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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]
Citations
Cites
Longitudinal data analysis using generalized linear models
LIANG, K.-Y., & ZEGER, S. L. (1986) · Biometrika · doi:10.1093/biomet/73.1.13 · Cited by 18,550
Using Heteroscedasticity Consistent Standard Errors in the Linear Regression Model
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
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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Chansky, M. C., Price, S. M., Aikin, K. J., & O’Donoghue, A. C. (2022) · BMC Family Practice · doi:10.1186/s12875-022-01666-2 · Cited by 5
El-Kattan, M., Khattab, M. A., Maksoud, F. A., Eldein, M. E., Abdel-raof, N. E., Awad, W., & Elshatory, A. (2023) · Zagazig Journal of Forensic Medicine · doi:10.21608/zjfm.2023.218877.1154 · Cited by 5
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Lavigne, J. E., Mathews, J. L., & Knox, K. L. (2010) · Journal of Pharmaceutical Health Services Research · doi:10.1111/j.1759-8893.2010.00013.x · Cited by 5
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BackgroundNeuroethical Issues in Cognitive Enhancement
Sahakian, B. J., & Morein‐Zamir, S. (2015) · FOCUS The Journal of Lifelong Learning in Psychiatry · doi:10.1176/appi.focus.130308 · Cited by 5
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Carneiro, A. V., & Costa, J. (2013) · Revista Portuguesa de Cardiologia · doi:10.1016/j.repc.2013.01.006 · Cited by 5
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Cole, L. W., Kesselheim, J. C., & Kesselheim, A. S. (2011) · Journal of Bioethical Inquiry · doi:10.1007/s11673-011-9342-y · Cited by 5
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Irwin, B. B., Hirsch, B. R., Samsa, G. P., & Abernethy, A. P. (2012) · Journal of Oncology Practice · doi:10.1200/jop.2011.000523 · Cited by 5
“Exclusion criteria were that the study (1) described only predictors of response, (2) focused on pharmacokinetics (ie, a study in which outcomes are drug levels), or (3) was conducted in a nonhuman setting (ie, animal model or in vitro).”
BackgroundMethodInfluentialGuo, Y., Wang, Y., Wang, X., Ye, G., Jiang, Y., & Xiong, W. (2015) · Medical Science Monitor · doi:10.12659/msm.894662 · Cited by 5
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Johnson, S. A., Yarbrough, P. M., Rose, R. S., & Lanspa, M. J. (2015) · Blood Coagulation & Fibrinolysis · doi:10.1097/mbc.0000000000000333 · Cited by 5
Hussain, S. A., Abbas, A. N., Alhadad, H. A., Al‐Jumaili, A. A., & Abdulrahman, Z. S. (2017) · Pharmacy Practice · doi:10.18549/pharmpract.2017.03.979 · Cited by 5
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BackgroundAdverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems
Han, N., Oh, J. M., & Kim, I. (2021) · Therapeutics and Clinical Risk Management · doi:10.2147/tcrm.s321789 · Cited by 5
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BackgroundWang, B., Studdert, D. M., Sarpatwari, A., Franklin, J. M., Landon, J. E., & Kesselheim, A. S. (2017) · PLoS ONE · doi:10.1371/journal.pone.0175313 · Cited by 5
Mayhew, M. S. (2009) · The Journal for Nurse Practitioners · doi:10.1016/j.nurpra.2008.11.009 · Cited by 5
Vargas-Rivas, J. E., Montes-Casas, M. M., Cancela-Díez, B., Martínez, F. M., Sabater‐Hernández, D., & Calleja‐Hernández, M. Á. (2011) · Farmacia Hospitalaria · doi:10.1016/j.farma.2011.02.009 · Cited by 5
Patient Data: Property, Privacy & the Public InterestPreprint
Rodwin, M. A. (2010) · SSRN Electronic Journal · doi:10.2139/ssrn.1599192 · Cited by 5
Vargas-Rivas, J. E., Sabater‐Hernández, D., Calleja‐Hernández, M. Á., Faus, M. J., & Martínez‐Martínez, F. (2011) · International Journal of Clinical Pharmacy · doi:10.1007/s11096-011-9532-z · Cited by 5
“This non-approved use is called ‘‘off-label’’ drug use [2].”
