april06nabpnewsletter

The pharmacist manpower challenge fi rst began ringing alarm bells in the late 1990s, when everyone from employers to educators to regulators began to assess the scope and origins of the challenge, and brainstorm possible strategies for dealing with it. Now, almost a decade later, it seems clear that, despite fl uctuations, the challenge is a long-term situation driven by medical, demographic, and public policy trends. In response, state boards of pharmacy, among other stakeholders in the pharmacy profession, have been fi nding long-term strategies. Many of these involve expanding the role of pharmacy technicians and increasing the use of technology, but the goal is

State Boards, Pharmacy Schools Address Pharmacist Manpower Challenge with Technology, Technician Regulations

always to ensure access to needed care so the public health and safety will not be compromised.

Demand for pharmacists varies by state, and not all areas are experiencing shortages. As of November 2005, the Aggregate Demand Index (ADI), a monthly survey of the pharmacy professional labor force sponsored by the non-profi t Pharmacy Manpower Project, estimated that in 16 states the demand for pharmacists equaled the supply, while in one state – Hawaii –pharmacist supply somewhat exceeded demand. Still, 34 states, many with high population densities, faced shortages, as measured by employers having at least

some diffi culty fi lling open pharmacist positions.

Coping StrategiesThe boards of pharmacy and other members of the pharmacy sector have developed tools to help fi ll in potential gaps in service that may occur due to the pharmacist manpower challenge. Two of the biggest are technology and technicians.

Technology in general, of course, has provided many opportunities for the pharmacy profession, as well as headaches for regulators. Internet pharmacies, telepharmacy, automated dispensing devices, prescription kiosks: All of these and many more

newsletterNational Association of Boards of Pharmacy®

aid to governmentthe profession

the public1904 to 2006

In This Issue. . . .Professional Affairs Update:

FDA Cautions Consumers About Filling US Prescriptions Abroad

April 2006 / Volume 35 Number 4

75 76 9286

Association News:NABP Announces New Partnership for FPGEC Administration; FPGEE Blueprint Update Process Begins

Legal Briefs:Professional Examinations: Help Wanted

102nd Annual Meeting: CE Programming at NABP’s 102nd Annual Meeting Offers Attendees Opportunity to Earn Up to 6.5 Hours

This Month on www.nabp.net:HeadlinesThe Honorable Tommy G. Thompson, Former HHS Secretary, to Speak at NABP’s 102nd Annual Meeting

Explorer and Cultural Anthropologist Dr Jeff Salz to Share Inspiring Life Lessons at NABP’s 102nd Annual Meeting

NABP’s 102nd Annual Meeting Provides an Opportunity to Discuss Regulatory Issues

NABP Hosts 102nd Annual Meeting Educational Presentation Area

Upcoming MeetingsSunday-TuesdayAugust 6-8, 2006NABP/AACP District III MeetingCharleston, SC

Thursday-SaturdayAugust 10-12, 2006NABP/AACP District V MeetingInn at the Forks,Winnipeg, Manitoba, Canada

Wednesday-SaturdayOctober 4-7, 2006NABP/AACP District VII and District VIII MeetingDisneyland HotelAnaheim, CA

Thursday-Saturday, October 12-14, 2006NABP/AACP District I and District II MeetingRenaissance Harborplace HotelBaltimore, MD

(continued on page 74)

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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 refl ect the

offi cial views, opinions, or policies of NABP or any board unless expressly so stated. The subscription

rate is $35 per year.

National Association of Boards of Pharmacy

1600 Feehanville Drive Mount Prospect, IL 60056

847/391-4406www.nabp.net

[email protected]

Carmen A. CatizoneExecutive Director/

Secretary

Dale J. Atkinson, JDLaurel Berger O’Connor

Contributing Editors

Larissa DoucetteEditorial Manager

Don TalendTechnical Editor

Lara R. JacksonEditor

Lisa HuxholdProofreader

©2006 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.

Feature News

Manpower(continued from page 73)


applications of technology allow the profession to handle more patients and more prescriptions with fewer personnel. Boards of pharmacy and state legislatures have worked, and are continuing to work on, maximizing the benefi ts of technology while minimizing the risks. Sometimes, however, a machine cannot substitute for a person, and in the absence of another pharmacist, that person is often a technician.

Non-pharmacist assistants are nothing new to the pharmacy profession, of course. But the last two decades have seen a huge move from unregulated, unlicensed personnel receiving their only training on the job to registered, licensed, and certifi ed employees designated “pharmacy technicians” or even “certifi ed pharmacy technicians” going through formal training programs and keeping up to date with CE. (See sidebar on page 84 for a summary of NABP’s involvement in the regulation of technicians over the years.) “There is an evolutionary shift in the profession,” says Melissa Murer Corrigan, executive director and chief executive offi cer of the Pharmacy Technician Certifi cation Board (PTCB), which seeks to promote and provide national, standardized certifi cation for pharmacy

technicians. (NABP became a partner in PTCB in 2002.) “Not that long ago, [technicians] weren’t even in the regulations.”

As formalized training and certifi cation have provided greater quality assurance within the pharmacy, technicians’ roles have expanded, often on a pharmacy-by-pharmacy and state-by-state basis. “Of course, pharmacy technicians have expanded roles with patient confi dentiality; third-party payers, specifi cally the new Medicare implementation (in community settings); and supervision of other technicians,” says Corrigan. “Emerging trends include allowing pharmacy technicians to accept prescription refi ll requests, perform prescription transfers, or contact prescribers to clarify prescriptions. Technicians have an expanded role with quality assurance, too.”

The private sector and the state boards have supported technician certifi cation. PTCB certifi cation – which requires candidates to pass the national examination (the Pharmacy Technician Certifi cation Examination, or PTCE) and to recertify every two years in part by completing 20 hours of CE, including at least one hour in pharmacy law – appears in the regulations of 26 states, says Corrigan. States often allow or require PTCB certifi cation in combination with other state-specifi c

requirements. Many major employers, meanwhile, “require all their technicians to pass their internal training program and then become PTCB certifi ed, usually within the fi rst year of their employment,” says Corrigan. “Successful candidates often receive a pay raise or bonus upon passing the examination. Major employers also pay for the recertifi cation program.”

Increased use of certifi ed, regulated technicians “is absolutely necessary,” says Katherine Knapp, dean of the Touro University College of Pharmacy and project director for the ADI. “The work is there to get done. . . . Someone has to fi gure out how to provide safe pharmaceutical care.” With the formation of the PTCB and its success in developing a national, standard certifi cation, “the pharmacist is confi dent in [the technician’s] ability.”

Technicians is not the only tool available to the state boards of pharmacy. Facing one of the nation’s highest pharmacist shortages, the Arizona State Board of Pharmacy sent a letter to the state’s governor in late 2005 urging the formation in Phoenix of a branch campus of Arizona’s state-run pharmacy school, which is based in Tucson. Hal Wand, the Board’s executive director, noted that many pharmacy school graduates stay in the area after they graduate. But even with more

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Association News

Executive CommitteeDonna M. Horn Chairperson, District IOne-year term

Dennis K. McAllisterPresident, District VIIIOne-year term

Lawrence H. MokhiberPresident-elect, District IIOne-year term

Charles R. YoungTreasurer, District IOne-year term

Charles Curtis “Curt” BarrMember, District VServing second year of a three-year term

Reginald B. “Reggie” DilliardMember, District IIIServing fi rst year of a three-year term

John R. Dorvee, Jr Member, District IServing fi rst year of a two-year term

Patricia F. HarrisMember, District VIIIServing fi rst year of a three-year term

Richard A. PalomboMember, District IIServing second year of a three-year term

Oren M. Peacock, JrMember, District VIServing third year of a three-year term

Gary A. SchnabelMember, District VIIServing third year of a three-year term

William T. WinsleyMember, District IVServing fi rst year of a three-year term

NABP’s Executive Committee is elected each year at the Association’s Annual Meeting. The 102nd Annual Meeting is April 8-11, 2006, at the Westin St Francis in San Francisco, CA.

Beginning April 14, 2006, NABP will partner with Educational Credential Evaluators, Inc (ECE) for the educational credential evaluation of applicants to the Foreign Pharmacy Graduate Examination Committee™ (FPGEC®) Certifi cation Program. This change to the processing of FPGEC Certifi cation Program applications has been made in response to a continuous increase in applications for the FPGEC Certifi cation Program and NABP’s ongoing efforts to improve processing times.

The FPGEC Certifi cation Program is accepted by 50 of NABP’s member boards of pharmacy as a means of documenting the educational equivalency of a candidate’s foreign pharmacy education. Foreign-educated pharmacists awarded FPGEC Certifi cation are considered to have partially fulfi lled eligibility requirements for licensure in those states that accept the Certifi cation.

Founded in 1980, ECE is a non-profi t public service organization specializing in the evaluation of foreign educational credentials. ECE has identifi ed the United States equivalence of foreign educational credentials for more than 1,000 educational institutions, employers, and

NABP Announces New Partnership for FPGEC Administration; FPGEE Blueprint Update Process Begins

professional licensing boards for over 20 years.

The improved processing time that the new method is designed to achieve has resulted in the fi rst increase of the $700 FPGEC fee to occur in 21 years. The fee for ECE to evaluate an applicant’s educational credentials is $85.

Under this new process, a link on NABP’s Web site at www.nabp.net will bring applicants to ECE’s Web site, where they can complete an application form requesting evaluation of their educational credentials either online or after downloading and printing an Adobe® Acrobat® PDF application. Applicants must also contact NABP for an FPGEC Application Form for Examination and Certifi cation Program. The applicant then sends the ECE application form to ECE along with offi cial transcripts, offi cial proof of degree, and $85. The applicant also sends the FPGEC Application Form for Examination and Certifi cation Program to NABP along with required documentation and $700.

