Use of off-label or unlicensed drugs for pediatrics in brazilian public hospital
Keywords:Uso de medicamentos; Utilização em Indicações não Aprovadas; Pediatria.
Because of many particularities that limit the use of medicines in the pediatric population, many drugs are used off-label or are not licensed for this group. This study aimed to determine the prevalence of off-label or unlicensed drugs prescribed for use in a pediatric unit of a Brazilian public hospital, analyzing the therapeutic indication. This was a descriptive, retrospective study, which analyzed the medical records of patients admitted in the 1st trimester of 2012 in the pediatric unit. It was determined the profile of patients, the pharmacotherapeutic profile according ATC (anatomical-therapeutic-chemical classification index) and evaluated the use of off-label or unlicensed drugs using the information available on the National Agency for Sanitary Surveillance (ANVISA) database and the MICROMEDEX 2.0 database. The medical records of 107 patients were analyzed, prevailing female, with a mean age of 6.0 years. Analgesics predominated among the prescriptions. Almost half of the patients had at least one pharmaceutical specialty prescribed off-label and 23.3% received some unlicensed. According to ANVISA database, 49.9% of the items defined as off-label were also considered off-label for the same indications in adults. In the case of unlicensed, 14% also had no indication of use in adults in the situations for which they were prescribed. The same analysis was done using the MICROMEDEX and the percentages were 76.9% and 12.4%, respectively. The results obtained are similar to those found in other studies, suggesting the adoption of effective actions to promote the rational use of medicines in the pediatric population.
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