PA PSRS Patient Saf Advis 2005 Dec;2(4):17.
Study Finds Noncompliance with Drug Black Box Warnings is Common

A large, nationwide study of prescribing patterns for drugs with black box warnings (FDA’s strongest labeling requirement) found that these high-risk medications are prescribed frequently—often in a way that does not comply with the label warnings.

Over the 30-month study period, more than 40% of patients in the health plans studied received at least one drug with a black box warning that could apply to them. The most frequent type of non­compliance identified in the study was a failure to get a baseline laboratory test before initiating ther­apy with drugs where monitoring is recommended.

The study was conducted by retrospective review of automated claims data from 10 geographically diverse health plans throughout the US with more than 929,000 enrollees. It was released electroni­cally on November 18 and will appear in an up­coming issue of Pharmacoepidemiology and Drug Safety.


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