While ECE verifi es the educational background information, NABP verifi es the applicant’s professional licensing and registration information. Following NABP’s receipt of a General

Evaluation Report from ECE verifying the applicant’s educational equivalency and completion of the Association’s own licensure and registration verifi cation processes, the applicant receives a Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®) acceptance letter. An applicant’s receipt of the FPGEE acceptance letter allows him or her to sit for the FPGEE. By receiving a passing score, along with passage of the Test of English as a Foreign Language™

(TOEFL®) and the Test of Spoken English™ (TSE®), or the TOEFL Internet-based Test (iBT), applicants obtain the FPGEC Certifi cate. The FPGEC Certifi cate allows foreign-educated and -licensed pharmacists to move toward obtaining licensure to practice in the US.

To apply for FPGEC Certifi cation, or for more information about the FPGEC Certifi cation Program or the FPGEE, visit NABP’s Web site at www.nabp.net.

FPGEE Blueprint UpdateOn January 9, 2006, representatives from the Accreditation Council for Pharmacy Education, the American Association of Colleges of Pharmacy, and


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Legal Briefs

Of course, NABP provides the North American Pharmacist Licensure Examination™ (NAPLEX®) and Multistate Pharmacy Jurisprudence Examination® (MPJE®) as services to its membership. The NAPLEX and MPJE are designed to assess applicants’ entry-level minimum competence for licensure as pharmacists,

Professional Examinations: Help Wanted

It is essential for boards of pharmacy to have a basic understanding of

the examination development and administrative processes, which are encompassed, in part, in the licensure application process. Boards of pharmacy comprise the membership of NABP, which exists to provide programs and services to its member boards consistent with the public protection mission associated with regulating the practice of pharmacy. NABP programs lessen burdens on boards of pharmacy through access to expertise and programs that facilitate the boards’ task of fulfilling their public protection responsibilities, while at the same time promoting uniformity to the regulation of the profession. Active participation by the membership in the development and administration of NABP programs ensures responsiveness to the needs of the boards of pharmacy, as well as instills the knowledge necessary to assist in the defense of any such program in the event of a political or legal challenge.

and are developed for use by boards of pharmacy as eligibility criteria in the licensure process. Several additional criteria exist in statute that boards of pharmacy must assess in determining licensure eligibility. These additional criteria generally include education, experience, good moral character and, perhaps, other factors.

Rather than blindly deferring to NABP with regard to the examination element of the licensure process, member boards are, from a legal and practical perspective, encouraged to participate in the process of developing the NAPLEX and MPJE. Boards of pharmacy should also regularly report NABP activities at their public board meetings as a means of informing all board members of Association events.

Participation and understanding of NABP’s programs will facilitate a defense by the board in the event of a legal or political challenge to the use of a particular program. While challenges to the examination process have diminished, they do occasionally surface. Consider the following example involving professional licensure in a different field.

In order to be licensed as a customs broker, an applicant must, among additional prerequisites, successfully complete the licensure examination. In the matter in dispute, the applicant failed the licensure examination by a single incorrect answer. Based upon this failure, the applicant was denied licensure and he appealed the decision. Specifically, the applicant argued that

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Legal Briefs


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

one particular question on the examination was ambiguous and that the answer he selected was actually more specific and, thus, correct as opposed to the answer used in the key.

Procedurally, candidates who fail to obtain licensure as a customs broker may challenge their result by filing a written appeal with the Bureau of Customs, which was undertaken by the applicant. The Bureau denied the appeal filed by the applicant, who further petitioned the matter to the secretary of the treasury. The secretary also denied the petition and the applicant appealed the matter to the United States Court of International Trade. The court denied the appeal and the applicant appealed the matter to the US Court of Appeals for the Federal Circuit.

The court of appeals was confronted with the issue of whether or not the question challenged by the applicant was ambiguous or whether or not there was more than one correct response contained in the answers. The item in question addressed the issue of the classification of a particular beer imported from Mexico with an alcoholic strength by volume of 0.4%. The applicant argued that the stem did not specify the temperature

at which the alcoholic strength by volume was measured, thus rendering the 0.4% inconclusive. The answers to choose from contained citations to various classifications codes contained in the Harmonized Tariff Schedule of the United States (HTSUS). The lower court and the secretary upheld the findings of the Bureau through a detailed analysis of the item and the responses with a justification for the findings that the key contained the correct answer.

On appeal, the court first established that the grounds for lawfully denying a license included the failure to pass the licensure examination. Also, the court cited the fact that the determinations by the administrative tribunal are conclusive so long as supported by the record, that is, whether or not substantial evidence supports the findings of the Bureau. Substantial evidence means such relevant evidence that a reasonable mind might accept as adequate to support a conclusion.

With this basis, the appellate court reviewed the record and held that no ambiguity existed surrounding the item in question. The court cited the record established in the lower tribunals and held that the

applicant ignored the facts contained in the item and now “. . . labors to find a justification for doing so.” The administrative tribunal was confronted with a complete record to establish the basis for the item in question and the rationale for the correct response. In short, the item stipulated the alcoholic strength by volume, which obviated the need to provide additional information about the temperature. This analysis illustrates the importance of item development and justification for the correct response.

High-stakes licensure examinations (that is, those that are used to determine eligibility for licensure as a prerequisite to practice one’s chosen profession) are developed under stringent standards to ensure their validity and reliability under statistical and psychometric principles. These examinations are built upon a platform developed through a practice analysis designed to identify practice characteristics and the importance of each particular task. Based upon a blueprint developed through an assessment of the practice analysis, content areas are identified. Thereafter, items can be generated by subject matter experts within each content area of the blueprint. Once

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Association News

A recent meeting of NABP’s Task Force on Standards for Compounding resulted in the presentation of six recommendations to the Executive Committee pursuant to the Task Force’s charge of reviewing standards set forth in United States Pharmacopeia (USP) Tests and Assays Chapter 795 (USP Chapter 795), “Pharmaceutical Compounding – Nonsterile Preparations,” and USP Tests and Assays Chapter 797 (USP Chapter 797), “Pharmaceutical Compounding – Sterile Preparations.” The review was for the purpose of recommending revisions and providing comments to USP on the respective standards.

The complete Task Force report will be available on NABP’s Web site at www.nabp.net by the second quarter of 2006.

The Task Force met on November 11, 2005, following its appointment at the direction of the NABP Executive Committee in response to Resolution 101-2-05, Sterile Compounding and the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act), which was passed during NABP’s 101st Annual Meeting,

NABP Task Force Recommends Collaborative Efforts with Pharmacy Profession in Addressing Complex Compounding Issues

held in New Orleans, LA, in May 2005. Resolution 101-2-05 directed NABP to review and revise, where appropriate, its Model Rules for Sterile Pharmaceuticals to reflect applicable standards set forth in USP Chapter 797 in all practice settings that will protect the public health, as well as the safety of the pharmacist and pharmacy technician involved in the compounding of sterile pharmaceuticals.

USP Chapters 795, 797 AddressedAt the meeting, Roger L. Williams, MD, vice president and chief executive officer of USP, provided an overview of USP Chapters 795 and 797 and discussed the USP Sterile Compounding Committee’s proposed revisions to USP Chapter 797. Dr Williams reviewed the major components of USP Chapter 795, including the responsibility of the compounder, selection and sources of ingredients, quality control, and the stability of non-sterile compounded preparations.

Dr Williams reiterated to the Task Force members that USP Chapter 797 addresses the procedures and requirements for compounding sterile preparations including the

facilities for such preparations; the training and assessment of personnel regarding the principles and practices of aseptic manipulations; air quality evaluation and maintenance; and principles and practices of sterilization and solution stability. During his presentation, Dr Williams also addressed the organization and components of USP Chapter 797, emphasizing the risk-based approach in applying the standards based upon the risk level of the sterile preparation being compounded. (A draft revision of USP Chapter 797 is expected to be made available for a 90-day public comment period and posted on USP’s Web site in May 2006.)

RecommendationsDiscussion among Task Force members produced six recommendations, which were approved by the Executive Committee in March 2006.

1. The Task Force agreed that the practice of compounding is a complex area of growing concern. The Task Force recommended to the Executive Committee that NABP communicate to the member boards of pharmacy that increased scrutiny should be directed to compounding activities with equal

emphasis on sterile and non-sterile compounded preparations.

The Task Force members recognized the inherent risks that incorrectly prepared contaminated intravascular compounded medications pose to patients, but also acknowledged that non-sterile compounded medications (such as topical creams, gels, and ointments) may pose significant risks as well and, therefore, require the member boards of pharmacy to be equally vigilant and proactive concerning the regulation of non-sterile compounding.

The Task Force members also agreed that the member boards of pharmacy continue to encounter pharmacies that “manufacture” bulk preparations under the guise of compounding. The Task Force reiterated that the member boards of pharmacy should consider such factors as the compounded prescription volume, existence of a practitioner/patient/pharmacist relationship, the use of commercial scale manufacturing or testing equipment for compounding drug products, and whether or not the compounded product is a copy, or

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Association News

essentially a copy, of a commercially available Food and Drug Administration (FDA)-approved drug product in the market place in distinguishing legitimate compounding from manufacturing.

2. The Task Force recommended to the Executive Committee that NABP continue to work with USP and FDA to clarify the application of USP compounding chapters to the pharmacy profession based upon risk-based assessments of compounding practices.

USP Chapter 797 recognizes three risk levels (low, medium, and high risk) of compounded sterile preparations based upon the probability of microbial, chemical, and physical contamination. Based upon the risk level, USP Chapter 797 provides general guidance on the compounding manipulations, equipment requirements, and specification of the compounding environment. Generally, high-risk compounded sterile preparations require the most stringent and comprehensive quality assurance procedures, including

suitable compounding environments.

The Task Force members and FDA expressed concern that some pharmacies may not recognize the risk-based assessment approach to USP Chapter 797, which often results in the excessive and costly reconstruction of sterile compounding areas and purchasing of unnecessary equipment. Although extensive upgrades to compounding areas and procedures may be warranted and justified, pharmacies should investigate more cost-efficient means to meet USP Chapter 797 compliance based upon the risk level(s) of compounding performed.

