July 1995 Bulletin

FDA develops CME article on adverse drug events

The U.S. Food and Drug Administration (FDA) has developed a continuing medical education article, Clinical Therapeutics and the Recognition of Drug-Induced Disease, to give physicians increased insight into drug-induced disease and provide information about how to report serious events to the FDA. Two hours of free CME credit is offered. A copy of the article and self-assessment questions can be obtained by writing to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md., 20857; phone (301) 433-0117; or fax, (301) 443-5776. Following is an excerpt of the article:

In everyday clinical practice, adverse events (ADEs) associated with the use of medical products can lead to hospitalization, permanent disability, and even death.

Articles reviewing the numerous studies of the occurrence of adverse effects report that between 3 percent and 11 percent of hospital admissions could be attributed to adverse effects.

In an effort to increase health professionals' awareness of the extent of drug and device-induced disease, the FDA announced in June 1993 the launch of MedWatch, an initiative designed both to educate physicians and other health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events; and to facilitate reporting directly to the FDA.

Although the FDA has one of the most rigorous pre-approval processes in the world, clinical trials cannot uncover every safety problem, and they are not expected to do so.

Due to the limited size and controlled nature of premarketing clinical trials, only the most common adverse events (i.e., those occurring more frequently than 1 in 1,000 exposures) will be observed and subsequently listed in the product's official labeling at the time of approval.

Furthermore, as new drugs enter the marketplace, the potential for interactions with other drugs, medical devices, and foods increases.

In certain situations the safe and effective therapeutic range of a drug may become narrower. Factors that may cause narrowing include age, sex, individual pharmacokinetic or pharmacodynamic sensitivity, underlying disease, and concomitant medications.

Classification of ADEs into predictable (Type A) or unpredictable (Type B) toxicity, while not entirely satisfactory due to possible clinical overlap, is a generally accepted, simple way of looking at this issue.

Drug manufacturers are required by federal regulation to notify the FDA of all adverse events of which they are aware. Unfortunately, many physicians do not think to report ADEs either to the manufacturer or to the MedWatch program at the FDA.

Most hospitals maintain some type of ADE surveillance system to qualify for accreditation by the Joint Commission on Accreditation of Healthcare Organizations. These institutional systems are also dependent on active participation by physicians.

The FDA does not want a report on every ADE encountered; this is not practical for reporters nor useful to the FDA. The key to reporting to MedWatch is to remember that FDA is particularly interested in serious adverse events (both Type A and Type B).

To report serious adverse events to MedWatch, an individual can mail a postage-paid MedWatch form which
is available from hospital pharmacies or by calling 800-FDA-1088. Individuals also can also report adverse events by phone at 800-FDA-1088; fax, 800-FDA-0178; or by modem, 800-FDA-7737.

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