OBJECTIVES: To investigate the current situation of management of off-label drug use (OLDU) in tertiary hospitals of Guizhou province, and to provide baseline evidence for the development of a unified administration regulation for OLDU in Guizhou Province in China.

METHODS: In line with the relevant policies and regulations, a questionnaire including basic information of the person filling out the form, basic information of the hospitals, and the information of OLDU was developed. The questionnaire was sent to 84 tertiary hospitals in Guizhou Province through the " Questionnaire Star".

RESULTS: A total of 84 questionnaires were distributed and recovered, with a reponse rate of 100.00%. Of the 84 hospitals, 77 (91.67%) had OLDU, of which 68 (88.31 %) had established a management system for OLDU. Among the 77 hospitals with OLDU, 65 (84.42%), 35 (54.55%), 58 (75.32%), 36 (46.75%), 15 (19.48%), and 21 (27.27%) hospitals respectively required approval from the Committee on Drug Administration and Pharmacotherapy before OLDU, restricted the qualifications of doctors prescribing OLDU, required informed consent from patients or their families before OLDU, recorded the matters and reasons in the medical records of patients treated with OLDU, followed up patients in their files and evaluated the reasonableness of the OLDU, and carried out special reviews for OLDU. Only 30 (38.96%) hospitals have set up a catalogue of OLDU, and 58 (75.32%) hospitals have urgent needs to set up a unified provincial catalogue of OLDU.

CONCLUSIONS: The pharmacy administration level of OLDU in tertiary hospitals of Guizhou province is relatively low, so there is an urgent need to establish a unified OLDU management system and medication catalogue in the province.