3. The Task Force recommended to the Executive Committee that NABP continue to work with USP to ensure that USP Chapters 795 and 797 provide standards and guidance that are valid, justifiable, and reasonable to achieve integrity of the compounded preparation in consideration of patient safety.

The Task Force agreed that some standards identified in the USP compounding chapters, particularly USP Chapter 797, should be based primarily upon sound scientific research

that corresponds to the appropriate level of rigor necessary to achieve the accepted level of quality for the compounded sterile preparation. Conversely, Task Force members also cautioned that standards within USP Chapter 797 should also meet existing practice guidelines to ensure patient safety.

4. The Task Force recommended to the Executive Committee that NABP endorse the adoption of USP compounding chapters within the Model Act.

The Model Act’s Good Compounding Practices Applicable to State Licensed Pharmacies currently recognize and mandate that pharmacists and pharmacies practice in accordance with the current USP-National Formulary (NF) Chapters on compounding and sterile product preparation. NABP’s 2004-2005 Committee on Law Enforcement/Legislation amended the Model Rules for Sterile Pharmaceuticals in consideration of the risk level of sterile products being compounded consistent with USP Chapter 797.

Although agreeing that the member boards of pharmacy incorporate USP chapters on compounding into

state rules and regulations, the Task Force members cautioned that NABP and the member boards of pharmacy recognize that USP is working to revise USP Chapter 797 in consideration of comments, revisions, and suggestions received from the health care professional community.

5. The Task Force recommended to the Executive Committee that NABP and the member boards of pharmacy continue to engage in collaborative efforts with FDA, USP, Joint Commission on Accreditation of Healthcare Organizations, and other stakeholders to define and address compounding activities in a cohesive and unified manner.

The Task Force members agreed that uniformity among conforming assessment bodies could ensure consistency and recognition of one standard in pharmacy compounding. The Task Force members also recommended that the member boards of pharmacy work cooperatively with FDA with respect to investigations and enforcement activities.

6. The Task Force recommended to the Executive Committee

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Association News

The November 18, 2005 Task Force on Model Regulations for Long-Term Care (LTC) meeting resulted in five recommendations to NABP’s Executive Committee, including four recommendations to revise the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act). The complete report will be available on NABP’s Web site at www.nabp.net by the second quarter of 2006.

The appointment of this Task Force came at the direction of NABP’s Executive Committee in response to a recommendation from the 2004-2005 Government Affairs Subcommittee to convene a task force to include representatives from the American Society of Consultant Pharmacists (ASCP) to continue collaborative efforts on revising the Model Act with respect to LTC pharmacy practice. As part of this collaboration, Ross Brickley, chairman of ASCP, attended the Task Force meeting and discussed the issues, barriers, and concerns of LTC pharmacy practice with respect to state laws and regulations. Brickley also identified specific sections of the Model Act that could be revised and amended to reflect the current practice of the unique aspects of LTC pharmacy practice. During

NABP’s Long-Term Care Task Force Reviews Issues Impacting the Practice of Pharmacy in Model Rules

the meeting, Task Force members also discussed Brickley’s comments in the context of changing LTC pharmacy practice and the Model Act.

The Task Force’s charge was to review the issues defined by and impacting the practice of pharmacy in LTC settings so as to identify provisions of the Model Act that may necessitate revision.

RecommendationsFollowing are a list of the Task Force’s recommendations, which were approved by the Executive Committee in March 2006.

1. The Task Force recommended to the Executive Committee that the NABP Model Rules for Institutional Pharmacy in the Model Act be amended to increase the recognition of the practice of LTC pharmacy. The Task Force further recommended that the Model Act incorporate a definition of “Chart Order.”

Task Force members agreed that the NABP Model Rules for Institutional Pharmacy should be amended to recognize LTC pharmacy practice as a subset of institutional pharmacy practice. Members recommended specific changes to Section 1

(Applicability) of the NABP Model Rules for Institutional Pharmacy and also provided amendments to the definition of “Institutional Pharmacy.”

These revisions would allow pharmacies serving LTC facilities (LTCFs) to:

Provide emergency drug kits as provided in Section 4 (Absence of Pharmacist) within the NABP Model Rules for Institutional Pharmacy;

Be exempt from patient counseling requirements as provided within Section 3 (Pharmacy Practice) Subsection H (Patient Counseling) of the NABP Model Rules for Pharmaceutical Care; and

Utilize a drug formulary system as provided within Section 1 (Facility) of the Model Rules for Pharmaceutical Care.

2. The Task Force recommended to the Executive Committee that the NABP Model Rules for Institutional Pharmacy incorporate centralized prescription processing for “Immediate Need Medications” for institutional patients based upon valid chart orders.

The Task Force members agreed that institutional pharmacies, and specifically those that provide services to LTCFs, often utilize

centralized prescription processing arrangements to provide continuous services to inpatients. Task Force members recommended that centralized prescription processing be incorporated within the NABP Model Rules for Institutional Pharmacy, recognizing the use of a valid chart order and further specifying that the institutional pharmacy outsourcing services have approval from the institutional facility.

3. The Task Force recommended to the Executive Committee that the Model Act incorporate guidance that specifies how the practitioner’s agent is designated with respect to the transmission of chart orders (prescription drug orders).

Drug Enforcement Administration (DEA) does not recognize the LTCF nurse as an agent of the physician. In DEA’s April 2001 Federal Register notice, DEA conveyed that since no legal agency relationship exists between the LTCF nurse and the physician, LTCF nurses who relay change in the treatment to the pharmacist would not be in compliance with legal requirements. Mindful that the Model Act does not specify the legality of the relationship between a practitioner and the

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Compounding(continued from page 79)

practitioner’s agent, Task Force members agreed that prescription drug orders for non-controlled medications could be communicated by a practitioner’s agent as long as the agent was authorized in accordance with written policies and procedures applicable to state and federal laws.

4. The Task Force recommended to the Executive Committee that the Model Act include a defi nition of “Prepackaging” and that the NABP Model Rules differentiate the act of “Prepackaging” from “Repackaging.”

While developing this recommendation, the Task Force members emphasized the difference between “repackaging” and “prepackaging.” According to the Model Act, the act of

“repackaging” is considered manufacturing, which is the “production, preparation, propagation, 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.” Task Force members wanted to distinguish pharmacies, which perform repackaging and relabeling operations beyond the usual conduct of dispensing from those performing “prepackaging” operations, emphasizing that the former are subject to state and federal laws and regulations with respect to manufacturing.

Many member boards of pharmacy, including Arizona, Minnesota, Montana, and Nevada, have developed prepackaging regulations

that specify labeling and recordkeeping requirements.

5. The Task Force recommended to the Executive Committee that NABP collaborate with ASCP to issue a white paper on LTC pharmacy practice regulatory issues for the purpose of educating the member boards of pharmacy and the pharmacy profession on issues of mutual concern.

The Task Force members recognized that such a publication could also serve to educate those in LTC pharmacy practice on how the practice is regulated by the member boards of pharmacy and other regulatory agencies. The white paper could specifi cally address the need for regulations on prepackaging, centralized

prescription processing agreements for assuring immediate medication access by institutional facilities, and recognition of chart orders as valid and lawful orders.

Members of the 2004-2005 Task Force on Model Regulations for Long-Term Care include Task Force Chair Patricia F. Donato, member, New York State Board of Pharmacy; David Flashover, member, New York State Board of Pharmacy; Julie D. Frazier, member, Tennessee Board of Pharmacy; Richard J. Oubre, member, Louisiana Board of Pharmacy; Sara St Angelo, member, Indiana Board of Pharmacy; and Ann L. Zweber, member, Oregon State Board of Pharmacy. Richard A. Palombo, Executive Committee liaison, and ex-offi cio member Brickley of ASCP were also in attendance.

that NABP work with USP and FDA to develop training workshops and educational programming for the member board of pharmacy inspectors or compliance investigators and other NABP members on USP compounding chapters and compounding practices.

As more states begin to incorporate regulations and rules mandating compliance with USP Chapter 797 and other USP compounding chapters, the Task Force members agreed that member board of pharmacy inspectors or compliance investigators could benefi t from training and educational programming. USP volunteered to participate in this effort and indicated

that it was necessary and benefi cial.

Members of the Task Force on Standards for Compounding include Judy Lynn Gardner, member, Georgia State Board of Pharmacy and Task Force chair; Charles L. Haytaian, member, Rhode Island Board of Pharmacy; Dennis M. Jones, executive secretary, South Dakota State Board of Pharmacy; Sheila Mitchell, member, Tennessee Board

of Pharmacy; Wallace E. Nelson, member, North Carolina Board of Pharmacy; Richard R. Smiga, member, Pennsylvania State Board of Pharmacy; and Susan L. Warren, program director, Colorado State Board of Pharmacy. Also in attendance were John R. Dorvee, Jr, NABP Executive Committee liaison; USP’s Williams; and ex-offi cio members Brenda Uratani and Samia Nasr of FDA.

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NABP recently released the 2005 test administration results for its North American Pharmacist Licensure Examination™ (NAPLEX®), Pre-NAPLEX®, Multistate Pharmacy Jurisprudence Examination® (MPJE®), Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®), and Pre-FPGEE®. Four of the fi ve programs saw an increase of candidates from 2004 to 2005.

NAPLEX, Pre-NAPLEXThe number of candidates who sat for the NAPLEX in 2005 increased by 377, or 3.5%, from those testing in 2004. From January 1, 2005 through December 31, 2005, a total of 11,190 candidates sat for the NAPLEX compared to 10,813 administrations in 2004. This increase in NAPLEX administrations can be attributed to a small increase in the number of pharmacy school graduates, and to candidates seeking licensure in California, where both new graduates and pharmacists

NAPLEX, Pre-NAPLEX, MPJE, FPGEE, and Pre-FPGEE 2005 Administration Results Released

who were previously licensed in another state must successfully complete the NAPLEX after January 1, 2004. Of those taking the NAPLEX in 2005, 8,297 were fi rst-time candidates from Accreditation Council for Pharmacy Education-accredited programs. As in the past, these fi rst-time candidates performed better than those retaking the examination, with a 91% passing rate compared to an overall passing rate of 85%. Generally, fi rst-time candidates perform better on the NAPLEX because their knowledge and skills related to the practice of pharmacy are most up-to-date.

