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U.S. physician knowledge of the FDA‐approved indications and evidence base for commonly prescribed drugs: results of a national survey
Author(s) -
Chen Donna T.,
Wynia Matthew K.,
Moloney Rachael M.,
Alexander G. Caleb
Publication year - 2009
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.1825
Subject(s) - medicine , family medicine , respondent , medical prescription , off label use , drug , alternative medicine , institutional review board , psychiatry , pharmacology , pathology , political science , law
Purpose The Food and Drug Administration (FDA) regulates prescription drug marketing, not prescribing. However, off‐label use is common, often lacks supporting evidence, and may expose patients to unwarranted risk. We sought to determine physicians' knowledge of the FDA‐approved indications of commonly prescribed drugs, and to assess whether physicians' belief that an indication is FDA‐approved increases with level of evidence supporting such use. Methods We conducted a national random sample mail survey of 599 primary care physicians and 600 psychiatrists from November 2007 to August 2008. Physicians were presented with 14 drug‐indication pairs (e.g., gabapentin [Neurontin®] for diabetic neuropathy) that varied in their FDA‐approval status and levels of supporting evidence. Results The adjusted response rate was 47%, respondents were similar to non‐respondents, and physicians commonly prescribed the drugs examined. The average respondent accurately identified the FDA‐approval status of just over half of the drug‐indication pairs queried (mean 55%; median 57%). Accuracy increased modestly (mean 60%, median 63%) when limited to drugs the respondent reported having prescribed during the previous 12 months. There was a strong association between physicians' belief that an indication was FDA‐approved and greater evidence supporting efficacy for that use (Spearman's ρ 0.74, p < 0.001). However, 41% of physicians believed at least one drug‐indication pair with uncertain or no supporting evidence (e.g., quetiapine [Seroquel®] for dementia with agitation) was FDA approved. Conclusions 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. Copyright © 2009 John Wiley & Sons, Ltd.