Conflict of Interest Policy Guide for Medical Schools and Academic Medical Centers
Community Catalyst offers this Policy Guide to Academic Medical Centers and Medical Schools to assist leaders, faculty, staff and medical students in successfully adopting and improving policies to address conflicts of interest and interactions with the pharmaceutical and device industries. Policies such as these and their effective implementation are of critical importance to the integrity of medical education and patient care.
We hope you will use and distribute these toolkits, along with their associated resources, in your institution. Community Catalyst staff are also available to answer questions or assist you in the process of policy development. We have consulted with academic, clinical and compliance experts across the country to develop these recommendations and to incorporate best practices and example policies. We welcome your feedback and encourage you to share your own successes and challenges with us, as well.
Toolkit on Transparency and Disclosure
This toolkit addresses transparency and disclosure of industry relationships with physicians, researchers and medical institutions. The rationale for disclosure policies is discussed, including evidence that these relationships may bias clinical decision making. Policy options covered include requiring disclosure to the institution, as well as to patients, students, research participants and the public. The toolkit also discusses the relationship between institutional policies and mandated reporting by the U.S. Public Health Services, for investigators, and the CMS Open Payments program (the “Sunshine Act”), which requires industry reporting of payments to physicians and teaching hospitals.
Toolkit on Gifts, Meals and Entertainment
Industry provides gifts, including meals and entertainment, to physicians and other prescribers in order to influence treatment decisions, medical education and research. In this toolkit, the ways in which gifts create bias and undermine professionalism are discussed, along with widely adopted recommendations for prohibition by medical leaders. We recommend that institutions prohibit personnel from accepting industry gifts and meals, and extend the policy to all faculty, including voluntary clinical faculty in the community. Three model medical school and AMC policies are included.
Toolkit on Relations with Sales Representatives
Industry invests heavily in drug and device sales representatives who conduct "detailing" visits with prescribers in order to market their products and influence prescribing decisions. In this toolkit the prevalence and impact of these industry practices are discussed, along with arguments that have been made for and against meeting with sales representatives. Policy solutions and model policies are presented, ranging from exclusion to tight restrictions on drug representatives, as well as procedures to supervise device representatives that provide technical support.
Toolkit on Promotional Speaking
Promotional speaking (speakers bureaus) is the practice of pharmaceutical companies recruiting and training physicians to give talks promoting company products. Companies seek physician speakers because they are highly effective in influencing their peers. In this toolkit, a ban is recommended to maintain the integrity of patient care and clinical research, and methods to minimize bias in that absence of a complete prohibition are presented. Three model policies are included.
Toolkit on Continuing Medical Education
This toolkit addresses the issue of pharmaceutical and device industry support for continuing medical education. It outlines concerns about the effects of such support on the information that clinicians receive through CME programs and subsequent bias in prescribing decisions. Arguments for and against commercial support for CME are summarized, followed by a recommendation that medical schools and AMCs eliminate industry support in the interests of professionalism and patient care. A range of policy responses and model institutional policies are summarized, from outright prohibition to policies to help minimize the potential for bias.
Toolkit on Ghostwriting and Name-Lending
This toolkit addresses the practice of fraudulently hiding the true identity of authors in medical research and publishing. Industry has used ghost-writing and name-lending to market drugs and devices under the guise of purportedly objective, unbiased scientific data. Medical schools and AMCs should unambiguously condemn name-lending by their faculty and staff as a violation of professional ethics. Policy and enforcement recommendations, a checklist for preventing this practice, and two model policies are included.
Toolkit on Samples
The pharmaceutical industry distributes over $5 billion in samples annually, which is a key tactic in increasing sales of new and higher cost brand name drugs by influencing prescribers and patients. This toolkit addresses the cost problems created by samples even for low income patients. In addition, new drugs do not have established safety records, and by supplying samples directly to clinicians, industry representatives bypass hospital quality control procedures. The only ethically defensible reason for using samples is to assist patients who otherwise could not afford to purchase the drugs and where no other low-cost alternative exists. The toolkit discusses policy options and examples, from banning samples to strictly controlling their use, and suggests other methods to assist patients in gaining access to low-cost medications.
Toolkit on Pharmaceutical and Therapeutics Committees
The COI Toolkit on Pharmaceutical and Therapeutics Committees describes how policies and practices of PTCs can insulate hospital formulary decisions and patient care from potential conflicts of interest and bias. Policies discussed are disclosure, bans on those with financial conflicts from participation in the PTC, and required recusal from decisions on specific products or issues. Pharmaceutical and Therapeutics Policies from University of Mississippi Medical Center and Penn State College of Medicine are provided.
Toolkit on COI Policy Implementation
This toolkit provides a guide to the process of COI policy development and implementation. Faculty and staff who are interested in helping to expand or improve COI policies in their institution will find it helpful. The toolkit discusses the importance of making professionalism your central tenet, developing a good process, focusing on broad principles first and enlisting key leaders, as well as other key concepts. No single strategy or formula will be right for every institution, but the recommendations reflect a broad consensus of opinion and are generally applicable across institutions.
Conflict of Interest Curriculum Toolkit
This toolkit provides the rationale for teaching about conflict of interest in medical schools and residency programs and a succinct overview of the competencies learners should achieve, along with the theory supporting various educational approaches. It provides examples of actual curricula and optimal timing for such programs, as well as model institutional policies that could foster broader incorporation of such curricula in medical school and residency education.
Conflict of Interest Curriculum Resources:
- Albert Einstein College of Medicine has an exemplary model curriculum, integrating conflict-of-interest education into a first-year medical school course. Professor Elizabeth Kitsis has given us permission to share her slides, available as a PDF or PowerPoint.
- The University of Iowa Carver College of Medicine has its third-year medical students participate in a course called "Clinical Beginnings" just before they embark on their clinical clerkships in the community. Steven Craig, M.D. graciously shares his slides, available as a PDF or PowerPoint.
- University of Texas San Antonio's Professor Pedro Delgado provides third-year psychiatry residents with a seminar titled "Physician Relationships w/Industry & Conflict of Interest." He has shared his slide set in PDF and PowerPoint.
- University of Massachusetts Medical School has an entire curriculum available online, with the option to receive CME credit. See: Making the CA$E for Drug Company Independence.
- The University of Connecticut School of Medicine's Eric Jackson, PharmD, in the Dept. of Family Medicine has produced an excellent "Conflict of Interest Curriculum" slide set that includes COI background and significance, resources, an examination of UCSOM's policies, and teaching scenarios. COI issues will be further addressed by faculty in a 1st-year presentation on "Health Law and Ethics," a 2nd-year presentation on "Pharmaceutical Law and Policy," and in orientations for 1st- and 3rd-year medical students.
This project is supported by the Partnership to Advance Conflict Free Medical Education (PACME), a collaboration of Community Catalyst, the National Physicians Alliance, the American Medical Student Association and The Pew Charitable Trusts that is supported by the Attorney General Consumer and Prescriber Grant Program, with funds from the multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin. PACME's goal is to address the need for improvements in conflict-of-interest standards at the approximately 150 medical schools and 400 affiliated teaching hospitals in the United States.