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Report Finds Physicians Lack Knowledge of Off-Label Drug Use and FDA Approval Status
ScienceDaily, in their August 23, 2009, on-line edition, highlighted the results
of a recent national survey concerning physicians’ knowledge of off-label drug use
and approval status from the Food and Drug Administration (FDA). The survey showed
a substantial number of physicians mistakenly believed certain off-label uses of
prescription drugs were approved by the FDA. This erroneous belief could potentially
result in physicians prescribing drugs despite a lack of scientific evidence supporting
such use. (http://www.sciencedaily.com/releases/2009/08/090821135011.htm).
Researchers from the University of Chicago Medical Center surveyed 1,199 physicians
(599 primary care physicians and 600 psychiatrists) in 2007-2008 regarding 22 drug-indication
pairs (a particular drug prescribed for a particular condition), their FDA approval
status, and on-label to off-label usage. Overall, physicians identified the FDA-approval
status correctly for just over half (mean 55%) of the 22 drug-indication pairs.
In many cases, the proportion of physicians who mistakenly believed a certain drug
was approved by the FDA for a specific indication was higher among physicians who
had prescribed the drug for that indication. For example, the results showed that
26% of all physician respondents erroneously believed that Lorazepam was approved
by the FDA for chronic anxiety. For physician respondents who had prescribed Lorazepam
for chronic anxiety, the percentage rose to 33%.
G. Caleb Alexander, MD, MS, Assistant Professor of Medicine at the University of
Chicago Medical Center and corresponding author of the study, believes the results
highlight an urgent need for more effective methods of informing physicians about
the level of evidence supporting off-label drug use, especially off-label uses which
are ineffective or carry unacceptable risks of harm.
Other studies, such as one published in the Archives of Internal Medicine in 2006,
revealed that approximately 21% of drug uses in the US occur for off-label purposes.
From the off-label drug uses identified in the study, 73% lacked scientific evidence
for the drug’s effectiveness. The highest rates of off-label use were for anticonvulsants
(74%), antipsychotics (60%), and antibiotics (41%).
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