Healthy Skepticism Library item: 5083

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Publication type: Journal Article

Radley DC, Finkelstein SN, Stafford RS.
Off-label prescribing among office-based physicians.
Arch Intern Med 2006 May 8; 166:(9):1021-6
http://archinte.ama-assn.org/cgi/content/full/166/9/1021

Abstract:

BACKGROUND: Unlike medicines prescribed for Food and Drug Administration-approved indications, off-label uses may lack rigorous scientific scrutiny. Despite concerns about patient safety and costs to the health care system, little is known about the frequency of off-label drug use or the degree of scientific evidence supporting this practice. METHODS: We used nationally representative data from the 2001 IMS Health National Disease and Therapeutic Index (NDTI) to define prescribing patterns by diagnosis for 160 commonly prescribed drugs. Each reported drug-diagnosis combination was identified as Food and Drug Administration-approved, off-label with strong scientific support, or off-label with limited or no scientific support. Outcome measures included (1) the proportion of uses that were off-label and (2) the proportion of off-label uses supported by strong scientific evidence. Multivariate analyses were used to identify drug-specific characteristics predictive of increased off-label use. RESULTS: In 2001, there were an estimated 150 million (95% confidence interval, 127-173 million) off-label mentions (21% of overall use) among the sampled medications. Off-label use was most common among cardiac medications (46%, excluding antihyperlipidemic and antihypertensive agents) and anticonvulsants (46%), whereas gabapentin (83%) and amitriptyline hydrochloride (81%) had the greatest proportion of off-label use among specific medications. Most off-label drug mentions (73%; 95% confidence interval, 61%-84%) had little or no scientific support. Although several functional classes were associated with increased off-label use (P<.05), few other drug characteristics predicted off-label prescription. CONCLUSIONS: Off-label medication use is common in outpatient care, and most occurs without scientific support. Efforts should be made to scrutinize underevaluated off-label prescribing that compromises patient safety or represents wasteful medication use

Keywords:
Adult Amines/administration & dosage Amitriptyline/administration & dosage Anticonvulsants/administration & dosage Cardiovascular Agents/administration & dosage Cyclohexanecarboxylic Acids/administration & dosage Drug Labeling* Drug Utilization Review Female Humans Male Middle Aged Multivariate Analysis Physician's Practice Patterns/statistics & numerical data* Prescriptions, Drug/statistics & numerical data* Research Support, N.I.H., Extramural United States United States Food and Drug Administration gamma-Aminobutyric Acid/administration & dosage