Bureau of Voluntary Compliance Advisory Committee

Transcription

1 Bureau of Voluntary Compliance Advisory Committee Members Present: William A. Fitzpatrick, Chair (MO); Suzanne L. Neuber (OH); Norene Pease (MD); William L. Buck Stevens (MS). Ex-Officio Members Present: Michael T. Bogumill, U.S. Consumer Product and Safety Commission; Tom Crow, U.S. Drug Enforcement Administration; George C. Heil, SmithKline Beecham Pharmaceuticals; Elizabeth E. Hiner, U.S. Food and Drug Administration. Others Present: Kevin E. Kinkade, Executive Committee Liaison; Carmen A. Catizone, NABP Executive Director/Secretary; M. Standifer Shreve (CA); Anna Geraci and Janet Teplitz, NABP Staff. Introduction: The Bureau of Voluntary Compliance (BVC) Advisory Committee met January 17, 1997, at NABP headquarters in Park Ridge, Illinois. The BVC s mission is to promote voluntary compliance with state and federal drug law through the development of educational programs and services. For many years, the Bureau of Voluntary Compliance has achieved this mission through such programs as the BVC State Newsletter Project, the BVC Seminar at NABP s Annual Meetings, and the biennial Institute for Teachers of Pharmacy Law. The BVC has also overseen the development of the NABP Foundation/Glaxo Wellcome/U.S. Pharmacist continuing education series of articles on patient counseling and medication errors, as well as well as video workshops designed to familiarize pharmacists with patient counseling requirements and how to work with government agencies. In addition to its membership, which is composed of representatives from the state boards of pharmacy, the BVC Advisory Committee includes ex-officio members representing the Consumer Product Safety Commission (CPSC), the Drug Enforcement Administration (DEA) the Food and Drug Administration (FDA), the Health Care Financing Administration (HCFA), and the pharmaceutical industry who provide information from their organizations that is of interest to the state regulatory boards. Review of Committee Charge: The BVC Advisory Committee members reviewed their charge and, proposing no changes, accepted it as follows: 1. Promote voluntary compliance with state and federal drug laws by all health care professionals. 2. Plan, organize, and conduct the BVC Annual Seminar, an educational seminar held in conjunction with the NABP Annual Meeting. NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/ (F) 847/

2 3. Strengthen and increase communications between boards of pharmacy, practitioners, and pharmacy students by: a. Promoting and maintaining state participation in the BVC State Newsletter Project; and b. Expanding the Newsletter Project to include participation by all boards of pharmacy so they may provide information concerning compliance issues to all licensees/registrants. 4. Strengthen and increase communications between boards of pharmacy and other pharmacy and health care organizations (e.g., boards and associations) by: a. Expanding the role of education in obtaining voluntary compliance and exploring alternative opportunities open to BVC involvement; and b. Exploring opportunities to develop programming that will enable, encourage, and assist boards of pharmacy in developing their own efforts aimed at obtaining voluntary compliance from their licensees. 5. Promote and maintain continuing liaison and dialogue with the federal agencies primarily impacting on the practice of pharmacy; for example, the FDA, the DEA, the CPSC, and the HCFA BVC Seminar The BVC Seminar serves as the opening continuing education program for the Annual Meeting. Although the BVC Advisory Committee customarily selects the topic for the NABP Annual Meeting s BVC Seminar, the need to reschedule the Committee s winter meeting from its usual December date to mid-january did not provide sufficient time to finalize the seminar topic before the release of the Annual Meeting promotional materials. When planning the program, Committee members consider the timeliness and appropriateness of the subject; whether it meets the BVC s mission to promote voluntary compliance with state and federal drug law; and if it is of interest to the executive officers, members, and staff of the state boards of pharmacy. In line with these objectives, pain management was selected as the topic for the 1997 BVC Seminar. The Committee considered various speakers and formats for the program, and after much discussion, decided to engage a speaker who would provide an overview of the legal and ethical issues associated with pain management and summarize how different health care professions (e.g., physicians, nurses, pharmacists) approach pain management. The session would then shift to a panel discussion in which representatives from three or four state boards of pharmacy would discuss their state efforts to incorporate pain management initiatives through legislative actions and cooperative efforts with other health care professions Institute for Teachers of Pharmacy Law The Committee members reviewed the Institute for Teachers of Pharmacy Law program, titled Quality Assurance Issues in Pharmacy Practice, which was held in conjunction with the American Association of Colleges of Pharmacy (AACP) Annual Meeting, July 12-13, 1996, at the Nugget Hotel in Reno, Nevada. Co-sponsored by the NABP Foundation, AACP, and the American Society for Pharmacy Law (ASPL) and partially funded through a grant from Smith Kline Beecham Pharmaceuticals, the 1996 Institute focused on quality assurance as it relates to NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/ (F) 847/

