| 引用本文：冯霄婵, 杨悦.美国鼓励仿制药替代使用政策与措施研究[J].中国卫生政策研究,2019,12(2):7-14 |
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| 美国鼓励仿制药替代使用政策与措施研究 |
| 投稿时间：2018-04-07 修订日期：2018-11-20 PDF全文浏览 HTML全文浏览 |
| 冯霄婵1, 杨悦1,2 |
1. 沈阳药科大学工商管理学院 辽宁沈阳 110016;
2. 国际食品药品政策与法律研究中心 辽宁沈阳 110016 |
| 摘要:目的：分析美国鼓励仿制药替代使用的立法过程、政策措施以及关键要素，为我国仿制药经一致性评价后制定替代使用政策提供建议。方法：通过查阅美国联邦法律、各州法律、指南文件、国内外文献等，全面分析美国鼓励仿制药替代使用的基本原则、监管理念和实施挑战。结论：美国仿制药替代法律的制定经历探索、发展和调整三个阶段。医师、药师和患者是美国各州法律鼓励仿制药替代的关键要素，联邦政府和FDA通过橙皮书、分级医保支付和开展认知教育的途径指导和影响仿制药替代。建议我国以尊重患者为基本原则，将鼓励仿制药替代写入法律，明确界定仿制药替代使用范围；建立具有替代决策支持工具的电子处方系统；加强宣传教育提高仿制药认知度。 |
| 关键词:仿制药替代 一致性评价 医保支付 仿制药认知度 |
| 基金项目:国家食品药品监督管理总局药化注册司课题（20170012）；国家卫计生委药政司课题（20170005） |
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| Analysis of policies and measures to encourage generic substitution in the United States |
| FENG Xiao-chan1, YANG Yue1,2 |
1. Business Administration School, Shenyang Pharmaceutical University, Shenyang Liaoning 110016, China;
2. International Food & Drug Policy and Law Research Center, Shenyang Liaoning 110016, China |
| Abstract:Objective:To analyze the policy-makingprocess, policies and key elements of generic substitution in the U.S, and after consistence assessment, provide recommendations for developinggeneric substitution policies in China.Methods:By reviewing the relevant federal laws, state laws, guidance documents and literature,this paper comprehensively analyzesthe basic principles, regulatory concepts and implementation challenges of the US's generic substitution.Conclusions:The generic substitution laws in the U.S. have undergone three stages:exploration, development, and adjustment. Physicians, pharmacists and patients played the mostsignificant rolesin encouraging generic substitution regulations. To conduct and promote the generic substitution, the U.S. government and FDA use Orange Book, tiered health insurance payments and public education.In this paper, it is suggested that China encourages generic substitution from a legal perspective,regards patient consent as a premise, clearly defines the scope of substitutable generic, establishes anelectronic prescribing system with alternative decision support tools, and strengthens publicity and public education to improve the public awareness of generic substitution. |
| Key words:Generic substitution Consistence assessment Tiered health insurance payments Public awareness of generic substitution |
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