| 引用本文：任晓悦, 颜建周, 丁瑞琳, 邵蓉.域外典型国家药品使用环节仿制药替代促进政策的经验及启示[J].中国卫生政策研究,2023,16(12):49-55 |
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| 域外典型国家药品使用环节仿制药替代促进政策的经验及启示 |
| 投稿时间：2023-09-19 修订日期：2023-12-11 PDF全文浏览 HTML全文浏览 |
| 任晓悦, 颜建周, 丁瑞琳, 邵蓉 |
| 中国药科大学国家药物政策与医药产业经济研究中心 江苏南京 211198 |
| 摘要:目的：从药品使用环节为完善我国仿制药替代促进政策提供建议。方法：采用文献研究法探究欧、美、日等国外促进仿制药替代的思路与典型措施，结合我国仿制药替代使用过程存在的问题，提出完善我国药品使用环节仿制药替代促进政策的具体建议。结果和结论：通过欧、美、日等国外经验研究，发现域外典型国家在促进仿制药替代过程中形成了“接受仿制药—科学合理替代—持续反馈与改进”的思路，建议我国将医患主体的意见纳入仿制药替代决策、基于风险建立仿制药替代规则、加强仿制药可替代性真实世界数据研究和监测评估、加强仿制药信息公开与政策宣传力度，进一步完善我国药品使用环节仿制药替代促进政策，促进仿制药替代使用。 |
| 关键词:仿制药替代 临床使用 医患偏好 国际经验 |
| 基金项目:教育部人文社会科学研究规划基金（22YJAZH126） |
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| Experience and enlightenment of generic drug substitution promotion policy in drug use in typical foreign countries |
| REN Xiao-yue, YAN Jian-zhou, DING Rui-lin, SHAO Rong |
| Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing Jiangsu 211198, China |
| Abstract:Objective: From the link of drug use to improve China's generic drug substitution promotion policy to provide suggestions. Methods: Literature research method was used to explore the ideas and typical measures of promoting generic drug substitution in Europe, the United States, Japan and other countries. Combined with the existing problems in the process of generic drug substitution in China, specific suggestions were put forward to improve the promotion policy of generic drug substitution in the process of drug use in China. Results and conclusions: Through the experience research of Europe, the United States, Japan and other countries, it is found that typical countries outside the region have formed the idea of "accepting generic drugs-scientific and reasonable substitution-continuous feedback and improvement" in the process of promoting generic drug substitution. It is suggested that China incorporate the opinions of doctors and patients into the generic drug substitution decision-making, establish generic drug substitution rules based on risk, strengthen the real-world data research and monitoring and evaluation of generic drug substitution, strengthen the disclosure of generic drug information and policy publicity, further improve the promotion policy of generic drug substitution in the drug use process in China, and promote the alternative use of generic drugs. |
| Key words:Substitution of generic drugs Clinical use Doctor-patient preferences International experience |
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