. This guide can be obtained from FDA’s Web site at www.cfsan.fda.gov/~dms/ds-savv2.html.

Pharmacists, regardless of practice setting, must be knowledgeable about dietary supplements and especially their potential effects on the patient’s medication therapy. Assessing the patient’s medication plan includes the consideration of the patient’s use of dietary supplements and other complementary alternative therapies. Resources such as the Professional’s Handbook of Complementary & Alternative Medicines, Natural Therapeutics Pocket Guide, and Natural Medicines Comprehensive Database may be useful.

2004. Federal Register Docket No. 1995N-1304.

5. Shekelle P, Morton S, Maglione M, et al. Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Effi cacy and Side Effects. Evidence Report/ Technology Assessment. Prepared by Southern California Evidence-Based Practice Center, RAND Corporation. Agency for Healthcare Research and Quality,

Docket No. 1995N-0304, BKG3, vol. 300.

6. Kew J, Morris C, Aihie A, et al. Arsenic and mercury intoxication due to Indian ethnic remedies. British Medical Journal. 1993; 306:506-7.

7. Gurley BJ, Gardner SF, Hubbard MA. Content versus label claims in ephedra containing dietary supplements. Am J Health-Syst Pharm. 2000; 57:963-9.

nabp newsletter

88

Legal Briefs

they engaging in activities that may affect the uniformity in respect to licensure transfer that NABP has sought over its 100-year history? Emphatically, yes!

Eligibility for initial licensure is determined strictly by the state legislatures through the practice acts and not by boards of pharmacy or NABP. NABP urges that the criteria for original licensure be uniform among the states to facilitate licensure transfer. A state that would permit licensure transfer of individuals who are not graduates of ACPE-approved programs and who did not take the NAPLEX but were licensed by fi at to facilitate the dispensing of drugs from Canada to patients or facilities in the US would, in our opinion, be in violation of the NABP Constitution and Bylaws. Uniformity would be destroyed because of the elimination of the NAPLEX, which is the lynchpin of the licensure transfer system.

Under a literal interpretation of the Constitution and Bylaws of NABP, several states could be found in violation of the Association’s governing documents. Such fi ndings, however, would not be in keeping with the historical development of NABP, particularly when the activities of these “delinquent” boards do not effect and, perhaps, foster uniformity in respect

to licensure and licensure transfer. A continual strict interpretation of the Constitution and Bylaws would stagnate the growth of the Association. Based on these concepts and considerations, the Executive Committee made the decision to declare Active Membership status for California and Florida boards. It did so without compromising the principles and philosophy of NABP.

Perhaps the historical progress of NABP over the last 100 years that has been fostered by the fl exibility of its members, governing documents, and governing body and the understanding and patience of its membership is best expressed in a poem by an anonymous member of the Maine Board

(continued from page 81)

of Pharmacy published in 1904 (see sidebar below).

A Note from Atkinson & Atkinson

Our law fi rm has had the honor of providing legal services for NABP since 1965. During the period of our representation, we have had the privilege of participating in so many of NABP’s historical developments that have brought the Association to its most prestigious position in pharmacy regulation today. These would include the examination program (Blue Ribbon Exam, National Association of Boards of Pharmacy Licensure Examination, NAPLEX, Foreign Pharmacy Graduate Equivalency Examination®, Federal Drug Law Examination, MPJE); obtaining Section

501(c)(3) status from the Internal Revenue Service; the formation of the NABP Foundation; the formation of the FPGEC; exempting NABP from real estate and sales taxes in Illinois; the acquisition of the Park Ridge and Mount Prospect properties; the development of the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy; the Verifi ed Internet Pharmacy Practice Sites™ program; International Pharmaceutical Federation; Electronic Licensure Transfer Program®; annual meetings; district meetings; and presentations and seminars, to name a few.

During this historical period, NABP has emerged as one of the most respected and meaningful

If I knew you and you knew me,‘Tis seldom we would disagree;Without our having yet clasped hands,We often fail to understand,That each of us intend what’s right,And treat each other ‘honor bright,’Now little to complain there’d be,If I knew you and you knew me.

When Maine ‘holds up’ a candidate,Or passes one you would not rate;From irritation you’d be free,If I knew you and you knew me.Or when you’d write for information,On a point of some vexation,The subject would be cleared, you see,If I knew you and you knew me.

