Best Practices for Academic Medical Centers (AMCs)
Best Practices For Managing Conflicts of Interest
Public perception of physicians’ relationships with pharmaceutical and device companies and related government policy are changing. In 2004, a joint task force appointed by the American Board of Internal Medicine Foundation (ABIM) and the Institute on Medicine as a Profession (IMAP) concluded that existing guidelines and policies were inadequate in managing physician-industry relationships and resulting COI. The ABIM-IMAP task force published its policy recommendations on conflict of interest in JAMA in 2006. The proposals stimulated many academic medical centers (AMCs) to evaluate existing guidelines or formulate new ones. Below are their recommendations.
Pharmaceutical vendors have often had relatively unrestricted access to large academic medical centers (AMCs), community hospitals, and physicians’ offices. Vendor visits are often accompanied by gifts and meals that have been shown to influence prescribing. Indeed, the pharmaceutical industry spends around $15,000 per physician in marketing (not including samples), a sum that produces significant returns on investment. Moreover, industry sales representatives frequently do not provide complete and accurate information regarding the efficacy of their products.
AMCs should provide quality, evidence-based care, and create an educational environment that is free of the undue influence of pharmaceutical and device industry marketers. AMCs must ensure the privacy of their patients. To this end, leading AMCs have begun to implement policies that limit the access of pharmaceutical and device industry representatives to students, residents, physicians, and patients. Most policies controlling the access industry representatives have to medical center areas require: registration of all vendors; badges for vendors that distinguish them from hospital employees; access to physicians only by prior appointment; no gifts or meals.
- Compliance with state and local law
- Restrict interactions between industry representatives and staff to meetings by appointment only
- Patient privacy
- Shaping behavior of trainees (residents, students, interns)
- Establish a compulsory registration process for any sales or marketing representatives who will be on medical center grounds for work purposes
- Establish a process for determining who is responsible for enforcing vendor liaison policies
- Create mechanisms to replace industry information
Of the $29 billion spent by the pharmaceutical industry to promote its products, over 60%, or about $18 billion a year goes to “free” samples. Samples encourage physicians and patients to rely on medications that are expensive, but often not more effective than other available drugs. Samples have been shown to increase physician prescribing of the marketed product, independent of the effect of detailing by industry sales representatives. Developing a samples policy requires consideration of the marketing impacts of samples, the needs of under-insured patients, patient safety concerns associated with dispensing samples, compliance with accreditation standards and the invisible overhead costs associated with logging, tracking, and dispensing medications from a traditional sample closet.
The pharmaceutical and medical device industries give gifts to medical professionals to cultivate goodwill, influence prescribing behavior, and gain access to prescribers. Gifts may include items such as pens and notepads, textbooks, travel support, lunches, meals at five-star restaurants, entertainment, and other items of value. Such gifting, however small, influences prescriber behavior.
Numerous health care organizations and academic medical centers (AMCs) have adopted no-gifts, no-meals policies.
- Gifts should be banned in their entirety, regardless of nature or value
- Industry-sponsored meals and snacks should be banned in their entirety within the institution. (Some departments have budgeted to replace industry-funded meals, while others require that medical residents and staff purchase their own meals)
- Enforcement strategies focused on vendors
- Acceptance and implementation
Ghostwriting and speakers’ bureaus present work created to further industry marketing goals as the independent work of leaders in academic medicine. Ghostwritten articles appear to be authored by a prominent physician, but are in fact the work of an industry employee or a freelancer working closely with a pharmaceutical, medical device, or medical education and communication company. Speakers’ bureaus are speaking events where physicians give presentations based largely or entirely on material provided by a pharmaceutical or medical device company. The role of industry in organizing the data, and drafting the article is obscured by excluding the true author, and only including the apparently independent academic physician.
- Ensuring faculty members only participate in legitimate speaking engagements
- There is no room for industry ghostwriting in an academic environment
Pharmacy and therapeutics (P&T) committees are an effective tool for hospitals and health centers to ensure the practice of quality, cost effective and evidence-based medicine. Conflict of interest issues arise when individuals who have a direct role in decisions related to drug or medical equipment procurement also have financial relationships with manufacturers, including any receipt of gifts, grants, contracts, or an otherwise compensated relationship. It is essential that academic medical centers (AMCs) establish policies to ensure that conflicts of interest do not influence purchasing decisions and jeopardize quality, evidence-based care.
- Compliance with state law
- Reinforcing the formulary
- Implementation strategies
Since the late 1990s, industry support of CME has grown as other avenues of pharmaceutical promotion have come under increased scrutiny and regulation.
Pharmaceutical companies often control events indirectly through Medical Education Communication Companies (MECCs). The MECCs organize events for physicians, but serve the needs of their clients–the industry that pays the bills.
The Accreditation Council for Continuing Medical Education (ACCME) has established standards for commercial support. However, ACCME does not audit individual programs and its standards have not been effective in ensuring the independence of CME events. Many programs continue to receive accreditation, despite serving primarily marketing purposes.
It is critical that policies to address conflicts of interest at academic medical centers (AMCs) include provisions to maintain the independence and rigor of CME. A model CME policy for an academic medical center should aim to eliminate both real and perceived conflicts of interest derived from the involvement of pharmaceutical and device companies playing such a central role in physician education.
- Incorporation of ACCME standards
- Disclosure is not sufficient
- Reviewing CME for bias
- Establishing a central education fund
- Funding CME solely through academic medical center support and attendance fees