newsletter - NABP · rate is $35 per year. National Association of Jessen, RPh, JD, executive...

newsletterNational Association of Boards of Pharmacy®

aid to governmentthe profession

the public1904 to 2007

June -July 2007 / Volume 36 Number 6

(continued on page 91)

In This Issue. . . .Association News: NABP/AACP District Meetings Address Current Issues, Future Goals

91 94 10092

Feature News: Pharmacy Groups Respond to News Media Portrayal of Medication Error ‘Epidemic’

Association News: June FPGEE Administration Numbers Reported

Legal Briefs: 103rd Annual Meeting Report of Counsel

Upcoming Events

August 5-7, 2007 NABP/AACP District 3 Meeting Royal Plaza in the Walt Disney World Resort Orlando, FL

August 16-18, 2007 NABP/AACP District 5 Meeting Holiday Inn Express Hotel & Suites Deadwood, SD

September 16-18, 2007 NABP Fall Legislative Conference Hyatt Regency Crystal City Arlington, VA

October 3-6, 2007 NABP/AACP District 7 and District 8 Meeting Ashland Springs Hotel Ashland, OR

October 11-12, 2007 NABP/AACP District 2 Meeting Hotel DuPont Wilmington, DE

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Professional Affairs Update: FDA Evaluates Creating BTC Class of Drugs

NABP recently awarded its first durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) accreditation to North Coast Medical Supply, dba Advanced Diabetes Supply. Pharmacies accredited through the NABP DMEPOS program are doing their part to ensure that Medicare beneficiaries receive the appropriate products, services, and patient care associated with DMEPOS products and will position themselves for participation in the Centers for Medicare and Medicaid Services’ (CMS) competitive bidding process.

“We chose the NABP DMEPOS accreditation program because we are a pharmacy,” says Tim Cady, president of Advanced Diabetes Supply. “We looked at the processes of the different accrediting

NABP Awards First DMEPOS Accreditation; CMS Opens Competitive Bidding

bodies in the market and decided that NABP had the most well laid out procedures. As we went through the accreditation, NABP followed up quickly every step of the way, returning phone calls promptly, processing our application quickly, and approaching us in a professional manner. They did exactly what they said they would do and the deadlines they quoted were right on target.”

In November 2006, NABP received deeming authority from CMS to accredit pharmacies that supply DMEPOS products. The Association’s DMEPOS accreditation program, which meets all CMS quality standards, is the best suited for understanding the needs of pharmacies that provide a limited line of

durable medical equipment while falling in line with the Association’s mission to protect the public health.

“NABP has more than 100 years experience in pharmacy regulation and therefore understands the complexities of pharmacy practice and regulation and invites pharmacies seeking DMEPOS accreditation to apply to the NABP impartial and independent accreditation program,” states NABP President Oren M. Peacock, Jr, RPh. “NABP provides pharmacies with a cost-effective and straight forward accreditation process that meets CMS requirements and is the only pharmacy-specific

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The NABP Newsletter (ISSN 8756-4483) is published 10 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 reflect the

official 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

847/391-4406 www.nabp.net

[email protected]

Carmen A. Catizone Executive Director/

Secretary

Mary A. Dickson Associate Executive

Director

Larissa Doucette Editorial Manager

©2007 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.

Association News

Two new Executive Committee members were inaugurated during the NABP 103rd Annual Meeting, May 19-22, 2007, in Portland, OR. Elizabeth Scott “Scotti” Russell, RPh, executive director of the Virginia Board of Pharmacy, was elected to a three-year member term representing District 2, and Cathryn J. Lew, RPh, a member of the Oregon State Board of Pharmacy, was elected to a two-year member term representing District 7. In addition, Lloyd K. Jessen, RPh, JD, executive director/secretary of the Iowa Board of Pharmacy (District 5), and Karen M. Ryle, MS, RPh, a member of the Massachusetts Board of Registration in Pharmacy (District 1), were both re-elected to serve three-year member terms.

Elizabeth Scott “Scotti” Russell, RPhRussell was named executive director of the Virginia Board of Pharmacy in 1991, after serving as pharmacy investigator/inspector since 1982. Prior to joining the Board, she served as a pharmacist in institutional and community practice settings. An active member of NABP, Russell has served on many Association committees and task forces including the Task Force

on Standardizing Student Pharmacist Experiential Requirements, the Task Force on E-Pedigree Requirements, and the Committee on Constitution

and Bylaws. In addition, she is a commissioned officer of the United States Department of Health and Human Services Food and Drug Administration. She is also a member of the National Association of State Controlled Substances Authorities and the Virginia Pharmacists Association. Russell graduated from the Medical College of Virginia/Virginia Commonwealth University with a bachelor of science degree in pharmacy.

Cathryn J. Lew, RPhLew was first appointed

to the Oregon State Board of Pharmacy in 2001 and was reappointed in 2004. During this time, she

was elected by the Board to serve as president for one year and as vice president for two years. As an active member of NABP, she has served on the Committee on Law Enforcement/Legislation. Currently, Lew is a clinical staff pharmacist at Sacred Heart Hospital, Home Infusion/Hospice, a position she has held since 1983. In addition, she serves as a pharmacy consultant at the Oregon Endoscopy Center and Oregon SurgiCenter. Previous positions she has held include serving as a pharmacist at the

University of Oregon Student Health Center as well as staff pharmacist at the Salem Hospital – SHAPES. A graduate of Oregon State University, Lew earned a bachelor of science degree in pharmacy.

Two New Executive Committee Members Inaugurated at NABP 103rd Annual Meeting

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Executive CommitteeLawrence H. “Larry” Mokhiber Chairperson One-year term

Oren M. Peacock, Jr President One-year term

Richard A. “Rich” Palombo President-elect One-year term

Gary A. Schnabel Treasurer One-year term

Karen M. Ryle Member, District 1 Serving first year of a three-year term

Elizabeth Scott “Scotti” Russell Member, District 2 Serving first year of a three-year term

Reginald B. “Reggie” Dilliard Member, District 3 Serving third year of a three-year term

William T. “Bill” Winsley Member, District 4 Serving third year of a three-year term

Lloyd K. Jessen Member, District 5 Serving first year of a three-year term

Malcolm J. Broussard Member, District 6 Serving second year of a three-year term

Cathryn J. Lew Member, District 7 Serving first year of a two-year term

Patricia F. Harris Member, District 8 Serving third year of a three-year term

The NABP Executive Committee is elected each year at the Association’s Annual Meeting.

On June 23, 2007, the Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®) was administered to approximately 2,150 individuals, the largest number since 2003. In comparison, 1,865 individuals sat for the examination in June 2006 and 1,618 individuals in December 2006. Of the 2,150 individuals who tested in June, approximately half were repeat test takers.

To accommodate the large number of applicants wishing to sit for the June administration, NABP opened a fourth test site, which was quickly filled. The only other time the number of administrations surpassed 2,000 was in June 2003 when the FPGEE was reintroduced

as a paper-and-pencil examination and the FPGEE administration reached a total of 2,025.

NABP provides the Foreign Pharmacy Graduate Examination Committee™ (FPGEC®) Certification Program as a means of documenting the educational equivalency of an applicant’s foreign pharmacy education to assist state boards of pharmacy in qualifying applicants for United States licensure. The FPGEE is one component of this program. To qualify for FPGEC Certification, applicants are required to submit appropriate documentation of their pharmacists’ credentials, including transcripts, degree, and licensure and/

or registration for review by FPGEC. In addition, applicants are required to pass the Test of English as a Foreign Language™ Internet-based test (TOEFL® iBT), or the TOEFL and Test of Spoken English™ (TSE®) if their country does not offer the TOEFL iBT.

The next FPGEE will be administered on December 1, 2007. Information regarding the test site locations and registration will be forthcoming in a future issue of the NABP Newsletter. Additional information can be found in the FPGEC Application Bulletin and Frequently Asked Questions both located on the NABP Web site at www.nabp.net.

June FPGEE Administration Numbers Reported

organization approved for DMEPOS accreditation.”

NABP has conducted surveys of several other pharmacies and continues to receive and process applications from both chain and independent pharmacies.