For the third consecutive year, the number of individuals who utilized the Pre-NAPLEX grew – the number of candidates continues to increase as the benefi ts of this tool, which was launched in 2003, become more widely known. In 2005, a total of 4,764 examinations were taken, an increase of approximately 849, or 22%,

from 2004. In 2005, 23% of the individuals took both forms of the Pre-NAPLEX. The Pre-NAPLEX is the only practice examination for NAPLEX created and developed by NABP.

MPJE Administrations IncreaseA total of 15,953 candidates sat for the MPJE in 2005 compared to 15,219 candidates who sat for the examination in 2004. This represents a 5% increase for MPJE administrations in 2005. This increase is likely due to a small increase in the number of pharmacy school graduates as well as the addition of Idaho to the MPJE program in December 2005. The overall passing rate for 2005 was 86%. The MPJE was offered by 45 jurisdictions in 2004 and by 46 jurisdictions in 2005.

FPGEEThe total number of applicants who sat for the FPGEE examination in 2005 was 3,665, compared

to 3,869 applicants in 2004, a 5.3% decrease compared to 2004. The Foreign Pharmacy Graduate Examination Committee™ (FPGEC®) processed 4,049 applications in 2005 and 3,290 of those applicants qualifi ed to sit for the FPGEE. (Note: Applicants have two opportunities to test and therefore the number qualifi ed in a year may be lower than the number who actually take the exam.) Applicants from approximately 70 countries sit for the FPGEE each year.

India had the highest number of applicants who sat for the FPGEE, followed by the Philippines, Egypt, Korea, and Nigeria; applicants from these countries comprised 75% of the applicants.

In 2005, 701 applicants utilized the Pre-FPGEE compared to 1,148 in 2004. This is due the to fact that only one form of the Pre-FPGEE was available in 2005 compared to the two forms that were available in 2004.

Colleges of Pharmacy, and NABP convened the fi rst meeting of the FPGEE Blueprint Committee at NABP Headquarters in Mount Prospect, IL. The fi rst task that the Committee agreed to complete was

Partnership(continued from page 75)

conducting a survey of 55 schools and colleges of pharmacy in the spring of 2006 in which credit hours devoted to various areas of the schools’ and colleges’ pharmacy curricula will be validated. The responses from this fi rst survey are to be used as a basis of a larger survey to be sent to all US schools and

colleges of pharmacy for the purpose of validating their curricula hours. Following the validation, the Committee will revise examination standards, reposition the examination item pool to determine if items from the old blueprint fi t the updated blueprint,

and revise the examination by the end of 2007.

NABP regularly conducts surveys to update and validate the FPGEE blueprint. These surveys ensure that the blueprint accurately refl ects the educational equivalency of a candidate’s foreign pharmacy education.

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Feature News


The National All Schedules Prescription Electronic Reporting (NASPER) Act (HR 1132) that was recently signed into law will allow prescribers (physicians) and dispensers (pharmacists) to access patient records in order to determine what controlled substances (CS) have already been prescribed and dispensed to a patient, and prevent the duplication of prescriptions and adverse reactions. The legislation also provides for the spending of $60 million from fiscal years (FY) 2006 to 2010 to create a federal grant program to be housed in the United States Department of Health and Human Services (HHS). This grant program will be available to states seeking to (1) establish and implement a new prescription monitoring program (PMP); or (2) make improvements to an existing PMP.

Although the NASPER legislation has been signed into law, Congress had yet to appropriate funds to HHS in support of the new grant program as of press time. Without an appropriation, the new NASPER program is an authorized but unfunded program.

The passage of this legislation has come at a time when prescription monitoring has been the subject of increased awareness at the state

New Federal Law Aims to Stop Duplicate CS Administrationlevel. Twenty-two states currently have existing PMPs or are in the process of establishing programs, while several others are proposing legislation or regulations that would allow them to take advantage of this new grant program. Each of the CS monitoring programs has different data collection and dissemination standards, as well as differing user populations. For example, some programs are used only by prescribers and pharmacists; others are used only by law enforcement officers as a part of diversion investigations; and some programs authorize access for both user populations.

Further, the NASPER grant program is not the first of its kind. Many states that have existing programs owe the development and success of their programs to the Harold Rogers Prescription Drug Monitoring Grant Program, which is still available. Beginning in FY 2002, Congress appropriated funding to the US Department of Justice (USDOJ) to award Harold Rogers Grants to states that wished to (1) study the establishment of a program; (2) establish a new program; or (3) enhance an existing program.

To date, 39 states have applied for and received some level of funding from

the Harold Rogers Grant Program; this includes at least 17 boards of pharmacy, according to data from the USDOJ. The responsibility for the PMPs may fall on different levels of governments. In some states, the narcotics bureau houses and administers the PMPs, while in other states, the responsibility falls on the board of pharmacy.

Future of FundingThe FY 2006 Harold Rogers Grant Solicitation closed in mid-December 2005. The FY 2006 applicants are now awaiting word about their awards. As Congress moves into making its appropriations for FY 2007, two programs are authorized to receive funding for prescription drug monitoring: the Harold Rogers Grant Program and the NASPER program. Chances are, funding eventually will be available under these programs.

Impact on the Boards of PharmacyPrior to the creation of the federal grant programs, some states struggled to find the human and fiscal resources to implement or establish PMPs. While these grant programs provide the states with the resources to establish or implement CS monitoring programs, they also establish a clear set of expectations and qualifications that states

must meet. In order to qualify for the NASPER grant funding, a state must meet criteria as a part of an application for funds.

Standards are delineated in law specific to the information about the monitoring program, which the applicant must submit at the time of application. For example, among these informational requirements, the applicant must:

Identify how the state intends to maintain the integrity of the database, as well as the security of information in the database;

Establish policies and procedures for the timely collection and dissemination of information;

Submit a cost estimate for the administration of the program;

Provide information on penalties for the unauthorized use or disclosure of data; and

Provide information about an interoperability agreement.

The state must demonstrate that it has enacted legislation or regulations to permit the implementation of a state CS monitoring program. If a state is awarded a grant, the NASPER legislation also sets standards for grant compliance and monitoring.

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(continued from page 74)

Feature News

pharmacists from other states requesting licensure transfer to practice in Arizona than vice versa, and the two existing pharmacy schools turning out roughly 170 graduates a year, the numbers of pharmacists are unable to keep pace with the ever-increasing demands of the population.

A new pharmacy school may help in the future,

Manpower but the Arizona Board has done more recently to encourage pharmacists to practice in the state. Since pharmacists registered in California now must pass the North American Pharmacist Licensure Examination™ (NAPLEX®), the Arizona Board decided in 2005 to grant reciprocity to California-licensed pharmacists, despite California’s restrictions on accepting pharmacists licensed in Arizona. Already,

the Board is seeing a positive response to the policy, Wand reports. When taken in combination with the Board’s 2003 elimination of technician-pharmacist ratio requirements and the state’s licensing and certifi cation requirements for technicians, the Board’s actions may well have an impact on the state’s shortage problem.

North Dakota has used both technology and technicians in its now well-known approach to providing

remote communities with quality pharmacist care. (See “Telepharmacy Offers Convenience, Poses Challenges” November-December 2005 NABP Newsletter, page 194.) North Dakota has faced a chronic pharmacist shortage; if not the largest in the nation –“probably a 2% shortage now,” says Howard C. Anderson, Jr, executive director of the North Dakota State Board of Pharmacy, though he says it has been

NABP’s involvement of the regulation of pharmacy technicians, as displayed through the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act), refl ects the profession’s shift as a whole. Following are some of the highlights.

In 1993, in response to several resolutions from NABP’s 89th Annual Meeting, the Association convened the Task Force on Pharmacy Technicians to examine the status of the utilization of pharmacy technicians, existing regulations, and registration by the state boards of pharmacy.

Changes to NABP’s Model Act Refl ect Profession-wide Shift in Technician Regulations

The Task Force on Pharmacy Technicians’ recommendations included:

Formal recognition and regulation of pharmacy technicians by the state boards of pharmacy;

Adoption of the term “pharmacy technician”;

Development of a national competency assessment examination;

State board involvement in training programs, with eventual national standardization; and

Development of a technician disciplinary clearinghouse; and

Drafting model language for technician regulation.

At that time, the Model Act defi ned “pharmacy technician” as “supportive personnel who work under the immediate supervision

of a Pharmacist.” Besides maintaining a current list of pharmacy technicians with the Board, the pharmacist-in-charge was to “develop and implement written policies and procedures to specify the duties to be performed by Pharmacy Technicians. The duties and responsibilities of these personnel shall be consistent with their training and experience. These policies and procedures shall, at a minimum, specify that Pharmacy Technicians are to be personally and directly supervised by a Pharmacist stationed within the same work area who has the ability to control, and who is responsible for, the activities of Pharmacy Technicians, and that Pharmacy Technicians are not assigned duties that

may be performed only by a Pharmacist.”

In 1999, delegates to NABP’s Annual Meeting approved Resolution No. 95-7-99, Task Force to Investigate the Expanded Use of Technicians, calling for the formation of another task force on technicians, the Task Force on Standardization of Technicians’ Role and Competencies, to “investigate and make recommendations on how technicians should be positioned to empower pharmacists to move away from the mechanical preparation of prescriptions and to allow for pharmacists to undertake a greater

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Feature News

more serious in the past. Given the state’s scattered rural population, “It’s really a demographic shortage, not just a pharmacist shortage,” says Anderson.

