|
 Experts
see drug safety as crucial to America’s public
health
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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