Use of off-label drugs in the neonatal intensive care unit in India

Abstract

Background: Off-label use of drugs is widespread in pediatrics and almost all neonates hospitalized in NICU are affected by the use of off-label drugs regardless of gestational age and birth weight. This is because of the lack of regulation for medications in the neonatal population and the delays in updating drug instructions. This is mainly due to the ethical difficulty in the research and difficulties in conducting clinical trials in this vulnerable population. Hence, the study was planned to assess the extent of the use of off-label drugs in the NICU. Methods: An observational study was carried out in the NICU of a tertiary care center from May 2021 to Oct 2022 and case records of neonates admitted to the NICU were evaluated. Results: Among 1745 drug prescriptions in 360 neonates, 1208 (69.22%) were off-label. Anti-infectives were the most commonly used off-label class of drug, Piperacillin+tazobactam was the most commonly used off-label drug and most common reason for off-label prescriptions was indication and administration. It was found that 79.44% of neonates received at least one off-label drug. Conclusions: Off-label use of drugs, specifically anti-infective drugs, is common in NICUs of India as in other countries. So, more research should be done to generate evidence-based guidelines for the rational use of drugs in neonates.