In mid-May, CMS began soliciting bids for the first round of the Medicare DMEPOS Competitive Bidding Program for the first 10 metropolitan statistical areas (MSAs). With all bids due on July 13, 2007,

NABP is working to move applicants through the process quickly and efficiently while maintaining CMS quality standards. According to the final rules announced by CMS on April 2, 2007, suppliers in the first 10 MSAs that are selected to provide products in the competitive acquisition program must be accredited by a CMS-approved accreditation organization such as NABP. Those suppliers that are pending accreditation may submit a bid; however, their accreditation must be

complete by August 31, 2007, to be awarded a contract. The 10 MSAs that currently require accreditation are:

lCharlotte-Gastonia-Concord, NC-SC

lCincinnati-Middletown, OH-KY-IN

lCleveland-Elyria-Mentor, OH

lDallas-Fort Worth-Arlington, TX

lKansas City, MO-KSlMiami-Fort

Lauderdale-Miami Beach, FL

lOrlando, FLlPittsburgh, PA

DMEPOS(continued from page 89)


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Many judicial opinions impact the operations of boards of pharmacy

regarding the essential mission of regulating pharmacists and pharmacies in the interest of public protection. Case law, which is determined in one particular jurisdiction on regulatory issues, while not necessarily binding in other states, may impact additional jurisdictions on a judicial basis, but certainly is most helpful on an educational basis as a learning tool. These opinions also provide guidance to all regulatory boards, health care boards and others, intra- and interstate, regarding important regulatory matters.

Legal Briefs

By Dale J. Atkinson, JD

103rd Annual Meeting Report of Counsel

The purpose of the NABP Report of Counsel for 2007 is to provide an analysis of two significant regulatory cases and analyze the impact to NABP member boards of pharmacy. Readers are encouraged to place the issues and judicial opinions in the context of their respective jurisdictions and laws and assess the potential impact on board operations.

What’s a Burden?In December 2006, the

Washington Supreme Court issued one of the most important recent opinions in addressing the issue of what burden of proof (sometimes referred to as a standard of proof) is constitutionally permissible in certain

administrative actions. The burden of proof refers to the obligation of the board to establish by evidence a requisite degree of belief concerning facts in the mind of the trier of fact, court, or board.

All regulatory boards, including boards of pharmacy, conduct administrative actions to “discipline” individuals who have violated applicable provisions of the practice act or regulations. Most administrative disciplinary charges must be “proven” under either a “preponderance of the evidence” burden or “clear and convincing” burden. Members of the boards of pharmacy are encouraged to understand

the concept of burden of proof and what burden is necessary to substantiate an administrative conviction in your jurisdiction.

The significance of the Washington Supreme Court opinion is that it declares a preponderance burden in a professional license disciplinary proceeding impermissible under the United States Constitution.

To review, differing adversarial actions require differing burdens of proof (ie, criminal matters require proof beyond a reasonable doubt and civil matters require a preponderance of the evidence). In an administrative matter against an individual, boards of pharmacy (or the corresponding departments) must adhere to the burden of proof necessary to sustain an adverse action. The burden in administrative matters, usually a preponderance of the evidence or clear and convincing evidence, can usually be found in the practice act, rules/regulations, or administrative procedures act.

The burden of proof should be referenced in final orders to substantiate that the administrative proceedings were conducted in a manner consistent with applicable law. Reference to the burden also provides

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Legal Briefs

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


the judiciary with notice of the standard used by the board in the event of an appeal. As readers know, licensees possess a property interest in their license. Accordingly, an adversarial administrative proceeding must satisfy “due process” requirements as part of the administrative prosecution against such license. Many jurisdictions require a preponderance of evidence standard in order to take adverse action against a license. Recently, the preponderance standard was subjected to a constitutional analysis in Washington as related to the due process rights to which licensees are entitled.

A nursing assistant was “registered” to practice in Washington State and will be referred to as “registrant.” For purposes of this report, registration and licensure are synonymous in that such registration creates a governmentally granted right to practice the profession and a corresponding property interest.

The registrant was accused of abuse of a patient in the nursing home in which she was employed. Based upon a complaint filed with the Washington State Department of Health, an investigation of allegations

of unprofessional conduct were initiated. In addition, she was charged with fourth degree assault. The criminal proceedings were eventually dismissed by the court. The department investigated the matter and conducted an administrative hearing. The registrant, for whom English was a second language, represented herself in the administrative matter. Testimony from three witnesses and numerous documents and affidavits were made a part of the record. As acknowledged by all parties involved, the evidence was in serious conflict.

The hearing officer concluded, and so stated in his recommended order, that the state had not proven its case by clear and convincing evidence. However, Washington law requires a preponderance standard and the hearing officer concluded that the preponderance standard had been met. Washington law also states that the presiding officer shall not declare any statute or rule invalid. Based upon the preponderance of the evidence, the hearing officer suspended the registration (license) of the registrant for a period of 24 months and ordered a report of the final action

to the Healthcare Integrity and Protection Data Bank (HIPDB).

The ruling was appealed to the superior court, which affirmed the use of the preponderance standard. The appellate court also affirmed the lower court and the matter was appealed to the Washington Supreme Court. The Supreme Court phrased the issue as whether proof by a preponderance of the evidence in a professional disciplinary proceeding satisfies due process.

The court analyzed a previous decision (Nguyen v Department of Health) in assessing the necessary standard of proof in an administrative proceeding. In Nguyen, the Washington Supreme Court held that a professional disciplinary proceeding subjects a doctor to grave concerns, which include the “potential loss of patients, diminished reputation and professional dishonor.” It also recognized the doctor’s liberty interest in the license and the right to protect a professional reputation. The court held that a clear and convincing standard must be met in an administrative proceeding against a licensed physician.

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Association News

NABP/AACP District Meetings Address Current Issues, Future Goals

Held annually, the district meetings bring together members of the boards of pharmacy and faculty of the colleges and schools of pharmacy in each of the Associations’ eight districts to discuss regional issues of mutual concern, as well as national issues affecting the districts. District meetings also generate grassroots input to NABP and AACP.

Formal presentations have a place in district meetings, but workshop sessions and group participation are the primary emphasis, and many sessions qualify for continuing education credit. The national associations often suggest programming topics, which the districts then combine with subjects of more immediate or regional concern.

For this year’s district meetings, NABP has suggested topics including accreditation for providers of durable medical equipment, prosthetics, orthotics, and supplies; recent findings and safeguards relating to counterfeit prescription medications; and the 2007

Foreign Pharmacy Graduate Equivalency Examination® blueprint, which was applied beginning with the June 23, 2007 examination.

The district meetings also provide an opportunity for the boards of pharmacy to collaborate with the colleges and schools of pharmacy as they review pharmacy curriculum and educational requirements and revise their educational guidelines and standards. Highlighting the importance of communication between the boards of pharmacy and the schools and colleges of pharmacy in this regard, the 2006-2007 NABP Task Force on Standardizing Student Pharmacist Experiential Requirements advises NABP and AACP to work together to ensure college-based pharmacy practice experience programs meet the competencies and expectations established by the Accreditation Council for Pharmacy Education (ACPE) and described in ACPE’s Accreditation Standards and Guidelines for the Professional Program

in Pharmacy Leading to the Doctor of Pharmacy Degree.

To further encourage communication between NABP and AACP, the task force encourages colleges of pharmacy to include board of pharmacy representatives on appropriate college committees and to appoint a liaison to attend board meetings.

At each district meeting, the NABP president and an AACP representative will present their annual reports, attendees from NABP and AACP will hold break-out sessions to discuss specific issues, and business sessions will provide a forum for the reports of the treasurer and the district committees.

Additionally, the boards of pharmacy may draft resolutions at district meetings to formalize action plans for addressing issues affecting the boards and/or the schools and colleges of pharmacy in that district. Each district appoints a Resolutions Committee to compile the resolutions drafted at the district meeting and forward them to NABP. Resolutions drafted at the 2007 district meetings will be considered and voted upon at the NABP 104th Annual Meeting in 2008.

Beginning in 2005 with a change in the NABP Constitution and Bylaws, the district meetings serve

The joint district meetings of NABP and the American Association of Colleges

of Pharmacy (AACP) afford a unique opportunity to address not only professional issues affecting today’s pharmacy practice, but also educational matters influencing tomorrow’s pharmacists.

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Association News

as a forum to nominate candidates to fill open member positions on the NABP Executive Committee for the respective districts. This year, Districts 3, 4, and 8 will nominate candidates for NABP Executive Committee member positions to be filled during the 104th Annual Meeting. The boards also will elect representatives (one delegate and one alternative) to serve on the NABP Committee on Resolutions at the 104th Annual Meeting.

