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.
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.
Members of the media interested in speaking with UMHS leaders about these issues may contact Kara Gavin, firstname.lastname@example.org. Representatives from other institutions that are considering similar policies may e-mail Jim Stevenson, Pharm.D, email@example.com or Steve Bernstein, M.D., email firstname.lastname@example.org.
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: Four 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 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
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.