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Hendel, R. C., & Frost, L. E. (2012) · Journal of Nuclear Cardiology · doi:10.1007/s12350-012-9643-5 · Cited by 5
“Should we only use medications ‘‘on-label’’ indications? It has been estimated that 21% of prescriptions are written for an off-label use.(16) Certainly few question the common wisdom of using beta blockers in heart failure—despite the lack of an FDA-approved indication for such practice.”
MethodCardiac Resynchronization Therapy for Heart Failure
McAlister, F. A. (2008) · Circulation · doi:10.1161/circulationaha.108.800722 · Cited by 5
Measuring Exaptation in the Pharmaceutical Industry
Andriani, P., Ali, A. H., & Mastrogiorgio, M. (2015) · Academy of Management Proceedings · doi:10.5465/ambpp.2015.17085abstract · Cited by 5
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BackgroundThe Market-Expanding Role of Regulatory Approval in Medicine
Berger, B., Chandra, A., & Garthwaite, C. (2021) · National Bureau of Economic Research · doi:10.3386/w28889 · Cited by 5
Annotating off-label drug usage from unconventional sources
Avram, S., Halip, L., Curpan, R., Borota, A., Bora, A., & Oprea, T. I. (2022) · medRxiv · doi:10.1101/2022.09.08.22279709 · Cited by 4
“In contrast to heavily discussed drugs uses, we identified 4 cases with one or no supporting publications (Table 2), which is not unusual for off-label uses.(7) However, supporting evidence could be sought for closely related drugs evaluated for the same use.”
BackgroundInfluentialOff-Label Use of Drugs and Devices
Long, D. M., & Watts, C. C. (2013) · Neurosurgery · doi:10.1227/neu.0b013e31828ba778 · Cited by 4
“It is not clear how much off-label use is practiced by physicians, but 1 brief study suggested that 21%of prescriptions were for off-label uses.(4) The major problem with off-label use is that adequate scientific data are often not available in support of that use, because the sponsoring company has focused its time a…”
BackgroundHormônios sexuais, moralidades de gênero e contracepção de emergência no Brasil
Brandão, E. R. (2018) · Interface - Comunicação Saúde Educação · doi:10.1590/1807-57622017.0216 · Cited by 4
Antipsychotic Medication Risk of Dementia and Death: A Propensity Matched Cohort Study
Lowe, X. R., Merchant, M. A., & Whitmer, R. A. (2022) · Current Drug Research Reviews · doi:10.2174/2589977514666220301102717 · Cited by 4
Davidson, L., Canelón, S. P., & Boland, M. R. (2022) · JMIR Medical Informatics · doi:10.2196/32229 · Cited by 4
“In addition, a major limitation of using standard pharmacology and drug-related terminologies is that approximately 11% of medications used in women’s health are off-label [48].”
BackgroundHow to be a Better Doctor: Recognizing How Cognitive Biases Shape—and Distort—Clinical Evidence
Baxendale, S. (2025) · British Journal of Hospital Medicine · doi:10.12968/hmed.2024.0743 · Cited by 4
Aronsohn, A. I., Reau, N. S., & Jensen, D. M. (2013) · Hepatology · doi:10.1002/hep.26903 · Cited by 4
“Off-label prescribing is legal and has been shown to occur in over one fifth of office-based prescriptions.(1) Upcoming generations of DAAs represent robust therapeutic innovation, which will likely outpace the breadth and capacity of the FDA-approved label.”
BackgroundNarimatsu, H., Oiso, G., Ono, S., & Kami, M. (2009) · Journal of Clinical Oncology · doi:10.1200/jco.2009.23.9020 · Cited by 4
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Poitras, G. (2009) · International Journal of Business Governance and Ethics · doi:10.1504/ijbge.2009.023789 · Cited by 4
“In general, Radley et al. (2006) estimate that 21% of all drug use in the USA among office based physicians was for off-label indications and that 73% of off-label uses lacked strong scientific evidence.”
BackgroundPrescription Medication Misuse
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Alyami, D., Alyami, A. A., Alhossan, A., & Salah, M. (2022) · Cureus · doi:10.7759/cureus.23082 · Cited by 4
“A previous study of 160 commonly prescribed drugs concluded that a higher number of off-label drugs are prescribed with a lack of scientific support [8].”
