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Farmacia Hospitalaria

On-line version ISSN 2171-8695Print version ISSN 1130-6343


PEREIRA GOMES, Vanessa; MELO DA SILVA, Kédma; OLIVEIRA CHAGAS, Suely  and  RAFAEL DOS SANTOS MAGALHAES, Igor. Off-label and unlicensed utilization of drugs in a Brazilian pediatric hospital. Farm Hosp. [online]. 2015, vol.39, n.3, pp.176-180. ISSN 2171-8695.

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.

Keywords : Off-label use; Drug prescription; Pharmacoepidemiology.

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