Análise da utilização de medicamentos em uma Unidade Neonatal de Cuidados Progressivos

Abstract

The absence of children, in particular of neonates, in clinical studies of drugs contribute to the use of off label and unlicensed drugs in neonatal care. The lack of adequate drugs for children is another reason for the use of off label and in particular of unlicensed drugs. Studies of drug use in neonatal care bring knowledge of the standard prescription and evaluate the strength of the available scientific evidence. This study aims: to analyse the profile of prescribed drugs in a neonatal intensive care unit (NICU) in a teaching hospital, to examine the association between prenatal and clinical-care variables and to analyse the use of off label and unlicensed drugs according to the regulatory agencies in Brazil (Agência Nacional de Vigilância Sanitária - ANVISA) and the US (Food and Drug Administration - FDA). This observational and prospective study investigated 187 patients in NICU from January at June 2012. Pharmacotherapeutic, prenatal and demographic information of the patients were collected. All prescribed drugs were collected from the medical records. The classification of drugs as off label or unlicensed was based on the electronic records of ANVISA and the Drug Reax from Micromedex database and site of the FDA. The availability of pediatric/ neonatal content of the Brazilian information sheets was also analysed. The data was then analyzed using univariate analysis and quasipoisson regression. Of the patients included in the study, 157 (84%) were treated with drugs. 1187 prescribed items of 127 different drugs were analysed. The most used drugs were of the following therapeutic groups: drugs acting on the nervous system, anti-infective and on the alimentary tract and metabolism. An inverse proportionality was found between gestational age, low birth weight and the number of drugs prescribed. For the 157 patients that were treated with drugs, it was shown that 56.0% of the drugs were off label according to ANVISA and 49.9% according to FDA; 7.2% were unlicensed according to ANVISA and 3.4% according to FDA. The frequency of neonates treated with off label drugs was 95.5% using ANVISA and 72.0% using the FDA registry. Of all drugs used, only 26 (20.5%) contained information for use on neonates in the information leaflet: of these only 12 (9.5%) contained information for prematures. The results of this investigation show that neonates were frequently exposed to different classes of drugs, and that the use of off label and unlicensed drugs was high. Specific information for neonates in the information leaflets is still scarce in Brazil. Therefore government action to improve the leaflets and incorporate the available scientific information about drug use in neonatal medicine aiming to provide guidelines for safe, efficient and evidence based pharmacotherapy is necessary. Another important measure is to encourage the development of clinical studies of pharmacotherapy in neonates.