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Objective:

Prior research indicates that off-label use is common in the ICU; however, the safety of off-label use has not been assessed. The study objective was to determine the prevalence of adverse drug reactions associated with off-label use and evaluate off-label use as a risk factor for the development of adverse drug reactions in an adult ICU population.

Design:

Multicenter, observational study

Setting:

Medical ICUs at three academic medical centers.

Patients:

Adult patients (age≥ 18 yr old) receiving medication therapy.

Interventions:

All administered medications were evaluated for Food and Drug Administration–approved or off-label use. Patients were assessed daily for the development of an adverse drug reaction through active surveillance. Three adverse drug reaction assessment instruments were used to determine the probability of an adverse drug reaction resulting from drug therapy. Severity and harm of …