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Off-label Prescribing Among Office-Based Physicians
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 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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Off‐label prescriptions of drugs used for the treatment of Crohn’s disease or ulcerative colitis
Simsek, M., Lissenberg-Witte, B. I., van Riswijk, M. L. M., Verschuren, S., Hoentjen, F., Oldenburg, B., Ponsioen, C. Y., van der Woude, C. J., Jong, A. E. V. D. M., Pierik, M. J., et al. (2019) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.15229 · Cited by 6
“In the largest cohort study among office‐based physicians, an estimated 21% of overall prescriptions (725 million) were off‐label.(11) In the treatment of inflammatory bowel diseases (IBD), off‐label drugs are prescribed as well, especially in patients who failed standard treatment regimens.”
BackgroundAssessment of gabapentin misuse using prescription drug monitoring program data
Zhang, Y., Castracane, A. R., & Winstanley, E. L. (2021) · Substance Abuse · doi:10.1080/08897077.2021.1891602 · Cited by 6
Investigation of Psychoactive Medications: Challenges and a Practical and Scalable New Path
Taliaz, D., & Serretti, A. (2022) · CNS & Neurological Disorders - Drug Targets · doi:10.2174/1871527321666220628103843 · Cited by 6
Connor, G. S., Labiner, D. M., Schabert, V. F., Weingarten, M. M., Wade, C. T., Stern, S., & Becker, D. A. (2024) · Epilepsy & Behavior · doi:10.1016/j.yebeh.2024.109649 · Cited by 6
“The specific reasons for gabapentin prescriptions in this study could not be determined [24,25].”
BackgroundNewton, P. J., Davidson, P. M., & Sanderson, C. R. (2012) · BMC Palliative Care · doi:10.1186/1472-684x-11-6 · Cited by 7
“The off-label prescribing of medicines may occur in as many as 20–40% of adults [2,3].”
BackgroundRàfols, J. M. V. P. I. (2009) · Medicina Clínica · doi:10.1016/j.medcli.2009.10.039 · Cited by 6
theraTRACE®: a mechanism unbiased in vivo platform for phenotypic screening and drug repositioning
Saporito, M. S., & Reaume, A. G. (2011) · Drug Discovery Today Therapeutic Strategies · doi:10.1016/j.ddstr.2011.06.002 · Cited by 6
Camilleri, M. (2008) · Current Opinion in Pharmacology · doi:10.1016/j.coph.2008.06.001 · Cited by 6
Making Risks Visible: The Science, Politics, and Regulation of Adverse Drug Reactions
Marks, H. M. (2013) · Palgrave Macmillan UK eBooks · doi:10.1057/9781137291523_5 · Cited by 6
An Integrative Approach to Obesity
Nicolai, J. P., Lupiani, J. H., & Wolf, A. J. (2012) · Elsevier eBooks · doi:10.1016/b978-1-4377-1793-8.00038-8 · Cited by 6
Prescriptions hors AMM supervisées de méthylphénidate dans le TDAH de l’adulte
Carton, L., Dondaine, T., Deheul, S., Marquié, C., Brigadeau, F., Amad, A., Devos, D., Danel, T., Bordet, R., Cottencin, O., et al. (2018) · L Encéphale · doi:10.1016/j.encep.2018.05.008 · Cited by 6
Prescriptions hors autorisation de mise sur le marché en psychiatrie publique hospitalière
Andréoli, L., Gaudoneix-Taieb, M., Beauverie, P., & de Beaurepaire, R. (2013) · Therapies · doi:10.2515/therapie/2013054 · Cited by 6
Asthma/COPD drugs reflecting disease prevalence, patient adherence and persistence
Nilsson, J. L. G., Haupt, D. W., Krigsman, K., & Moen, J. (2009) · Expert Review of Respiratory Medicine · doi:10.1586/17476348.3.1.93 · Cited by 6
Introduction to the Choice of Antiepileptic Drugs
Perucca, E. (2015) · doi:10.1002/9781118936979.ch27 · Cited by 6
The case for using social media to aggregate patient experiences with off-label prescriptions
Frost, J. H. (2011) · Expert Review of Pharmacoeconomics & Outcomes Research · doi:10.1586/erp.11.43 · Cited by 6
Entrepreneurship in Off-Label Drug Prescription: Just What the Doctor Ordered!Preprint
March, R. J. (2015) · SSRN Electronic Journal · doi:10.2139/ssrn.2631188 · Cited by 6
van Oosterhout, W. P. J., Kanis, L., Wiendels, N. J., & Reijngoudt, J. W. (2024) · Journal of Sleep Research · doi:10.1111/jsr.14241 · Cited by 5
“Amitriptyline can also be prescribed for both the prophylaxis of migraine and insomnia (Radley et al., 2006).”
Combs, K. G., Vickers‐Smith, R., Stewart, C., Wacker, D., & Hincapie‐Castillo, J. M. (2025) · International Journal of Drug Policy · doi:10.1016/j.drugpo.2025.105064 · Cited by 5
Clinical Prescribing (and Off-Label Use) in a Second-Best World
Alexander, G. C. (2010) · Medical Care · doi:10.1097/mlr.0b013e3181d60408 · Cited by 5
“Such uses would not be of as much concern if they represented a negligible fraction of prescription drug use, however, according to one of the most comprehensive analyses to date, approximately one-fifth of office-based prescribing occurs off-label, and of these medication uses, nearly three-fourth have uncertain scie…”
BackgroundPromotion and Leakage under a Pharmaceutical Price-Volume Agreement
Zhang, H., & Zaric, G. S. (2011) · INFOR Information Systems and Operational Research · doi:10.3138/infor.49.4.247 · Cited by 5
“Radley et al. (2006) investigated off-label prescribing by office-based physicians in the U.S. and found that approximately 21% of prescriptions are off-label and that most of the off-label uses (73”
BackgroundAnalysis of medication and indication occurrences in clinical notes.
Sohn, S., & Liu, H. (2014) · PubMed Central · Cited by 5
Metadata
- Authors
- Radley, D. C., Finkelstein, S. N., & Stafford, R. S.
- Affiliations
- Dartmouth College (US)
- 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)
- 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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