Pharmacists and Industry: Guidelines for Ethical Interactions

American College of Clinical Pharmacy

Disclosures

Pharmacotherapy. 2008;28(3):410-420. 

In This Article

Guideline 8

Pharmacists participating in continuing education programs or preparing written material on drug therapy should deliver fair and unbiased presentations. Pharmacists should disclose any apparent or potential conflicts of interest. The presentation of continuing education free from bias is in the best interest of health care providers as well as patients.

One of the most common ways in which industry now interacts with practicing pharmacists is through continuing education programs. The interaction can entail the pharmacist as facilitator, organizer, presenter, and attendee of the continuing education program. The revised, voluntary PhRMA code outlines in detail acceptable procedures for industry support of continuing education activities that allow independence for the provider.[2] The OIG guidelines state that companies face little risk of noncompliance if the recommendations provided by the PhRMA code are followed.[3] More recently, the ACCME updated their guidance to enhance and protect the independence and integrity of CME activities.[4] At its October 2006 board meeting, the ACPE approved an update to their Criteria for Quality and Interpretive Guidelines related to commercial support of continuing education activities.[5] Providers have been evaluated using the updated ACPE guidelines since January 1, 2008. All of the revised and updated guidelines provide consistent recommendations for industry, including for-profit medical education and communication companies, continuing education sponsors, speakers, and participants, which are reflected in the discussion below.

The ACPE defines continuing education for the profession of Pharmacy as "a structured educational activity designed or intended to support the continuing development of pharmacists and/or pharmacy technicians to maintain and enhance their competence. Continuing pharmacy education should promote problem-solving and critical thinking and be applicable to the practice of pharmacy."[61] The educational value of the continuing education conference or activity must be the primary consideration in the pharmacist's decision to attend or participate. Pharmacists choosing among continuing education activities should assess their educational value and select only those activities that are of high quality, conducted by qualified faculty, and appropriate for the pharmacist's professional needs. Although amenities unrelated to the educational purpose of the activity may play a role in the pharmacist's decision to participate, this should be considered secondarily. Pharmacists should claim credit commensurate only with the actual time spent attending a continuing education activity or in studying the continuing education material.

Pharmacists who participate in industrysponsored speakers' bureau activities (e.g., accept support and expenses for attendance at speaker training or similar educational programs regarding specific statements about the industry product) should disclose this information in all of their activities relating to continuing education. In addition, any other conflicts of interest or biases, such as financial connection to a particular commercial firm or product, should be disclosed by faculty members to the activity's sponsor and to the audience. It is important to note that the updated ACCME and ACPE standards state that simple disclosure of potential conflicts of interest by providers, speakers, and authors of written materials is no longer sufficient. In addition to the requirement that all relevant financial relationships within the past 12 months be revealed, conflicts of interest must be resolved before the continuing education activity begins. The provider must be able to show that all individuals involved in the educational activity disclosed all relevant financial relationships with any commercial interest to the provider. Any individual who refuses to disclose relevant financial relationships will be disqualified from involvement with CME activities. Also of note, the ACCME and ACPE standards define financial relationship as "a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interests, or other financial benefit."[4,61] No minimum dollar amount is established in the updated standards because the council has determined that "inherent in any amount is the incentive to maintain or increase the value of the relationship."[4]

Pharmacists serving as presenters, moderators, or other faculty at an accredited ACPE or CME program, or any other health professional conference, should ensure that research findings and therapeutic recommendations are based on scientifically accurate, up-to-date information and are presented in a fair, balanced, and unbiased manner. The program development and execution should be consistent with guidelines outlined for ACPE or CME programs. It is the responsibility of sponsors, providers, and faculty members to ensure that the guidelines are met. Representatives of industry or other financial contributors should not exert control over the choice of moderators, presenters, or other faculty, or otherwise modify the content of faculty presentations. Funds from industry in support of an ACPE or CME activity may be accepted as long as the program provider controls the distribution of funds and the sponsor does not profit unfairly or charge a fee that is excessive for the content and length of the program.

Faculty may accept reasonable honoraria and reimbursement for expenses. Receipt of payment disproportionate to the amount of effort and time required may be considered a gift and should be avoided. Pharmacists who are routinely invited to speak or prepare written materials on behalf of industry may want to question their personal motives and the motives of the sponsors who fund their work. A subtle bias may be occurring. If the presenter or writer does not deliver the correct message, he or she will not be asked again to perform sponsored work. Also, is the invitation to give a presentation simply a means for providing a gift? This may be an issue to consider if multiple presentations are given that result in considerable income.

Nonfaculty or nonauthor participants of a continuing pharmacy education activity should not accept reimbursement for travel, lodging, honoraria, or personal expenses. Pharmacists should be wary of the liberal use of the terms "consultation" as a means of providing a gift of travel and lodging for a meeting and "consulting fee" as a means of providing a gift for attending a symposium at a meeting.

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