公共卫生事件中医疗机构中药制剂应急管理探讨

目的 回顾与总结新型冠状病毒肺炎疫情下医疗机构中药制剂应急管理措施，为进一步改进和完善我国应对突发公共卫生事件中药品应急管理体系建设提供参考。方法 结合本次新型冠状病毒肺炎疫情中各省医疗机构中药制剂应急管理工作实践，梳理开展医疗机构中药制剂应急管理工作流程，探讨突发公共卫生事件中医疗机构中药制剂管理策略及措施。结果 目前，19个省份发布新型冠状病毒肺炎防控用医疗机构中药制剂应急管理文件，25个省份完成百余种医疗机构中药制剂备案审批并投入临床使用。结论 建立完善的药品应急管理体系，可以提高监管效率，协调指导相关工作有序进行，进一步提高突发公共卫生事件应对能力。

Discussion on the Emergency Management for Traditional Chinese Medicine Preparations in Medical Institutions in Public Health Emergencies

OBJECTIVE To review and summarize the practical experience of emergency preparedness for traditional Chinese medicine(TCM) preparations in medical institutions in the COVID-19 pneumonia epidemic situation, and provide a reference for further improving and perfecting the construction of an pharmaceutical emergency management system for public health emergencies. METHODS Combined with the practice of emergency management for TCM in medical institutions in the COVID-19 pneumonia epidemic situation, the work process of emergency preparedness for TCM in medical institutions was combed, and the emergency preparedness for TCM in medical institutions management strategies and measures for public health emergencies were discussed. RESULTS At present, laws of emergency management for TCM in medical institutions for epidemic prevention and control has been issued by drug regulatory authorities in 19 provinces, more than 100 kinds of TCM in medical institutions have been registered and approved in 25 provinces and put into clinical use. CONCLUSION The establishment of a sound emergency preparedness for drug management system can improve the efficiency of administration, coordinate and guide related work in an orderly manner, and further improve the emergency management ability of public health emergencies.