North Dakota’s telepharmacy program allows one pharmacist to oversee up to four remote sites staffed by pharmacy technicians. The pharmacist uses computer and video links to oversee the technician’s work and then to dispense the medication and provide counseling to

the patient. Not surprisingly, the system requires not only technology but also more highly trained technicians. All pharmacy technicians in North Dakota must graduate from an American Society for Health-System Pharmacists (ASHP)-accredited program, Anderson says, and take 20 continuing education (CE) credits every two years; technicians who staff remote telepharmacy sites must also have at least one year of experience before they may

work at the remote site. “We use telepharmacy to provide services to communities that otherwise wouldn’t have it,” says Anderson.

At press time, Alaska was preparing to enact its own telepharmacy regulations, similar to the North Dakota model, and for similar reasons. “We’re always in need of pharmacists,” says Sher Zinn, licensing examiner for the Alaska Board of Pharmacy. “We have so many remote areas . . . It’s hard to

fi nd people to go there.” The regulations were scheduled to go into effect in mid-February 2006, or as soon as the licensing requirements were drawn up. “It should relieve pressure in remote areas,” says Zinn. “There’s been a lot of interest.”

Alaska has licensed pharmacy technicians since the late 1990s, though certifi cation has not been required. In fact, the state contains more registered technicians than

role in the transfer of information to the patient.” One recommendation to come out of the Task Force on Standardization of Technicians’ Role and Competencies was the elimination of the technician-to-pharmacist ratio in settings with documented internal quality assurance programs. The Association also at this time recognized two levels of support personnel in the pharmacy: pharmacy technicians and certifi ed pharmacy technicians.

One year later, Annual Meeting attendees passed a resolution directing NABP to explore

technician certifi cation programs. In 2002, in demonstration of its commitment to a national competence assessment program for technicians, NABP became a partner in the PTCB, which had been founded in 1995.

Also in 2002, NABP convened the Task Force on Transition of Pharmacy Regulation from the Dispensing Process to Outcomes, which focused on the transition of pharmacy regulation from the dispensing process to outcomes; its charge included an examination of the expanded role of the technician. This Task Force recommended that certifi ed pharmacy technicians be allowed to accept new prescription drug

orders, a change that was included in the Model Act.

The current Model Act includes sections on the registration of certifi ed pharmacy technicians and pharmacy technicians. Per Section 307, Registration of Certifi ed Pharmacy Technicians, among other requirements, the certifi ed pharmacy technician must have “(i) graduated from a pharmacy technician training program approved by the Board of Pharmacy; or (ii) been documented by the Pharmacist-in-Charge of the Pharmacy where the applicant is employed as having successfully completed a training program and having successfully completed an

objective assessment mechanism prepared in accordance with any rules established by the Board” and “have successfully passed an examination or examinations approved by the Board of Pharmacy.” Per Section 308, Registration of Pharmacy Technicians, the pharmacy technician must “have been documented by the Pharmacist-in-Charge of the Pharmacy where the applicant is employed as having successfully completed a training program and having successfully completed an objective assessment mechanism prepared in accordance with any rules established by the Board.”

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102nd Annual Meeting

Interested in exploring such topics as an analysis of issues that have dramatically changed health care in the United States, a discussion and review of key legislative activities affecting the states, an exploration of the regulation of medical gas fillers and applicable good manufacturing practice regulations, an examination of the major sections of US Pharmacopeia (USP) Chapter 797 related to sterile compounding compliance, tips on effective communication, and structuring an effective disaster plan?

If so, NABP’s 102nd Annual Meeting, to be held April 8-11, 2006, at the Westin St Francis in San Francisco, CA, is the place to hear about all of those topics while earning up to 6.5 hours of continuing education. The Association has developed joint programming sessions as well as tracks designed specifically for executive officers and board members, compliance officers, and professional development.

Monday, April 10Joint Programming

Public Policy Decisions: An Analysis of Issues That Have Dramatically Changed Health Care in the United States Health care in the United States has undergone a

CE Programming at NABP’s 102nd Annual Meeting Offers Attendees Opportunity to Earn Up to 6.5 Hours

dramatic transformation as a result of the passage and implementation of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and other public policy decisions. The expansion of the Medicare program has raised a number of public policy health issues concerning access to medications and the optimal management of medication therapy in consideration of patient safety. Additionally, federal and state agencies are continuing to examine public health policies regarding the importation of drugs from countries outside of the US’s regulatory safety net, an effort that has largely been spearheaded by US Food and Drug Administration (FDA). The Honorable Tommy G. Thompson, former US Department of Health and Human Services secretary, will discuss and analyze these issues from his unique perspective while overseeing the department. By the conclusion of this session, participants will be able to identify factors and influences that shape public health policy and discuss the dynamics of public health policy development given the varying and sometimes conflicting interests of patient safety, special interests, and politics.

A Legislative Update for State Boards of PharmacyFaced with the Internet, the increasing importance of prescription medications as a stalwart of therapy and valuable commercial commodity, and an unprecedented consumer activism, state boards of pharmacy are continually being faced with an often confusing patchwork of legislations and regulations. From the regulation of methamphetamine precursors to the licensure of wholesale distributors to electronic prescribing, state boards are increasingly the focal point for state legislatures and the public to address a range of serious health concerns. During this session, participants will discuss and review key legislative activities that are occurring in the states.

Tuesday, April 11Executive Officer and Board Member Programming

Medical Gases: A Food and Drug Administration Invitation to Partner with the State Boards of Pharmacy

In March 2001, FDA issued a public health advisory and guidance document to alert hospitals, nursing homes, and other health care facilities of medical gas mix-ups. From approximately 1997 to 2001, FDA had received reports

involving seven deaths and 15 injuries to patients who were thought to be receiving medical grade oxygen but were in fact receiving a different gas (eg, nitrogen) that had been mistakenly connected to the oxygen supply system. During this session, participants will explore and discuss opportunities on how the boards of pharmacy can partner with FDA in the regulation of medical gases. Additionally, the role of FDA in the regulation of compressed medical gas fillers (including companies engaged in home respiratory services) will be reviewed along with specific sections of the current good manufacturing practice regulations for drug products that are applicable to compressed medical gas fillers.

Compliance Officer Programming

USP Chapter 797: Surveying for Sterile Compounding Compliance

On January 1, 2004, USP released Test and Assays Chapter 797 (USP Chapter 797), “Pharmaceutical Compounding – Sterile Preparations,” which represented the organization’s latest efforts to address sterile compounding preparation

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Saturday, April 8, 20069 AM - 7 PM Registration Desk Open

1 - 5 PM

Educational Presentation Area Open/Poster Session

1 - 5 PM

Hospitality Suite in Presentation Area

Hosted by the California State Board of PharmacySponsored by Takeda Pharmaceuticals, Inc

1 - 5 PM

Spouse/Guest Tour: Alcatraz Island Tour

5:45 - 6:45 PM

New Member Seminar

7 - 10 PM

President’s Welcome ReceptionDinner will be served.Dress: business casual

Sunday, April 9, 20066:30 - 7:30 AM

Fun Run/WalkSponsored by Pfi zer US Pharmaceuticals

7:30 AM - 6 PM

Registration Desk Open

8 - 10 AM

Continental Breakfast(In Presentation Area.)

8 AM - noonEducational Presentation Area Open/Poster Session

1 - 1:15 PM

Welcome RemarksCarmen A. CatizoneNABP Executive Director/Secretary

1:15 - 2 PM

Keynote AddressJeff SalzExplorer, Cultural AnthropologistSponsored by AstraZeneca

2 - 2:15 PM

Refreshment Break

2:15 - 4:45 PM

First Business Session

4:45 - 5:45 PM

Open Microphone Session

Monday, April 10, 20067 AM - 3 PM


7 - 8 AM

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

8:15 - 10:15 AM

Joint CE ProgrammingPublic Policy Decisions: An Analysis of Issues That Have Dramatically Changed Health Care in the United StatesSponsored by Pfi zer US Pharmaceuticals

Program #: 205-000-06-001-L04(0.2 CEUs – 2.0 contact hours)

10:15 - 10:30 AM

Refreshment Break

10:30 AM - noonJoint CE ProgrammingA Legislative Update for State Boards of PharmacySponsored by Walgreen Co


April 8-11, 2006 Westin St Francis San Francisco, CA(Program subject to change.)

Noon - 12:15 PM Break

12:15 - 1:30 PM

Second Business Session

1:30 - 2:30 PM

Meet the Candidates Session(Lunch will be provided.)

Tuesday, April 11, 20067:30 AM - 4:15 PM


8 - 9 AM

Continental Breakfast

9 - 10:30 AM

Executive Offi cer and Board Member ProgrammingMedical Gases: A Food and Drug Administration Invitation to Partner with the State Boards of PharmacySponsored by Barr Laboratories


Compliance Offi cer ProgrammingUSP Chapter 797: Surveying for Sterile Compounding ComplianceSponsored by Medco Health Solutions, Inc


Professional Development ProgrammingEffective Communication and Delivery of Board Policy in Public Meetings and with the MediaSponsored by Wal-Mart Stores, Inc


10:30 - 10:45 AM

Refreshment Break

10:45 AM - 12:30 PM

Joint CE ProgrammingStructuring an Effective Disaster Plan: Lessons Learned

Part I: Rising to the Occasion: The State Boards of Pharmacy Vital to Hurricane Relief and Recovery EffortsPart II: Where Do We Go From Here? Open Forum and Panel Discussion on the State Boards of Pharmacy Role in Emergency Preparedness and Response


11:30 - 11:45 AM

Refreshment Break(Lunch will be provided.)

12:30 - 1 PM Break

1 - 4 PM

Final Business Session

2:30 - 2:45 PM Refreshment Break

5:45 - 6:45 PM

NABP/NACDS ReceptionSponsored by the National Association of Chain Drugs Stores

7 - 10:30 PM

Annual Awards DinnerDress: semiformal

NABP and the NABP Foundation are approved by the Accreditation Council for Pharmacy Education (ACPE) as providers of continuing pharmacy education. ACPE Provider Number: 205. Participants may earn ACPE-approved continuing education credit from NABP. Participants in continuing pharmacy education programs will receive credit by completing a “Statement of Continuing Pharmacy Education Participation” and submitting it to NABP. A validated Statement of Continuing Pharmacy Education Credit will be sent as proof of participation within approximately six weeks. Full attendance and completion of a program evaluation form for each session are required to receive continuing pharmacy education credit and a “Statement of Continuing Pharmacy Education Credit.”

