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Columns   |    
Best Practices: Developing Ethical Guidelines for Pharmaceutical Company Support in an Academic Mental Health Center
Jeanne L. Steiner, D.O.; Michael Norko, M.D.; Susan Devine, M.S.N.; Elizabeth Grottole, M.P.H., L.C.S.W.; Judith Vinoski, A.P.R.N.; Ezra E.E. Griffith, M.D.
Psychiatric Services 2003; doi: 10.1176/appi.ps.54.8.1079

Introduction by the column editor: Interactions between the pharmaceutical industry and clinicians have important consequences for patient care. So a "best practices" look at this topic is welcomed. The authors of this month's column have initiated a quality-assurance process in their organization by developing ethical guidelines for such interactions. Guidelines are an early step toward the ultimate achievement of best practices. Over time, with monitoring of the impact of their guidelines on their institution, these authors will understand more about this vital theme. Attempts by other clinical organizations to develop guidelines will be needed to add to a generalized strategy for interactions between the pharmaceutical industry and the clinician.

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Scholarly publications and the lay press have focused increasing attention on the involvement of pharmaceutical companies in hospital and community settings and in residency programs (1,2,3,4,5,6). In the context of the rising cost of medical care, perceptions of excessive profit margins for pharmaceutical companies, and budget deficits in mental health payer systems, concerns have been raised that there is increased potential for these companies to exert undue influence on prescribing practices.

Despite the criticism about financial support for clinical and educational activities and the development of new standards and codes of behavior (7), many providers find that the decisions involved in accepting such support for specific activities are by no means straightforward. In the era of cost containment in both private and public sectors, pharmaceutical companies may offer financial support for activities that have been curbed by an institution or that are not otherwise readily available, including supplies for indigent patients, continuing medical education, or resource materials for staff and trainees.

In academic centers the issues and potential conflicts of interest become even more salient as we struggle to teach the next generation of mental health care professionals how to think about their future professional roles, how to approach decision making, and how to critically analyze research and promotional data.

In this column we propose a conceptual framework and set of procedures for addressing these issues, from which an institution or agency can develop ethical guidelines that are flexible and practical in their implementation.

At the Connecticut Mental Health Center, an academic community mental health center jointly run by the State of Connecticut and Yale University, the medical and professional staff became concerned about the increasing presence of pharmaceutical representatives in a variety of activities. There appeared to be an increase in the number of lunches and programs sponsored and catered by the companies as well as an increase in the amount of direct marketing material visible in patient care areas. The level of concern was raised considerably when a company offered to pay a large sum of money for the staff of one program to engage in a day-long "retreat" that had dubious educational goals.

Senior medical staff decided to develop a mechanism for tracking all such requests for support and to develop a centerwide policy for future activities. The process, which evolved over the course of one year, produced a flexible set of guidelines that can be applied to a wide range of proposals. The benefit of such an approach is that staff have been engaged in a series of educational discussions about the ethics and merits of pharmaceutical company support for specific projects. We have taken an approach whereby an interdisciplinary committee assesses the risks and benefits of each proposal and makes a final determination of approval or refusal.

In February 2001 a memo was distributed to all staff that described the formation of a new committee that would screen and track all ongoing and new requests for support by pharmaceutical companies. The committee focused on clinical and educational activities and excluded clinical research from its purview. Although research efforts at this institution are funded by pharmaceutical companies, the formal medical structure does not have regulatory authority over nonclinical aspects of research.

The multidisciplinary committee, which was organized through the office of the medical director, included representatives from the ethics committee of the medical and professional staff, from clinical operations, and from administration. The committee offered no a priori criteria for approval of such activities, noting that the purpose would be to provide a centralized mechanism for monitoring the support and to develop guidelines as the data were collected. A simple form was provided for recording relevant data about the activity, such as purpose (educational, direct patient benefit, or other), level of involvement of pharmaceutical representatives in the activity (for example, leaving pamphlets and promotional items on tables or speaking directly to the group), and dollar amount of support.

The full committee reviewed each request, including the potential merits of the activity and any obvious pitfalls. On several occasions we requested clarification and more details. Questions were posed about the possible incentive for the pharmaceutical company's involvement in several of the proposals and any potential obligations that would arise from acceptance of the support. The members of the committee were able to reach consensus for each request. If we had not been able to reach a decision, a mechanism was developed by which the issue could have been referred to the ethics committee of the medical staff or to the center's senior management group.

Individual meetings between pharmaceutical representatives and physicians—"detailing"—were already subject to specific regulatory guidelines developed by the pharmacy and therapeutics committee and therefore were not addressed by this committee.

The committee received 21 formal requests between February 2001 and January 2002. Six of the requests involved ongoing activities, which were all allowed to continue. Of these six activities, one appeared to have direct clinical benefit—a weight reduction program for patients taking antipsychotic medications that had received seed money for best-practices research—and five involved multiple companies and multiple staff, such as monthly lunches at which information was distributed by rotating competing companies.

During the year the committee received 15 requests involving new activities, only two of which were approved. One of these approved activities was the purchase of reference books for the residents' on-call room through an unrestricted grant. The most common reasons for denial were unclear educational or clinical benefit, prominent display of a company name on items given to patients, existing sponsorship of the activity by the institution, and potential bias of an outside speaker proposed by a company.

