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In reply

Our study provided an estimate of the frequency of off-label drug use, situations when medications are prescribed for clinical indications not approved by the US Food and Drug Administration. We estimated that 21% of all drug uses in the United States are for off-label indications. Although this is an accepted part of medical practice often benefiting patients, far less scientific evidence is generally available to support off-label prescribing. As our article highlighted, 73% of off-label uses lacked strong scientific evidence.

Bright raises concern with several elements of our study's design, data, and conclusions. She takes issue with our primary reliance on DRUGDEX for ranking the level of evidence supporting off-label uses. We agree that capturing the true gradient of evidence underlying many prescription drug uses is difficult and that all current compendia fall short of providing complete information. Our intention was to scrutinize off-label use from the perspective . . . [Full Text of this Article]

AUTHOR INFORMATION
Randall S. Stafford, MD, PhD; David C. Radley, MPH; Stan N. Finkelstein, MD

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RELATED LETTER

Positive Outcomes Through the Appropriate Use of Off-Label Prescribing
Jennifer L. Bright
Arch Intern Med. 2006;166(22):2554-2555.
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