‘If I Knew You and You Knew Me’Or when disputed points arise,And back and forth the discussion fl ies;You’d take it in good part, you see,If I knew you and you knew me,With responsibilities ten thousand strong,Occasionally things will go wrong,Sometimes our fault, sometimes theirs,Forbearance would decrease all cares.Kind friends how pleasant it would be,If I knew you and you knew me.

Then let no doubting thought abide,Or fi rm good faith on either side;Confi dence to each other give,Living ourselves, let others live.And when we chance each others way,Call, fi nd the latch string out to stay,Then face to face we each shall be,And I’ll know you and you’ll know me.

(continued on next page)

Legal Briefs

may-june 2004

89

®�

Drug Importation

legislated aid and $3.2 million of its share of the state lottery funds. He noted that by switching Springfi eld’s prescription drug plan for maintenance drugs to a pharmacy in Windsor, Canada, the savings reaped by the city have enabled it to cover participants’ $15 copayments.

In an August 10, 2003 article from The Ottawa Citizen entitled “I noticed nobody said I was crazy,” Albano stated, “Every time somebody asks about the Springfi eld plan, they also quote the FDA, which repeatedly warns that it cannot guarantee the ‘safety’ of products from Canada. Well, I cannot guarantee my citizens safety with fewer police and fi refi ghters on hand to protect them.”

Senator Chris Lauzen (R-Illinois, 25th District) discussed the benefi ts

offered to Illinois residents who sign up with the Illinois Health Alliance (IHA); both uninsured and underinsured people can save an average of 50% on the cost of their prescriptions. Lauzen explained that the IHA works in partnership with government and private sectors and gives Illinois citizens access to a wide range of prescription drugs through a simple online order through “proven” Canadian sources.

Ram Kamath, PharmD, and Scott McKibbin, special advocates for prescription drugs for Illinois Department of Public Aid, discussed the central policy issue “Can Illinois state employees and retirees safely purchase prescription drugs in Canada at a lower cost to the taxpayers?”

According to Kamath and McKibbin, the answer is yes. They explained that safeguards have been built into this proposed plan to ensure patient safety. These safeguards include:

! ! The requirement that patients submit their medical history;

! ! The list of drugs that could be imported would exclude habit-forming medications and antibiotics that were generically available in the US, and those drugs that are likely to spoil in transit; and

! ! The requirement that patients only import drugs prescribed by a US doctor that have fi rst been dispensed by a local pharmacy as a 30-day supply.

In their research to fi nd lower cost prescription drugs for Illinois residents, McKibbin and Kamath stated that the regulatory systems in Canada and the US provide substantially equal protection for the health and safety of the public. Their fi ndings were:

! ! Methods of ensuring safety and effi cacy of prescription drugs are comparable;

(continued from page 85)

Feature News

! ! Requirements for manufacturing, warehousing, and storage of pharmaceuticals are comparable; and

! ! Pricing and distribution of drugs is less likely to foster drug counterfeiting.

The proposed Illinois plan consists of a contract with a non-domestic pharmacy benefi ts manager, or similar entity; the establishment of a primary care pharmacist model; and the requirement that shipping costs of Canadian sources be paid by the employees and retirees. The plan will only approve long-term use, brand-name drugs approved in the US by FDA.

The Illinois plan is based upon cost savings. According to McKibbin and Kamath, under this proposed plan all copayments will be waived and the participants will pay shipping costs estimated at $12 per order.

national and international organizations in pharmacy. This stems from its steadfast efforts to maintain its independence and to constantly focus upon its mission to aid its members

in the protection of the public health and welfare.

On behalf of the members of our fi rm, Jack Atkinson, Dale Atkinson, and Julia Works, and our staff, Lana Bolorforoush and Katie Litchman, we thank NABP; its board members; its affi liated

members; its Executive Committee members, past and present; and the NABP executive directors with whom we have so closely worked, Fred Mahaffey and Carmen Catizone, and congratulate NABP for 100 years of service that has so enhanced NABP’s member

boards, those in regulation, the profession of pharmacy, and the general public. We are forever grateful to NABP for providing our fi rm with the opportunities, knowledge, and experience that has fostered our many representations in the regulatory community.

