- Journal Information
- Archive
- Submission
- For Reviewers
- Statement and Policies
- 个人中心
- 退出登录
浏览全部资源
扫码关注微信
- Journal Information
- Journal Introduction
- Editorial Board
- Youth Editorial Board
- Editorial Board Charter
- Subscriptions
- Archive
- Current Issue
- Past Issues
- Priority Publication
- Virtual Collection
- Recommended Articles
- Submission
- Submission Process
- Submission Guidelines
- Download
- Contact us
- For Reviewers
- Guidelines for Reviewers
- Peer Reviewed Policies
- Statement and Policies
- Ethics and Malpractice
- Research Ethics Policies
- Repetition Detection
- Corrections and Retractions
- Editorial Policies
- Open Access Statement
- Website Responsibility
Comparative analysis on elderly-friendly management of drug instructions in China， the United States and Japan
- ZHONGGUO YAOFANG Vol. 36, Issue 9, Pages: 1030-1034(2025)
- 作者机构：
1.南京中医药大学养老服务与管理学院，南京 210023
2.南京中医药大学养老服务与管理研究院，南京 210023
- 作者简介：
- 基金信息：
DOI：10.6039/j.issn.1001-0408.2025.09.02
CLC： R954Received：23 November 2024，
Revised：2025-03-20，
Accepted：21 March 2025，
Published：15 May 2025
- 稿件说明：
移动端阅览
王思懿,喻小勇,姜佳缘,等.中美日药品说明书适老化管理的对比研究 [J].中国药房,2025,36(09):1030-1034.
WANG Siyi,YU Xiaoyong,JIANG Jiayuan,et al.Comparative analysis on elderly-friendly management of drug instructions in China， the United States and Japan[J].ZHONGGUO YAOFANG,2025,36(09):1030-1034.
王思懿,喻小勇,姜佳缘,等.中美日药品说明书适老化管理的对比研究 [J].中国药房,2025,36(09):1030-1034. DOI： 10.6039/j.issn.1001-0408.2025.09.02.
WANG Siyi,YU Xiaoyong,JIANG Jiayuan,et al.Comparative analysis on elderly-friendly management of drug instructions in China， the United States and Japan[J].ZHONGGUO YAOFANG,2025,36(09):1030-1034. DOI： 10.6039/j.issn.1001-0408.2025.09.02.
摘要
目的
2
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
2
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
2
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。
Abstract
OBJECTIVE
2
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
2
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
2
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.
关键词
Keywords
references
姜雪 ， 刘兰茹 ， 朱虹 ， 等 . 国外药物管理系统对我国老年用药管理的启示 [J ] . 医药导报 ， 2020 ， 39 （ 8 ）： 1166 - 1169 .
马慧艳 ， 赵志刚 ， 乔春凤 ， 等 . 河南省城镇老年慢病患者居家用药安全及影响因素研究：一项横截面调查 [J ] . 医药导报 ， 2024 ， 43 （ 12 ）： 1951 - 1957 .
国家药品监督管理局 . 国家药监局关于发布《药品说明书适老化及无障碍改革试点工作方案》的公告 [EB/OL ] .（ 2023-10-31 ）[ 2025-03-12 ] . https：//www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20231031153424162.html https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20231031153424162.html .
卢志坚 ， 范伟义 ， 宗申 . 看不清的药品说明书，谁来管？ [N ] . 检察日报 ， 2023-05-25 （005）.
李茜茜 ， 陆浩 ， 武明芬 ， 等 . 基于Web of Science的药品说明书适老化研究文献计量学分析 [J ] . 中国药房 ， 2024 ， 35 （ 2 ）： 231 - 236 .
唐张 ， 胡方 . 药品说明书适老化改造行政公益诉讼办案启示 [J ] . 中国检察官 ， 2023 （ 22 ）： 61 - 63 .
FDA . Specific requirements on content and format of labeling for human prescription drugs； addition of “Geri- atric use” subsection in the labeling [EB/OL ] .（ 1997-08-27 ）[ 2025-03-12 ] . https：//www.federalregister.gov/documents/1997/08/27/97-22701/specific-requirements-on-content-and-format-of-labeling-for-human-prescription-drugs-addition-of https://www.federalregister.gov/documents/1997/08/27/97-22701/specific-requirements-on-content-and-format-of-labeling-for-human-prescription-drugs-addition-of “geriatric use” subsection in the labeling.