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Association News

State boards of pharmacy members and staff and schools and colleges of pharmacy have a unique opportunity to share information about the latest legislative issues, technology, policy development, or disciplinary cases at the Fourth Annual Poster Session held during NABP’s 102nd Annual Meeting. The session will take place Saturday, April 8, 2006, from 1 to 5 PM and Sunday, April 9, 2006, from 8 AM to noon during the 102nd Annual Meeting, which will be held April 8-11, 2006, at the Westin St Francis in San Francisco, CA.

State boards of pharmacy as well as schools and colleges of pharmacy students and faculty are encouraged to participate in the Annual Meeting poster session. Encore presentations are accepted

and encouraged; posters will not be judged.

Last year’s poster session at the 101st Annual Meeting in New Orleans, LA, featured posters with such titles as “The California Health Communication Partnership,” “Indiana’s Passage of VAWD™: Issues and Obstacles,” “IPS Evolution,” “Nevada’s Innovations Regarding the Regulation of Drug Wholesalers,” “Expanded Pharmacist Practice in New Mexico,” and “Internet Prescribing: The Utah Board of Pharmacy Order for Public Safety and Protection.”

Interested in participating, but not sure where to start? Listed below are some tips on preparing a poster:

Limit text and utilize graphics; double-check that all items on the poster are necessary for presentation.

Prepare handouts to provide an overview of poster and/or additional information including contact names, should attendees have questions.

Keep your poster title short, highlighting the topic.

Make the font size at least 14 point and double-space paragraph lines to ensure readability from two to four feet.

Lay out the sections of your poster in a

Fourth Annual Poster Session at Annual Meeting: an Information Sharing Opportunity

logical order so that the poster is easy to follow. Rather than affixing your documents to one large piece of poster board, which can cause a strain on poster pins, break your materials into three or four sections. You should also be able to move them around on the board.

Enlist the help of students and/or interns on rotation in your office to prepare the poster.

Each participating board or school/college of pharmacy will be provided with one four-foot by six-foot bulletin board, which should be manned by a board-appointed representative during display times. To participate, interested boards should notify the NABP Meetings Desk. Please provide the poster topic.

The session will take place Saturday, April 8, 2006, from 1 to 5 PM and Sunday, April 9, 2006, from 8 AM to noon during the 102nd Annual Meeting.

On March 3, 2006, two wholesale drug distribution facilities operated by Livonia, MI-based Harvard Drug Group, LLC, earned accreditation under NABP’s Verified-Accredited Wholesale Distributors™ (VAWD™ ) program, increasing the

total of VAWD-accredited facilities to four. The Harvard Drug Group, LLC distributes prescription medications to retailers, medical professionals, and managed care providers. The accredited facilities include:

The Harvard Drug Group, LLC, dba Major

Recent VAWD-Accredited Wholesale Distribution FacilitiesPharmaceuticals, Indianapolis, IN; and

The Harvard Drug Group, LLC, Great Lakes Wholesale Drugs, Livonia, MI

The two Harvard Drug Group facilities join CVS/pharmacy’s Distribution Center in Indianapolis, IN, and US Oncology, Inc’s

Fort Worth, TX facility, which earned VAWD accreditation on February 8, 2006.

More information about NABP’s VAWD program, including frequently asked questions and application instructions, is available at NABP’s Web site at www.nabp.net.

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89

CE Program(continued from page 86)


not only in pharmacies but also in other settings that prepare or compound sterile preparations. According to a survey NABP conducted in March 2005, approximately nine states require compliance with USP Chapter 797; and additional information collected since the March 2005 survey indicates that additional states have begun to realign their regulations with USP Chapter 797. During this session, participants will examine the major sections of USP Chapter 797, with the overall emphasis on the effective incorporation of strategies in the survey process to measure compliance with USP Chapter 797. Participants will also review the recommendations of

the NABP 2005-2006 Task Force on Standards for Compounding.

Professional Development Programming

Effective Communication and Delivery of Board Policy in Public Meetings and with the Media

Executive offi cers, board members, and compliance offi cers must be able to communicate effectively in public meetings and in a variety of other settings when called upon to present the position of the board. Because of the role of the board in communicating information to the public and media, knowing what to say, how to say it, and when to say it are valuable communication skills that could potentially prevent problems such as the miscommunication

of critical information, confl icting messages being sent, and embarrassment. This session will provide guidance on assessing individual situations and determining effective and appropriate ways to deliver a message in a clear manner when engaged by the media, legislature, or other similar venues.

Joint Programming

Structuring an Effective Disaster Plan: Lessons Learned

Part One: Rising to the Occasion: The State Boards of Pharmacy Vital to Hurricane Relief and Recovery Efforts

Part Two: Where Do We Go From Here? Open Forum and Panel Discussion on the State Boards of Pharmacy Role in Emergency Preparedness and Response

In late summer 2005 Hurricanes Katrina and Rita and the resulting devastation presented the state boards of pharmacy with unique opportunities and challenges in meeting the emergent needs of the public. With the possible threats of an avian flu pandemic and terrorist attacks, the evolving role of the state boards of pharmacy in emergency preparedness and response warrants further consideration. By the conclusion of this session, participants will be able to better define the role of federal and state agencies in emergency situations. Also, participants will examine, explore, and discuss the current and evolving roles of the state boards of pharmacy in emergency preparedness and crises.

Information SharingOne of the more important criteria to the success of NASPER is that of interoperability. The law calls for the establishment of information sharing among states that operate PMPs. Given that each existing state program has been able to set its own laws and standards for the collection and dissemination of information, the interoperability of the programs is going to

require the establishment of national standards for information sharing. This is an area that is being studied on a national level by a work group developed through the Integrated Justice Information Systems (IJIS) Institute.

According to Scott Serich, PhD, project manager for IJIS, “The IJIS Institute Prescription Drug Monitoring Project seeks to build capabilities for automated exchange of PMP data between states seeking to abate prescription drug fraud.

The project, currently in its second phase, will provide technical assistance to construct a proof-of-value pilot capability for automated exchanges between PMP systems in California and Nevada. Technical artifacts and lessons learned will provide a foundation to support future exchange initiatives by other states.”

More information on the IJIS Institute or the Prescription Drug Monitoring Project is available at www.ijis.org.

Many states that have established CS monitoring programs have found great success in improving overall patient care and in helping curb prescription drug abuse, diversion, and fraud. NABP stands with the states in the adoption of uniform standards for prescription monitoring in the US. NABP is available to provide educational and regulatory assistance to states interested in establishing a CS monitoring program. For assistance, please contact NABP’s Executive Offi ce at exec-offi [email protected].

NASPER(continued from page 83)

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90

Feature News

pharmacists. Alaska does not have mandated technician-pharmacist ratios, Zinn says.

Clearly, no silver bullet exists that will solve the pharmacist shortage and its related problems. Still, by taking advantage of the positive trends of increasingly sophisticated technology, better and more uniformly trained technicians, and expanded numbers of graduating pharmacists, along with a careful examination of regulations, boards of pharmacy can help alleviate effects of the shortage – and continue protecting the public health.

An Analysis of the ChallengeThe situation now, while not ideal, remains less acute than it was just a few years ago, shortly after industry observers became aware of the problem. According to Knapp, the National Association of Chain Drug Stores (NACDS) was the fi rst to detect a shortage in 1998-99, through complaints from its members about a lack of candidates for open pharmacist positions. The shortage seemed to peak in about 2000-2001. In August 2001 an NACDS survey indicated 7,743 open pharmacist positions reported by participating chains – before decreasing somewhat; an NACDS survey in the summer of 2005

indicated 5,971 open full- and part-time positions.

Recent data indicate an upturn in vacancies again within the last year, and a longer time needed to fi ll them in recent months. ASHP found in a summer 2005 survey that respondents reported an average of 6.5 months needed to fi ll an empty pharmacist position in 2005, as compared to 5.3 months in 2004. Knapp notes, however, that it is premature to consider the new numbers a major change in the situation until more data are collected.

A number of factors have been traced in the initial pharmacist shortage and some new ones in its expected continuance. One “important driver of demand,” as Knapp puts it, is the continuous increase in the volume of prescriptions, more than a 30% increase over the 1992-1999 period alone. While the rate of increase has slowed down more recently, says Knapp, it is now going up again. As the Medicare Part D legislation providing Medicare drug benefi ts to all seniors takes effect, this upsurge may well continue – to say nothing of increased administrative responsibilities (and therefore pharmacist hours) connected with the program. Moreover, as the Baby Boom generation ages and naturally requires more health care services, including medications, the prescription growth rate is likely to accelerate even more.

Other factors have infl uenced the shortage as well. The administrative requirements of handling third-party payments take many hours of pharmacists’ time – time that will only increase due to the new Medicare drug benefi t. And the changing face of pharmacy in recent years, with an increasing scope of practice, including more and more emphasis on such health care aspects as disease state management, patient counseling, and other more “cognitive” services, has taxed pharmacist capacity. “People [pharmacists] are being stretched and stretched to do more,” says Knapp. “It’s a good thing for the profession. But the workforce reality is that every new [advancement] stretches the workforce. It’s just a reality.” Moreover, with increasing recognition by policymakers of pharmacists’ potential role as a key element in reaching larger swathes of the patient population – “Pharmacists are an extremely accessible health care point,” Knapp notes – their role in public health is likely only to increase.

One factor in the early years of the shortage appears to have been solved: a paucity of pharmacy school graduates. This phenomenon was due in part to a decreased number of applications in pharmacy schools, which led to smaller class sizes. The switch to the PharmD as the standard pharmacy school graduate’s degree also caused a brief break in the otherwise constant supply

of new pharmacists, as the additional year of study meant that most schools went without a graduating class for at least one year. Interestingly, market forces largely took care of the application numbers. As pharmacists became scarcer, salaries climbed. At the same time, Knapp says, after the dot-com boom and subsequent crash in technology in 2000-2001, many workers in the computer systems and engineering areas found themselves suddenly out of work and looking for more stable fi elds. Health care seemed a good prospect, offering both stability and growth potential – and pharmacy offered good salaries.

