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Off-label Prescribing Among Office-Based Physicians

Radley, David C., Finkelstein, Stan N., Stafford, Randall S.·2006·Archives of Internal Medicine

DOI 10.1001/archinte.166.9.1021

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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.

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Additional file 2 of Detection of adverse drug events in e-prescribing and administrative health data: a validation study
Habib, B., Tamblyn, R., Girard, N., Eguale, T., & Huang, A. R. (2021) · Figshare · doi:10.6084/m9.figshare.14478960
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Authors: Radley, D. C., Finkelstein, S. N., & Stafford, R. S.
Affiliations: Dartmouth College (US)
ORCID: Radley, David C.
Finkelstein, Stan N.
Stafford, Randall S.
Venue: Archives of Internal Medicine
Publisher: American Medical Association (AMA)
Published: 2006-05-08
Volume: 166
Issue: 9
Pages: 1021
ISSN: 0003-9926 (ISSN-L)
DOI: 10.1001/archinte.166.9.1021
OpenAlex: W2121487587
Cited by: 711
References: 25
Citations by year: 2026: 16 · 2025: 26 · 2024: 24 · 2023: 23 · 2022: 37 · 2021: 45 · 2020: 30 · 2019: 32 · 2018: 40 · 2017: 31 · 2016: 34 · 2015: 54 · 2014: 43 · 2013: 44 · 2012: 53
FWCI: 31.47
Type: journal article
Language: en
Open access: closed
Locations: Archives of Internal Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: Agency for Healthcare Research and Quality (R01-HS013405)
Topics: Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
Keywords: off-label drug use, office-based physicians, prescribing patterns, cardiovascular drugs, antiepileptic drugs, gabapentin, amitriptyline, outpatient care, patient safety, medication use
MeSH terms: Gabapentin, Adult, Amines, Amitriptyline, Anticonvulsants, Cardiovascular Agents, Cyclohexanecarboxylic Acids, Drug Labeling, Female, gamma-Aminobutyric Acid, Humans, Male, Middle Aged, Practice Patterns, Physicians', Drug Prescriptions, United States, United States Food and Drug Administration, Multivariate Analysis, Drug Utilization Review

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Off-label Prescribing Among Office-Based Physicians

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