University Med Center Restricts Samples

The University of Pittsburgh Medical Center is putting the finishing touches on a conflicts-of-interest policy that will establish new guidelines for distributing sample medications provided by drugmakers,

The wide-ranging policy also will impose restrictions on consulting relationships, ban gifts from sales reps and call for other restrictions. The policy will apply to about 50,000 people - faculty, staff and students of the university's Schools of the Health Sciences, and other professionals and staff employed or contracted by UPMC's US operations. The move comes after the American Medical Student Association began an aggressive campaign ranking med school policies in hopes of reducing industry influence. The organization recently held its annual Pharm-Free Week to promote the idea.

An earlier draft policy had proposed curtailing use of drug samples, but concerns were raised that that could deny some uninsured or underinsured patients access to needed medication. Others noted, however, that current methods of distributing samples help reps gain access to docs to influence their behavior. A working group of pharmacists, physicians and administrators will consider other ways of distributing samples, the paper writes. While policy details are being finalized, a central facility within UPMC will accept samples from companies, then provide them to doctors' offices.

The new arrangement will "remove the relationship between company representatives and prescribers," Barbara Barnes, associate dean for continuing medical education at the Pitt School of Medicine, tells the paper. The new approach should be in place by next spring or summer, adds Robert Weber, co-chairman of the working group and chairman of the Pitt School of Pharmacy.

In the interim, sales reps could have more limited access for sample distribution at doctors' offices, he tells the Gazette, and monitoring and tracking of samples will be more stringent. The overall conflicts-of-interest policy is scheduled to take effect Feb. 15.

For UPMC or Health Sciences personnel, penalties for noncompliance would range from counseling to written reprimands, revoking hospital privileges, fines or termination. Companies repeatedly violating the policy could have their sales and marketing personnel suspended from UPMC and the Health Sciences schools for a year or more.

Among the provisions:

• UPMC and Health Sciences personnel would be unable to accept tickets to sporting events or other gifts from drug industry representatives, including pens and note pads. Food provided by the industry generally would be banned, though some exceptions could be made for continuing education events and industry-sponsored off-campus meetings.

• Sales and marketing representatives may only have access to clinical facilities if their companies have registered with UPMC supply chain management or the Pitt purchasing department. Company representatives also would have to be invited to meet with health care providers for a specific purpose.

• UPMC and Health Sciences personnel could attend off-campus, industry-sponsored meetings, but with certain restrictions. Speakers could receive travel reimbursement and "a modest honorarium not to exceed $2,500," but would have to determine their own lecture content and present a balanced assessment of treatment options.

• Industry support for scholarships and fellowships would require a written agreement, with selection of awardees controlled by Pitt or UPMC personnel.

• Consulting services provided to industry must involve a contract stipulating specific tasks and products to be delivered, "with payment commensurate with the tasks assigned."

For Health Sciences personnel, consulting arrangements must be approved in advance by a faculty member's dean, department chairman or administrator. Written approval by the dean will be required if annual payment from one company would exceed $10,000. UPMC personnel who are not faculty would need prior written approval from supervisors. While guidelines for consulting relationships already are in place, the new policy "does formalize the requirement for a written contract," UPMC officials say.

As part of a Justice Department settlement, several orthopedic firms recently disclosed consulting fees paid to doctors and institutions around the nation, including $2.82 million paid so far this year in the Pittsburgh area. Some of those payments went to UPMC, its physicians or departments. At the time, Pittsburgh surgeons and medical institutions said their compensation was commensurate with the level of consulting and research work they've done for the companies. Barnes says Pitt and UPMC officials are reviewing the info.

It is common for academic medical centers to work with industry to advance research or medical treatment, says David Korn, a senior vp for the Association of American Medical Colleges. If docs help to develop a device, they and their academic centers may be entitled to royalties, though the centers would have to use the funds for research, he explains, but other scenarios are more troubling. If device companies, for example, make payments based on the number of devices implanted in patients, "those really smell like kickbacks," he says.

That kind of relationship also could distort a medical center's ability to make objective decisions about device purchases, he adds, and the association will probably consider the complex issue of consulting relationships with industry next year.