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Physicians May Not Comply with Black Box Warnings

No baseline monitoring in half of cases where it was indicated

WEDNESDAY, Nov. 23 (HealthDay News) -- Many patients get prescription drugs with Black Box Warnings (BBW), but their doctors may fail to comply with safety guidelines for administering the high-risk medication, according to a study reported online in the Nov. 18 issue of Pharmacoepidemiology and Drug Safety.

Anita K. Wagner, Pharm.D., M.P.H., D.P.H., of Harvard Medical School in Boston, and colleagues examined the claims data of nearly 930,000 enrollees in 10 geographically diverse health plans in the United States between January 1999 and July 2001. Their goal was to estimate how frequently 216 BBW drugs or drug groups are used, and whether physicians prescribe them in compliance with the BBWs, which are the U.S. Food and Drug Administration's strongest labeling requirements for high-risk medication.

The researchers found that over 30 months, more than 40% of enrollees received at least one drug that had a BBW that could potentially affect them. But physician compliance with recommended guidelines varied depending on the drug. Baseline laboratory monitoring was most often the problem and was not performed in 49.6% of appropriate cases. In a few cases, pregnant patients were prescribed drugs that are "absolutely contraindicated" in pregnancy.

"Many individuals receive drugs considered to carry the potential for serious risk. For some of these drugs, use is largely consistent with their BBW, while for others it is not," the authors write, adding that the study "indicates the need for better methods of ensuring the safe use of medications that are considered to carry serious risks."

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