BackgroundA snapshot on the usage pattern of gabapentinoids in Oman
Badi, A. S. A., Al‐Hashar, A., Riyami, I. A., & Za’abi, M. A. (2022) · Pharmacy Practice · doi:10.18549/pharmpract.2022.3.2693 · Cited by 3
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Williams, J. M., & Grossberg, G. T. (2018) · Springer eBooks · doi:10.1007/978-3-319-74604-3_2 · Cited by 4
Profiling off-label prescriptions in cancer treatment using social health networks
Nikfarjam, A., Ransohoff, J. D., Callahan, A., Polony, V., & Shah, N. H. (2019) · JAMIA Open · doi:10.1093/jamiaopen/ooz025 · Cited by 4
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BackgroundPharmacists’ role in facilitating evidence-based prescribing for unlabeled use of medications
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Ghinea, N., Lipworth, W. L., & Kerridge, I. (2015) · Therapeutic Innovation & Regulatory Science · doi:10.1177/2168479015570337 · Cited by 4
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BackgroundMulberg, A. E., & Cripps, T. (2019) · Current Therapeutic Research · doi:10.1016/j.curtheres.2019.01.006 · Cited by 4
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Gilyarevskiy, S. R. (2020) · Rational Pharmacotherapy in Cardiology · doi:10.20996/1819-6446-2020-04-14 · Cited by 4
Walton, S. M., Schumock, G. T., Alexander, G. C., Meltzer, D. O., & Stafford, R. S. (2010) · Archives of Internal Medicine · doi:10.1001/archinternmed.2010.69 · Cited by 4
Kirk, A. D. (2010) · American Journal of Transplantation · doi:10.1111/j.1600-6143.2010.03025.x · Cited by 4
“drug prescriptions (2) and the percentage is likely much higher in transplantation.”
BackgroundClinical trial data: get them while you can
Doshi, P., Groves, T., & Loder, E. (2014) · BMJ · doi:10.1136/bmj.g63 · Cited by 4
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Rosero‐Bixby, L., Modrek, S., Domino, M. E., & Dow, W. H. (2015) · Springer eBooks · doi:10.1007/978-981-287-080-3_37-1 · Cited by 4
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Patel, S. N., Kim, S. H., & Sternberg, P. W. (2022) · Ophthalmology · doi:10.1016/j.ophtha.2022.11.008 · Cited by 4
Karami, S., Yoo, J. W., Woods, C. M., Conrad, S. W., McAninch, J., Meyer, T. E., & Mallama, C. A. (2026) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2026.113026 · Cited by 3
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Duś‐Ilnicka, I., Małysa, A., Mazur, M., & Paradowska-Stolarz, A. M. (2026) · International Journal of Molecular Sciences · doi:10.3390/ijms27020914 · Cited by 3
“This process, however, is not the first-line approach to treatment and requires active patient consent, as topical tacrolimus ointments are prescribed off-label [20].”
Thangaraju, P., Mahesh, K., & Venkatesan, S. (2022) · Indian Journal of Pharmacology · doi:10.4103/ijp.ijp_783_20 · Cited by 3
“[5,6] In case of India, it is the Central Drugs Standard Control Organization (CDSCO) approving all indications of all the approved essential drugs being a Government of India body.”
Cook, K., Havens, J. R., Slavova, S. S., Thompson, K. L., Young, A. M., & Vickers‐Smith, R. (2025) · International Journal of Drug Policy · doi:10.1016/j.drugpo.2025.104904 · Cited by 3
Wu, H., & Wu, G. (2013) · Therapeutic Innovation & Regulatory Science · doi:10.1177/2168479013491753 · Cited by 3
“Many of these drugs are complementary therapy, which can be an issue of contention between hospitals and patients.(33) From a legal/ethical point of view, the off-label use of medication represents a delicate balance between the statutory regulation of medication (which aims at safeguarding patients against unsafe and…”
BackgroundPRESCRIÇÃO DE MEDICAMENTOS OFF-LABEL
Escoval, A., Valongo, A. S., Carneiro, Â. M., Carneiro, A. V., Alcobia, A., Marques, F. B., Nascimento, J., da Silva, J. A., Cunha-Vaz, J. G., Delgado, M., et al. (2015) · DOAJ (DOAJ: Directory of Open Access Journals) · doi:10.25756/rpf.v3i3.87 · Cited by 3
Shanshal, A. M., & Ataimish, A. H. (2019) · Iraqi Journal of Pharmaceutical Sciences · doi:10.31351/vol28iss2pp115-123 · Cited by 3
“The term off-label drug use (OLDU) is widely used in the medical literature and the media ((1)).”
