Page 12 - 《中国药房》2025年9期

中美日药品说明书适老化管理的对比研究
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王思懿 ，喻小勇 ，姜佳缘 ，田 侃 （1.南京中医药大学养老服务与管理学院，南京 210023；2.南京中医药大
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学养老服务与管理研究院，南京 210023）
中图分类号 R954 文献标志码 A 文章编号 1001-0408（2025）09-1030-05
DOI 10.6039/j.issn.1001-0408.2025.09.02

摘 要 目的 对比中美日三国药品说明书适老化管理的措施，为我国药品说明书适老化改革提供参考。方法 查阅我国国家药
品监督管理局、美国FDA以及日本医药品医疗器械综合机构等部门官方网站公布的相关文件，并基于中国知网、万方数据、Web
of Science等综合数据库和搜索引擎中的相关文献，了解中美日三国在药品说明书适老化管理过程中采取的措施，对中美日三国
药品说明书适老化情况进行对比分析，为我国药品说明书适老化改革提出建议。结果与结论 中美日三国在药品说明书适老化管
理过程中采取的措施侧重点不同：中国主要针对老年人对药品说明书“看不清、看不懂”问题，采用大字、简化版药品说明书；美国
在药品说明书“特殊人群”项下设立了专门的“老年用药”小节并发布了老年用药信息撰写原则；美国和日本均建立了患者版药品
说明书和医疗专业人员版药品说明书的分类管理体系，推行了结构化电子版药品说明书，构建了统一的电子说明书平台。建议我
国在药品说明书的撰写要求中加入单独针对老年人的“老年用药”小节，完善药品说明书适老化改革的激励措施，提高电子版药品
说明书的可访问性和阅读性，搭建药品说明书信息公开平台，从而更好地保障老年人用药的安全性。
关键词 药品说明书；适老化；老年人；用药安全；国际比较

Comparative analysis on elderly-friendly management of drug instructions in China， the United States and
Japan
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WANG Siyi ，YU Xiaoyong ，JIANG Jiayuan ，TIAN Kan（1. School of Elderly Care Services and Management，
Nanjing University of Chinese Medicine， Nanjing 210023， China；2. Institute of Elderly Care Services and
Management， Nanjing University of Chinese Medicine， Nanjing 210023， China）
ABSTRACT OBJECTIVE To compare the measures taken by China， the U.S. and Japan to adapt drug instructions to aging，
and provide reference for the reform of elderly-friendly drug instructions in China. METHODS The relevant documents published
by the official websites of National Medical Products Administration of China， the U.S. FDA， and Pharmaceuticals and Medical
Devices Agency of Japan， were consulted. Additionally， relevant literature from comprehensive databases such as CNKI， Wanfang
data， and Web of Science， as well as search engines， was reviewed to understand the measures taken by the above countries in
elderly-friendly management process of drug instructions. The comparative analysis was conducted for elderly-friendly adaptations of
drug instructions in China， the U. S. and Japan， and the suggestions were put forward for the reform of elderly-friendly drug
instructions in China. RESULTS & CONCLUSIONS The measures taken by China， the U. S.， and Japan in the process of elderly-
friendly management of drug labels had different emphases： China adopted large fonts and simplified drug instructions to alleviate
the problem of the elderly being unable to read and understand drug instructions； the U.S. had set up a special section for the
elderly in the drug instructions for special populations and issued the principles for writing information on medications for the
elderly. The U. S. and Japan had established a classification management system for patient instructions and professional
instructions， promoted structured electronic instructions， and built a unified electronic instructions platform. It is recommended that
China incorporate elderly-specific medication information into the writing requirements of drug instructions， improve specific
measures to encourage the reform of drug instructions suitable for the elderly， improve the accessibility and readability of electronic
drug instructions， and build a drug instruction information disclosure platform to better ensure the safety of medication for the
elderly.
KEYWORDS drug instructions； elderly-friendly； the elderly； medication safety； international comparison

Δ 基金项目 江苏省社会科学基金项目（No.24CSB003） 老年人属于疾病多发人群，通常具有共病，对药品
＊第一作者 硕士研究生。研究方向：养老政策与法规、老龄化政
的使用量大于年轻群体，存在多种药物共用情况 ，且在
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策。E-mail：wangsiyvuu@163.com
# 通信作者 教授，博士生导师，硕士。研究方向：医药卫生与养老 面对专业术语多、内容繁杂的药品说明书时存在理解困
政策法规。E-mail：tiankane@aliyun.com 难问题，导致用药时易发生药物不良反应，影响其自身

· 1030 · China Pharmacy 2025 Vol. 36 No. 9 中国药房 2025年第36卷第9期