Traditional Chinese Medicine (TCM) safety evaluation and pharmacovigilance

In recent years, there has been an increase in the number of adverse reactions/events associated with Traditional Chinese Medicine (TCM). This could be due to the passive state of the safety and risk management of TCM, which has not only led to adverse effects but also restricted the healthy and long-term development of industrial disciplines in the field of TCM. To overcome the problems associated with the safe use of TCM, we propose to speed up the establishment of a pharmacovigilance technology system in line with the characteristics of TCM, and ensure the transformation of TCM safety risk management from a passive response to active prevention and control at the earliest. Therefore, this paper systematically discusses: (1) The basic context and issues related to drug safety, (2) main challenges in the safe clinical use of TCM, and (3) pivotal pharmacovigilance methods and approaches applicable for Chinese medicine products. Drug-induced liver injury (DILI) triggered by Polygonum multiflorum and other TCMs is a current worldwide concern. Thus, we established an integrated pharmacovigilance approach of “objective identification-mechanism analysis-risk prevention and control” to solve this problem. The established pharmacovigilance technology system applied an “integrated evidence chain-based causality evaluation method” and “three-level diagnostic criteria” for the causality assessment of DILI. A new toxicology evaluation model and method, named as “disease-syndrome-based toxicology”, was developed for the safety evaluation of TCM. This system was designed for the prevention and control of TCM safety risks based on the identification of susceptible individuals, control of factors that enhance susceptibility to adverse reactions, and clinical precision medicine. Moreover, this system enables multi-source data fusion, sharing, and co-creation for DILI active monitoring and evaluation to provide data support for safety supervision and clinical drug decision making. Additionally, it provided the first online safe drug information inquiry platform, named “Inquiring Drug Safety”, for online data sharing and co-creation. Moreover, it helped construct a new model for the prevention mechanisms of TCM safety risks in people. The proposed system has been successfully used in the formulation of strategies to prevent and control safety risks of TCM and related preparations, such as Polygonum multiflorum and Rhubarb. Furthermore, this system led to the development of the first technical standard for the safe use of TCM: “Guidelines for safe use of Polygoni Multiflori Radix”. In conclusion, the established pharmacovigilance technology system overcomes the problems of causality evaluation, as well as risk prevention and control of DILI caused by TCM. Furthermore, it supports the clinical rational and safe use of TCM, and makes important contributions to ensure the healthy and sustainable development of TCM disciplines and its industry.