Why do you suppose physicians frequently prescribe medications for non-FDA approved uses?
A recent survey has confirmed the worst possible reason ends up causing a lot of it: physicians simply don’t know what the FDA has approved, and what it hasn’t.
That’s the discouraging news from a study designed by G. Caleb Alexander and colleagues from the University of Chicago to characterize physicians’ knowledge of the FDA-approved indications of commonly prescribed drugs.
The scientists found in particular that a nationally representative sample of PCPs and psychiatrists knew the correct FDA-approval status for only 55% of drug-indication pairs.
That dismal performance increased to 60% for drugs actually prescribed by the physicians within the last year.
In the study, physicians were asked to complete a questionnaire focusing on 14 common drug-indication pairs, which varied with respect to FDA-approval status and level of supporting evidence. Subjects were asked to indicate whether each pair had FDA approval.
The drug-indication pairs included valproic acid for bipolar disorder and mania, gabapentin for diabetic neuropathy, Lexapro for panic disorder, trazodone for insomnia, Seroquel for dementia with agitation and Effexor for adjustment disorder.
41% of subjects believed that at least one drug-indication pair with uncertain or no supporting evidence had FDA approval, as is the case for the use of Seroquel in patients having dementia and agitation.
Psychiatrists showed better knowledge of FDA approval status than PCPs (66% vs 42%).
“These results indicate an urgent need for effective methods of disseminating information to physicians about the level of evidence supporting off-label drug uses, with specific attention to common off-label uses known to be ineffective or to carry unacceptable risk of harm,” concluded the authors.
The write-up appears in Pharmacoepidemiology and Drug Safety.