3 the delivery of care, the detection of errors, civil liabilities and corporate responsibility, regulatory approaches to enabling pharmaceutical care, and innovative approaches to teaching state laws. Food and Drug Law Institute For many years, the Institute for Teachers of Pharmacy Law has provided a sueful forum for the state boards of pharmacy and the pharmacy law instructors of the nation s colleges and schoos of pharmacy to exchange information. In recent years, however, attendance has declined as other programs with similar content have been introduced to the market. The NABP Foundation will no longer sponsor the Institute for Teachers of Pharmacy Law but will now work with the Food and Drug Law Institute (FDLI) in support of its Federal Drug Law & Regulatory Education Program. This first NABP/FDLI collaboration will occur in conjunction with NABP s Executive Officers Conference, November 15-16, 1997, at the Sanibel Harbour Resort and Spa in Florida. A limited number of seats will be reserved for staff and members of the state boards of pharmacy who wish to attend. Conversely, those individuals attending the FDLI program will be welcome to attend the Executive Officers Conference. State Newsletter Project Since 1979, the NABP Foundation s BVC State Newsletter Project has provided participating state boards of pharmacy with a vehicle to communicate essential information to their licensees. Articles prepared by the state boards generally discuss new or amended laws or rules, disciplinary actions, and other information of interest to pharmacy practitioners. The NABP Foundation s National Pharmacy Compliance News section concentrates on such issues of national interest as the activities of the FDA, DEA, CPSC, HCFA, and other organizations, including NABP. With 36 boards participating in the project, approximately 140,000 pharmacists across the nation currently receive the quarterly state board BVC newsletters. Several other boards have expressed interest in participating in the project and are currently investigating this possibility. Following the success of the continuing education article series that focused on patient counseling and drug utilization review, the NABP Foundation again collaborated with U.S. Pharmacist and Glaxo Wellcome Inc. to produce a new series that focuses on medication errors. Distributed as an insert in the BVC newsletters, the medication errors articles discussed such important issues as what constitutes a medication error, how to prevent such errors, what pharmacists should do when an error occurs, and what are the legal implications for practitioners. The series, which concludes in June 1997, has received positive recognition from practitioners, the pharmacy industry, and other pharmacy and health care organizations. Public Education Program At NABP s 92 nd Annual Meeting, the Association s membership approved REsoultion No , NABP s Public Health Education Program, which resolved: Whereas, the pharmacist is the professional best trained to provide pharmaceutical care; and NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/ (F) 847/

4 Whereas, the pharmacist enhances the protection of the hhealth and welfare of the patients served; and Whereas, the public would benefit from additional information explaining the essential role of the pharmacist in rendering pharmaceutical care; Therefore Be It Resolved that NABP and its member boards, in conjunction with other interested pharmacy organizations, where appropriate, provide for the dissemination of information that advises the public of the role played by the pharmacist in patient health care as it relates to the protection of the public health; and Be It Further Resolved that this information be made available for use by state boards of pharmacy to increase the understanding that the public has of the essential services which the pharmacist provides as a health care professional. In response to this resolution, NABP s Executive Committee assigned the development of a public education program to the BVC Advisory Committee. At their January meeting, the Committee was provided with information about a consumer education campaign that had been implemented by the California State Board of Pharmacy and with a summary of various options that would fulfill the public education goals established by NABP s membership in Resolution No BVC Recommendation #1 The BVC Advisory Committee recommends to the Executive Committee that the following three public education options be pursued in their designated priority. 1. Release a consumer column that would be provided to the print media for dissemination to the public. 2. Provide the state boards with an audio public service announcement (PSA) for broadcast through the state s local radio stations. 3. Broadcast a video PSA to a nation-wide audience. The Committee members recommended the above three options because they believed these would be the most effective methods of reaching the public, would cover all three major media forums (i.e., print, audio, and visual media), and were proven successful in the California Board s campaign, which reached an audience of more than five million people. BVC Recommendation #2 The BVC Advisory Committee recommends to the Executive Committee that the same membership be retained on the Committee throughout the planning and implementation of the public education program. The Committee members felt that retaining the same membership would provide the consistency and motivation necessary to complete a successful public education program. NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/ (F) 847/

5 BVC Recommendation #3 The BVC Advisory Committee recommends to the Executive Committee that the Committee be allowed to meet at least twice a year during the planning and implementation of the public education program. The Committee members stressed the urgency and significance of developing a public education program that focuses on the benefits pharmacists can provide to patients through their knowledge of medications, particularly in light of the apparent languid efforts of various states to implement and enforce patient counseling initiatives. The Committee felt that meeting more than once per year would allow the members to continually monitor their efforts and make any necessary revisions to the program s direction. NATIONAL ASSOCIATION OF BOARDS OF PHARMACY (P) 847/ (F) 847/