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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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  • A study mining US NDTI prescription data showed that 21% of overall drug use is off-label, of which 73% had little or no scientific support.

    “A study mining US Health National Disease and Therapeutic Index (NDTI) prescription data showed that 21% of overall drug use is off-label, of which 73% had little or no scientific support (17).”

    From DrugCentral 2023 extends human clinical data and integrates veterinary drugs (2023) · cites this paper as [17]

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Authors
Radley, D. C., Finkelstein, S. N., & Stafford, R. S.
Affiliations
Dartmouth College (US)
ORCID
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
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › 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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