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Cited by 368Pharmaceutical studies and practicesPharmaceutical industry and healthcarePharmaceutical Economics and Policy

The DOI matches its Crossref record; 48 of the 48 references it cites were found in a registry or an index.

Ten Common Questions (and Their Answers) About Off-label Drug Use

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Wittich, Christopher M., Burkle, Christopher M., Lanier, William L.·2012·Mayo Clinic Proceedings
DOI 10.1016/j.mayocp.2012.04.017PMC PMC3538391
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Abstract

The term off-label drug use (OLDU) is used extensively in the medical literature, continuing medical education exercises, and the media. Yet, we propose that many health care professionals have an underappreciation of its definition, prevalence, and implications. This article introduces and answers 10 questions regarding OLDU in an effort to clarify the practice's meaning, breadth of application, acceptance, and liabilities. Off-label drug use involves prescribing medications for indications, or using a dosage or dosage form, that have not been approved by the US Food and Drug Administration. Since the Food and Drug Administration does not regulate the practice of medicine, OLDU has become common. It occurs in every specialty of medicine, but it may be more common in areas of medicine in which the patient population is less likely to be included in clinical trials (eg, pediatric, pregnant, or psychiatric patients). Pharmaceutical companies are not allowed to promote their medications for an off-label use, which has lead to several large settlements for illegal marketing. To limit liability, physicians should prescribe medications only for indications that they believe are in the best interest of the patient. In addition, health care professionals should educate themselves about OLDU to weigh the risks and benefits and provide the best possible care for their patients.

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  1. Qureshi, 2011, Enforcement actions involving Medicaid fraud and abuse, 1996-2009, Arch Intern Med, 171, 785
  2. Thomas, 2012, Glaxo agrees to pay $3 billion in fraud settlement, New York Times

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Metadata

Authors
Wittich, C. M., Burkle, C. M., & Lanier, W. L.
Affiliations
Mayo Clinic (US)
Corresponding author
Wittich, Christopher M.
ORCID
Venue
Mayo Clinic Proceedings
Publisher
Elsevier BV
Published
2012-10
Volume
87
Issue
10
Pages
982-990
ISSN
0025-6196 (ISSN-L)
DOI
10.1016/j.mayocp.2012.04.017
PMC
PMC3538391
OpenAlex
W2166119767
Cited by
368
References
48
Citations by year
2026: 17 · 2025: 24 · 2024: 62 · 2023: 42 · 2022: 32 · 2021: 35 · 2020: 26 · 2019: 29 · 2018: 25 · 2017: 25 · 2016: 21 · 2015: 11 · 2014: 12 · 2013: 4 · 2012: 3
FWCI
8.41
Type
journal article
Language
en
Open access
Licence
Locations
  • Mayo Clinic Proceedings (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
Keywords
off-label drug use, FDA-approved indications, prescribing patterns, physician liability, pharmaceutical marketing, pediatric prescribing, pregnant patients, psychiatric patients, risk-benefit assessment
MeSH terms
Attitude of Health Personnel, Drug Labeling, Female, Humans, Male, Patient Education as Topic, Physician-Patient Relations, Practice Patterns, Physicians', Drug Prescriptions, United States, United States Food and Drug Administration, Safety Management, Off-Label Use

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