U-M Health System industry interaction policies: Drug samples, drug reps, conflict of interest & beyond

The U-M Health System was one of the first medical institutions in the country to place strong limitations on the interactions between our clinicians and representatives of companies that make or sell medications, medical devices or other products. We were also one of the first to eliminate the use of drug samples in clinics and hospitals.

In May, 2007, were recognized by the American Medical Student Association as one of only five academic medical centers to receive an "A" for such efforts. We have continued to receive "A" grades from AMSA for our policies.

As the nation begins to pay more attention to the relationships between major medical centers and the companies that make medical products, we provide this summary of our policies and the impact they have had.

See a one-page fact sheet summarizing our approach to interacting with industry here.

Members of the media interested in speaking with UMHS leaders about these issues may contact Kara Gavin, kegavin@umich.edu.

For more details about how we handle specific forms of interaction with industry:

Drug Samples

Interactions with industry vendors (e.g. 'drug reps')

Continuing Medical Education funding

Conflict of interest and industry-sponsored speaking

 

 

Issue 1: Drug samples

What we did: Banned the use of samples of prescription and non-prescription drugs from all clinics and hospitals operated by the University of Michigan Health System. (These represent the vast majority of locations at which U-M Medical School faculty physicians and residents practice.) 

A system of vouchers for a limited list of medications was created to allow patients to receive free starter doses from the pharmacy of their choice. Only vouchers approved by the in-house formulary committee, for medications that have been identified as "preferred" because of their efficacy and cost, may be given out. A provision was made for extremely limited use of samples in outpatient clinics, based on clinical-need applications from lead physicians and subject to tight security and an annual review. Only one such exception has been granted.  For patients with financial hardship, the staff focused on switching to lower cost medications when possible and on qualifying patients for assistance programs when a high cost drug was necessary.

Why we did it: Drug samples, while apparently convenient for patients, are accompanied by regulatory and security concerns, pose potential safety risks for patients, and encourage prescribing of high cost, non-preferred brand name medications.  There are no free samples of generic medications, the lower cost medications that provide the best value.

When we did it: September 2002

What has been the result: Years after the start of the program the University's clinics are still free of samples.  The thousands of medical students and residents that spent time in those clinics learned to practice without the influence of drug samples, encouraging them not to prescribe higher cost brand name medications when a generic or lower cost brand would work as well.  Very few vouchers for free starter doses of medications were used. Pharmaceutical companies requested approval for only a few vouchers.

Note: In late 2006, the U-M Women's Hospital Birth Center banned sample bags of infant formula and related materials that had previously been given to new mothers.

 

Issue 2: Interactions between vendors (drug reps and others) and U-M clinicians

What we did: Implemented an across-the-board policy that substantially increased the restrictions on interactions between representatives of pharmaceutical companies and other "vendors" and our physicians, physicians-in-training, students, and other clinicians. In addition to setting strict conditions for in-person visits and other contacts, these changes included a ban on gifts, "leave-behinds" and food and drink.  

The changes pertain to any representative of a manufacturer or company who visits any part of the U-M Hospitals & Health Centers for the purpose of soliciting, marketing, or distributing information regarding the use of medications, products, equipment and services.

Before their first visit to U-M, drug reps must register with and receive information from the Pharmacy department, and they and other vendor reps must also register with the Contracts & Procurement Office. Before being allowed to visit any clinician, representatives must have an appointment with that specific clinician, must check in at the facility, and wear a red colored vendor badge during their visit. The reps are prohibited from roaming the halls or visiting areas frequented by clinicians to create a "chance encounter."  They may provide informational material, such as product literature or journal articles, only at the request of a faculty or staff member. If they discuss any drug that is not on the U-M formulary or preferred drug list, they must disclose this fact.

Vendor representatives may not provide food or drink of any kind, nor personal gifts of any type (including items such as pens, magnets, pre-printed prescription pads, or tickets to events). They may not leave behind information for clinicians or patients except as invited by faculty. They may present textbooks and items of educational value to the department (not an individual), and only with the approval of the relevant department chair or director.

Vendor representatives may still sponsor educational programs through grants to the institution, but only with the approval of the chief or director of the area hosting the program, who is responsible for assuring the educational integrity of the program. Food may be purchased with part of such grants at the discretion of the department or division hosting the program. Vendor representatives may not speak or present information in conjunction with such programs, nor can they promote or market specific products in conjunction with those programs. They can be present at such programs as long as specific patient information is not discussed. No displays of their products are permitted.

With appropriate written authorization, vendor representatives whose non-pharmaceutical products are already in place in the institution can be scheduled to come to a UMHHC facility to help staff implement and learn appropriate use of their product. Similarly, representatives can schedule visits if they are monitoring the progress of a UM clinical research trial involving their product.  All such visitors must sign confidentiality agreements regarding confidential patient information and are only allowed to address the stated purpose of their visit. Detailing (promoting products) during such visits is prohibited.

Vendors who violate this policy may have their business privileges revoked, and their company may be restricted from any access to the property. Faculty and staff who violate the policy will be reported to their supervisor, and disciplinary action (including discharge) may be taken depending on the severity of the violation.

