Use of unlicensed and off-label drugs in neonates in a Brazilian university hospital

ABSTRACT This study was designed to investigate the use of off-label and unlicensed drugs in a Neonatal Care Unit (NCU) and to compare the frequency of use of off-label drugs according to the drug regulatory agencies in Brazil (Agência Nacional de Vigilância Sanitária-ANVISA) and the United States Food and Drug Administration (FDA). A prospective observational study was carried out in the NCU. Prescriptions were classified as off-label and unlicensed using both ANVISA and FDA criteria. A total of 157 newborns and 1187 prescriptions were analyzed. The most prescribed drug was fentanyl (9.3%), followed by multivitamin (8.4%) and gentamicin (7.9%). According to ANVISA criteria, there were 665 (56.0%) off-label prescriptions and 86 (7.2%) unlicensed prescriptions and 95.5% of newborns received at least one drug off-label. By contrast, according to FDA criteria, there were 592 (49.9%) off-label prescriptions and 84 (7.1%) unlicensed prescriptions, and 72.0% of newborns received at least one drug off-label. The off-label use of drugs registered by ANVISA differed significantly from that of drugs registered by the FDA. There was a high frequency of off-label and unlicensed drug use in the investigated NCU, and there was an inverse relationship between off-label and unlicensed usage and the gestational age of the newborns.

Drug utilisation profile in the neonatal unit of a university hospital: a prospective observational study in Brazil.

BACKGROUND: Advances in neonatology have contributed to changes in the drug utilisation profile in neonates, both in the number of drugs and the pharmacotherapeutic groups. OBJECTIVE: To analyse drug use in the neonatal care unit of a teaching hospital in Brazil and to evaluate the associations among perinatal, clinical care and drug use data. SETTING: The neonatal care unit of a teaching hospital in Brazil. METHODS: A prospective observational study was conducted. Perinatal, clinical care and pharmacotherapy data were collected from the patients' medical records. Labelling information regarding neonatal use was analysed for prescribed drugs. The data were analysed using univariate descriptive statistics and quasi-Poisson regression. MAIN OUTCOME MEASURE: Frequency of drug use by gestational age. RESULTS: The study included 187 patients; 157 (84.0 %) received drugs. The mean gestational age was 35.8 weeks. The mean number of drugs prescribed per patient was 6.4. The number of drugs used was inversely correlated to gestational age and birth weight. The most commonly prescribed drugs belonged to the following anatomical therapeutic chemical groups: nervous system drugs, anti-infectives for systemic use, and alimentary tract and metabolism drugs. Information regarding neonatal use was given in the labelling of only 20.5 % of the prescribed drugs. Of these, only 9.5 % had information specific for preterm infants. CONCLUSIONS: Drug administration to neonates is frequently and inversely correlated to gestational age and birth weight. Neonates are exposed to different therapeutic classes, reflecting scientific advances in neonatology. In Brazil, the percentage of drugs with neonate-specific labelling information is low. Consequently, there is an evident need for efforts to guarantee effective and safe pharmacotherapy for neonates.