我国药物分级管理现状的循证评价

Evidence-based Evaluation of the Current Status of Drug Classification Management in China

目的系统评价我国药物分级管理的现状,以期为药物的合理使用以及保障患者用药安全提供证据支撑。方法检索CNKI,VIP和万方数据库,中华人民共和国国家卫生健康委员会、国家药品监督管理局、中华医学会、中国药学会、各省药学会及百度等网站,同时补充检索纳入文献的参考文献,检索截止时限均为2020年4月,归纳和总结我国实施分级管理药物类型和制定分级管理的方法和内容,对研究结果进行描述性分析。结果共纳入12篇文献,均为药物分级管理在我国的应用现状,涉及到的药物类型有高危药品、超说明书用药、抗菌药物、抗肿瘤药物和中药的分级管理,制定机构分别为国家卫健委(2篇)、中国药学会(1篇)和医疗机构(9篇),分级原则和制订方法中仅有3篇文献提及了参考循证医学证据,部分分级标准中包含的药品种类存在差异。结论我国医疗机构药物分级管理策略能有效提高临床用药安全性,但分级原则、制定方法和具体分级均存在差异,建议各医疗机构根据实际情况结合循证医学证据进行药物分级管理。

OBJECTIVE To systematically evaluate the current status of drug classification management in my country,with a view to providing evidence support for the rational use of drugs and ensuring the safety of patients′medication.METHODS Search CNKI,VIP and Wanfang databases,the National Health Commission of the People′s Republic of China,the State Administration of Drug Administration,the Chinese Medical Association,the Chinese Pharmaceutical Association,the provincial pharmacy associations and Baidu.The deadlines are all in April 2020.Summarize the types of drugs implemented in China and formulate methods and contents for classification management,and conduct a descriptive analysis of the research results.RESULTS A total of 12 documents were included,all of which are the current status of the application of drug classification management in China.The types of drugs involved are the classification management of high-risk drugs,over-the-label drugs,antibacterial drugs,anti-tumor drugs and traditional Chinese medicine.the National Health Commission of the People′s Republic of China(2 articles),the Chinese Pharmaceutical Association(1 article)and medical institutions(9 articles),only three articles mentioned reference to evidence-based medical evidence in the grading principles and formulation methods,and there are differences in the types of drugs included in some grading standards.CONCLUSION The medical classification management strategy of medical institutions in my country could effectively improve the safety of clinical medication,but the classification principles,formulation methods and specific classifications are different.Medical institutions are recommended to carry out drug classification management based on actual conditions and evidence-based medical evidence.