December 17, 1998: Wishwa Kapoor, University of Pittsburgh

CERTs could have a valuable role in improving the quality of pharmaceutical use while also addressing issues of cost. CERTs should focus on building infrastructure to develop the capability to do research and education in the Long-term.

How CERTs should be organized

CERTs should be organized as research centers that propose specific research projects involving multidisciplinary teams. The organizational structure needs to demonstrate several key elements: 1) the CERT has the multidisciplinary involvement and resources required to truly monitor and influence pharmaceutical care (i.e., high level representation and commitment from Internal Medicine, Surgery, Pharmacy, Public Health, Biomedical Informatics, Health Care Administration, etc.); 2) the organizational structure of the CERT needs to demonstrate the fact that it has a leadership role in the current and future information systems that exists across their respective patient care environment(s); and 3) the organizational structure needs to demonstrate how the CERT is prepared to assess and influence pharmaceutical care across a patient's continuum of care (i.e., inpatient, long-term care, home care, managed care, ambulatory care, etc.) and in a variety of health care environments (i.e., tertiary/University-based teaching hospitals, community hospitals, rural and urban hospitals, Department of Veterans Affairs (VA) practice, rehab, etc).

The appropriateness of AHCPR or these centers seeking additional funding partners to increase the resources available for research

The amount of funding proposed is small relative to the needs of the program. Additional funding from other agencies (such as the National Institutes of Health (NIH), VA, foundations) should be sought in the forms of grants or contracts. Pharmaceutical industry funding may raise issues of conflict of interest and should have close scrutiny.

Initial areas of emphasis

Three large areas are mentioned in the notice (drugs, biological products, and devices). Limiting initial applications to one area would provide experience in developing centers and can be used in the future funding for other areas. Furthermore, limited funding will not allow initiatives in all of three broad areas. Would recommend starting with uses of drugs with focus on appropriate uses of drugs and preventing adverse effects and its consequences. Areas to consider are: high drug utilization (i.e., elderly patient populations, transplantation, etc.); higher potential for serious drug errors/ADRs (i.e., elderly, psychiatric patients, transplantation, hematology/oncology, pediatrics, etc.); and high drug expense (i.e., transplantation, biotechnology, hematology/oncology, etc.). Additionally, areas should be considered where there is a high potential improvement in the provider/patient decision-making.

Focus of initial RFA

The focus should be on three areas: infrastructure, research, and education. Although significant infrastructure funds are needed, these centers are more likely to show initial success if they also conduct research as they begin to function. The research activities will be relatively modest but it is hoped that building infrastructure will allow funding from other sources including future Agency for Health Care Policy and Research (AHCPR)/Food and Drug Administration (FDA) applications. Each of the centers should devote efforts toward education and developing methods of providing education to health professionals.

Wishwa Kapoor, M.D., M.P.H.
Professor of Medicine
Chief, Division of General Internal Medicine
Director, Center for Research on Health Care
University of Pittsburgh

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