Journal
JOURNAL OF CRITICAL CARE
Volume 26, Issue 1, Pages 89-94Publisher
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1016/j.jcrc.2010.06.012
Keywords
Off-label; Critical care; Intensive care; Patient safety
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Funding
- University of Chicago
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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. (C) 2011 Elsevier Inc. All rights reserved.
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