Newswise — Four of the nation's most prominent drug safety experts warned of dangers facing American patients at a symposium titled, "The Future of Drug Safety: Trials, Errors, and the Promise of Pharmaceuticals," held at University of the Sciences in Philadelphia (USP) on March 21. The experts, from government, industry, health care, and academia, agreed that action is needed to prevent large numbers of deaths and injuries.
"The public came to believe that once a drug is approved, there is a 100 percent safety certainty. But this is not the case," said moderator Dr. Michael R. Cohen, president of the Institute for Safe Medication Practices (ISMP) and recipient of a McArthur Foundation Genius Award. "In 2005, one in four reported medical errors was related to medication errors, which is a major issue."
Reform and reinvigoration of the Food and Drug Administration captured much of the panelists' focus. "The FDA needs more resources in order to change current systems and processes," advised Dr. Susan S. Ellenberg, professor and associate dean for clinical research at the University of Pennsylvania School of Medicine and former director of biostatistics and epidemiology at the FDA's Center for Biologics Evaluation and Research. Congress is presently debating several proposals to enhance FDA's monitoring of drug risks.
The FDA's role is especially important because no drug is entirely safe. "The real issue is not whether the drug is safe. It is rather how safe or unsafe," warned Dr. Gerald A. Faich, senior vice president for epidemiology and risk management at United Biosource Corporation and former director of the FDA's Office of Epidemiology and Statistics. Drug recalls, which are frequent, are "simply inherent in how drugs are studied and approved today," he added.
Drug safety is a rapidly growing concern as the population ages. The elderly are more sensitive to the effects of drugs, including adverse reactions. Many of the elderly take multiple medications, which increase the chance of side effects. Dr. Mark Beers, retired editor-in-chief of the Merck Manuals, cautioned, that "whatever the future of drug safety is, it must focus on the elderly."
Among the solutions that the experts considered were better information for prescribing physicians and a greater role for pharmacists in counseling patients. However, the medical system is not well equipped to accommodate such changes. "Retail pharmacists have the right tools, they just don't have the right systems," said Dr. Beers. All agreed that an overhaul of drug safety oversight is needed.
Dr. Robert Field, chair of USP's Department of Health Policy and Public Health, and main organizer for the symposium opened the event by telling the 200 people in the audience that this was an "on-going dialogue" on drug safety. USP will maintain an active role as a forum for ongoing debates on drug safety. The school has an active research program in health policy through its Department of Health Policy and Public Health which co-sponsored the symposium along with ISMP.
University of the Sciences in Philadelphia is a private, coeducational institution founded in 1821 as Philadelphia College of Pharmacy, the first college of pharmacy in North America. It is where the founders of six of the top pharmaceutical companies in the world launched their futures. Comprising four colleges across a broad range of majors, USP specializes in educating its 2,800 students for rewarding careers through its undergraduate, graduate, and doctoral degree programs in pharmacy, science, and the health sciences.
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