RESUMEN
OBJECTIVE: To establish an evidence-based evaluation process of off-label drug use with the guidance of evidence-based medicine to provide decision support for clinical application of off-label drug use. METHODS: With the guidance of evidence-based medicine, the evaluation process of off-label drug use was established according to the requirements of Cochrane handbook 5.1 and the GRADE system. RESULTS: A standardized evidence-based evaluation process was established as follows; first, search and retrieve the evidence; second, assess the risk of bias of the study; third, assess the quality of evidence; last, achieve a consensus on the recommendations of off-label drug use. CONCLUSION: The process of evidence-based evaluation of off-label drug use will provide scientific decision support for Pharmacy Administration Drug and Therapeutics Committee of hospital to decide the clinical application of off-label drug use. It will effectively regulate the management of off-label drug use.