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Dispense As Directed

August 26, 2009

The FDA “regulates prescription drug marketing, not prescribing” writes a team of medical researchers from the University of Chicago in the current Pharmacoepidemiology and Drug Safety. That means physicians have the leeway to prescribe drugs “off-label,” or for uses other than what the drug was approved for. “Off-label use is common, often lacks supporting evidence, and may expose patients to unwarranted risk,” continues the report. To assess the average physician’s knowledge of the FDA-approved indications of commonly prescribed drugs and the evidence behind the drug, the researchers sent out a mail survey to 599 primary care physicians and 600 psychiatrists with 14 drug-indication pairs that varied in their FDA-approval status and levels of supporting evidence. The results are startling. The average respondent accurately identified the FDA-approval status of just over half of the drug-indication pairs. More disturbing were some of their misconceptions such as thinking a drug was approved for a particular use when in fact it wasn’t and carried contraindictions to that effect. One notable example is the drug quetiapine (Seroquel) which many respondents had prescribed for patients with certain cases of dementia whereas the drug actually has a black box—the FDA’s strongest warning—against giving it to elderly dementia patients in particular. As the authors conclude, “These findings highlight a pressing need for more effective methods to inform physicians about the evidence base, or lack thereof, for drugs they prescribe off label.” Until then, a little patient research could go a long way.