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Chen, S., Barner, J. C., & Cho, E. (2021) · Journal of Comparative Effectiveness Research · doi:10.2217/cer-2021-0048 · Cited by 3
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Cambrosio, A., Campbell, J., Keating, P., Polk, J. B., Aguilar‐Mahecha, A., & Basik, M. (2021) · Social Science & Medicine · doi:10.1016/j.socscimed.2021.114576 · Cited by 3
ASCP Policy Statement Use of Antipsychotic Medications in Nursing Facility Residents
(2011) · The Consultant Pharmacist · doi:10.4140/tcp.n.2011.583 · Cited by 3
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Sutherell, J. S. (2011) · Interventional Cardiology · doi:10.2217/ica.11.63 · Cited by 3
Gupta, Y., Singh, H., Mohan, P., & Kumar, R. N. (2016) · Journal of Natural Science Biology and Medicine · doi:10.4103/0976-9668.175098 · Cited by 3
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Selmin, F., Musazzi, U. M., Cilurzo, F., & Minghetti, P. (2017) · Medicine Access Point of Care · doi:10.5301/maapoc.0000005 · Cited by 3
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Yang, J., Lin, W., & Chen, Y. (2019) · International Journal of Clinical Pharmacy · doi:10.1007/s11096-019-00788-5 · Cited by 3
Auffret, M., Rolland, B., Behal, H., Labreuche, J., Jouanjus, É., Bordet, R., & Gautier, S. (2019) · Therapies · doi:10.1016/j.therap.2019.06.002 · Cited by 3
Off-Label Drug Use in Pediatrics
Kırmızı, N. İ., Aydın, V., Akıcı, N., & Akıcı, A. (2020) · Journal of Literature Pharmacy Sciences · doi:10.5336/pharmsci.2019-73101 · Cited by 3
Liu, S., Mello, M. M., & Kesselheim, A. S. (2021) · Journal of Health Politics Policy and Law · doi:10.1215/03616878-8893571 · Cited by 3
Ferorelli, D., Spagnolo, L., Marrone, M., Corradi, S., Silvestre, M. E. A., Misceo, F., Bianchi, F. P., Stefanizzi, P., Solarino, B., Dell'Erba, A. S., et al. (2021) · Vaccines · doi:10.3390/vaccines9050423 · Cited by 3
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Falabregues, A., Daul, M., Pourroy, B., Gauthier-Villano, L., Pisano, P. S., Rathelot, P., & Vialettes, B. (2015) · Therapies · doi:10.2515/therapie/2015008 · Cited by 3
Ramanathan, A., Pullum, L., Hobson, T. C., Stahl, C. G., Steed, C. A., Quinn, S. P., Chennubhotla, C. S., & Valkova, S. (2015) · Frontiers in Public Health · doi:10.3389/fpubh.2015.00182 · Cited by 3
“( 28–32)], very little research has been carried out in terms of using them as potential data sources for digital public health surveillance. eHRCs have a distinctlagtimeassociatedwithclaimsprocessingandbeingmade available for analysis.”
BackgroundAllen, P. S., Brown, A. W., Brown, M. M. B., Hsu, W. H., & Beitz, D. C. (2015) · Nutrition and Dietary Supplements · doi:10.2147/nds.s88888 · Cited by 3
“As prophylactic prescriptions of off-label pharmaceuticals and autonomous administration of over-the-counter nutraceuticals becomes the norm, thorough assessments of these compounds in animal models and improved human market surveillance are warranted.(3) The original intent of the experiment described herein was to a…”
Todd, A. E. (2011) · American Journal of Law & Medicine · doi:10.1177/009885881103700209 · Cited by 3
Nuevo real decreto de acceso a medicamentos en situaciones especiales
Montero, D., Vargas, E., de la Cruz, C., & Andres-Trelles, F. (2009) · Medicina Clínica · doi:10.1016/j.medcli.2009.07.004 · Cited by 3
Simplifying Thromboprophylaxis Could Improve Outcomes in Orthopaedic Surgery
Friedman, R. J. (2010) · Thrombosis · doi:10.1155/2010/108049 · Cited by 3
Use pattern and off-label use of atypical antipsychotics in bipolar disorder, 1998-2002.