The NABP/AACP District Meeting schedule for 2007 will be as follows. Updates will be provided on the NABP Web site as new information becomes available.

District 1, October 25-27, Burlington, VT at the Wyndham Burlington Hotel. (Constituents include Connecticut; Maine; Massachusetts; New Brunswick, Canada; New Hampshire; Nova Scotia, Canada; Prince Edward Island, Canada; Quebec, Canada; Rhode Island; and Vermont).

District 2, October 11-12, Wilmington, DE, at the Hotel DuPont. (Constituents include Delaware; District of Columbia; Maryland; New Jersey; New York; Ontario, Canada; Pennsylvania; Virginia; and West Virginia).

District 3, August 5-7, Orlando, FL, at the Royal Plaza in the Walt Disney World Resort. The theme will be “Advancing Pharmacy through Leadership and Education.” A continuing education session on “Online Education and International Education in Pharmacy” will be presented by William H. Riffee, dean of the College of Pharmacy at University of Florida; Peter H. Vlasses, executive director of ACPE; and Carmen A. Catizone, executive director/secretary of NABP. Other programs will include “Pharmaceutical Pedigree: Ensuring Product Quality and Standards,” “PRx: a Dose of Media Relations for the Pharmaceutical Industry,” “E-learning and International Programs: Working with Regulatory Agencies,” and “Medicare Part D: Lessons Learned and Looking Forward.” More information is available at http://conferences.dce.ufl.edu/NABP-AACP. (Constituents include Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, Puerto Rico, South Carolina, Tennessee, and Virgin Islands.)

District 4, November 14-16, Indianapolis, IN, at the Omni Severin Hotel. The

meeting will be co-hosted by Butler University and the Indiana Board of Pharmacy. More information will be available in July at http://pharmacy.wayne.edu/nabpaacp. (Constituents include Illinois; Indiana; Michigan; New South Wales, Australia; Ohio; South Africa; and Wisconsin.)

District 5, August 16-18, Deadwood, SD, at the Holiday Inn Express Hotel & Suites. (Constituents include Iowa; Manitoba, Canada; Minnesota; Nebraska; North Dakota; and South Dakota.)

District 6 meeting information was unavailable as of press time. (Constituents include Arkansas; Kansas; Louisiana; Missouri; Oklahoma; Texas; and Victoria, Australia.)

Districts 7 and 8, October 3-6, Ashland, OR, at the Ashland Springs Hotel. (District 7 constituents include Alaska; Alberta, Canada; British Columbia, Canada; Idaho; Montana; Oregon; Washington; and Wyoming. District 8 constituents include Arizona; California; Colorado; Guam; Hawaii; Nevada; New Mexico; New Zealand; and Utah.)

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Association News

The proposed Safe Drug Compounding Act of 2007 seeks to establish who may compound drug products and under what circumstances, and what regulatory agency has the authority to regulate

pharmacy compounding. While NABP and the

state boards of pharmacy support the intent of the proposed legislation to ensure the safe compounding of drug products and to define legal compounding, the Association opposes provisions of the bill that would preempt the states’ authority to regulate compounding.

NABP states this opinion in a May 4, 2007 letter to Senators Edward Kennedy, Pat Roberts, and Richard Burr, who drafted the proposed legislation. NABP also states its opposition to provisions of the bill that conflict with the Model State Pharmacy Act and Model Rules of the National Association of Boards of

Pharmacy (Model Act) and that unnecessarily restrict the practice of pharmacy.

NABP recommends revising the language of the proposed legislation “to acknowledge state regulation of compounding, to distinguish legitimate compounding from manufacturing, and to avoid preempting existing state statutes or regulations.”

As a general rule, the Federal Food, Drug, and Cosmetic Act (FD&C Act) governs manufacturing, while regulations and guidelines, including current Good Manufacturing Practices, implement the act. Food and Drug Administration (FDA) does not regulate the practice of pharmacy and generally defers to states to inspect, sanction, and regulate pharmacies that participate in legal compounding activities.

NABP maintains that clarifying the blurry line

between compounding and manufacturing will help to distinguish legal compounding practices from manufacturing activities that are subject to a distinct set of restrictions. “NABP reaffirms its long-held position that pharmacy compounding is a legal and legitimate facet of pharmacy practice; manufacturing is not,” NABP states in the letter to the senators.

The NABP Model Act defines compounding as:

the preparation of Components into a Drug product (i) as the result of a Practitioner’s Prescription Drug Order based on the Practitioner/patient/Pharmacist relationship in the course of professional practice, or (ii) for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or Dispensing. Compounding includes the preparation of limited amounts of Drugs or Devices in anticipation of receiving Prescription Drug Orders based on routine, regularly observed prescribing patterns.

By contrast, the Model Act defines manufacturing as:

the production, preparation, propagation,

NABP Comments on Proposed Federal Regulation of Compounding

With an estimated 30 million to 40 million prescriptions

compounded each year in the United States, the importance of industry-wide quality standards and patient safeguards is clear. What remains to be seen, however, is who will regulate the practice in times to come.

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conversion, or processing of a Drug or Device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis. Manufacturing includes the packaging or repackaging of a Drug or Device or the Labeling or relabeling of the container of a Drug or Device for resale by pharmacies, Practitioners, or other Persons.

NABP further affirms its commitment to assist FDA and the state boards of pharmacy in their common goal to protect the public health. “The state boards of pharmacy should regulate compounding and, as part of that effort, work with the FDA to distinguish it from manufacturing. Boards of pharmacy and FDA should work together to legally and competently investigate questionable practices,” NABP states. “This way, it can be assured that compounding and manufacturing are regulated appropriately and in the best interest of the patient.”

Having clearly established its interest in preserving state regulatory

authority over pharmacy compounding, NABP states its support for some concepts included in the bill:

1. NABP supports ensuring and explicitly defining the bona fide relationship between the patient, prescriber, and pharmacist;

2. NABP supports outlining the communications and documentation required for collaboration among the prescriber, pharmacist, and patient regarding the decision to prescribe and compound a drug product; and

3. NABP supports addressing the special characteristics that define sterile compounding and the standards to which compounders must adhere to appropriately compound sterile products.

In addition to supporting these fundamental tenets, the Association advises the senators that it also supports defining certain terms and practices in federal statutes and regulations, and that doing so would assist with the state regulation of pharmacy compounding

and promote uniformity among the states. NABP agrees that the following terms and practices need to be defined or clarified:

1. “Valid prescription order”

2. A product that is “essentially a copy of a drug approved by the Secretary” and when such a product can or cannot be used

3. The use or prohibited uses of bulk substances and inactive ingredients

4. The prohibitions on drug products that have been withdrawn or removed from the market because such drug products or the components of such drug products have been found to be unsafe or not effective

5. The use or prohibited uses of drug products that are demonstrably difficult to compound

In regard to industry-wide quality standards and patient safeguards for compounding practices, the Model Act describes current Good Compounding Practices for the preparation of drug products by state-licensed pharmacies for dispensing and/or administration to humans or animals. The Model Act encourages compounding pharmacists and pharmacies to abide by

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Legal Briefs(continued from page 93)

Turning its attention to the lower court analysis, the Supreme Court addressed the findings of the appellate court. The appellate court held that “a nursing assistant who loses her license may suffer some slight damage to her reputation, but such damage does not approach the significant stigma attached to loss of the right to practice medicine.” The appellate court also held that the sanction in the current case (24-month suspension) also distinguished the matter from Nguyen (revocation of licensure). Finally, the appellate court distinguished the current matter from Nguyen finding that the subjective facts at issue in Nguyen created a greater risk of error than the objective facts at issue in the current case. Thus, the appellate court held that the preponderance burden of proof in the instant matter was appropriate, in spite of the clear and convincing standard required by the Supreme Court in Nguyen.

In rejecting these analyses, the Supreme Court held that the interest of the state to protect the public welfare was just as significant in dealing with physicians as nursing assistants. It also held that a license creates a property interest,

that the due process protections afforded individuals apply to all such professional licenses, and that differing burdens cannot be justified based upon the type of license at stake. Accordingly, the Supreme Court rejected the findings of the appellate court and held that the due process protections under the United States Constitution require all administrative proceedings to use a clear and convincing standard in adversarial proceedings against a professional licensee. In short, it held that the regulation establishing a preponderance standard in a professional license proceeding is unconstitutional.

