The American Society for Clinical Pharmacology and Therapeutics (ASCPT) is pleased to have this opportunity to respond to the Federal Register notice of November 3, 1998, requesting comments on the organization and focus of the Centers for Education and Research in Therapeutics (CERTs). The ASCPT is a national organization of 2,000 physicians and scientists who have special training and expertise in the optimal and appropriate use of medications. Our members are focused on the development and continued evaluation of new and established medications. Based on our collective experience, the ASCPT believes that the CERTs program should be an important new component of AHCPR programs aimed at improving the quality and cost-effectiveness of health care through research on and education about prescription medications.
Our comments will focus specifically on the six questions/issues raised on page 59314 of the Federal Register notice. Specifically:
How should the Centers be organized?
In terms of AHCPR oversight of the CERTs program, we recommend that the Agency appoint a CERTs Steering Committee. This Committee would provide general guidance to and oversight of the entire program and would identify "hot" research questions for study by the CERTs. It should be composed of 12-15 people and must have strong representation from the disciplines of clinical pharmacology, medicine, pharmacology, clinical pharmacy, pharmacy, nursing, and relevant governmental agencies. The Steering Committee would include the Director or an alternative representative from each funded CERTs. Non-voting representatives from the pharmaceutical and biotechnology industry should be invited to participate.
In the opinion of the ASCPT, the AHCPR should select three CERTs for funding in FY 1999. (See comments below regarding the need for an additional $1 million for a total CERTs budget of $3 million.) One of the three Centers would serve as a coordinating center to serve as a repository of information regarding the activities and findings of all three CERTs sites and take responsibility for disseminating information to health care providers regarding conclusive results generated within the CERTs. The principal goals of the Coordinating Center will be to:
An Executive Committee made up of the Director and one other representative of each CERTs site would meet by monthly conference call to oversee the activities of the Coordinating Center. The Executive Committee would review proposals for research and educational programs to be conducted by the Centers.
Is it appropriate for AHCPR or the Centers to seek additional funding partners?
In the opinion of the ASCPT, the CERTs program should be structured to allow individual investigators to work in the CERTs with grant funding from Federal or private sources (whether non-profit or for-profit). The individual CERTs should be encouraged to seek supplemental support from the Center for Disease Control (CDC), the Food and Drug Administration (FDA), other appropriate government agencies, and/or non-profit, private sector organizations. However, the Centers themselves should not seek or receive direct support from for-profit industry sources.
Should the Agency list specific research topics or focus primarily on infrastructure and identify topics following selection of Centers to be funded?
In the opinion of the ASCPT, the Agency should not list specific research topics to be the focus of applications for CERTs grant funding. Some of the most important findings related to adverse drug reactions and interactions have resulted from observations in the clinical setting. The CERTs program should be viewed by clinicians as a "clearinghouse" with the ability to respond with research and education programs when a pattern of adverse drug reactions is observed. There is currently no single agency or entity with the expertise or resources to respond to such stimuli. On a local or regional level, the CERTs could serve this function, and the ASCPT believes that health care providers will be far more likely to contact a local or regional center than a central Federal agency. However, if the AHCPR specifies a research focus for each CERTs, the individual Centers will not be able to receive and act upon information generated through clinical practice. In the view of the ASCPT, targeting of CERTs to specific research questions would undermine this very important "clearinghouse" function and minimize the potential leadership role of the CERTs program in identifying a pattern of adverse drug reactions regarding which further research should be pursued. In summary, research questions for consideration by the CERTs should be generated based on local clinical experience and the collective experience of members of the Steering Committee recommended above.
What should be the initial areas of emphasis?
The scope of work authorized in statute is far too broad to be addressed by an initial $2-3 million budget. Among the "required activities" enumerated in the statute, the entire genesis of the CERTs program presumed that the initial emphasis would be on clinical and laboratory research designed to improve the safe use of drugs and the dissemination of definitive research results to health care providers. As the CERTs program develops and grows, the AHCPR should expand this focus to include research on potential new uses of drugs and biological products as well as the dissemination of new information to the public.
What are the high priority research topics?
As outlined above, the ASCPT does not believe that the AHCPR should enumerate specific research topics in the solicitation for CERTs proposals. Research questions for consideration by the CERTs should be generated based on local experience and the collective experience of members of the Steering Committee.
Are there other issues that should be taken into account as the Agency implements the legislation?
The ASCPT's major concern with respect to the November 3 announcement is that the Agency states that the budget will be limited to $2 million. For the CERTs program to be initiated successfully, AHCPR should provide a minimal budget of $3 million. We offer three arguments in favor of an additional $1 million for the CERTs program in FY 1999:
First, this would be consistent with the Congressional authorization level for FY 1999 of $3 million. In the context of providing the AHCPR with a significant budget increase for the coming year, Members of Congress have expressed particularly strong support for the CERTs program.
The issue of drug safety should be a high priority as the AHCPR seeks to obtain the greatest possible impact per dollar spent. Over two billion prescriptions are written in the United States each year at a cost of over $60 billion. Prescribing errors are the second largest cause for malpractice claims in the United States, with over 40% of these errors resulting in death or permanent disability. A study published in the January 22, 1997 issue of the Journal of the American Medical Association estimated the annual post-event costs of adverse drug reactions in just one 700-bed hospital to be $5.6 million annually. Clearly, a budget much greater than $2 million or even $3 million is needed to develop and disseminate knowledge that will optimize the use of drugs and thereby improve the quality and reduce the cost of health care.
As outlined above, the ASCPT believes that the successful implementation of the CERTs program requires initial funding of at least three centers. Only two could be funded with the proposed $2 million budget.
Again, the ASCPT appreciates the opportunity to provide these recommendations regarding implementation of the CERTs program. Should you have any questions regarding our comments, please contact me or our Washington Representative, Ms. Lynn Morrison, at 202-543-7460. Thank you for considering the views of the American Society for Clinical Pharmacology and Therapeutics.
Carl C. Peck, M.D.
President
American Society for Clinical Pharmacology and Therapeutics
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