High prevalence of off-label and unlicensed drug prescribing in a Brazilian intensive care unit *

SummaryObjectiveTo describe the use and determine the prevalence of off-label and unlicensed drug use prescribing in a pediatric intensive care unit in a Southeastern Brazilian hospital.MethodsCross-sectional study of inpatients in a pediatric intensive care unit from May 2008 through January 2009. The classification according to the Brazilian regulatory agency (Agência de Vigilância Sanitária – Anvisa) approval criteria was based on the Anvisa electronic package insert list, Pharmaceuticals Dictionary, and the analysis was conducted through R software.ResultsWe analysed 1,054 prescription items for 73 patients. Females predominated (52%), and the patients’ age ranged from 0 to 16 years. Among the prescribed items, 23.4% were off-label, 12.6% were unlicensed, 1.4% were both off-label and unlicensed, 86% had at least one item off-label, and 67% had at least one unlicensed drug. The most frequently prescribed therapeutic groups were systemic anti-bacterial, analgesic, psycholeptic, and antiasmathic agents.ConclusionThe current study results confirm the high prevalence of unlicensed and off-label drug use in a pediatric intensive care unit.