Our notion of potential bias was not based on an individual speaker's qualifications. We assumed that any speaker had the potential to present a perspective that was influenced by his or her sponsor and that the optimal method for addressing this potential bias was to present multiple speakers on certain topics. For example, three different companies were allowed to present comparison data on atypical antipsychotic medications.

Of the 13 proposals that were not approved, five were considered to have clear merit and to be worthy of funding through the institution's regular channels via administrative funds—for example, food for staff team-building activities and mandatory training sessions and purchase of scales to monitor the weight of patients receiving antipsychotic medications. The value of these activities was relatively clear, but the relative value of allowing a pharmaceutical company to be involved seemed less obvious.

The net result was an overall decrease in the number of clinical and educational activities that were sponsored directly by pharmaceutical companies, a direction that was favored by many members of the medical and professional staff. On the other hand, activities that met certain ethical standards were allowed to continue—with financial support from the institution—in a manner consistent with the mission and values of the organization. The medical staff will need to continue to monitor the outcomes of this initiative in order to assess the impact on patient care and educational opportunities. Although we do not have access to accurate data about the level of activities before our intervention, which was one important stimulus for us to develop a centralized tracking mechanism, we will be surveying staff about their perceptions of the changes and any apparent consequences.

The guidelines we developed for reviewing proposals for pharmaceutical support for clinical and educational activities have evolved as a set of questions rather than a rigid policy. In a manner similar to weighing the risks and benefits of a particular medication or therapeutic intervention, each proposal for support can be viewed as having potential value, which may or may not outweigh any potential drawbacks inherent in the involvement of funding from a for-profit company. A four-person committee was able to reach consensus on 21 proposals by assessing the apparent balance between these factors in our setting.

The questions to be asked about each activity, from which principles or guidelines easily follow, include:

•Will the activity provide direct benefit to patients?

•What incentive does the company have to sponsor the activity?

•Are alternative funding mechanisms available to support the activity?

•If a company is presenting potentially biased information—for example, comparison data that are favorable to its own product—is there an opportunity for other views and data to be presented?

•Is the opportunity for support equitably distributed among staff or programs within the facility?

In summary, we have presented a best-practices model, developed by a medical and professional staff, to sort through the complex issues of accepting resources from pharmaceutical companies within the culture of an academic mental health center. By taking a risk-benefit approach to the specific requests and opportunities and by asking relevant ethical and practical questions, our group was able to reach consensus decisions and provide an educational structure from which flexible guidelines are derived. This model provides a conceptual framework for approaching ethical decisions and is readily adaptable to other settings. Clearly the model will need to be evaluated over time and in other settings to assess any further positive or negative impact on patient care, the educational program, and interprofessional relationships.

The authors are affiliated with the Connecticut Mental Health Center and the Yale University School of Medicine, 34 Park Street, New Haven, Connecticut 06519 (e-mail, jeanne.steiner@yale.edu). William M. Glazer, M.D., is editor of this column.

Lichstein PR, Turner RC, O'Brien K: Impact of pharmaceutical company representatives on internal medicine residency programs: a survey of residency program directors. Archives of Internal Medicine 152:1009–1013,  1992
[CrossRef] | [PubMed]
 
Rosner F: Pharmaceutical industry support for continuing medical education programs: a review of current ethical guidelines. Mount Sinai Journal of Medicine 62:427–430,  1995
[PubMed]
 
Schwartz TL, Kuhles DJ, Wade M, et al: Newly admitted psychiatric patient prescriptions and pharmaceutical sales visits. Annals of Clinical Psychiatry 13:159–162,  2001
[PubMed]
 
Wazana A: Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 283:373–380,  2000
 
An unhealthy influence on doctors (editorial). New York Times, Sept 10, 2001
 
Vendantam S: Industry role in medical meeting decried. Washington Post, May 25, 2002
 
ABIM Foundation, ACT-ASIM Foundation, and European Federation of Internal Medicine: Medical professionalism in the new millennium: a physician charter. Annals of Internal Medicine 136:243–246
 
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References

Lichstein PR, Turner RC, O'Brien K: Impact of pharmaceutical company representatives on internal medicine residency programs: a survey of residency program directors. Archives of Internal Medicine 152:1009–1013,  1992
[CrossRef] | [PubMed]
 
Rosner F: Pharmaceutical industry support for continuing medical education programs: a review of current ethical guidelines. Mount Sinai Journal of Medicine 62:427–430,  1995
[PubMed]
 
Schwartz TL, Kuhles DJ, Wade M, et al: Newly admitted psychiatric patient prescriptions and pharmaceutical sales visits. Annals of Clinical Psychiatry 13:159–162,  2001
[PubMed]
 
Wazana A: Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 283:373–380,  2000
 
An unhealthy influence on doctors (editorial). New York Times, Sept 10, 2001
 
Vendantam S: Industry role in medical meeting decried. Washington Post, May 25, 2002
 
ABIM Foundation, ACT-ASIM Foundation, and European Federation of Internal Medicine: Medical professionalism in the new millennium: a physician charter. Annals of Internal Medicine 136:243–246
 
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