This opinion is of enormous significance to regulatory boards. While only applicable in Washington State, the analyses stimulate legal debate over the due process rights afforded licensees in administrative actions. The burden of proof necessary to sustain action against individuals accused of violating the practice act impacts all phases of an administrative investigation, prosecution, and adjudication. A clear and convincing standard applied to all administrative adjudications could change the landscape upon which such

prosecutions are based. Stay tuned.

Ongom v State of Washington, 148 P. 3d 1029 (WA 2006)

Notice Anything Missing?

Numerous requirements must be adhered to when administratively pursuing action against an individual for alleged violations of the practice act or regulations. As referenced above, the constitutional principles of due process protect the property interests of licensees in their license to practice their chosen profession. Readers are also aware that many licensees choose not to appear at administrative proceedings. The reasons for such absences are many and varied, sometimes related to intimidation by the process, moving to another jurisdiction, or generally not finding it necessary to protect the particular license. In addition, contemporaneous criminal proceedings may cause the licensee to avoid participation in the administrative matter.

Regardless, administrative matters proceed in the absence of the licensee, sometimes referred to as “default” judgments and the public is served through discipline of licensees found to have violated applicable law. Pursuit of disciplinary actions under default judgments must also follow the necessary procedures

to comport with the due process provisions of state and federal constitutions. A recent appellate court opinion addressed the fundamental notice requirements of an accused licensee.

A licensed practical nurse (licensee) under the authority of the Tennessee Board of Nursing was under criminal indictment for alleged felonies related to aggravated burglary and reckless endangerment with a weapon. In August 2001, the licensee entered a guilty plea to two felonies and was sentenced to four years and two years respectively for the convictions, both sentences were suspended, however, in lieu of probation. With respect to both charges, the licensee was placed on judicial diversion, a form of probation whereby the defendant, upon the expiration of time and satisfaction of conditions, has the criminal conviction removed from the public record.

After the convictions and placement on judicial diversion, the licensee, in November 2001, submitted her application for renewal of her license. She did not reveal the convictions, in spite of specific questions on the renewal application related to criminal convictions. In March 2004, counsel for the board mailed the licensee a notice of intent to discipline. The notice

Legal Briefs

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was sent certified mail, return receipt requested to the address of record with the board. The notice was returned to the board and received on April 20, 2004, marked as “unclaimed” by the US Postal Service.

In addition to the notice of intent to discipline, board counsel sent via certified mail, return receipt requested, a formal notice of charges. The formal charge notice was sent April 6, 2004, and returned unclaimed on April 27, 2004. The notice of formal charges cited the guilty pleas, the Tennessee statutes under which she was charged, and the unprofessional conduct portions of the practice act as grounds for administrative discipline against her license. Finally, the notice informed the licensee of a hearing date and that failure to appear may result in a default judgment.

On April 14, 2004, the Administrative Procedures Division of the Secretary of State’s office mailed the licensee a prehearing order. This mailing was returned July 19, 2004, with a sticker from the Postal Service noting “Box Closed-Unable to Forward-Return to Sender.” All the above notices were sent to the licensee’s address of record with the board.

On May 13, 2004, the board convened a contested case hearing. The

licensee was not present and the state’s attorney made a motion for default under Tennessee law. The administrative law judge found that the licensee had received adequate service of the Notice of Charges. After presentment of the evidence related to the criminal convictions, suspended sentences, placement on diversion, and applications and renewals for licensure, the board found the licensee to be guilty of a crime and unprofessional conduct under Tennessee law. It revoked her license and issued a civil penalty of $1,500. The final order of the board was entered June 30, 2004.

On August 27, 2004, the licensee filed a Petition for Judicial Review of the board order. The licensee argued that she was not “convicted” of the felonies due to the placement on judicial diversion and that she was not given appropriate notice of the administrative proceedings. The lower court found in favor of the board and upheld the revocation and civil penalty. Then licensee appealed the matter to the court of appeals.

After addressing the standard of review on appeal, the appellate court turned its attention to the substantive issues. Regarding the notice provided to the licensee, the court reviewed the applicable Tennessee law, which requires licensees to receive notice and an

opportunity to be heard before a license may be terminated. Specifically, the law states:

(c) No revocation, suspension, or withdrawal of any license is lawful unless, prior to the institution of agency proceedings, the agency gave notice by mail to the licensee of facts or conduct that warrant the intended action, and the licensee was given an opportunity to show compliance with all lawful requirements for the retention of the license.

However, in the event of a default judgment, the court cited the regulations that identify certain factors to be considered before allowing the hearing to proceed without the licensee in attendance. The court stated:

However, in the event of a motion for default where there is not indication of actual service on a party, the following circumstances will be taken into account in determining whether to grant the default, in addition to whether service was complete as defined above:

(a) Whether any other attempts at actual service were made; (b) Whether and to what extent actual service is practicable in any given case; (c) What attempts were made to get in contact with the party by

telephone or otherwise; and (d) Whether the agency has actual knowledge or reason to know that the party may be located elsewhere than the address to which the notice was mailed.

According to the record before it, the court held that the board had not complied with the requirements of the regulations. In ruling, the court noted that the transcripts of the proceedings before the administrative law judge merely provided that the board had no other addresses for the licensee. The record was silent as to any potential additional attempts to actually serve the licensee or to contact her using other information on file with the board. The court also noted that the licensee had 30 days to notify the board of an address change. The first notice received by the board of failed service was on April 20, 2004. Yet, the hearing was held on May 13, 2004, less than 30 days from the returned notice. The court held that it is conceivable that the licensee closed out her post office box in late April and the hearing was held before the 30-day address change requirement date.

Finding that the default judgment took place without the requisite notice, the court reversed the administrative judgment and imposed the


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Feature News

Pharmacy Groups Respond to News Media Portrayal of Medication Error ‘Epidemic’

“The incidents portrayed in the media underscore the mission of NABP and the state boards of pharmacy to protect the public health, and the importance of following through on safety initiatives,” says Oren M. Peacock, Jr, NABP president. “NABP will continue to work with the boards of pharmacy to develop and implement systematic approaches to preventing prescription errors and keeping patients safe.”

Regulation of Technicians Advised

One of the primary allegations of the ABC 20/20 exposé was that pharmacy technicians are often not qualified to assist in the practice of pharmacy, contributing to the occurrence of preventable errors.

“NABP has long been an advocate for standardized, formal training and competency assessment as prerequisites to registration or licensing of pharmacy technicians by the state boards of pharmacy,” Peacock said.

The Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act) recommends a two-tier system consisting of pharmacy technicians and certified pharmacy technicians. As suggested in this system, requirements for certified pharmacy technicians include graduation from a pharmacy technician training program recognized by the state boards and successful completion of a board-approved examination.

The Model Act suggests that the boards require registration or licensing. Further, the Model Act recommends that the boards may perform criminal background checks on individuals seeking to register as certified pharmacy technicians or pharmacy technicians.

Currently, according to the NABP 2007 Survey of Pharmacy Law, 37 states license or register pharmacy technicians, and 30 states have training requirements for pharmacy technicians. As of May 2007, according to data compiled by NABP, 29 states recognize pharmacy technician certification.

The American Society of Health-System Pharmacists (ASHP), in its response to the ABC 20/20 report on pharmacy errors, advocates a model for training, credentialing, and regulating technicians to optimize patient safety. ASHP maintains that pharmacy technician education should be consistent across all states and for all sites of practice in conformity with uniform national standards. The group also wants pharmacy technicians to pass a

Several pharmacy organizations have responded publicly to the ABC News

portrayal of a prescription medication error “epidemic,” which aired on March 30, 2007. Common themes that emerged from their responses included a need for standardized training, testing, and licensing for pharmacy technicians; continuous quality improvement programs for pharmacies; consistent error reporting; and better patient education.

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Feature News


standard examination and certification process, based on sound psychometric principles, before engaging in the responsibilities authorized by their state. In addition, ASHP encourages the state boards of pharmacy to register pharmacy technicians, providing a means to regulate them and to eliminate from the workforce technicians who do not meet appropriate qualifications or performance requirements.

