Off-label medication use in adult critical care patients

Abstract Purpose This study evaluated the use of off-label medications in the intensive care unit (ICU) setting and their varying levels of evidence. Materials and Methods Thirty-seven ICUs from 24 US sites participated in this prospective, multicenter, observational study during a single 24-hour pe...

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Bibliographic Details
Published in:Journal of critical care 2011-02, Vol.26 (1), p.89-94
Main Authors: Lat, Ishaq, PharmD, Micek, Scott, PharmD, Janzen, Jeffrey, BA, Cohen, Henry, PharmD, Olsen, Keith, PharmD, Haas, Curtis, PharmD
Format: Article
Language:English
Subjects:
Adult
Ambulatory care
Colleges & universities
Critical Care
Critical Care - methods
Drug Labeling
Drug therapy
Drug use
Evidence-Based Medicine
FDA approval
Health care
Hospitals
Humans
Intensive care
Intensive Care Units
Off-label
Off-Label Use - statistics & numerical data
Patient safety
Pharmacology
Practice Guidelines as Topic
Practice Patterns, Physicians' - statistics & numerical data
Prospective Studies
Substance abuse treatment
United States
United States Food and Drug Administration
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Summary:Abstract Purpose This study evaluated the use of off-label medications in the intensive care unit (ICU) setting and their varying levels of evidence. Materials and Methods Thirty-seven ICUs from 24 US sites participated in this prospective, multicenter, observational study during a single 24-hour period. All medication orders were evaluated for Food and Drug Administration–labeled indications, strength of evidence, and strength of recommendation. Off-label medication orders were evaluated for indication, dose, route of administration, duration of therapy, and whether they were supported by institutional guidelines. Results A total of 414 patients were enrolled, yielding 5237 medication orders for analysis. Of these, 1897 orders (36.2%) were off-label. The 3 drug classes that accounted for the most off-label orders were bronchorespiratory, gastrointestinal, and immunology. The majority of off-label medication orders (89.1%) were initiated after patient admission to the ICU. Nine hundred twenty-eight (48.3%) of the off-label medication orders had grade C or no evidence. Conclusions The use of off-label medication therapies in the US adult critical care units is common, a majority of which are initiated after admission to the ICU and a significant portion of which are supported with inferior levels of evidence.
ISSN:0883-9441
1557-8615
DOI:10.1016/j.jcrc.2010.06.012