OBJECTIVE: To investigate the status of off-label drug use in outpatient department of a stomatological hospital（ hereinafter referred to as "the hospital"）

so as to provide reference for improving the level of rational drug use in stomatological hospital. METHODS: Off-label drug use information in outpatient prescriptions of the hospital from Jul. 2019 to Jun. 2020 was collected. PASSPA2 system was used to randomly select outpatient prescriptions according to the rate of 3%. Pareto chart and related rules were used to retrospectively analyze the prescriptions of off-label drug. RESULTS: Totally 5 153 outpatient prescriptions were selected

including 9 444 medical orders. There were 1 393 prescriptions with off-label drug use

and the incidence of off-label drug use was 27. 03%. There were3 174 medical orders for off-label drug use

and the incidence was 33. 61%. The main factors of off-label drug use were off-label indications. The secondary factors were the administration routes. The general factors were off-label population

off-label usage and dosage

and off-label precautions. CONCLUSIONS: Analysis of off-label drug use in the outpatient department of the hospital by Pareto chart is helpful to identify the main and secondary factors of off-label drug use in the outpatient department of the hospital. In response to these factors

medical institutions should continue to strengthen the management of off-label drug use and improve the level of rational drug use in hospitals.