Demland, J. A., Jing, Y., Kelton, C. M. L., Guo, J. J., Li, H., & Wigle, P. R. (2009) · Europe PMC (PubMed Central) · Cited by 3
Review of Use of Drugs for Conditions Not Included in Product Characteristics
García-Sabina, A., Rey, R. R., & Martı́nez-Pacheco, R. (2011) · Farmacia Hospitalaria (English Edition) · doi:10.1016/j.farmae.2010.06.006 · Cited by 3
Klein, T. (2012) · Journal of the American Academy of Nurse Practitioners · doi:10.1111/j.1745-7599.2011.00687.x · Cited by 3
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BackgroundOff-label prescribing: best practice or malpractice?
Stahl, S. M. (2013) · CNS Spectrums · doi:10.1017/s1092852913000011 · Cited by 3
Ruble, J. H. (2012) · Journal of Pain & Palliative Care Pharmacotherapy · doi:10.3109/15360288.2012.671243 · Cited by 3
“Radley et al reported on the off-label prescribing patterns of US office-based practitioners(11).”
BackgroundUS Perspective on Off‐label Use in Pediatrics
Karesh, A., & Mulberg, A. E. (2012) · Journal of Pediatric Gastroenterology and Nutrition · doi:10.1097/mpg.0b013e3182824ccb · Cited by 3
The changing landscape of off-label prescription drug promotion
Sarkees, M. E., & Fitzgerald, M. P. (2016) · International Journal of Pharmaceutical and Healthcare Marketing · doi:10.1108/ijphm-08-2015-0042 · Cited by 3
Getting stem cell patients 'on the grid'
Wicks, P. J., & Heywood, J. (2016) · Nature Biotechnology · doi:10.1038/nbt.3740 · Cited by 3
Justification de la prescription hors-AMM d’antibiotiques chez l’enfant hospitalisé
Berthod, C., Kassaï, B., Boussageon, R., Adélaïde, L., Jacquet‐Lagrèze, M., & Lajoinie, A. (2017) · Therapies · doi:10.1016/j.therap.2017.04.002 · Cited by 3
Blaser, D. A., Eaneff, S., Loudon-Griffiths, J., Roberts, S., Phan, P., Wicks, P. J., & Weatherall, J. (2017) · AAPS Open · doi:10.1186/s41120-017-0020-y · Cited by 3
“An estimated 20% of outpatient prescriptions in the United States are written for off-label use (Radley et al., 2006).”
Basak, R., & McCaffrey, D. J. (2017) · International Journal of Clinical Pharmacy · doi:10.1007/s11096-017-0567-7 · Cited by 3
Who cares about a label? The effect of pediatric labeling changes on prescription drug utilization
Ody, C. J., & Schmitt, M. (2019) · International Journal of Health Economics and Management · doi:10.1007/s10754-019-09265-y · Cited by 3
Drenska, M., Grigorova, V., Elitova, S., Naseva, E., & Getov, I. N. (2019) · Drugs & Therapy Perspectives · doi:10.1007/s40267-019-00638-4 · Cited by 3
Stephens, K. M., Johnson, T. L., & Gurenlian, J. R. (2018) · PubMed · Cited by 3
Shah, K., Gor, K., Joshi, P. B., Joshi, H. M., Rana, D., & Malhotra, S. (2020) · Perspectives in Clinical Research · doi:10.4103/picr.picr_117_18 · Cited by 3
“With rising number of drug pattern evaluation studies and off-label drug studies which are being carried out in different aspects of clinical sciences both in abroad as well as in India, surprisingly presents a distinct lack of research on off-label use of drugs with only a few articles in India till the date.[9-11] A…”
BackgroundEthical Transparency and Government Regulation of Canada's Medical Research Industry
Poitras, G., & Meredith, L. N. (2008) · Forum on public policy · Cited by 3
Upton, R. (2022) · Elsevier eBooks · doi:10.1016/b978-0-323-85542-6.00003-2 · Cited by 3
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Zhao, M., & Yang, C. C. (2018) · IEEE International Conference on Healthcare Informatics (ICHI) · doi:10.1109/ichi.2018.00010 · Cited by 3