The National Pharmacy Technician Association (NPTA) posted an open letter to ABC News, in which it calls the current educational standards and professional requirements for pharmacy technicians “not acceptable.” NPTA advises that all individuals should be required to complete a standardized, accredited training program prior to working in a pharmacy environment. The association also advises that pharmacy technicians should be required to pass a standardized competency-based examination, such as the Pharmacy Technician Certification Board (PTCB) examination. Established

in 1995, PTCB was created through the joint efforts of four founding pharmacy organizations that, along with NABP, are members of the PTCB Board of Governors.

NPTA also maintains that all pharmacy technicians should be registered with the state board of pharmacy, which could then provide oversight and monitoring.

In their response to the 20/20 report, the California Society of Health-System Pharmacists and the California Pharmacists Association encourage the endorsement of standardized national technician training program accreditation; development and adoption of uniform state laws and regulations regarding pharmacy technicians; mandatory completion of a nationally accredited standardized program of education and training as a prerequisite to pharmacy technician licensure; and mandatory certification by PTCB or other board-approved certification program as a prerequisite for technicians to engage in the full scope of state-authorized responsibilities.

Health Plans Called Upon to Help

In a separate response, the California pharmacist groups cite the cost-saving tactics of health insurance plans, often leading pharmacies to cut costs in staffing, as a threat to patient safety. “Substandard reimbursement leads to inferior services and error rate increases,” the press release states. “Insurance companies should be mandated to provide reasonable reimbursement to cover costs.”

CQI, Error Reporting Advocated

As stated in the Model Act, NABP encourages each pharmacy to establish a continuous quality improvement (CQI) program that includes periodic pharmacy staff meetings to consider the effects of staffing levels, workflow, and technological support on the quality of the pharmacy system. These meetings should include a review of data showing evidence of the quality of care for patients served by the pharmacy, and the development of plans to improve the system of pharmacy practice to

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Higher Expectations for Pharmacists Fuel Demand for Quality Practice Experience

Feature News

The switch to doctor of pharmacy as the entry-level degree for pharmacists has increased the net volume of required practice experience rotations and, thus, competition for practice sites. At the same time, enrollment in schools and colleges of pharmacy is on the rise, feeding the demand still further.

“Our profession faces an acute need to increase the number and quality of experiential education sites for training pharmacy students to meet this demand as well as the challenges presented by a changing health care system,” the American Association of Colleges of Pharmacy (AACP) states in a 2005 report, Pharmacy Experiential Education Present and Future: Realizing the Janus Vision. “While some institutions and organizations have made significant progress in addressing challenges in experiential learning

during recent years, and a number of successful examples are readily found, widespread progress across the pharmacy education/practice interface has not yet been achieved.”

Stakeholders Take Action

Because the experiential aspect of pharmacy education is so important to producing competent entry-level pharmacists, the boards of pharmacy and AACP are assisting in exploring and implementing strategies to ensure that practice experience programs provide pharmacy students with the skills they need.

Involved in this initiative is the Accreditation Council for Pharmacy Education (ACPE) and the revised educational requirements described in its Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree (Standards 2007). Effective

July 1, 2007, Standards 2007 requires that at least 30% of the professional curriculum be dedicated to experiential education: at least 5% (300 hours) for introductory pharmacy practice experiences and at least 25% (1,440 hours) for advanced pharmacy practice experiences, for a total of 1,740 hours. Introductory pharmacy practice experiences, which are integrated in the beginning years of the professional degree program, introduce professionalism and allow the development of practical skills early in a student’s professional learning.

The NABP 2006-2007 Task Force on Standardizing Student Pharmacist Experiential Requirements recommended that the boards of pharmacy adopt the ACPE Standards 2007 as the basis for their own practice experience requirements. Toward this end, the Executive Committee approved revising the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy to increase the required number of practice experience hours from 1,500 to 1,740.

Karen M. Ryle, who served as Executive Committee liaison to

Today’s higher expectations for entry-level pharmacists place more

pressure than ever on pharmacy practice experience programs to equip them with the skills they need to excel in practice. So far, some stakeholders say, the availability and suitability of practice experience sites and preceptors have not kept pace with the demand.

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Feature News

the task force, says more exposure to practical work environments will better prepare students for pharmacy practice. A member of the Massachusetts Board of Registration in Pharmacy, Ryle says that, while Massachusetts is not experiencing the shortage of practice experience sites and preceptors felt on a national scale, members of the state Board have noted that recent pharmacy graduates are too often ill-equipped to practice, lacking basic attributes like strong work ethics, multi-tasking abilities, and communication skills.

Ryle attributes this trend not to a shortage of quality practice sites and preceptors, but to a lack of work experience. “Right now, we as a Board are not as confident in recent pharmacy graduates as we’d like to be because they’re entering practice without enough practical experience,” Ryle says.

She said she expects the uniform implementation of Standards 2007 will help to alleviate this problem, as students begin to be routinely immersed in introductory pharmacy practice experiences early in their curriculum and to gain additional work and direct patient care experience before entering practice.

AACP Spotlights Exemplary Partnerships

Raising the bar for practice experience programs, AACP will announce the winners of its new Academic-Practice Partners Recognition Program at its Annual Meeting in July 2007. The program spotlights successful examples of practice sites and preceptors that demonstrate exemplary patient care and teaching.

The following academic-practice partnerships were selected to receive the AACP 2007 Crystal APPLE (Academic Practice Partnerships for Learning Excellence) award: University of Florida College of Pharmacy and Shands Jacksonville Medical Center; University of Iowa College of Pharmacy and Osterhaus Pharmacy; Northeastern University School of Pharmacy and Harbor Health Services Inc, Neponset Health Center; University of Mississippi School of Pharmacy and North Mississippi Medical Center; University of Missouri – Kansas City School of Pharmacy and Branson Drug; Ohio State University College of Pharmacy and Kroger Patient Care Center;

University of Oklahoma College of Pharmacy and Valu-Med Pharmacy; and Texas Tech University Health Sciences Center School of Pharmacy and North Texas VA Medical Center.

The winning partnerships were selected for their patient-care model, integration of student learning experiences to meet educational outcomes, practice support for patient-care vision and commitment to education, preceptor attributes as role model practitioner and effective teacher, and academic-practice partnership model at the site and preceptor level. By spotlighting successful academic-practice partnerships and documenting their attributes, the program holds up the award winners as models of excellence which others may emulate.

Practice Sites Stand to Benefit

By demonstrating the advantages to practice sites of partnering with academic programs, AACP hopes to encourage other practice sites and preceptors to participate in academic-practice partnerships, notes Arlene

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Error Prevention(continued from page 101)

Feature News

(continued on next page)

. . . NABP and the boards of pharmacy encourage the use of “do not use” lists of abbreviations, acronyms, and symbols among health care providers and educators to avoid errors resulting from misreading prescriptions.

increase good outcomes for patients. According to the 2007 NABP Survey of Pharmacy Law, 14 state boards of pharmacy require pharmacies to maintain a CQI program to monitor and prevent quality-related events.

These programs speak to the recommendation of the Institute of Medicine’s (IOM) report Preventing Medication Errors: Quality Chasm Series, released in July 2006, which examines the frequency and causes of medication errors in the United States. In the report, IOM advises the state boards of pharmacy to implement quality improvement programs and convene voluntary panels of pharmacists to review major quality and safety issues associated with medication dispensing. The full report is available via the IOM Web site at www.iom.edu/?id=35961.

The NABP Model Act further recommends that the boards require pharmacists to report medication errors to a designated error reporting program.

The Washington State Pharmacy Association encourages pharmacies to implement a CQI process that includes documentation not only

of errors that reach the patient, but also of “near misses” that were caught and corrected prior to the patient receiving the product or service. These “near misses,” the group maintains, are important factors to consider when evaluating work flow and process to eliminate future errors.

Likewise, ASHP maintains that “[s]erious medication errors that result in temporary or permanent harm, disability, or death should be reported to the appropriate regulatory agency or accrediting body. . . . Errors that do not cause harm should be reported to voluntary reporting systems and used as part of quality-improvement efforts to ensure that similar errors are not repeated.”

Better Communication Encouraged

The California Medication Errors Panel issued a report on March 6, 2007, recommending changes to avert medication errors, including improving communication between physicians, pharmacists, and patients. The panel’s report advocates improving the legibility of handwritten prescriptions, setting a deadline for the implementation of electronic prescribing, requiring the intended

use of medications to be included on all prescriptions and labels, and improving access to and awareness of language

translation services. The full report is available via the Pharmacy Foundation of California Web site at www.pharmacyfoundation.org/AM/Template.cfm?Section=Med_Errors.

