【摘要】 药品说明书对保障用药安全具有重要作用。随着我国人口老龄化程度不断加深，老年人口数量持续增长，药品说明书“看不清、看不懂”等问题日显突出。2023年国家药品监督管理局出台了《药品说明书适老化及无障碍改革试点工作方案》，推动药品说明书适老化改革工作，探索提供大字版、简化版和电子版等多样化格式的药品说明书，以提升药品说明书对患者的可读性与可及性。欧盟、美国和日本在药品说明书适老化方面已形成较为成熟的体系，其经验和做法可以为我国提供有益借鉴。本文基于文献研究，梳理了欧美日在患者版药品说明书管理机制、内容设计及实践特点等方面的情况。通过对比分析发现，欧美日在患者版药品说明书管理体系方面已积累了丰富且各具特色的经验，如建立患者参与的可读性验证程序、采用多样化患者说明书类型并推行结构化电子说明书、开展适老化改革等。与欧美日相比，我国的药品说明书适老化改革工作仍处于起步阶段，任重道远。通过持续完善相关制度、推动技术创新和优化服务模式，我国将逐步探索出一条适合国情的药品说明书适老化改革路径，为老年患者提供更加优质、便捷、安全的用药信息服务。更多还原

【Abstract】 Drug instructions play a significant role in ensuring the safety of medication. With China’s aging population growing steadily, drug instructions "hard-to-read and hard-to-understand" for eldrly has become increasingly prominent. National Medical Products Administration(NMPA) launched the Pilot Work Plan for Elderly-Friendly Drug Instructions Reform in 2023, promoting elderlyfriendly adaptations of drug instructions through formats like large-print versions, simplified formats, and digital formats to enhance readability and accessibility. The EU, US, and Japan have established mature systems for elderly-friendly drug instructions, offering valuable references. Based on literature research, this article sorts out the situations of EU, US, and Japan in terms of the management mechanism, content design and practical characteristics of patient medication instructions. These countries have developed distinctive approaches in the management of patient medication instructions, such as establishing patient-involved readability verification procedures, adopting diverse instruction formats with structured digital versions, and implementing elderly-friendly reforms. The elderlyfriendly reform for drug instruction in China remain in infancy. Continuous improvements in regulations, technological innovation, and service optimization will enable to develop a tailored reform path, ultimately providing elderly patients with higher-quality, more convenient, and safer medication information services.更多还原