Off-label medication use in adult critical care patients

Ishaq Lat, Scott Micek, Jeffrey Janzen, Henry Cohen, Keith Olsen, Curtis Haas

Research output: Contribution to journalArticlepeer-review

47 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)89-94
Number of pages6
JournalJournal of Critical Care
Issue number1
StatePublished - Feb 2011


  • Critical care
  • Intensive care
  • Off-label
  • Patient safety

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine


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