Better means of communicating risks needed
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 Administrations 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, 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."
Wagner, Richard Platt (chairman of DACP and principal investigator of the Agency for Healthcare Research and Quality–funded Prescribing Safety Study), and colleagues in HMOs across the country conducted a retrospective study over two and a half years to find out how many ambulatory care patients were prescribed drugs with BBWs and to assess compliance to these warnings. BBWs are warnings printed in a black frame in the package insert of a drug and are intended to alert prescribers to the serious risks that may be associated with certain drugs. They describe the drugs risks, can list specific precautions for its use, and must appear on all promotional materials.
Leah Gourley | EurekAlert!
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