Legal Briefs(continued from previous page)

®�

nabp newsletter

90

100th Annual Meeting

ACPE Executive Director Peter H. Vlasses presented this engraved Steuben Crystal gift entitled “Partnership,” symbolizing the collaboration and cooperation that NABP and ACPE share. The piece suggests “partnership of equals based on shared values and ideals.”

Lois Cantin, president of the Manitoba Pharmaceutical Association and the past president of NAPRA, presents a token of NAPRA’s appreciation and congratulations to NABP, a Panichini original oil painting of a Montreal street.

Kathy Apple, executive director of the National Council of State Boards of Nursing, comes forward to bestow a crystal vase that reads “National Association of Boards of Pharmacy, 1904-2004, 100 Years of Dedicated Public Protection Service Presented by the National Council of State Boards of Nursing, April 25, 2004.”

From the Pharmacy Board of New South Wales, Gerard McInerney presents a gift from the Board and its members, a plaque made of Australian native wood embedded with two medals depicting the name and established year of the Pharmacy Board of New South Wales. The inscription on the plaque reads “Presented to the National Association of Boards of Pharmacy in Recognition of a Hundred Years Service, 2004.”

Congratulatory Presentations to NABP During Its 100th Annual Meeting and Centennial Celebration

During the First Business Session held on Sunday, April 25, 2004, at The Fairmont Chicago in Chicago, IL, the Accreditation Council for Pharmacy Education (ACPE), National Association of Pharmacy Regulatory Authorities (NAPRA), National Council of State Boards of Nursing (NCSBN), the Pharmacy Board of New South Wales, and the United States Pharmacopeia, Inc (USP) graciously honored NABP with congratulatory presentations in

celebration of the Association’s 100th anniversary. All of these organizations had many positive things to say about NABP and their relationship with NABP. NCSBN stated, “In honor of NABP’s Centennial Celebration, this is a crystal vase with the inscription ‘The National Association of Boards of Pharmacy, 1904-2004, 100 Years of Dedicated Public Protection Service Presented by the National Council of State Boards of Nursing, April 25, 2004.’” USP stated, “In recognition, USP has commissed an artistic work, a collage that has representations of the close history of NABP and USP.”

®�

may-june 2004

91

100th Annual Meeting

USP Executive Vice President and CEO Roger L. Williams accompanied by Angie Long come forward to present their gift, a shadow box and collage that contain representations of the close history between NABP and USP.

NABP Receives Congratulatory Letters from Allied Pharmacy Associations, Federal Agencies

In honor of NABP’s 100th anniversary, the Association received a multitude of letters from allied pharmacy associations and federal agencies offering anniversary greetings. Each letter was incorporated into NABP’s historical publication, The National Association of Boards of Pharmacy: The Consolidating Years: 1979 – 2004, as well as on display during the Association’s 100th Annual Meeting and Centennial Celebration, April 24-27, 2004, at The Fairmont Chicago in Chicago, IL.

NABP truly appreciates the kind sentiments from the following associations and agencies:

Academy of Managed Care Pharmacy

Accreditation Council for Pharmacy Education

American Association of Colleges of Pharmacy

American College of Clinical Pharmacy

American Pharmacists Association

American Society for Pharmacy Law

American Society of Consultant Pharmacists

American Society of Health-System Pharmacists®

Consumer Healthcare Products Association

Federation of Associations of Regulatory Boards

Healthcare Distribution Management Association

National Association of Chain Drug Stores

National Association of Pharmacy Regulatory Authorities

National Community Pharmacists Association

National Council on Patient Information and Education

National Institute for Standards in Pharmacist Credentialing

The Pharmacy Examining Board of Canada

Pharmacy Technician Certifi cation Board

United States Drug Enforcement Administration

United States Pharmacopeia

For a copy of NABP’s historical publication, The National Association of Boards of Pharmacy: The Consolidating Years: 1979 – 2004, please contact the Customer Service Department at 847/698-6227 or via e-mail at custserv@nabp.net.

