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 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.

Keywords: Off-label, Critical care, Intensive care, Patient safety