On a related note, NABP and the boards of pharmacy encourage the use of “do not use” lists of abbreviations, acronyms, and symbols among health care providers and educators to avoid errors resulting from misreading prescriptions. For instance, the Institute for Safe Medication Practices (ISMP), which provides a patient safety column for the National Pharmacy Compliance News section of the NABP State Newsletter Program, discourages use of the abbreviation u for units, and encourages using a zero (0) as a placeholder

for prescription dose levels expressed as decimals less than 1 to avoid errors resulting in overdose.

ISMP provides a list of abbreviations prone to misinterpretation and error, along with several other error prevention and reporting resources, on its Web site at www.ismp.org.

States Implement Safety Initiatives

Several state boards of pharmacy have developed medication safety initiatives, such as the following examples:

lThe Arizona State Board of Pharmacy adopted a resolution in 2001 encouraging a 30-minute break for pharmacists to reduce errors resulting from fatigue.

lThe Florida and New York State Boards of Pharmacy both require pharmacists to obtain continuing education credit in the area of patient safety. The Accreditation Council for Pharmacy Education recently added the topic designator “Patient Safety” as part of its revised definition of continuing pharmacy education, effective January 1, 2008.

lThe Massachusetts Board of Registration

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NEWLY ACCREDITED VAWD FACILITIESThe following facilities were recently accredited through the NABP Verified-Accredited Wholesale Distributors® (VAWD®) program:

A full listing of accredited VAWD facilities can be found on the NABP Web site at www.nabp.net.

Feature News

ASD Specialty Healthcare, Inc Brooks, KY Accredited March 22, 2007

BD dba BD Distribution Center Plainfield, IN Accredited April 19, 2007

Becton, Dickinson and Company dba BD Distribution Center Redlands, CA Accredited April 12, 2007

Benco Dental Supply Co dba Benco Dental Company Fort Wayne, IN Accredited April 19, 2007

Bloodworth Wholesale Drugs Tifton, GA Accredited March 8, 2007

Cardinal Health Zanesville, OH Accredited March 15, 2007

Cardinal Health 108 dba Cardinal Health LaVergne, TN Accredited February 16, 2007

in Pharmacy in 2001 adopted Best Practice Recommendations encompassing CQI initiatives applicable in all pharmacy practice settings to improve performance, increase patient safety, reduce medication errors, and enhance medication

delivery systems. The Massachusetts

Board also undertook a Medication Error Study of a sample of errors reported by pharmacies in the state. The study found that 88% of the medication errors were due to wrong drug and/or wrong strength, and that medication errors were more likely to occur when

pharmacists reported being understaffed. Both documents are available via the Board’s Web site at www.mass.gov/dpl/boards/ph/index.htm.

lThe New Hampshire Board of Pharmacy has undertaken a nonpunitive approach to the voluntary and anonymous reporting of prescription errors to provide

informational resources enabling the Board to compile and share the various scenarios with other New Hampshire pharmacies. The goal is strictly educational and is intended to reduce similar medication and dispensing errors.

lThe New Mexico Board of Pharmacy requires dispensing

TM

Cardinal Health 110 dba Cardinal Health Aurora, IL Findlay, OH Accredited February 16, 2007

Caremark, LLC dba Caremark Redlands, CA Accredited April 19, 2007

CVS Pharmacy, Inc Lumberton, NJ Accredited April 19, 2007

Darby Dental Supply, LLC Memphis, TN Accredited March 15, 2007

H.D. Smith Wholesale Drug Company Springfield, IL Accredited April 12, 2007

Leitner Pharmaceuticals Piney Flats, TN Accredited March 22, 2007

McKesson Drug O’Fallon, MO Accredited April 19, 2007

McKesson Corporation dba McKesson Drug Company Washington Courthouse, OH Accredited April 5, 2007

McKesson Specialty Distribution, LLC Washington Courthouse, OH Accredited April 5, 2007

Medco Supply Company, Inc Tonawanda, NY Accredited March 22, 2007

Metro Medical Supply Wholesale, Inc dba Metro Medical Supply Wholesale, Inc Nashville, TN Accredited March 9, 2007

Midlothian Laboratories, LLC Montgomery, AL March 15, 2007

Moore Medical, LLC Visalia, CA New Britain, CT Jacksonville, FL Accredited April 19, 2007

MWI Veterinary Supply Company Harrisburg, PA Accredited, March 22, 2007

Precision Dose, Inc South Beloit, IL Accredited March 22, 2007

Prodigy Health Supplier Corporation Austin, TX Accredited March 15, 2007

Safco Dental Supply Company Northbrook, IL Accredited March 9, 2007

St Mary’s Medical Park Pharmacy Oro Valley, AZ Accredited April 5, 2007

Walgreen Company Mt Vernon, IL Accredited March 15, 2007

Woodland, CA Accredited April 12, 2007

Willow Birch Pharma, Inc Taylor, MS Accredited April 7, 2007


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Around the Association

State Board News


Washington Pharmacies Must Fill EC Prescriptions

The Washington State Board of Pharmacy ruled in April 2007 that pharmacies have a duty to deliver lawfully prescribed drugs in a timely manner, regardless of individual pharmacists’ personal objections to any particular medication, except in cases of obvious or known errors, contraindications, or suspected fraud.

The rule was prompted by complaints regarding some pharmacists’ objections to selling emergency contraceptives (EC). The rule accommodates pharmacists’ moral objections by allowing pharmacies to assign alternate staff members to fill any prescriptions in question.

Improperly Compounded Colchicine Blamed for Deaths

The Oregon and Texas State Boards of Pharmacy have opened investigations into the deaths of two patients who were administered compounded colchicine that was 10 times as potent as labeled. One patient was in Oregon, the other in Washington, and state officials are investigating the drug’s role in a third death, also

in Oregon, the Portland Tribune reported on April 27, 2007.

The drug was sent to a Portland, OR, clinic by ApothéCure, Inc, a Dallas, TX-based compounding pharmacy that distributes its drugs throughout the country. The two patients who died had received injections of colchicine as a treatment for back pain. Lab tests revealed that the colchicine administered in the two deaths had a potency of 4 mg/ml, rather than the 0.5 mg/ml stated on labels.

According to Gary A. Schnabel, executive director of the Oregon State Board of Pharmacy, ApothéCure, a licensed Texas pharmacy, may be operating as a manufacturer. Both the Oregon Board and the Texas State Board of Pharmacy have opened investigations into the incident. The Texas Board advised ApothéCure to stop making colchicine; the company agreed, the Portland Tribune reported.

On May 2, Food and Drug Administration (FDA) announced the recall of all strengths, sizes, and lots of injectable colchicine prepared and sold by ApothéCure within the last year. The FDA MedWatch safety summary on this issue is available at www.fda.gov/ medwatch/safety/2007/safety07.htm#Colchicine.

States Tighten Wholesaler Licensure Requirements

The states continue to make progress in tightening licensure requirements for wholesale drug distributors in an effort to protect their citizens from counterfeit drugs that might otherwise infiltrate the supply chain. So far during this legislative session, three states have passed legislation giving the boards of pharmacy greater authority in the accreditation of wholesale drug distributors. In addition, each of these states requires pedigrees for prescription drugs that leave the normal distribution channel and requires the board to set a targeted implementation date for track-and-trace technology for tracking prescription drugs through the supply chain.

lIdaho: Senate Bill 1184, signed into law on March 30, gives the Idaho Board of Pharmacy the authority to recognize an accreditation body to inspect and accredit wholesale distributors.

lMaryland: House Bill 1030, signed into law on May 8, gives the Maryland Board of Pharmacy the authority to recognize an accreditation body

Executive Director Change

Marcia Wooden, RPh, has been appointed executive director for the District of Columbia Board of Pharmacy. Wooden obtained a bachelor of science degree in pharmacy in 1964 from Howard University and a certificate as a public manager in 1999 from George Washington University. She has worked for the District of Columbia Department of Health Pharmaceutical Control Division from 1998 through the present. Before that, she worked for the District of Columbia Government Department of Consumer and Regulatory Affairs from 1985 to 1998. Wooden filled the open position left by Bonnie Rampersaud.

Board Member Appointments

Dirk White, RPh, was appointed a member of the Alaska Board of Pharmacy, replacing Bill Altland. White’s appointment will expire on March 1, 2011.