®�

NABP counsel, the law fi rm of Atkinson & Atkinson, also made a congratulatory presentation, an elegant Pharmacy Lladro Figurine with the inscription “NABP, 100 Years of Public Service, 1904-2004, Atkinson & Atkinson, to NABP on Friday, April 23, 2004.”

nabp newsletter

92

Around the Association

Work, Wright Receive APhA Awards

The American Pharmacists Association (APhA) recognized two NABP members with awards during its Annual Meeting, March 27-30, 2004, in Seattle, WA. North Carolina Board of Pharmacy Executive Director David R. Work, RPh, received the Hubert H. Humphrey Award for infl uencing the North Carolina legislative process by stimulating debate and promoting the pharmacist as a health care professional. APhA also awarded the Gloria Niemeyer Francke Leadership Mentor Award to Sr Margaret Wright, RSM, PhD, for her contributions to the pharmacy profession. Throughout the years, Sister Margaret has demonstrated a continued commitment to leadership and mentoring of new pharmacists.

Luce Installed on APhA Board of Trustees

Wisconsin Pharmacy Examining Board Member Daniel F. Luce was installed on the

(continued on page 94)

Association News

Rudolph Giuliani, former mayor of New York City, shared some of his experiences as mayor and his recent involvement in the illegal drug importation issue during NABP’s 100th Annual Meeting and Centennial Celebration, on Monday, April 26, 2004, in Chicago, IL. During his remarks, he told attendees that the illegal importation of foreign drugs leaves the United States drug supply open to biological and chemical attacks.

Giuliani cautioned that bioterrorism and chemical attacks are very real threats, as evidenced by the anthrax attacks in Washington, DC, and New York City after September 11, 2001. Americans tend to forget these attacks happened, he added. Giuliani said that as politicians focus on the lower cost of drugs from foreign sources, Americans are lulled into a false sense of confi dence over the safety of the drugs they order over the Internet.

Currently, Giuliani’s consulting fi rm, Giuliani Partners, is studying foreign drug importation. As part of his research, Giuliani toured the John F. Kennedy International Airport postal facility in New York

Former Mayor Giuliani Addresses NABP Members on Drug Importation

to study how drugs are entering the US drug system from foreign countries. He learned that the facility receives 40,000 parcels a day from foreign countries; however, only about 500 of these can be inspected on a daily basis. Giuliani told the audience that while at the facility he saw expired medications, and drugs that are inappropriate for self-administration –for example, Lupron, the injectable hormone he received to stop the spread of prostate cancer.

Giuliani noted that he himself was a benefi ciary of the US health care system. Without it, he said, he would not have been able to survive prostate cancer. “It is critical for America to ensure that we have the proper medication to preserve our lives, extend our lives, and improve the quality of our lives,” he said.

“Americans can save money by purchasing their drugs from foreign sources, but it is at a substantial cost to their safety,” Giuliani stressed. Conditions he cited that compromise the safety of patients who purchase drugs from foreign sources include the lack of patient-doctor interaction,

access to drugs without a prescription, no control over multiple medications and contraindications, lack of government inspections for imported drugs, unmanaged polypharmacy, and the requirement that Americans sign a waiver releasing pharmacies from liability.

®�

Attendees of NABP’s 100th Annual Meeting and Centennial Celebration had the opportunity to hear Rudolph Giuliani, former mayor of New York City, speak on the dangers of drug importation. After his speech, Giuliani held a news conference to talk about the importation study his consulting fi rm, Giuliani Partners, is currently conducting.

may-june 2004

93

The United States Food and Drug Administration (FDA) presented NABP the FDA Commissioner’s Special Citation from the United States Food and Drug Administration (FDA) for the Association’s leadership in protecting the public from the emerging threat of counterfeit drugs through the Model Rules for Licensure of Wholesale Distributors, which is part of the Model State Pharmacy Act and Model

NABP Awarded Comissioner’s Special Citation from FDARules of the National Association of Boards of Pharmacy. The citation was presented at FDA’s Agency Ceremony on Friday, May 7, 2004, in Gaithersburg, MD.

FDA noted that the Association’s Model Rules for Licensure of Wholesale Distributors protects the public from counterfeit drugs by allowing state regulators to enhance individual state regulatory safeguards.

Association News

Pictured above from left are John M. Taylor, associate commissioner for Regulatory Affairs; John A. Fiacco, NABP past president; Donna S. Wall, chairperson of the NABP Executive Committee; Carmen A. Catizone, NABP executive director/secretary; and Lester M. Crawford, acting commissioner for Regulatory Affairs.