萧惠来 . 美国食品药品管理局（FDA）对药品说明书中老年用药信息的要求及启示 [J ] . 药物评价研究 ， 2021 ， 44 （ 2 ）： 305 - 313 .
程凯 ， 张伊楠 ， 许瑞 ， 等 . 中、美药品说明书老年信息相关指南和政策的差异分析 [J ] . 临床药物治疗杂志 ， 2025 ， 23 （ 1 ）： 1 - 6 .
FDA . Geriatric information in human prescription drug and biological product labeling guidance for industry [EB/OL ] .（ 2019-09-16 ）[ 2024-11-10 ] . https：//www.fda.gov/media/142162/download https://www.fda.gov/media/142162/download .
郭小弦 ， 申欣悦 ， 李晓光 . 共享数字时代的福祉：互联网使用与老年人生活满意度 [J ] . 宁夏社会科学 ， 2023 （ 5 ）： 156 - 165 .
FDA . Providing regulatory submissions in electronic format：drug establishment registration and drug listing [EB/OL ] .（ 2009-06-01 ）[ 2025-03-28 ] . https：//www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-drug-establishment-registration-and-drug-listing https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-drug-establishment-registration-and-drug-listing .
郑妤婕 ， 蒋蓉 ， 陈艺瑄 ， 等 . 电子药品说明书的国际实践及经验启示 [J ] . 中国药房 ， 2024 ， 35 （ 17 ）： 2061 - 2067 .
厚生労働省 . 医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律施行規則 [EB/OL ] .（ 2020-09-29 ）[ 2024-11-22 ] . https：//www.mhlw.go.jp/web/t_doc-dataId=81006000&dataType=0 https://www.mhlw.go.jp/web/t_doc-dataId=81006000&dataType=0 .
厚生労働省 . 医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律等の一部を改正する法律の公布について [EB/OL ] .（ 2019-12-04 ）[ 2024-11-22 ] . https：//www.mhlw.go.jp/web/t_docdataId=00tc4641&dataType=1&pageNo=1 https://www.mhlw.go.jp/web/t_docdataId=00tc4641&dataType=1&pageNo=1 .
唐菀晨 ， 顾淼 . 浅谈电子药品说明书 [J ] . 中国食品药品监管 ， 2023 （ 9 ）： 98 - 103，186 .
李海琦 ， 蒋蓉 ， 郑妤婕 ， 等 . 日本电子药品说明书管理实践及启示 [J ] . 中国新药与临床杂志 ， 2024 ， 43 （ 12 ）： 904 - 910 .
FDA . E 7 studies in support of special populations：geri- atrics questions and answers [EB/OL ] .（ 2012-02-14 ）[ 2025-03-12 ] . https：//www.fda.gov/files/drugs/published/E7-Studies-in-Support-of-Special-Populations-Geriatrics-Questions-and-Answers.pdf https://www.fda.gov/files/drugs/published/E7-Studies-in-Support-of-Special-Populations-Geriatrics-Questions-and-Answers.pdf .
丛端端 ， 耿莹 ， 李强 ， 等 . 新药研发与临床研究中对于老年人群的若干考虑 [J ] . 中国医药工业杂志 ， 2024 ， 55 （ 9 ）： 1282 - 1288 .
文丽娟 ， 高紫琦 . 药品说明“适老化”改造还得加把劲 [N ] . 法治日报 ， 2024-12-25 （004）.
0
Views
32
下载量
0
CSCD
- L-PDFDownload
- WORDDownload
- Meta-XMLDownload
- BibTeXDownload
- EndnoteDownload
- RefMan Download
- NoteExpressDownload
- NoteFirstDownload
Publicity Resources
Related Articles
Related Author
Related Institution
- Address：8th Floor, Sihuan Building, No. 129 Daping Main Street, Yuzhong District, Chongqing, China Postal code：400042
- Technical support is provided by Beijing Founder Electronics co., LTD 渝ICP备15012710号
公网安备50010302001817 - It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
- Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.