Abstract:

AIM: To understand off-label drug use of traditional Chinese medicine injection, and to provide reference for establishing off-label drug use evaluation standard and standardized management of off-label drug use. METHODS: Based on the drug instructions, 24 cases of each of the top 10 Chinese medicine injections discharged from hospital in 2017 were statistically analyzed from the indication, dosage, route of administration, frequency of administration, drug concentration, course of treatment, selection of solvent, taboo and compatibility. Reference was made to the Chinese Medicine Diagnosis and Treatment Prescription issued by the State Administration of Traditional Chinese Medicine. The reasonableness of the case, the principle of syndrome differentiation, treatment of traditional Chinese medicine, and the literature were evaluated. RESULTS:Among the 240 discharge cases, 123 cases were treated with off-label drugs, among which the first three were super-functional attending treatment, over-dose course and super-solvent selection, some of which were recommended by TCM Diagnosis and Treatment Program or related guidelines, and 24 were suspected adverse drug reactions. CONCLUSION: Off-label drug use of traditional Chinese medicine injection is common, safety management should be strengthened and rational clinical use should be standardized.

Key words: traditional Chinese medicine injection, off-label drug use, super-functional attending, treatment based on syndrome differentiation, rationality evaluation