Off-label medication use in adult critical care patients.
OBJECTIVE
This study evaluated the use of off-label medications in the intensive care unit (ICU) setting and their varying levels of evidence.


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.
Lat
Ishaq
I
University of Chicago Medical Center, Chicago, IL 60637, USA.
Micek
Scott
S
Janzen
Jeffrey
J
Cohen
Henry
H
Olsen
Keith
K
Haas
Curtis
C
D000328:Adult; D003422:Critical Care / Q000379:methods*; D004348:Drug Labeling; D019317:Evidence-Based Medicine; D006801:Humans; D007362:Intensive Care Units; D056687:Off-Label Use / Q000706:statistics & numerical data*; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D011446:Prospective Studies; D014481:United States; D014486:United States Food and Drug Administration