NABP’s second item- writing workshop for the Pharmacist Self-assessment Mechanism™ (PSAM™) was held April 30, May 1, and May 2, 2004, in Rosemont, IL, with development of the tool progressing on schedule. The PSAM is one part of NABP’s Continuing Professional Development (CPD) program, a cyclical process that includes refl ecting upon one’s practice, conducting a learning needs assessment, developing a learning plan, implementing the learning plan, and evaluating the learning plan outcomes. As a component of CPD, the PSAM facilitates the general pharmacy practitioner’s ability to conduct a needs assessment and develop a learning plan.

PSAM Development Moving ForwardThe PSAM will consist of

approximately 100 stand-alone and profi le-based multiple-choice questions. After completing the PSAM, pharmacists will receive feedback on their results including information on correct and incorrect answers and references for each question so that users can research more information on the topics covered. One of the most important elements of the PSAM is that the tool goes beyond testing knowledge of drugs and disease states by providing important feedback on a pharmacist’s ability to assess and communicate with patients.

The PSAM is intended to be a non-punitive means

by which a pharmacist can assess his or her own strengths and weaknesses; thus, all PSAM score

information will be reported only to the candidate; employers and boards

of pharmacy will not have access to any score information. The fi rst PSAM version will be a generalist examination applicable to pharmacists in any practice setting. In the future, the PSAM may expand to include versions specifi c to practice sites.

The third PSAM item-writing workshop is scheduled for July 19-21.

NABP anticipates that the PSAM will be available by the end of 2004.

®�

NABP have registered 1,678 candidates for the Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®). The FPGEE is being offered at two United States locations: Northlake, IL (Chicago area); and Hempstead (New York City area), NY.

To prepare for the FPGEE, candidates can take the Pre-FPGEE™, which is accessible at www.nabp.net and www.pre-fpgee.com.

For more information on the FPGEE, visit NABP’s Web site at www.nabp.net.

June 2004 FPGEE Approaching

®�

®�

nabp newsletter

94

Around the Association(continued from page 92)

APhA Board of Trustees on March 30, 2004.

Missouri Board Has New Web Address

The Missouri Board of Pharmacy, through the Division of Professional Registration, has a new Web site address: www.pr.mo.gov. Upon reaching the Division Web site, click on the icon representing “regulated professions,” then fi nd the notation for pharmacists and pharmacies and click on that link, which will take you to the Board of Pharmacy Web site.

New Offi cers at Indiana Board

The titles of several Indiana Board of Pharmacy offi cers and members have recently changed. Jesse Burks is now president, Winnie Landis is now vice president, and Sara St Angelo is now a member.

Tennessee Appoints New Board Member

Monica K. Franklin was named public board member of the Tennessee Board of Pharmacy on January 28, 2004. Her term will expire on December 31, 2009.

®�

Professional Affairs Update

Washington Rxs Provide Increased Access to Hormonal Contraceptive

The University of Washington School of Pharmacy and Department of Obstetrics and Gynecology in Seattle, WA, recently launched a research study intended to give women better access to birth control methods without fi rst having to visit a physician or other health care practitioner. The study, which is funded by the National Institutes of Health, has already enrolled 50 women; by the end of the study, researchers hope to enroll as many as 300 women.

Enrollees in the study are able to obtain hormonal contraceptives from a pharmacist if they meet certain requirements. If study participants are “18-45” years old, pass a good-health checklist, weigh less than 200 pounds, and have a normal blood pressure, they can obtain three months of birth control pills or patches. The fee for the pharmacy visit is $25 plus the cost of the medication.

Eight pharmacies located in the Seattle area are participating in this research study. Pharmacists must complete a training session and follow strict protocol guidelines. Advocates of the research study hope that the idea will gain momentum in other states.

The Associated Press, March 15, 2004

New Barcode Requirements Aim to Reduce Risk of Medication Errors

In late February, Food and Drug Administration (FDA) issued the fi nal rule “Bar Code Label Requirements for Human Drugs Products and Biological Products.” This fi nal rule requires the inclusion of linear bar codes on most prescription drugs and certain over-the-counter medications. Each bar code must, at minimum, contain the drug’s National Drug Code number, but companies are encouraged to include additional information such as the product’s lot number and expiration date. The fi nal rule also specfi es certain bar code requirements for blood and blood products used in transfusions. FDA is hoping that the bar code rule will encourage the widespread adoption of advanced information systems that, in some institutions, have reduced medication errors by 85%.

