Pharmacists and Industry: Guidelines for Ethical Interactions

American College of Clinical Pharmacy

Disclosures

Pharmacotherapy. 2008;28(3):410-420. 

In This Article

Guideline 3

Pharmacists should disclose financial, consulting, or other relationships that are or appear to constitute conflicts of interest. Although disclosure is an important tool in the management of potential conflicts of interest, it does not absolve pharmacists from avoiding situations in which potential conflict would make their participation inappropriate.

Pharmacists should recognize the potential for conflicts of interest arising from their financial relationships with industry. A conflict of interest is a set of conditions in which professional judgment concerning a primary interest (e.g., research or patient welfare) tends to be unduly influenced by a secondary interest (e.g., financial gain).[42] Disclosures of real, potential, and perceived conflicts of interest are in the best interest of patients and thus in the best interest of pharmacists. In the case of publications and presentations, disclosure allows the reader or listener to decide whether or not the real or potential conflict might influence the content. Conflicts of interest can take a variety of forms, with some more obvious than others. Examples of such relationships that could be perceived by our patients or colleagues as potential conflicts of interest include employment, consultancies, honoraria, stock ownership or options (excluding diversified mutual funds; sector funds with large holdings in a few companies could be a problem), expert testimony, grants received, grants pending, patents received, patents pending, royalties, or any other financial relationships of significance, including those that may be held by the pharmacist's spouse or dependent children. Although the presence of a potential conflict of interest "does not necessarily result in an outcome different than the result would have been without a conflict,... the potential for differing results is the problem at hand."[9]

Pharmacists who have financial or other personal arrangements with industry, whether as speakers, consultants, or investors, should not compromise their objective clinical judgment or the best interests of their patients as a result of these arrangements. Pharmacist relationships with industry and other entities should be transparent and available for examination by the public and members of the profession. Prior to any interactions, pharmacists should make a good-faith effort to evaluate the potential for influence and determine which relationships are ethically appropriate, and should not enter into relationships that could affect objectivity in decision-making. For example, pharmacists involved in formulary or drug-purchasing decisions should not make decisions based on relationships (e.g., owning stock or having previous or ongoing financial support) with industry. Drug products should be chosen on the basis of their therapeutic value, potential benefit to patients, and cost.

Disclosure of all interactions with industry is a key component for managing potential conflicts of interest.[43] Disclosure is vital to ensure the trust of the public and the trust of colleagues in pharmacy and other health professions. Pharmacists and other health care professionals should comply with disclosure policies established by their institution, as well as other relevant third parties (e.g., journal editors or professional or institutional committees). Pharmacists have the responsibility to know, understand, and follow the requirements for disclosure associated with each professional activity undertaken. Disclosure of all relationships with industry should be mandatory when undertaking any activity involving decision-making so that colleagues, students, trainees, and patients can evaluate these activities for themselves.

Although disclosure is an important tool in the management of potential conflicts of interest, it does not absolve pharmacists from avoiding situations in which potential conflicts would make their participation inappropriate.[28,33,42,43] For example, disclosure of a relationship followed by a passionate appeal to support a product for which the pharmacist has a relationship with the manufacturer is still inappropriate. Whenever possible, pharmacists should recuse themselves from all deliberations and decisions when these situations arise.

The OIG guidelines identify specific financial arrangements between industry and health care professionals that may present a significant potential for abuse.[3] Specific individuals or entities with special influence are also identified, including purchasers, benefit managers, formulary committee members, and group purchasing organizations. The guidelines offer the following questions to help identify problematic arrangements:

  • Does the arrangement or practice have the potential to interfere with, or skew, clinical decision-making?

  • Does the arrangement or practice have a potential to increase costs to the federal health care programs, beneficiaries, or enrollees?

  • Does the arrangement or practice have a potential to increase the risk of over utilization or inappropriate utilization?

  • Does the arrangement or practice raise patient safety or quality-of-care concerns?

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