The use of unlicensed and off label medicines for children admitted to the neonatal intensive care unit of a median complexity university Hospital in São Paulo / Perfil da utilização de medicamentos não licenciados e sem indicação para crianças em UTI neonatal de Hospital Universitário de média complexidade 

AUTOR(ES)

Sandra Cristina Brassica

DATA DE PUBLICAÇÃO

2009

RESUMO

Introduction. In pediatrics utilization of unlicensed an off-label drugs are a common practice and this account for ethical and economic reasons. The utilization of unlicensed and off label drugs is not illegal, but can expose patients to risk of harm. Physicians and pharmacists have legal responsibility for any adverse event that may result from this use. Some studies in the pediatric field suggest an increased risk to adverse reactions related to unlicensed and off label use. Objective. To assess the exposure to unlicensed and off-label medicines in neonates admitted to the Neonatal Intensive Care Unit (NICU) in a Brazilian medium complexity University Hospital. Materials and Methods. A cross sectional descriptive study was conducted of prescribed medicines in the first 24 hours of admission for 79 patients admitted to the Neonatal Intensive Care Unit (NICU) in the University Hospital of the University of São Paulo (HU-USP), campus of São Paulo in the period of 12/03/08 to 03/11/08. The medicines were classified as unlicensed and off-label for use in neonatal population according to the criteria for licensing of medicines in Brazil and US. Results: There were a total of 346 medicines prescribed and according to the established criteria in Brazil 58% were unlicensed, 9.5% were off-label; 66% of patients were exposed to at least 1 item unlicensed and 18% at least 1 item off-label. In relation to the criteria in USA 53% were not licensed, 10.9% were off-label, and 63% of patients were exposed to at least 1 item unlicensed and 20% at least 1 item off-label. Conclusions: Brazilian neonates are exposed to unlicensed and off-label medicines already in the first 24 hours of hospitalization. Although efforts have been employed in several countries to reduce this practice, the problem was not solved. In Brazil, there is even different information in leaflets for medicines licensed in and, in relation, to unlicensed or off-label medicines there is no established policy.

ASSUNTO(S)

fármacos intensive care unit unlicensed use criança recém-nascido off label use children uso não licenciado unidades de terapia intensiva medicines hospitais universitários intensive care terapia intensiva neonate university hospital regulamentação) neonato uso off label utilização de fármacos (controle

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