Abstract: Objective To analyze the situation of off-label use at outpatient and emergency department in our hospital for references of rational drug use in the clinic. Methods The prescriptions of outpatient and emergency department from June 2012 to Nov. 2012 were selected in our hospital. The off-label use was analyzed according to the package inserts. Results Of the total 600 prescriptions, 63 ones involved off -label use. The problems were mainly over dosage(33.3%), beyond indication(23.8%), route of medication(20.6%) etc. Examples of off-label use mainly included nifedipine for the treatment of preterm labor, ambroxol hydrochloride injection nebulized for the treatment of respiratory tract infections, maxingganshi decoction for the treatment of respiratory tract infections in children etc. Conclusion The off -label use is widespreaded at outpatient and emergency department. Risks exist during the health care process. It is sensible for our hospital to pay great attention on off-label use to establish corresponding control system and procedure, so as to ensure safe use of drug in patients.

Key words: off-label use, investigation and analysis