欧美药品适老化体系研究及对我国的启示  

Drug Elderly-Oriented System in Europe Union and the United States and Reference to Our Country

作　　者：张伊楠 李新辰[1] 武明芬 李鹤 吴汀溪 赵志刚[1,2] ZHANG Yi-nan;LI Xin-chen;WU Ming-fen;LI He;WU Ting-xi;ZGAO Zhi-gang(Department of Pharmacy,Beijing Tiantan Hospital,Capital Medical University;Department of Clinical Pharmacy,School of Pharmaceutical Science,Capital Medical University)

机构地区：[1]首都医科大学附属北京天坛医院药学部 [2]首都医科大学药学院临床药学系

出　　处：《中国食品药品监管》2024年第9期104-111,共8页China Food & Drug Administration Magazine

摘　　要：随着我国老龄化程度日益加深,完善老年人健康支撑体系具有重要意义。药品适老化是老年人健康支撑体系的重要部分,目前我国的药品适老化体系尚处于发展阶段。本研究通过查阅美国和欧盟的药品监管部门网站,总结了其药物临床研究适老化和药品说明书适老化相关法规、指南和实施情况,发现欧美均关注到老年患者在用药方面的独特性,并通过法规、指南等鼓励支持临床研究纳入能代表实际使用群体的老年受试者进行充分的研究,通过规定说明书“老年用药”项的内容、设立患者使用说明书等改善老年用药相关信息的可及性与可读性,更好地满足老年群体在药物评价和药物信息沟通方面的需要。我国在完善药品适老化体系方面可以借鉴相关经验,如鼓励临床研究纳入恰当的老年受试者、开发患者药品使用说明书、完善电子药品说明书公开制度等,推动老年群体药物研究、药物信息可读性与可及性的发展,促进老年群体合理用药。With the increasing aging population in China,improving the health support system for the elderly has become of great significance.An elderly-oriented drug system is an important part of this health support framework.Currently,China's elderly-oriented drug system is still under development.This study reviews the websites of drug regulatory authorities in the United States and European Union,summarizing regulations,guidelines,and implementations pertaining to clinical drug research and drug labeling for older adults.The findings reveal that both the U.S.and Europe recognize the unique aspects of medication use among elderly patients.Through regulatory guidelines,they encourage and support clinical research that includes older subjects representative of the population using these drugs.Furthermore,by stipulating specific sections on“Geriatric Use”in drug labels and establishing patient medication information,they enhance the accessibility and readability of drug information about the elderly,thus better meeting the needs of this population in drug evaluation and communication.China can learn from these practices to improve its elderly-oriented drug system by encouraging the inclusion of appropriate older populations in clinical research,developing patient-friendly drug labels,and improving electronic label disclosure systems.These measures will promote advancements in geriatric drug research,improve the accessibility and readability of drug information,and ultimately foster rational medication use among older adults.

关 键 词：适老化 药物临床研究 药品说明书 老年人群 老龄化 

分 类 号：R95[医药卫生—药学]