Now, class sizes have grown and a number of new pharmacy schools are opening or slated to open. “The applicant pool is really rich right now,” says Knapp. On a cautionary note, however, a gender shift may affect the shortage in an unexpected way. More women than men are now entering the pharmacy profession; according to statistics cited by Knapp, women report working a lower number of hours per week than men, on average, and are more likely to work part-time. Nonetheless, even if the increased numbers of new graduates turn out to be insuffi cient for the projected demand growth, Knapp says, “We wouldn’t want it to go the other way . . . The trend is going the right way.”

Manpower(continued from page 85)

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State Board News

Minnesota, Wyoming Award CE Credit for NABP’s PSAM The Minnesota Board of Pharmacy and Wyoming State Board of Pharmacy recently became the latest NABP member boards of pharmacy to award pharmacists who complete NABP’s Pharmacist Self-Assessment Mechanism™ (PSAM™) with non-Accreditation Council for Pharmacy Education continuing education (CE) credit. The Minnesota board approved six hours of CE during its January 11, 2006 meeting. “Going away from a CE model and toward a Continuing Professional Development model is something that the Board is looking at, and we think that the PSAM will fit in nicely with that change,” notes Cody C. Wiberg, PharmD, executive director of the Minnesota Board of Pharmacy.

The Wyoming State Board approved four hours of CE on December 13, 2005, and included the PSAM in its revised rules. The Minnesota and Wyoming boards join the California, Idaho, and Tennessee boards of pharmacy – which approved awarding CE credit for taking the PSAM earlier in 2005 (November-December 2005 NABP Newsletter, page 204).

According to James T. Carder, executive director of the Wyoming Board, “The completion of the PSAM for four credit hours gives pharmacists more opportunity to obtain CE

credit. Pharmacists can use the PSAM to find out his or her weaknesses then the pharmacist can [attend] the appropriate CE sessions.”

The PSAM assessment tool is applicable to general pharmacy practice and all practitioners. It consists of 100 multiple-choice questions and is divided into three sections of equal length. PSAM questions are based on patient profiles and simulate real-life practice situations and patient therapies. Each section can be completed in as little as one hour; a maximum of three hours per section is allowed. Once a section is started, it must be completed.

Since the PSAM is a learning tool, the pharmacist is provided with feedback on each question. The feedback displays each question, the answer selected, the correct answer, a brief rationale for the correct answer, and a reference where more information about the answer or applicable treatment guidelines can be obtained. Upon completion of the PSAM, pharmacists receive a Record of Completion indicating their name and the date of completion. The assessment evaluation is directly reported to the pharmacist in a separate report; the individual results are NOT reported to the board of pharmacy, NABP, or any other person, group, or entity. The fee is $75.

The following item was published in the Colorado State Board of Pharmacy News, Volume 18, Number 1, February 2006.

Colorado’s New Internet Pharmacy RuleThe [Colorado State] Board of Pharmacy has concerns about the increase in Internet pharmacy transactions that appear to be outside the parameters of traditional pharmacy practices. For example, the Board has seen numerous cases with this type of scenario:

A prescriber in Puerto Rico, a patient in Ohio, and a dispensing pharmacy in Colorado.

While it has always been the responsibility of the pharmacist to use judgment when determining whether or not to dispense a prescription, the Board decided to clarify in a rule that such judgment is required in cases that appear to lack bona fide medical purpose or prescriber-patient relationships. The Board believes that such judgment is the key to maintaining the safety of Colorado residents.

Rule 3.00.21 was adopted by the Board to address these issues. It states:

A pharmacist shall make every reasonable effort to ensure that any order, regardless of the means of transmission, has been issued for a legitimate medical purpose by an authorized practitioner.

A pharmacist shall not dispense a prescription drug if the pharmacist knows or should have known that the order for such drug was issued on the basis of an [I]nternet-based questionnaire, an [I]nternet-based consultation, or a telephonic consultation, all without a valid preexisting patient-practitioner relationship.

The language for this rule was based on similar language adopted by the Missouri Board of Pharmacy. Other state boards recognize this situation as a threat to public safety, as well as a threat to the pharmacy profession. [More information about the rule is available at the Board’s Web site at www.dora.state.co.us/pharmacy.]

The following item was published in the Ohio State Board of Pharmacy News, Volume 27, Number 3, February 2006.

Ohio Board’s New and Revised Rules The [Ohio State] Board [of Pharmacy] filed several new and revised rules that became effective on January 1, 2006. [The full text of these rules, showing changes, can be found on the Board’s Web site at www.pharmacy.ohio.gov.] . . . Included in these rules are a new chapter dealing with charitable pharmacies (4729-36) and a new chapter dealing with


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Professional Affairs Update

FDA Cautions Consumers About Filling US Prescriptions AbroadFood and Drug Administration (FDA) issued a warning to health care professionals and consumers that filling their prescriptions abroad may have adverse health consequences due to the confusion with drug brand names that could inadvertently lead consumers to take the wrong medication for their condition. In an investigation, FDA has found that many foreign medications, although marketed under the same or similar-sounding brand names as those in the United States, contain different active ingredients than in the US.

FDA found 105 US brand names that have foreign counterparts that look or sound so similar that consumers who fill such prescriptions abroad may receive a drug with the wrong active ingredient. For example, in the United Kingdom, Amyben®, a brand name for a drug product containing amiodarone, used to treat abnormal heart rhythms, could be mistaken for Ambien®, a US brand name for a sedative. Using Amyben instead of Ambien could have a serious adverse outcome. For more information on this topic, visit www.fda.gov/oc/opacom/reports/confusingnames.html.

Implementation of the Anabolic Steroid Control Act of 2004According to the December 16, 2005 Federal Register, effective January 20, 2005, the Anabolic Steroid Control Act of 2004 amended the Controlled Substances Act (CSA) and replaced the existing definition of “anabolic steroid” with a new definition. This new definition changed the basis for all future administrative scheduling actions relating to the control of the anabolic steroids as Schedule III controlled substances (CS) by eliminating the requirement to prove muscle growth. Also, the Act lists 59 substances as being anabolic steroids; these substances and their salts, esters, and ethers are Schedule III CS. The Act also revised the language of the CSA requiring exclusion of certain over-the-counter products from regulation as CS.

According to the House Report, the purpose of the Act is “to prevent the abuse of steroids by professional athletes. It will also address the widespread use of steroids and steroid precursors by college, high school, and even middle school students.”

The changes to the definition include the following:

Correction of the listing of steroid names resulting from the passage of the Anabolic Steroid Control Act of 1990;

Replacement of the list of 23 steroids with a list of 59 steroids, including both intrinsically active steroids as well as steroid metabolic precursors;

Automatic scheduling of the salts, esters, and ethers of Schedule III anabolic steroids without the need to prove that these salts, esters, or ethers promote muscle growth;

Removal of the automatic scheduling of isomers of steroids listed as Schedule III anabolic steroids; and

Addition of dehydroepiandrosterone to the list of excluded substances.

FDA Provides Updates on Products that Require Medication Guides Upon DispensingFDA has approved updated labeling for two topical eczema drugs, Elidel® Cream (pimecrolimus) and Protopic® Ointment (tacrolimus). The labeling for these drugs will be updated with a boxed warning about a possible cancer risk and will also clarify that they are recommended for use as second-line treatments, ie, other prescription topical medicines should be tried first. Use of these drugs in children under two years of age is not recommended. In addition, a Medication Guide (FDA-approved patient labeling) will be distributed to pharmacists, who are required to provide it to patients when dispensing the

drug. Patients are advised to read the entire guide and talk to their health care provider if they have further questions.

Eczema, or atopic dermatitis, is one of the most common skin disorders in infants and children, affecting 10% to 15% of the childhood population. Although the cause is unknown, it is thought that an allergic or immune mediated component may be involved. Symptoms are chronic itching and dry skin that causes redness and damage to the skin due to rubbing and scratching.

A causal link has not been established, but rare instances of cancer have been reported among individuals using these products. The boxed warning informs health care professionals that the long-term safety of these drugs has not been established and that studies are ongoing.

Also, In January 2006, FDA announced the approval of Exubera®, an inhaled powder form of recombinant human insulin (rDNA) and the first available inhaled insulin product for the treatment of adult patients with type 1 and type 2 diabetes.

Exubera lowers blood sugar concentrations by allowing the blood sugar to be absorbed by cells as a fuel source. The patient can inhale the powdered insulin into the lungs using a specially designed inhaler.

A Medication Guide containing FDA-

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Professional Affairs Update

approved information will accompany Exubera prescriptions. Patients are advised to read the entire guide and talk to their health care provider if they have further questions.

New FDA Program Aims to Improve Medical Device SafetyA recently announced Postmarket Transformation Initiative by FDA’s Center for Devices and Radiological Health (CDRH) is designed to help the agency monitor the safety of medical devices –both existing and new technology – after they reach the market. The focus of the initiative is quicker identifi cation, analysis, and action on problems with devices, including quicker alerts to the public of problems with devices. Measures such as an electronic reporting

system for medical device adverse events and improving information in patients’ records may be used according to the initiative. Specifi c areas of initiative focus include:

Working toward an electronic reporting system for adverse medical device events;

Unique ways to identify medical devices including standardized and globally accepted names;

Ways to improve device information in patient records;

Improved internal collaboration on postmarket safety issues; and

Identifying opportunities to improve the safety of medical devices through collaborative efforts with professional organizations and the medical device industry.

Prior to announcing this initiative, FDA conducted a comprehensive, year-long inventory of the tools used to monitor the safety of devices following approval. The inventory considered how FDA:

Identifi es postmarket problems;

Assesses the information the agency obtains; and

Responds to that information through both stakeholder communication and enforcement action.

