Utilization of off-label and unlicensed medicines in neonatal intensive care unit.
Drug utilization, intensive care unit, off-label use, neonate.
Purpose: The aim of this study was to evaluate the use of off-label and unlicensed drugs in a Brazilian neonatal intensive care unit (NICU) of a teaching maternity specialized in high risk pregnancy. Methods: A descriptive, observational, cohort and prospective study was conducted. Newborns admitted consecutively in the NICU of the Maternity School Januário Cicco that had at least one medication prescribed and hospital stay longer than 24 hours were included. Demographic and clinical data were collected from neonates, as well as all medications prescribed during hospitalization. The classification of off-label and unlicensed drugs for the neonatal population was performed according to the Food and Drug Administration criteria (based on information from DrugDex-Micromedex® database). Results: A total of 17,421 prescriptions items were analyzed in 3,935 prescriptions of 220 newborns, of which 96.4% were exposed to off-label and 66.8% to unlicensed medications. Antimicrobials for systemic use were the most prescribed off-label pharmacological group and the most common drug classified as off-label for newborn was fentanyl (n= 1358), followed by gentamicin (n= 1197). Caffeine (n = 1226) was the most often prescribed unlicensed drug, followed by cardiovascular agents (n= 648) modified by nursing. CONCLUSION: There was a high rate of prescription and exposure of newborns to off-label and unlicensed drugs.