Warning labels on high-risk drugs inconsistently heeded by doctors

In a survey of approximately 930,000 ambulatory care patients, researchers from the Department of Ambulatory Care and Prevention (of Harvard Medical School and Harvard Pilgrim Health Care) and colleagues found that 42 percent received prescriptions for drugs with Black Box Warnings (BBW), the Food and Drug Administration’s strongest label for high-risk medication. Additionally, physicians’ compliance with the recommendations of the BBWs was highly variable, which suggests that better methods are needed for ensuring the safe use of medications that carry serious risks.

In the categories studied, doctors’ noncompliance to BBWs ranged from 0.3 percent to 49.6 percent. These results are reported online in the Nov. 18, 2005 issue of Pharmacoepidemiology and Drug Safety.

“In ambulatory care settings, approximately 1.4 billion prescriptions are written per year,” said Anita Wagner, Harvard Medical School assistant professor at DACP. “Until now, there has been no information about how frequently doctors prescribe BBW drugs, nor whether prescribing is consistent with the warnings. This study tells us that these drugs are prescribed often and that in some categories, prescribing is inconsistent with the warnings.”