Author(s): Ferreira Lde A, Ibiapina Cda C, Machado MG, Fagundes ED
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Abstract 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 Vigilância 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.
This article was published in Rev Assoc Med Bras (1992)
and referenced in Journal of Pharmaceutical Care & Health Systems