“Healthcare providers usually prescribe off-label drugs for the benefit of patients based on their experience, and some drugs are even used in off-label ways more often than their approved indications and deliver effective treatment, but still a majority of off-label uses have no or less scientific evidence [1], which…”
BackgroundVázquez‐Mourelle, R., Carracedo‐Martínez, E., & Figueiras, A. (2020) · BMC Health Services Research · doi:10.1186/s12913-020-05453-6 · Cited by 3
Off-Label Use of Pharmaceuticals: Trends and DriversPreprint
Bradford, D., Turner, J. L., & Williams, J. W. (2013) · SSRN Electronic Journal · doi:10.2139/ssrn.2230976 · Cited by 3
Off-label voorschrijven: medisch handelen en motieven van huisartsen
Jochemsen, H. M., Gijsen, R., & Caspers, P. (2007) · Huisarts en Wetenschap · doi:10.1007/bf03085159 · Cited by 3
Regulation of complementary medicines
Harvey, K. J. (2017) · Internal Medicine Journal · doi:10.1111/imj.13548 · Cited by 3
Drug Repurposing for Corneal Diseases—Should We Look Back More Often to Move Forward?
Oellerich, S., Larkin, F., & Dhubhghaill, S. N. (2025) · Cornea · doi:10.1097/ico.0000000000003877 · Cited by 2
Off-label policy through the lens of trazodone usage and spending in the United States
Kadiyala, S., Chenoweth, M. D., & Watanabe, J. H. (2025) · Health Affairs Scholar · doi:10.1093/haschl/qxaf114 · Cited by 2
Patel, R., Başer, O., Waters, H. C., Huang, D. Q., Morrissey, L., Rodchenko, K., & Samayoa, G. (2025) · Journal of health economics and outcomes research · doi:10.36469/jheor.2025.137909 · Cited by 2
After Amarin v FDA: What Will the Future Hold for Off-label Promotion Regulation?
Mackey, T. K., & Liang, B. A. (2016) · Mayo Clinic Proceedings · doi:10.1016/j.mayocp.2016.02.024 · Cited by 2
“In fact, offlabel drug use (ie, prescribing medications for a different disease or medical condition, different route of administration, and/or different dosage than that approved by the FDA) is relatively common, with a 2006 study estimating that 21% of commonly used drugs are prescribed off-label.(2) Despite regular…”
BackgroundPenggunaan Off-Label Misoprostol Pada Pasien Obstetri-Ginekologi Di Rumah Sakit Swasta Kab. Banyumas
Wibowo, M. I. N. A., Sugiri, M. P., Arrista, B., & Setiawan, D. (2021) · Jurnal Sains Farmasi & Klinis · doi:10.25077/jsfk.8.1.9-18.2021 · Cited by 2
Evaluation of discharge prescribing after rescheduling of gabapentin as a controlled substance
Robbins, M. J., Floroff, C. K., Ingemi, A. I., & Kaplan, M. C. (2021) · American Journal of Health-System Pharmacy · doi:10.1093/ajhp/zxab293 · Cited by 2
Nonopioid pain management in otolaryngology—head and neck surgery: the pharmacist's perspective
Britton, R., Kastelic, K., Osten, R., & Patel, R. (2022) · Elsevier eBooks · doi:10.1016/b978-0-323-79016-1.00007-6 · Cited by 2
Prescription of psychotropic drugs off label
Петрова, Н. Н., & Semenova, N. V. (2023) · S S Korsakov Journal of Neurology and Psychiatry · doi:10.17116/jnevro2023123071130 · Cited by 2
Off-label medications for addictive disorders
Vanderhoof, T. S. (2023) · Current Psychiatry · doi:10.12788/cp.0384 · Cited by 2
Should We Prevent Off-Label Drug Prescriptions? Empirical Evidence from France
Tunçel, T. (2024) · The Review of Economic Studies · doi:10.1093/restud/rdae060 · Cited by 2
Collaborative Approaches to Establishing and Implementing Pharmacovigilance Systems
Edwards, B. D., & Caro-Rojas, A. (2024) · Springer eBooks · doi:10.1007/978-3-031-51089-2_13 · Cited by 2
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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