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Summary of Remarks
The Future of Drug Safety Symposium
Overview
On March 21, 2007, the fourth in a series of symposia focusing on issues that are shaping the American healthcare system came to University of the Sciences in Philadelphia. This symposium, entitled “The Future of Drug Safety”, was assembled under the guidance of the Department of Health Policy and Public Heath. A panel of experts convened to discuss drug safety issues that will affect future policy.
The panel was moderated by Dr. Michael Cohen, who is one of the foremost experts in the world on medication errors. He is also a recipient of a McArthur Foundation Genius Award. The panel was comprised of experts in the field of drug safety. First was Dr. Mark Beers, recently retired editor-in-chief of the The Merck Manuals and executive director of geriatrics and clinical literature at Merck & Co., Inc. He is also the author of the Beers Criteria, which guides prescribing in the elderly. Second on the panel was Dr. Gerald A. Faich who is the senior vice president for epidemiology and risk management at United BioSource Corporation and formerly office director of the FDA’s Office of Epidemiology and Statistics as well as a deputy director of the Office of the U.S. Surgeon General. Third was Dr. Susan S. Ellenberg who is currently a professor and associate dean for clinical research at the University of Pennsylvania School of Medicine and previously director of biostatistics and epidemiology in the Center for Biologics Evaluation and Research at the FDA. Dr. Ellenberg also served as a member of the Institute of Medicine’s Committee on the Assessment of the U.S. Drug Safety System.
Each member of the panel began by discussing what they considered pressing drug safety issues. Dr. Beers focused on the appropriateness of medication use, especially in the elderly population. His research has, and continues to, focus on the complex world of medication use in the elderly population. Due to polypharmacy in this segment of the population, the elderly are at a disproportionate risk for adverse drug reactions. Dr. Beers suggested increasing the use of technology to compensate for human error. As more drugs are added to the market, it is becoming increasingly harder for physicians and pharmacists to keep a database in their heads of contraindicated medications. Computers can house the amount of information needed, and Dr. Beers recommended higher reliance on technology such as e-prescribing.
Dr. Ellenberg spoke next with a focus on organizations like the FDA and its chronic under-funding. All of the panelists agreed that post-market surveillance is key to the future of drug safety. But as Dr. Ellenberg pointed out, the resources of regulatory organizations are tight and without increased government or private funding, post-market surveillance will not change from its current status.
Dr. Faich focused on risk assessment, pointing out that measuring risk is a noble cause, but only half of the equation. In order for the data to be of any use, it must not only be collected, but also utilized to develop policies that promote a balance of the benefits of drug utilization over the potential risks.
The question and answer portion of the symposium included a wide range of issues from off-label uses to biogenerics. Two important questions were about the communication systems in place to report adverse drug reactions and the role that pharmacists play in reporting these events. The entire panel agreed that proper communication is key to the dissemination of information to prescribers and providers. The idea of tracking adverse drug reactions is acceptable in the academic and clinical trial environments. However, the retail pharmacist and the private physician may not have the time nor the resources to report adverse reactions to a central prescribing database. As the panel pointed out, the time of pharmacists should be focused on filling prescriptions, and time taken away from this task can lead to human errors. However, the panel suggested an evolution of the pharmacists’ role in relation to the future of drug safety.
In closing, the panel members discussed potential drug safety improvements that might ensure the future of drug safety. These included better quantity and quality of data in post-market surveillance and application of that data, increased funding for regulatory institutions like the FDA, studies to examine the entire lifecycle of drugs (and not just pre-market surveillance), and potential clinical studies in the elderly population.
These essential concerns are facing the American healthcare system today and the panel is in agreement on the need for more research. However, what they have all deemed as important in the evolution of drug safety can only go as far as public policy pushes it. Currently, political pressure is not high enough for policy makers to pursue tougher legislation or more funding for regulatory bodies.
Brian Colfer
PhD Student
Health Policy
Specific Proposals for Improving Drug Safety
The conclusion of the symposium focused on specific suggestions of the panelists for improving drug safety. These included the following:
Labeling requirements and advertising limits for new medications
Clarified authority and additional enforcement tools for the FDA
Clarification of FDA's role in gathering and communicating additional information on marketed products' risks and benefits
Mandatory registration of clinical trial results to facilitate public access to drug safety information
An increased role for FDA's drug safety staff
Pharmacists becoming more involved in counseling patients
Better nursing home review use of data accumulated under Medicare Part D
Large sample clinical trials
Better communication among prescribers, pharmacists, and patients
A large boost in funding and staffing for the FDA
Hoang Hoa Lee
MS Student
Pharmacy Administration
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