Objective: To systematically evaluate the research status of off-label drug use in hospitalized neonates

and investigate the characteristics of off-label drug use. Methods: CBM

CNKI

VIP

PubMed and EMBase were retrieved to collect off-label drug use studies of hospitalized neonates published in Chinese and English. The quality of included studies was evaluated by using the quality assessment tool of the current situation survey studies recommended by Joanna Briggs Institute (JBI) evidence-based Health Care Center in Australia

and RevMan3.4.0 software was used for Meta-analysis of homogenous studies. The incidence and types of off-label drug use and composition of related drugs were analyzed. Results: A total of 22 studies were collected

including 3

400 neonates and 47

226 prescriptions

and there were 26

172 off-label drug use prescriptions. The main types of off-label drug use were “without medication information for children”

off-label dose

off-label frequency and off-label age drug use. The main types of drugs were anti-infective drugs

nervous system drugs and cardiovascular system drugs. Preterm delivery and neonates in intensive care units were more likely to have off-label drug use. Conclusion: Off-label drug use is common in hospitalized neonates

which may increase the incidence of adverse drug reactions. Therefore

the study of off-label drug use should focus on the monitoring and evaluation of adverse drug reactions to ensure the safety of drug use in neonates.