Abstract: Objective To understand the off-label drug use in pediatric outpatients of our hospital,and provide basic data for safe and rational use of drugs. Methods A retrospective survey of 100 pediatric prescriptions in outpatient department every month had done from Sep. 2015 to Aug. 2016. The information of weight, gender, age, diagnosis and drugs were collected and analyzed. Results All the 1 200 prescriptions with 2 836 medical records were extracted which contained 594 off-label drug prescriptions of 874 records. The incidence rate of off-label drug use was 49.50% and 30.81% for prescriptions and records respectively. The most common type of off-label drug use was absence of information about child medication, accounting for 79.17%. The rate of wrong dosage was 10.18%, and the rate of frequency of administration was 8.24%. Conclusion We should pay attention to the safety of children's medication. We aim to call on the state to introduce relevant laws to regulate off-label drug use prescriptions in pediatric outpatients

Key words: off-label drug use, pediatrics, safe and rational use of drugs