A alta prevalência de prescri？？es de medicamentos off-label e n？o licenciados em unidade de terapia intensiva pediátrica brasileira

objective: to 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 methods: cross-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 vigilancia sanitária - anvisa) approval criteria was based on the anvisa electronic package insert list, pharmaceuticals dictionary, and the analysis was conducted through r software. results: we 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. conclusion: the current study results confirm the high prevalence of unlicensed and off-label drug use in a pediatric intensive care unit.