Objective: To investigate the application status of off-label drug use in children from pediatric intensive care unit (PICU)

and to analyze the risk factors of off-label drug use

so as to provide reference for promoting the rational drug use in PICU. Methods: Medical orders were selected from the PICU of Northwest Women’s and Children’s Hospital in 2019 through the proportionate stratified random sampling method

and off-label drug use was judged according to the drug instructions. The incidences of off-label drug use in different age groups

departments

levels of clinicians and different kinds of drugs were analyzed. Correlation between off-label drug use and children’s basic information (age

gender)

levels of clinicians and drug information (essential drugs

high-alert drugs) was analyzed. Results: A total of 864 children were enrolled

including 13

926 medical orders and 200 kinds of drugs. The incidence of off-label drug use was respectively 87.27%

53.02% and 56.00%. Newborns

female children

clinicians with high professional titles

essential drugs and high-alert drugs had higher risks of off-label drug use (P<0.05). Conclusion: Off-label drug use is widespread in children from PICU. Newborns

female children

clinicians with high professional titles

essential drugs and high-alert drugs are risk factors of off-label drug use. Pharmacists are supposed to play a role in guiding rational drug use

assisting clinicians in avoiding drug use risks and promoting the safe and rational drug use in critically ill children.