In addition to this policy implemented by the U-M Hospitals & Health Centers, University faculty and staff are also bound by the U-M Standard Practice Guide, which has additional guidance for interaction with business representatives.

For example, University employees are bound by SPG 507.1 which states that employees should not engage in activities with vendors if there is any commitment to do business or influence business. So, if a faculty or staff member is invited by a vendor to play golf, it would be proper for the faculty or staff member to contribute the cost of the golf greens fees themselves. The same would apply to a meal outside the Hospitals & Health Centers' facilities, such as at a national meeting.

Other guidelines govern research grants, contracts that allow faculty to perform consulting duties, and other matters.

Why we did it:  To hold our faculty, staff and trainees to the highest ethical standards in their dealings with industry representatives, to protect patient confidentiality, and to encourage efficient and cost- effective use of equipment, supplies, and pharmaceuticals.  By removing the chance encounters and the inducement of food, drinks, and pens, we ensure that the only contacts our faculty, trainees and staff have with vendor representatives are at our specific request. We eliminate the promotion of commercial products previously tied to our core educational events,

When we did it: March 2003

What has been the result:  Again, thousands of medical students and residents have rotated through UM clinical services over the past three plus years without being influenced by unsolicited pharmaceutical and other product marketing.  Trainees, faculty physicians, and nurses have learned they do not need these inducements to learn and deliver high quality healthcare. Residents and students comment that they are still exposed to both drug company sponsored lunches and free brand name drug samples when they rotate to other hospitals and doctors' offices.

 

Issue 3: Continuing Medical Education funding

What we did: The University of Michigan Medical School has changed the funding of continuing medical education programs (CME) in order to curtail industry influence on patient care and dispel the risk or appearance of conflict of interest.

The policy prohibits receiving commercial funding (including exhibit fees) to support UMMS CME activities. The commercial companies addressed in the policy are those that “produce, market, re-sell, or distribute health care goods or services consumed by, or used on patients or biomedical research subjects.” These companies are permitted to have commercial exhibits, but no fee can be charged. Other commercial entities may be charged exhibit fees. Commercial funds cannot be used to provide meals, honoraria, or social activities associated with a CME activity.

The U-M Medical School guideline to no longer accept industry funding of our CME programs was recommended by the Conflict of Interest Group (chaired by Paul Lichter, M.D., director of the Kellogg Eye Center) and was based on a review of literature about the influence on clinical faculty of industry-funded CME. The recommendation was extensively discussed by Medical School Department Chairs who then voted to cease industry support for CME.

Why we did it: CME funding is part of the changes sweeping through the health care industry. Questions have been raised about the most effective educational interventions and the need for more just-in-time delivery of information. Suggestions have been made about the potential value provided by new IT solutions to better meet changing needs. There is increasing focus on how to link CME to improvements in the quality and safety of our nation’s health care system.

The methods, vehicles, venues and funding models may change, but as an academic medical center, it is our responsibility to hold ourselves accountable and fulfill our educational mission to our physician colleagues’ continuing professional development.

When we did it: The guideline took effect on January 1, 2011

What has been the result: The Office of Continuous Professional Development within the Dean's office oversees CME activities and the awarding of CME credit. It provides guidance to departments and centers that wish to offer public CME programs online or in person, or programs aimed at U-M physicians only. It also accepts applications for funding of innovative projects through a competitive process. Departments and centers also provide funds for their CME activities.

A web page listing all CME activities currently available through the Medical School is available here.

In 2012, the Accreditation Council for Continuing Medical Education awarded the U-M Medical School with its "Accreditation with Commendation" rating. This award reflects our commitment to providing community physicians and Medical School faculty physicians with high-quality educational programs designed to meet the needs of a busy practice.

 

Issue 4: Conflict of Interest and Industry-sponsored speaking

What we did: In 2013, after much consideration, the U-M Medical School adopted new policies banning or severely limiting interactions by its faculty and staff with industry as consultants, members of "expert advisory panels" and participants in speaking opportunities and marketing activities.

For more information please see this page: http://www.uofmhealth.org/COIpolicies

These policies go above and beyond the mandatory reporting of potential and actual conflicts of interest required annually of all Medical School faculty, fellows and house officers; all Health System administrators; all Health System committee members; and all UMHS staff who have a potential conflict. Disclosures are reviewed by department chairs and/or department administrators/supervisors for any potential Conflict of Interest or Conflict of Commitment, and assessed both for the appropriateness of the activity as well as level of compensation to ensure it is commensurate with the effort. Disclosures are subject to further review by a COI Board, and when a conflict is found to exist, it is reduced, managed, or eliminated as appropriate.

In addition, in 2011 the Medical School adopted a policy that requires faculty members to disclose to students and trainees their relationships with the biomedical industry, including industry-supported research, effort supported by industry and formal outside relationships. In lecture settings, faculty members must disclose their industry relationships or that they have no industry relationships to students and trainees at the beginning of their presentations, either verbally or in writing (e.g., a slide in a presentation). Disclosure must also be made to students and trainees with whom a faculty member regularly interacts such as in laboratories and clinical rotations.

 

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