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Doctors key to triggering FDA's warning signals

The agency's MedWatch program monitors the safety of drugs and medical devices and sounds the alarm when problems surface.

By Susan J. Landers, amednews staff. Nov. 17, 2003.

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Washington -- The Food and Drug Administration has eyes all over the country. They just happen to belong to physicians.

Physicians are often the first ones to detect serious adverse reactions by their patients to prescribed drugs, medical products or dietary supplements, and the FDA would like to hear about those reactions via its MedWatch program.

MedWatch also alerts physicians and others about newly revealed drug problems and, in that capacity, has taken on a role in the fight against counterfeit drugs with alerts about fake Procrit and Lipitor posted on its Web site and e-mailed to electronic subscribers last spring.

About 25,000 physicians, patients and others filed reports last year with MedWatch when they suspected a medication or medical device caused a serious reaction. About 18,000 of those reports involved drugs. The rest were split among biologic products, medical devices and special nutritional products.

MedWatch can help connect a report from a doctor in Tacoma, Wash., with reports from physicians in Yuma, Ariz., Tallahassee, Fla., and Portland, Maine, said Norman S. Marks, MD, the program's medical director.

"Those four reports can become a signal that our safety evaluators can then explore more scientifically with epidemiological studies," he said. "Depending on the strength of the evidence, that information can become an FDA regulatory action."

The FDA counts on reports from physician offices across the nation as an important part of its postmarketing surveillance for drugs and medical devices that have received the agency's imprimatur.

"Although the FDA approves a drug after a vigorous trial, we know it is possible there could be some serious side effects that can't be detected in a trial," Dr. Marks said. Drug interactions, off-label use and the much larger pool of people using the drug all play roles in determining how a drug will behave in the real world.

The number of reports filed with the program has steadily increased over MedWatch's 10-year history, with a jump by about one-third during the past five years.

Actions taken

Information from reports filed either voluntarily by doctors or by drug manufacturers, who are required to file reports of adverse events, can produce agency actions ranging from labeling changes to letters warning of new concerns or even recalls.

Roche Diagnostics Corp. recently recalled its CoaguChek test strips commonly used in physicians' offices and patients' homes to determine blood clotting time for patients taking anticoagulants.

The company had found that some foil pouches in which the test strips were packaged were improperly sealed, allowing moisture and air to enter the packages, rendering the strips more likely to give false readings. Once Roche had reported its discovery, the word was spread on MedWatch for physicians to beware.

Physicians can receive alerts directly on their computers -- 36,000 people already have signed up -- or by checking the MedWatch Web site for postings. Medical organizations, including the AMA, which has had a long involvement with such surveillance programs, also post the notices on their Web site.

The AMA had operated a reporting system for physicians before the FDA took it over in 1961. The current MedWatch system was put in place in 1993 by then-FDA Commissioner David Kessler, MD, to consolidate what had become a confusing number of forms and reporting procedures.

The several forms that had existed were compiled into a single reporting form that is available on the program's Web site. The form is used for reporting the most serious drug side effects with the exception of vaccines, which have their own reporting form.

Some health care observers would like the MedWatch forms to be more streamlined for ease of reporting as well as to allow reporting of broader categories of events. Currently, MedWatch requests information only on unanticipated and potentially life-threatening side effects.

"But sometimes even an expected side effect can be much worse than was anticipated," said Diana Zuckerman, PhD, president of the National Center for Policy Research for Women and Families, a Washington, D.C., think tank.

"And you'll never find out if you don't ask people," she added.

Using the silicone breast implants as a example recently in the news, she said, "It is understood that breast implants break, but if that is not worth reporting, then it is difficult to find out how often they break in the first three months."

Public Citizen, the Ralph Nader-founded government watchdog group, uses MedWatch data to keep tabs on pharmaceutical safety issues.

"MedWatch is important, and we wish health professionals were more diligent in reporting adverse reactions," said Larry D. Sasich, PharmD, MPH, pharmacist and research analyst at Public Citizen. "But since MedWatch is a voluntary reporting system for physicians and others, you only get a small fraction of what actually occurs."

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