Off-label medication use in adult critical care patients

J Crit Care. 2011 Feb;26(1):89-94. doi: 10.1016/j.jcrc.2010.06.012. Epub 2010 Aug 16.


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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Critical Care / methods*
  • Drug Labeling
  • Evidence-Based Medicine
  • Humans
  • Intensive Care Units*
  • Off-Label Use / statistics & numerical data*
  • Practice Guidelines as Topic
  • Practice Patterns, Physicians' / statistics & numerical data*
  • Prospective Studies
  • United States
  • United States Food and Drug Administration