Off-label and unlicensed utilization of drugs in a Brazilian pediatric hospital.

AIM To describe the off-label and unlicensed utilization patterns of drugs in a Brazilian pediatric hospital. METHODS The research consisted of a descriptive, prospective and cross-sectional study. RESULTS A total of 1,158 medicines were prescribed for 320 patients, accounting for 65 different drugs. Regarding the classification of drug utilization, the majority of the drugs were prescribed as in-label (57.2%), followed by off-label (36.4%) and by unlicensed (6.3%). The prevalences of unlicensed and off-label utilization of drugs in the studied population were 20.9 and 77.8%, respectively. Polypharmacy was highly associated to both off-label and unlicensed regimen (OR 12.9; 95% CI 3.07-54.2 and OR 3.68; 95% CI 2.02-6.69, respectively) whereas preschool children were less prone to unlicensed prescription (OR 0.39; 95% CI 0.19-0.79). Sex and length of hospitalization were not related to these outcomes. CONCLUSIONS Further studies are necessary to verify the impact of this pattern on the occurrence of adverse drug events.