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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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LIANG, K.-Y., & ZEGER, S. L. (1986) · Biometrika · doi:10.1093/biomet/73.1.13 · Cited by 18,550
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Long, J. S., & Ervin, L. H. (2000) · The American Statistician · doi:10.1080/00031305.2000.10474549 · Cited by 1,779
Longitudinal Data Analysis Using Generalized Linear Models
Liang, K., & Zeger, S. L. (1986) · Biometrika · doi:10.2307/2336267 · Cited by 1,201
1995 Physicians' Desk Reference
Schild, S. M. (1995) · AORN Journal · doi:10.1016/s0001-2092(06)63819-2 · Cited by 502
Promotion of Prescription Drugs to Consumers
Rosenthal, M. B., Berndt, E. R., Donohue, J. M., Frank, R. G., & Epstein, A. M. (2002) · New England Journal of Medicine · doi:10.1056/nejmsa012075 · Cited by 431
Using Heteroscedasticity Consistent Standard Errors in the Linear Regression Model
Long, J. S., & Ervin, L. H. (2000) · The American Statistician · doi:10.2307/2685594 · Cited by 401
International Classification of Diseases, Ninth Revision, Clinical Modification
National Cancer Institute (2020) · Definitions · doi:10.32388/ggn38l · Cited by 296
The underutilization of cardiacmedications of proven benefit, 1990 to 2002
Stafford, R. S., & Radley, D. (2002) · Journal of the American College of Cardiology · doi:10.1016/s0735-1097(02)02670-0 · Cited by 286
MICROMEDEX Healthcare Series.
Yamazaki, S., & Tanigawara, Y. (2004) · Igaku Toshokan · doi:10.7142/igakutoshokan.51.239 · Cited by 269
Unlicensed and off label prescribing of drugs in general practice
McIntyre, J. (2000) · Archives of Disease in Childhood · doi:10.1136/adc.83.6.498 · Cited by 235

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Uso No Autorizado de Psicofármacos El nuevo Real Decreto 1015/2009
Albéniz, J. M., Yáñez, L. P., & Zardoya, M. J. (2009) · Norte de Salud mental · Cited by 2
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Intravenous immunoglobulin for the treatment of Alzheimer's disease: current evidence and considerations
Schindowski, K., Schindowski, C., & Zimmermann, J. (2014) · Degenerative Neurological and Neuromuscular Disease · doi:10.2147/dnnd.s51786 · Cited by 2
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“For example, one study reported that over 70% of off-label drug uses had little or no demonstrable scientific basis (12).”
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Off-Label Use of Medication
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(2008) · Nature Medicine · doi:10.1038/nm0108-1 · Cited by 2
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“Off-label prescribing is * V. Hoffman veena.hoffman@optum.com 1 Epidemiology, Optum , Ann Arbor, MI, USA 2 Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA 3 Epidemiology, Optum , Waltham, MA, USA relatively common in outpatient care settings in the USA [2].”
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Background
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Hierarchical Concept Relations Improve Detection of Off-Label Drug Use in Electronic Health Records Data.
Schiffer, K., Choi, Y. A., & Weng, C. (2023) · PubMed Central · Cited by 1
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Background
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Vadher, M. D., Patel, K., Vadher, D., Parkar, S. M., & Raval, C. M. (2017) · International Journal of Basic & Clinical Pharmacology · doi:10.18203/2319-2003.ijbcp20170817 · Cited by 1
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Glasser, S. P., Ashton, C. M., & Wray, N. P. (2014) · Springer eBooks · doi:10.1007/978-3-319-05470-4_6 · Cited by 1
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Roux, L., & Daniël, J. (2014) · Cited by 1
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Background
Federal Drug Administration Authority and the Emergency Nurse: Implications for Patient Safety
Hackenschmidt, A. (2006) · Journal of Emergency Nursing · doi:10.1016/j.jen.2006.05.028 · Cited by 1
Austerity and health in Greece
Konstantopoulos, K. (2014) · The Lancet · doi:10.1016/s0140-6736(14)60741-8 · Cited by 1
The Relationship Between Overall Utilization And Settlements Involving Off-Label Promotion Of Prescription Drugs
Bilek, J. C. (2013) · University of Minnesota Digital Conservancy (University of Minnesota) · Cited by 1
Marketing Off-Label Uses to Physicians: FDA's Draft (Mis)Guidance
Gass, A., & Wilson, J. G. (2008) · American Journal of Bioethics · doi:10.1080/15265160802116624 · Cited by 2
“To be sure, off-label prescriptions are already both ubiquitous and necessary; more than 20% of scripts are apparently written for indications other than those approved by the FDA (Radley et al. 2006), many of which include pediatric applications of products tested only in adults (Harris 2008).”
