FDA proposal intended to reduce prescribing errors

WASHINGTON (CNN) -- To reduce prescribing errors made by physicians, the Food and Drug Administration on Thursday proposed a new format for the informational leaflets included with prepackaged prescription drugs.

Among the changes would be sections designed to highlight drug interactions, doses and risks.

"It's what physicians say they need on the label," the FDA's commissioner, Dr. Jane Henney, said in a statement. "It clearly tells them that this is a new drug and to be alert for any adverse reactions because some of the things that are seen in the practice of medicine are different than what had been seen in the clinical trials."

The agency wants to reduce the number of errors made by physicians when they prescribe drugs. The National Academy of Sciences estimates those errors could be responsible for as many as 98,000 deaths annually in the United States.

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The proposal would not affect the informational literature often distributed with prescription drugs by pharmacies, nor would the labels on prescription medicines packaged by a pharmacist in those familiar brown containers be affected.

Henney said the proposed changes would be applied to leaflet inserts for new drugs or drugs for which new uses have been found.

The FDA proposal is designed to take the information required on the inserts, known officially as "prescription drug product labeling," and make it available in a redesigned, easier to read format. Among the features of this proposed redesign is a "highlights" section at the top of the leaflet. It will be designed to make physicians aware of recent labeling changes, newly discovered adverse reactions, and drug interactions.

The FDA will also incorporate a new symbol -- an inverted, dark triangle adjacent to the familiar Rx logo of a prescription drug. This symbol, long a fixture of drugs marketed in the United Kingdom, is designed to alert physicians to the fact that the drug is new, and that information on drug reactions and uses is incomplete.

The FDA proposal is subject to 90 days of public comment. Henney expects physicians and consumers will see the newly designed inserts by December 2001.

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Food and Drug Administration
Institute of Medicine
National Patient Safety Foundation

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