Sandra M. Simpson, was appointed a member of the Kentucky Board of Pharmacy, replacing

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Association News

On June 1, 2007, the NABP Advisory Committee on Examinations (ACE) saw a changing of the guard. ACE is in place to oversee the development and administration of all of the Association’s examination and certification programs. ACE also considers policy matters, evaluates long-range planning strategies, and recommends appropriate action to the NABP Executive Committee

NABP would like to thank the following individuals for contributing their time and dedicated service as members of the 2006-2007 ACE.

2006-2007 ACEChair .......................................................Kendall M. Lynch Nashville, TN

Member ..................................................Stephen M. Gross Long Island University

Arnold and Marie Schwartz College of Pharmacy and Health Sciences

Member ..................................................... Tom Houchens London, KY

Member ............................................................... Jeff Lurey Atlanta, GA

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

Member .......................................................... Jerry Moore Indian Springs, AL

Member ....................................................... Donna S. Wall Indiana Board of Pharmacy

Executive Committee Liaison ........ Malcolm J. Broussard

NABP Thanks Outgoing ACE Members for Service, Welcomes New Members to the Committee

The new members of ACE began their terms on June 1, 2007. The following individuals assumed the responsibility to safeguard the integrity and validity of the NABP examinations for the 2007-2008 ACE. As of press time the positions of chair and Executive Committee liaison were pending.

2007-2008 ACE

Member ........................................................Judy Gardner Georgia State Board of Pharmacy

Member .................................................Stephen M. Gross Long Island University

Arnold and Marie Schwartz College of Pharmacy and Health Sciences

Member .....................................................Tom Houchens London, KY

Member .................................................Kendall M. Lynch Nashville, TN

Member ............................................... Arthur Jacknowitz West Virginia University

Robert C. Byrd Health Sciences Center School of Pharmacy

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

Member ...................................................... Donna S. Wall Indiana Board of Pharmacy

ACE typically meets three to four times a year and its members include representatives from boards of pharmacy as well as faculty and/or staff who represent the diversity in pharmacy practice.

costs of the appeal on the Board of Nursing.

While boards of pharmacy are encouraged to pursue administrative remedies against licensees who fail to respond to charges or appear at

scheduled hearings, the procedural requirements for substantiating notice must be followed. These issues are particularly emphasized where licensees may have left the state and sought or received licensure elsewhere. Final disciplinary actions against licensees in absentia will be reported to the HIPDB and

NABP Clearinghouse for dissemination to additional jurisdictions for potential action.

Johnson v Tennessee Board of Nursing, 2007 WL 624353 (App Ct TN 2007)

These are just two of several significant recent administrative cases impacting the regulatory

community, including boards of pharmacy. Board members are encouraged to continue to identify and anticipate issues related to the essential public protection mission of regulating the profession. Look for additional summaries of recent cases in the NABP Newsletter.

(continued from page 99)

Legal Briefs

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Association News

Practice Experience(continued from page 103) lRiverside-San

Bernardino-Ontario, CA

lSan Juan-Caguas-Guaynabo, PR

The accreditation requirement will be expanded into 70 additional MSAs in 2009 and into additional areas after 2009. Detailed information about the bidding process and final rules are available on the CMS Web site at www.cms.hhs.gov.

North Coast Medical Supply, dba Advanced

Diabetes Supply (www.northcoastmed.com, 1-800/730-9887), is a pharmacy that specializes in diabetes equipment and supplies. Advanced Diabetes Supply, located in Carlsbad, CA, has much experience and works closely with patients nationwide who have Medicare and other private insurances.

For more information about NABP or its DMEPOS accreditation program, please visit the NABP Web site at www.nabp.net.

DMEPOS(continued from page 91)

A. Flynn, AACP vice president for professional affairs. Some practice sites, for example, find providing pharmacy practice experience an ideal way to pre-screen and recruit employees, notes Flynn, who participated in the NABP experiential education task force. Moreover, she adds, preceptors gain opportunities for professional development and access to educational resources at the

partnering academic institutions.

Ryle adds that schools and colleges of pharmacy can encourage practitioners to become preceptors by offering incentives such as continuing education (CE) credit for preceptor training and/or free registration for CE sessions. Additionally, she notes, practice sites can provide incentive for their pharmacists to become preceptors by incorporating this experience into the criteria for professional advancement.

In early June 2007, NABP released a report of the pass rates over a five-year period for the North American Pharmacist Licensure Examination™ (NAPLEX®) on its Web site. The statistics include a compilation of the pass rate percentages of first-time candidates who are graduates of United States Accreditation Council for Pharmacy Education-accredited schools and colleges of pharmacy between 2002 and 2006. NABP also released the per-state passing

rates for candidates sitting for the Multistate Pharmacy Jurisprudence Examination® for each school and college of pharmacy.

The recently released NAPLEX report consists of compiled pass rates listed alphabetically by the name of the school or college of pharmacy. In addition, the report has been broken down to include data displaying the passing percentages both before and after the updated blueprint and new NAPLEX passing

standard were deployed in May 2005.

The decision to publish these data, which are public information, was made by the NABP Executive Committee at its May 18, 2007 Executive Committee meeting in response to concerns that vital NAPLEX data were not being released and more importantly, to correct the misrepresentation of NAPLEX data by some colleges and schools of pharmacy. The data released is public

information already provided to the schools, colleges, and boards of pharmacy.

NABP plans to republish the NAPLEX and MPJE passing rate reports during the first quarter of every year, incorporating data for the most current five-year period. The reports, which are currently listed per pharmacy school from the years 2002 through 2006, are located at www.nabp.net under Examination Programs.

NAPLEX and MPJE School Pass Rate Statistical Analysis Now Available on NABP Web Site

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Professional Affairs Update


FDA Evaluates Creating BTC Class of Drugs

Food and Drug Administration (FDA) officials recently announced that the agency is considering the development of a regulatory process for a third, or behind-the-counter (BTC) class of drugs. Medications in this new class would be available without a prescription but not without consultation with a pharmacist, who could address any potential concerns about the drugs.

Officials said FDA will begin working with key stakeholders in the near future to evaluate whether existing regulations will allow for the development of a new class of drugs, or if legislation is needed before the change can take place.

As of press time, FDA had not yet undertaken serious talks with stakeholders or circulated a legislative proposal on the subject, according to an InsideHealthPolicy.com Today report.

Since 1995, NABP has advocated a third class of drugs, also known as a “transitional” class of drugs, to be dispensed without a prescription, only by pharmacists or licensed health care professionals authorized to prescribe and/or

dispense prescription drugs.

Proponents such as the American Pharmacists Association and the American Society of Health-System Pharmacists note that the creation of a third class of drugs might expand access to certain medicines that currently are available only by prescription.

Critics such as Consumer Healthcare Products Association, however, express concern that moving over-the-counter medications behind the counter would reduce the number of outlets where consumers could purchase the products, would limit competition, and would result in increased drug prices.

Purdue Pleads Guilty to Misbranding OxyContin

The Purdue Frederick Company, Inc agreed to pay more than $600 million to resolve criminal charges and civil liabilities in connection with several illegal schemes to promote, market, and sell OxyContin®, which the company produces, FDA announced on May 10, 2007.

An investigation by the FDA Office of Criminal Investigations uncovered an extensive, long-term scheme by Purdue to maximize revenues from

the sale of OxyContin through various illegal means, such as training its sales force to make false representations to health care providers about the difficulty of extracting oxycodone, the active ingredient, from the OxyContin tablet; and to claim that OxyContin did not cause euphoria and was less addictive than immediate-release opiates.

In addition, Purdue falsely labeled OxyContin as providing “fewer peaks and valleys than with immediate-release oxycodone,” and by representing that “. . . delayed absorption as provided by OxyContin Tablets is believed to reduce the abuse liability of the drug.”

To resolve the criminal charges, Purdue pled guilty to a felony count of misbranding a drug with intent to defraud and mislead. As part of the plea, Purdue will pay a $600 million settlement.

The FDA MedWatch Safety summary and press release are available at www.fda.gov/medwatch/safety/2007/safety07.htm#OxyContin.

