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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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“7 There are important clinical, ethical, and financial consequences of off-label medicines use, 8,9 including from potential ineffective or harmful effects.”
No evidence or no alternative? Taking responsibility for off‐label prescribing
Ghinea, N., Lipworth, W. L., Kerridge, I., & Day, R. O. (2012) · Internal Medicine Journal · doi:10.1111/j.1445-5994.2012.02713.x · Cited by 12
Shea, M. B., Stewart, M. D., Dyke, H. V., Ostermann, L., Allen, J. D., & Sigal, E. V. (2018) · Therapeutic Innovation & Regulatory Science · doi:10.1177/2168479018759662 · Cited by 12
Functional diversification and exaptation: the emergence of new drug uses in the pharma industry
Andriani, P., & Cattani, G. (2022) · Industrial and Corporate Change · doi:10.1093/icc/dtac023 · Cited by 13
Kannan, S., Bahl, A. K., & Khosla, P. P. (2015) · International Journal of Risk & Safety in Medicine · doi:10.3233/jrs-150664 · Cited by 12
Viola, E., Trifirò, G., Ingrasciotta, Y., Sottosanti, L., Tari, D. U., Giorgianni, F., Moretti, U., & Leone, R. (2016) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2016.1221401 · Cited by 12
Maloney, A. (2017) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.710 · Cited by 12
“In addition, Radley et al.12 reported 150 million off-label medications in the United States in 2001, and commented: “Most off-label drug mentions (73%; 95% confidence interval, 61–84”
BackgroundTrends in the off‐label use of β‐blockers in pediatric patients
Kaley, V. R., Aregullin, E. O., Samuel, B. P., & Vettukattil, J. J. (2019) · Pediatrics International · doi:10.1111/ped.14015 · Cited by 12
Jost, T. S. (2010) · American Journal of Law & Medicine · doi:10.1177/009885881003600203 · Cited by 12
Prescrição Off-Label no Brasil e nos EUA: aspectos legais e paradoxos
Nobre, P. F. D. S. (2013) · Ciência & Saúde Coletiva · doi:10.1590/s1413-81232013000300030 · Cited by 12
The Problem with Single-Payer Plans
Emanuel, E. J. (2008) · The Hastings Center Report · doi:10.1353/hcr.2008.0016 · Cited by 12
Ito, S. (2017) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.675 · Cited by 12
“time; one study demonstrated that nearly three-quarters of off-label drug usage in US clinics were without evidence, namely, off-evidence.(3) This is highly disturbing.”
BackgroundOff-label Psychotropics Use: Isn't it Now an Inevitable and a “Norm” in Psychiatry?
Khanra, S., & Das, B. (2018) · Indian Journal of Psychological Medicine · doi:10.4103/ijpsym.ijpsym_563_17 · Cited by 11
“[1,3‐11] Among all medications, psychotropics are one of the most commonly prescribed for off‐label purpose.[5,12] A few studies from the Indian subcontinent had found that off‐label use of psychotropics was seen in a significant proportion of prescriptions (up to 42%) and off‐label uses were most common for indicatio…”
BackgroundForbidden and Permitted Statements about Medications — Loosening the Rules
Avorn, J., Sarpatwari, A., & Kesselheim, A. S. (2015) · New England Journal of Medicine · doi:10.1056/nejmhle1506365 · Cited by 11
Zhao, D., Baek, J., Hume, A. L., McPhillips, E. A., & Lapane, K. L. (2022) · Journal of Pain Research · doi:10.2147/jpr.s345521 · Cited by 10
“The majority of the gabapentinoid use appeared to be for off-label indications, despite lacking evidence to support the off-label prescribing of gabapentinoids for pain management.(5,6) A Cochrane review concluded that gabapentin therapy for neuropathic pain other than PHN (an approved indication) and diabetic neuropa…”
BackgroundHas pharmaceutical innovation reduced the average cost of U.S. health care episodes?
Lichtenberg, F. R. (2023) · International Journal of Health Economics and Management · doi:10.1007/s10754-023-09363-y · Cited by 11
“…have demonstrated that a substantial fraction of prescriptions are “off-label,” i.e., used to treat medical conditions for which they have not been approved, and that off-label use frequently occurs with little or no scientific support (Lat et al., 2011; McKibbin, 2020; Radley et al., 2006).”
Balancing Burdens and Benefits: Ethical Issues of Off‐Label Prescription Pharmaceutical Use
Vox, F., Capron, A. M., Kraus, M. F., Alexander, G. C., & Kirschner, K. L. (2013) · PM&R · doi:10.1016/j.pmrj.2013.08.601 · Cited by 11
“Prescription of drugs for uses other than the ones for which the FDA has approved their use (ie, use of a drug to treat a condition different than the one for which it was licensed or to treat a different population, such as using a drug for children when it was only tested in adults) is widespread and accounts for at…”
BackgroundInfluentialGabapentin in the Treatment of Mental Illness: The Echo Chamber of the Case Series
Carey, T. S., Williams, J. W., Oldham, J. M., Goodman, F., Ranney, L. M., Whitener, L., Morgan, L. C., & Melvin, C. L. (2008) · Journal of Psychiatric Practice · doi:10.1097/01.pra.0000333584.75741.45 · Cited by 11
Regulating Off-Label Promotion — A Critical Test
Robertson, C. T., & Kesselheim, A. S. (2016) · New England Journal of Medicine · doi:10.1056/nejmp1611755 · Cited by 11
Off-Label Use in Orthopaedic Surgery
Taylor, B. C., Triplet, J. J., & El‐Sabawi, T. (2018) · Journal of the American Academy of Orthopaedic Surgeons · doi:10.5435/jaaos-d-18-00038 · Cited by 11
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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