The Center’s plan to strengthen its postmarket program focuses on:

Developing a “culture of collaboration” for postmarket safety within the Center;

Developing world-class data sources and systems to quickly and accurately collect, analyze, and disseminate information

about potential risks; Enhancing risk

communication efforts; and

Improving coordination with the FDA fi eld staff.

To guide the initiative, a CDRH Postmarket Transformation Leadership Team consisting of senior FDA leadership and consultants with expertise in device safety and product regulation has been formed. Its fi rst task will be reviewing CDRH’s Medical Device Postmarket Safety Program report and accompanying recommendations for possible ways to address areas that need improvement.

More information about CDRH’s Postmarket Transformation Initiative is available at http://origin.www.fda.gov/cdrh/postmarket/mdpi.html.

San Francisco Fact BoxSite of NABP’s 102nd Annual Meeting

April 8-11, 2006, Westin St Francis, San Francisco, CA

The Westin St Francis Coin Cleaning TraditionGuests of the Westin St Francis can still receive the quintessential white glove treatment, which is just one example of why the hotel has such an estimable reputation.

Since 1938, the Westin St Francis has operated the world’s only silver coin cleaning operation as a favor to its guests. This custom began when the hotel’s manager insisted that the silver coins – the currency of the day – be cleaned to keep female hotel guests’ white gloves from getting dirty. Periodically, the change is collected, washed, and polished in a silver-burnishing machine, rinsed off, and dried under

hot lights, then carried back to the front desk. For more than 31 years, Arnold Batliner has cleaned an estimated $17 million in change for the Westin St Francis. Today, every taxi driver and cashier in San Francisco knows that if they receive mint-clean money, it is probably from the Westin St Francis.

Source: www.westinstfrancis.com/default2.asp?sID=Hist

Since 1938, the Westin St Francis has operated the world’s only silver coin cleaning operation as a favor to its guests.

Wes

tin

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Legal Briefs

Around the Association


developed, such items can be statistically analyzed to validate their performance and items can remain intact, be modifi ed, or deleted as the case may be. Of course, this is a very simplistic explanation of an extremely complex and vital measurement of test performance.

Such an analysis provides legal defensibility to the program in the event of a challenge by an unsuccessful candidate. The psychometric principles are complex but provide a basis for important public protection decisions related to the granting or denial of a license by the board of pharmacy.

Applicants who are unsuccessful on the examination do not establish that they hold minimum competence for purposes of practice and are not granted the property interest of a license by the board.

In an academic setting, examinations are used to provide an analysis of knowledge gained from the particular course taken by the student. While important to the student, examinations in an academic environment do not encompass the “high-stakes” nature of a licensure examination. Academic courses and the curriculum of a program leading to a professional degree are intended to provide students with a lifelong learning experience to promote acquired

knowledge and the continued ability to learn. Educational achievements are also vital to the public protection mandates of the boards of pharmacy as illustrated by the separate educational prerequisite contained in the practice acts. Educational institutions and programs are under increasing pressure to assess, through outcomes measures, student performance during the educational experience and, perhaps, post-graduation assessment. Based upon the differences between entry-level practice premised upon a practice analysis for purposes of licensure (NAPLEX) and the educational curricula designed for lifelong learning of student pharmacists (accredited pharmacy programs), statistical analysis of student performance on the NAPLEX for use in assessing educational curriculum may not be adequate.

It is under this premise that a capstone assessment mechanism used to evaluate student performance upon graduation from an academic setting may be developed for use by the pharmacy programs. Such an evaluation will, by necessity, differ signifi cantly from the high-stakes licensure examination developed by NABP for its member boards of pharmacy. The NAPLEX is based upon a practice

analysis of pharmacists’ daily duties, while an educational assessment will be designed to assess the pharmacy curriculum and whether or not students have met the educational goals of the administration related to the pharmacy program.

NABP has already developed the foundation for an educational curriculum assessment in its Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®). FPGEE is designed to assess the educational equivalence of graduates of pharmacy programs located outside the US and, thus, are not recognized in the accreditation process undertaken by the Accreditation Council for Pharmacy Education. In order to better protect the public by ensuring that applicants who become licensed as pharmacists are prepared for practice as contemplated by the pharmacy practice acts, NABP member boards should look forward to the Pharmacy Curriculum Outcomes Assessment (PCOA) program being developed by your Association. The PCOA will provide schools and colleges of pharmacy with an objective means of measuring how effectively their curricula prepare students in each academic year for the practice of pharmacy.

Kenny v. Snow, 401 F.2d 1359 (Fed. Cir. App. Ct 2005)(continued on page 95)

New Board MembersStallard D. Mikell, Jr, RPh, was named to the Alabama State Board of Pharmacy, with a five-year term to expire on December 31, 2010. He replaces Lynda C. Staggs, RPh.

William J. Thompson, RPh, has replaced Cynthia Bamburg, RPh, as a member on the Mississippi State Board of Pharmacy. Thompson’s term expires on June 30, 2010.

Jim MacKenzie, RPh, has been named to the Montana Board of Pharmacy, replacing Robert C. Mann, RPh. MacKenzie’s term expires on July 1, 2010.

The following members have been named to the Pharmacy Board of New South Wales:

Alison J. Aylott, BPharm, who replaces Jennifer P. Zwart, BPharm, MPS, and whose term expires on September 30, 2008; and

Shane D. Scott, BPharm, who replaces Maree D. Simpson, BPharm,

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State Board News

(continued from page xx)

the Prescription Monitoring (drug database) program (4729-37). The next [Ohio State Board of Pharmacy] Newsletter [May 2006] will contain specifi c information about the new Prescription Monitoring program and the ways that pharmacists and prescribers can obtain information about their patients’ prescription histories.Another rule that was added in 2006 was Rule 4729-9-25 – “Drugs compounded for direct administration by a prescriber.” In 2005, the Legislature revised the defi nition of “Compounding” in §4729.01(C) of the Pharmacy Practice Act by adding paragraph 5 to allow for the limited supply of a compounded product to a

prescriber at his or her offi ce. The new paragraph in the defi nition of “Compounding” in the Revised Code is as follows:

(C) “Compounding” means the preparation, mixing, assembling, packaging, and labeling of one or more drugs in any of the following circumstances:

(5) Pursuant to a request made by a licensed health professional authorized to prescribe drugs for a drug that is to be used by the professional for the purpose of direct administration to patients in the course of the professional’s practice, if all of the following apply:

(a) At the time the request is made, the drug is not commercially available regardless of the reason that the drug is not available, including the absence of a manufacturer for the drug or the lack of a readily available supply of the drug from a manufacturer.

(b) A limited quantity of the drug is compounded and provided to the professional; and

(c) The drug is compounded and provided to the professional as an occasional exception to the normal practice of dispensing drugs pursuant to patient-specifi c prescriptions.

The new rule promulgated by the Board defi nes what a “limited quantity” is and it also defi nes what constitutes an “occasional exception to the normal practice of dispensing drugs” so that the pharmacy does not end up being charged by Food and Drug Administration or the Board with manufacturing in violation of federal law.


BSc (Hons), PhD, MPS, and whose term expires on September 30, 2006.

Bettie K. Wilson, DPh, has been named to the Tennessee Board of Pharmacy as a member with a term expiration date of July 31, 2011. Wilson replaces Robert E. Shutt, DPh.

Michael E. Stredler, RPh, has been named to the Virginia Board of Pharmacy as a member.

His term expires on June 30, 2006. Stredler replaces Michelle R. Easton.

Board ReappointmentsMember DuWayne “Dewey” Schlittenhard, RPh, has been reappointed to the North Dakota State Board of Pharmacy for a five-year term to expire on May 8, 2011.

New Board Offi cersThe Alabama State Board of Pharmacy has named the following individuals to officer positions:

Jackson A. Como, PharmD, president;

Calvin W. “Rick” Stephens, RPh, vice president; and

Roland Nelson, RPh, treasurer.

The Idaho Board of Pharmacy has named two individuals to officer positions:

Dwayne E. Sheffler, RPh, chair; and

K.W. “Kitty” Gurnsey, vice chairperson.

The Mississippi State Board of Pharmacy has named the following offi cers:

Roland E. “Eddie” Mullins, Jr, RPh, vice president;

Robert R. Sullivan,

RPh, president; and Maretta McLeod

Walley, RPh, secretary.The New Hampshire Board of Pharmacy has elected the following offi cers: Kristina Genovese,

RPh, president/chairperson;

George L. Bowersox, RPh, vice president; and

Vahrij Manoukian, RPh, treasurer.

The Washington State Board of Pharmacy has named two new officers: Asaad B. Awan, RPh,

chairperson; and Rebecca E. Hille, vice

chair.

Around the Association(continued from page 94)

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april 2006

Reminder

National Association of Boards of Pharmacy

1600 Feehanville Drive

Mount Prospect, IL 60056

nabp newsletter

Annual Meeting Travel Grant Program applications may be obtained by contacting NABP Headquarters and must be received at NABP Headquarters prior to the 102nd Annual Meeting, to be held at the Westin St Francis in San Francisco from April 8-11, 2006.

Association Highlights

NABP’s Committee on Law Enforcement/Legislation met at the NABP Headquarters in Mount Prospect, IL on January 27, 2006. Pictured from left to right are Oren M. Peacock, Jr, Executive Committee liaison; Sudhir C. Manek, member, Illinois State Board of Pharmacy; Davis C. Hook, Jr, member, South Carolina Board of Pharmacy; Allan Dulwick, ex-offi cio member; Debra L. Billingsley, executive secretary/director, Kansas State Board of Pharmacy; Howard M. Shaver, member, New Mexico Board of Pharmacy; Susan M. DelMonico, member, Rhode Island Board of Pharmacy; C. Richard Allen, deputy director, Georgia Drugs and Narcotics Agency; and Chairperson Malcolm J. Broussard, executive director, Louisiana Board of Pharmacy.

april06nabpnewsletter

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