New FDA Web Page Warns of Buying Isotretinoin Online

FDA has launched a special Web page to warn consumers about the dangers of buying isotretinoin (Accutane®)

online. Improperly used, isotretinoin can cause severe side effects, including birth defects and serious mental health problems. The Web page, www.fda.gov/buyonline/accutane, is positioned as a search result on Internet search engines when consumers initiate an online search for the drug under any one of its four names (isotretinoin is sold under the brand name of Accutane and in generic versions called Amnesteem™, Claravis™, and Sotret®). The Web page warns that the drug “should only be taken under the close supervision” of a physician and a pharmacist, and provides links to related information, including ways to check that drugs purchased online come from legitimate pharmacies.

To reduce risks, FDA and the manufacturers of isotretinoin have implemented a strict distribution program called iPLEDGE to ensure that women using isotretinoin do not become pregnant, and that women who are pregnant do not use isotretinoin. Isotretinoin is available only at pharmacies that are registered for this distribution program. Additionally, the distribution program is

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Professional Affairs Update

designed to prevent the sale of isotretinoin over the Internet. Dispensing must comply with the agency’s risk management requirements.

FDA Calls Halt on Unapproved Suppository Drugs

FDA notified health care professionals and consumers that companies must stop manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride.

The products have been marketed under various names, including Tigan®, Tebamide™, T-Gen, Trimazide, and Trimethobenz. Drugs containing trimethobenzamide in suppository form lack evidence of effectiveness. This action does not affect oral capsules and injectable products containing trimethobenzamide that have been approved by FDA.

FDA urges consumers currently using trimethobenzamide suppositories or who have questions or concerns to contact their health care professionals. Alternative products approved to effectively treat nausea

and vomiting are available in a variety of forms.

The MedWatch Safety summary and press release are available at www.fda.gov/medwatch/safety/2007/safety07.htm#trimethobenzamide.

DEA Rule Controls Chemical Used in Illicit Manufacture of Fentanyl

In response to hundreds of fentanyl-related deaths that authorities have linked to illicit manufacturing activities, Drug Enforcement Administration (DEA) issued an interim rule to control access to a chemical used in illegal production of the drug.

Effective April 23, 2007, this rule making classifies the chemical N-phenethyl-4-piperidone (NPP) as a List I chemical under the Controlled Substances Act. NPP has been identified as the starting material in several seized fentanyl clandestine laboratories.

DEA is accepting comments on this interim rule making via e-mail at [email protected] or via the electronic comment form available at www.regulations.gov.

Tampering Results in Misbranding of Ziagen as Combivir

GlaxoSmithKline and FDA warned health care professionals of an apparent third-party tampering that resulted in the misbranding of Ziagen®

as Combivir® and employed counterfeit labels for Combivir tablets.

Two 60-count misbranded bottles of Combivir tablets contained 300 mg tablets of Ziagen. The counterfeit labels identified are Lot No. 6ZP9760 with expiration dates of April 2010 and April 2009. The incident appears to be isolated and limited in scope to one pharmacy in California.

Pharmacists are advised to immediately examine the contents of each bottle of Combivir in their pharmacies to confirm that the bottles contain the correct medication. If a bottle contains anything other than Combivir tablets, pharmacists are advised to notify the manufacturer.

The letter from GlaxoSmithKline and FDA, containing photos of actual Combivir and Ziagen tablets, is posted on the FDA Web site at www.fda.gov/medwatch/safety/2007/Ziagen_Dear_RPh_03-29-2007.pdf.

Canadian Internet Pharmacy Sales to US Drop Nearly 50% in 2006

Canadian Internet pharmacy sales to the United States dropped sharply in 2006 compared to 2005, according to year-end data released March 19, 2007, by IMS Health, a provider of market intelligence to the pharmaceutical and health care industries.

While 2005 sales to the US recorded by Canadian Internet pharmacies reached $420 million, 2006 sales declined by almost 50% to reach $211 million. Declining sales have now been observed for every quarter since June 2004. While Internet pharmacies sold more than $121 million to the US in the first quarter of 2005, they made shipments worth just above $40 million in the last quarter of 2006.

FDA Asks for Warnings on Sleep Disorder Drug Labels

FDA has requested that all manufacturers of sedative-hypnotic drug products revise product labeling to include stronger language concerning potential risks. Adverse events could include anaphylaxis and angioedema, which can occur as early as the first time the product is taken, and complex sleep-related behaviors such as sleep-driving, making phone calls, and preparing and eating food (while asleep).

Along with the labeling revisions, FDA has requested that manufacturers send letters to health care providers to notify them about the new warnings and develop Patient Medication Guides to be dispensed with the drugs to inform patients about the risks and precautions.

More information and the list of affected drugs are available at www.fda.gov/cder/drug/infopage/sedative_hypnotics/default.htm.

Professional Affairs Update(continued from page 109)

june-july 2007

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Around the Association(continued from page 106)

Feature News


these Good Compounding Practices, their licensing board of pharmacy’s rules for sterile pharmaceuticals, and the current United States Pharmacopeia – National Formulary (USP–NF) chapters on compounding and sterile product preparation. The relevant USP guidelines are described in USP Chapter

Proposed Regulation(continued from page 97)

797, “Pharmaceutical Compounding – Sterile Preparations,” and USP Chapter 795, “Pharmaceutical Compounding – Nonsterile Preparations.”

In response to survey results indicating that several boards of pharmacy were interested in a training program on compounding standards compliance, NABP hosted a special pre-meeting continuing education

session just prior to the NABP 103rd Annual Meeting in May 2007 in Portland, OR. Led by Eric Kastango, RPh, MBA, of Clinical IQ, LLC, the session focused on compliance with USP chapters 797 and 795 and was targeted specifically toward board of pharmacy investigators.

NABP will provide updates on compounding standards and legislation as new information becomes available.

State Board News(continued from page 106)

to inspect and accredit wholesale distributors.

lNorth Dakota: House Bill 1455, signed into law on March 29, requires wholesale distributors

conducting business in North Dakota to obtain accreditation through the NABP Verified-Accredited Wholesale Distributors® (VAWD®) program or other accreditation process approved by the North Dakota State Board of Pharmacy. The legislation

is expected to take effect on August 1, 2007.

lSouth Dakota: House Bill 1155, signed into law on March 26, gives the South Dakota State Board of Pharmacy the authority to recognize an accreditation body to inspect and accredit wholesale distributors.

Becky Cooper. Simpson’s appointment expires on January 1, 2010.

Michael Tocco, RPh, MEd, was appointed a member of the Massachusetts Board of Registration in Pharmacy, replacing Harold Sparr. Tocco’s appointment will expire on November 11, 2011.

Robert Marshall, RP, BS, PharmD, was appointed a member of the Nebraska Board of Pharmacy, replacing Charles Curtis Barr. Marshall’s appointment expires November 30, 2011.

Thomas Richard Walsh was appointed a public member of the Nebraska Board of Pharmacy, replacing Linda Labenz. Walsh’s appointment will expire on November 30, 2011.

Richard A. “Rich” Palombo, RPh, was appointed a member of the New Jersey Board of Pharmacy, replacing Thomas Eagan. Palombo’s appointment will expire on May 31, 2009. Palombo also served on the Board from 1996 to 2005.

errors associated with adverse drug events to be reported to the Board and disseminates information about preventing medication errors through its Web site at www.rld.state.nm.us/pharmacy/events.html.

lThe Virginia Board of Pharmacy recently appointed a CQI committee to address patient safety and avoidance of dispensing errors.

lThe Washington State Board of Pharmacy, along with other stakeholders, provided consultation to the State Department

of Health in 2000 to develop recommendations for reducing medication errors, including the use of electronic prescribing to increase prescription legibility.

More information regarding patient safety initiatives and regulations will be forthcoming as new developments unfold.

nabp newsletter

112

june-july 2007

National Association of Boards of Pharmacy

1600 Feehanville Drive

Mount Prospect, IL 60056

nabp newsletter

Association Highlights

ReminderSee the Special Annual Meeting issue of the NABP Newsletter for highlights from the NABP 103rd Annual Meeting held May 19-22, 2007, in Portland, OR.

MPJE Item-Writing WorkshopPictured from left to right during the Multistate Pharmacy Jurisprudence Examination® (MPJE®) Item-writing Workshop, held June 15-16, 2007, at NABP Headquarters in Mount Prospect, IL, are Jeane Johnson, RPh, inspector, New Mexico Board of Pharmacy; Julia Eaton, RPh, member, Vermont Board of Pharmacy; Denise M. Frank, RPh, member, MPJE Review Committee; and Cody C. Wiberg, PharmD, executive director, Minnesota Board of Pharmacy.

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