FDA expects that, with full implementation, the linear bar codes will result in more than 500,000 fewer adverse events over the next 20 years and a 50% reduction in medication errors that would otherwise have occurred upon dispensing or administration. For more information including a link to the fi nal rule, please

visit the following Web site: www.fda.gov/oc/initiatives/barcode-sadr.

Generic Oxycodone Hydrochloride Extended-release Tablets Approved

On March 23, 2004, FDA announced that it had approved two generic versions of the popular opioid OxyContin®, which is used for the management of moderate-to-severe chronic pain.

FDA also expressed its concern for the potential of abuse, misuse, and diversion of oxycodone and similar products. In an attempt to confront the illegal diversion and abuse of prescription drugs, FDA, along with Drug Enforcement Administration and the Offi ce of National Drug Control Policy, announced a coordinated strategy in early March. The strategy includes more careful attention to the labeling and commercial promotion of opioid drugs; wider dissemination of education and training on appropriate pain management to physicians authorized to prescribe controlled substances; increasing the number of state prescription monitoring programs; and using technology to identify, investigate, and prosecute Internet pharmacies that illegally provide controlled substances.

®�

may-june 2004

95

Association News

®�

Even though NABP’s 101st Annual Meeting, May 21-24, 2005, at the Sheraton New Orleans Hotel in New Orleans, LA, is not for another 11 months, it is not too early to consider applying for NABP’s Annual Meeting Travel Grant.

This program assists those state boards of pharmacy that may not otherwise be able to send a voting delegate to the Annual Meeting. The program will reimburse the board’s offi cial delegate up to $750 in travel expenses including transportation,

Apply Now for NABP’s Annual Meeting Travel Grant hotel, accommodations, and meals. Boards of pharmacy that are not reimbursed for travel expenses by the state are eligible to receive a travel grant.

Interested boards must have their offi cial delegate complete an application, which can be obtained by calling, e-mailing the NABP Executive Offi ce, or downloading the application online at www.nabp.net, and submit documentation that his or her state will not provide reimbursement for Annual Meeting attendance. This documentation can be in

the form of a per diem or travel policy, or a letter stating that the state will not reimburse the board of pharmacy for expenses incurred by attending NABP’s Annual Meeting. Grant monies cannot be applied to Annual Meeting registration fees.

All applications and supporting documents must be received at NABP

Headquarters no later than December 31, 2004.

Applicants will begin receiving notifi cation in February 2005, stating whether or not they have qualifi ed for a grant.

For more information, e-mail the Executive Offi ce at exec-offi ce@nabp.net. Materials should be sent to the NABP Foundation, Attn: Annual Meeting Travel Grant Program, 700 Busse Hwy, Park Ridge, IL 60068.

Avery L. Spunt, RPh, MEd (left), NABP’s competency assessment director, presented Donald H. Williams (right), Advisory Committee on Examinations (ACE) chairman and executive director of the Washington State Board of Pharmacy, a plaque of appreciation for his service on ACE at the March 8, 2004 ACE meeting in Rosemont, IL. Williams’ term on ACE expired on May 31, 2004.

®�

NABP would like to clarify references to the Accreditation Council for Pharmacy Education’s (ACPE) role in the adoption of a technician accreditation program published in the February 2004 NABP Newsletter article “NABP Comments on ACPE Pharmacy Technician Accreditation Plan.” ACPE, which was studying technician accreditation at the request of the Council on Credentialing in Pharmacy (CCP), had no preconception that an accreditation system for pharmacy technician

Clarifi cationeducation and training –if agreed upon after profession-wide discussion –would be comparable to the accreditation system for the professional degree program in pharmacy. The feasibility of such a system, therefore, was not being studied by ACPE. Following publication of the article, CCP released a press release stating that further discussion must take place profession wide before a draft set of standards can be initiated. ACPE is not developing a draft set of competency-based standards.

nabp newsletter

96

National Association of Boards of Pharmacy

700 Busse Highway

Park Ridge, Illinois 60068

nabp newsletter

®�

Association Highlights

ReminderThe summer

administration of the Foreign Pharmacy

Graduate Equivalency Examination® will be held

June 26, 2004 in Northlake, IL, and Hempstead, NY.

Boards of pharmacy can direct candidate questions

to NABP’s Customer Service Department at

847/698-6227.