WHO和部分国家基本药物遴选与退出标准对我国的启示  

Enlightenment of WHO and some countries’selection and withdrawal standards of essential medicine to China

作　　者：颜建周[1] 丁瑞琳 邵蓉[1] YAN Jian-zhou;DING Rui-lin;SHAO Rong(Institute of Regulatory Science,China Pharmaceutical University,NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation,Nanjing Jiangsu 211198,China)

机构地区：[1]中国药科大学药品监管科学研究院国家药品监督管理局药品监管创新与评价重点实验室,江苏南京211198

出　　处：《中国卫生政策研究》2022年第4期59-66,共8页Chinese Journal of Health Policy

基　　金：2020年度高校哲学社会科学研究一般项目资助(2020SJA0074)。

摘　　要：目的:为我国基本药物遴选标准的优化提供思路与参考。方法:通过文献研究、对比研究等方法,梳理与对比WHO与部分国家的基本药物遴选与调整标准。结果:肯尼亚、巴西、印度和泰国在形成基本药物遴选标准的思路上存在一定差异,所形成的标准在操作性、稳定性和适用性等方面各具优劣,其参考WHO和部分国家基本药物目录、遴选标准示例解释、使用循证遴选框架、开发标准与方法一体化工具等做法对我国具有较好的借鉴价值。结论:建议我国完善基本药物目录遴选标准,实现以疾病谱为导向的遴选;基于国情对示范标准进行细化和发展,适当增加相关示例;将遴选标准与决策方法、工具相结合,提高遴选的客观性、科学性;形成多维度、基于临床应用的基本药物目录退出标准。Objective:To provide ideas and references for optimizing the selection criteria of essential medicine in China.Methods:The selection and adjustment criteria of essential medicine in WHO and some countries were combed and compared through literature research and comparative research.Results:Kenya,Brazil,India and Thailand have different ideas on the inclusion criteria of essential medicines,which have their own advantages and disadvantages in terms of operability,stability and applicability.Their approaches like referring to the WHO and typical national lists of essential medicines,interpretation of criteria using examples,the use of evidence-based selection framework,and development of integrated tools of criteria and methods have good reference value for China.Conclusions:It is suggested that China should improve the selection criteria of the essential medicine list and realize the disease spectrum-oriented selection.Refine and develop demonstration standards based on national conditions,and appropriately add relevant examples.It is suggested to combine selection criteria with decision-making methods and tools to improve the objectivity and scientificity of the selection of essential medicine,and establish the multi-dimensional,clinical application-based exit criteria of essential medicine.

关 键 词：WHO 基本药物 遴选 标准 

分 类 号：R197[医药卫生—卫生事业管理]