Background
Predictors of polypharmacy and off-label prescribing of psychotropic medications : a national survey of child psychiatrists
Kearns, M. A. (2011) · MOspace Institutional Repository (University of Missouri) · Cited by 1
Commentary on Zhou et al. : Policy levers to reduce co‐prescribing of opioids and gabapentinoids and overdose risk
Moyo, P., & Donohue, J. M. (2020) · Addiction · doi:10.1111/add.15308 · Cited by 1
Prescribing
Poole, S. G., & Dooley, M. J. (2009) · Elsevier eBooks · doi:10.1016/b978-0-323-05674-8.50127-4 · Cited by 1
Aging and Mental Health in a Longitudinal Study of Elderly Costa Ricans
Rosero‐Bixby, L., Modrek, S., Domino, M. E., & Dow, W. H. (2017) · Springer eBooks · doi:10.1007/978-981-287-082-7_37 · Cited by 1
‘Off-label’ use is common in medicine – a bioethicist and legal philosopher explain why the COVID-19 vaccines are different
Lanphier, E., & Fyfe, S. (2021) · doi:10.64628/aai.g5uaksgvx · Cited by 1
USE OF ORAL CHEMOTHERAPEUTIC MEDICATIONS IN NON-TRADITIONAL AMBULATORY SETTINGS
Arora, S. (2009) · VCU Scholars Compass (Virginia Commonwealth University) · doi:10.25772/ekh0-5k27 · Cited by 1
[Designing a software for drug management in special situations at a hospital's drug administration service].
Cuervo, M. S., García, M. M., de Silanes, M. E. G. D. S. L., & Vicedo, T. B. (2015) · PubMed · doi:10.7399/fh.2015.39.2.8491
Prescription Drug and Pharmaceutical Policy
Choi, P. A., & Gellad, W. F. (2013) · Springer eBooks · doi:10.1007/978-1-4614-7735-8_9
Navigating Health Sources on the Internet: A Mixed-Methods Examination of Online Consumer Reviews and Expert Text on Psychotropic Drugs
Hughes, S. (2010) · FIU - Digital Commons (Florida International University) · doi:10.25148/etd.fi10080406
Bias at the Gate?: The Pharmaceutical Industry's Influence on the Federally Approved Drug Compendia
Gabrielsen, L. (2014) · American Journal of Law & Medicine · doi:10.1177/009885881404000105
Off-label therapies in oncology
Telekes, A. (2009) · Orvosi Hetilap · doi:10.1556/oh.2009.28522
Prescripción de fármacos para indicaciones no aprobadas
Llor, C. (2009) · FMC - Formación Médica Continuada en Atención Primaria · doi:10.1016/s1134-2072(09)71274-5
Off-label prescriptions in diabetic foot
Andrade, L. J. D. O., França, L. S., de Melo, P. R. S., & Araujo, M. D. N. (2014) · Jornal Vascular Brasileiro · doi:10.1590/jvb.2014.025
DI-025 Dimethylfumarate for the treatment of multiple sclerosis: dosing regimen and safety data
Rousseaux, D., Letreguilly, F., Bancourt, T., Lefebvre, A., Decourcelle, C., & Floret, E. (2015) · doi:10.1136/ejhpharm-2015-000639.203
Off-label prescriptions: are we really so inhibited?
Scanelli, G. (2013) · Italian Journal of Medicine · doi:10.4081/itjm.2007.3.5
“[2] Radley DC, Finkelstein SN, Stafford RS.”
Bush's 'parting gifts'
Farley, S. J. (2009) · Nature Reviews Urology · doi:10.1038/ncpuro1321
ETHICAL PERSPECTIVES IN NEUROLOGY
Kass, J. S. (2007) · CONTINUUM Lifelong Learning in Neurology · doi:10.1212/01.con.0000267242.37992.eb
PHP17 CONTENT ANALYSIS OF OFF-LABEL DRUG USE: REPORTING PRINT MEDIA COVERAGE
Patel, D. (2009) · Value in Health · doi:10.1016/s1098-3015(10)73470-7

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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