《药品质量问题处置标准》制订与解析  

Formulation and Explanation of the Standard for Drug Quality Problems Handling

作　　者：杨佳丹[1] 陈永庆 蒙龙[1] 陆进[2] 罗子琅 邱峰[1] 甄健存 YANG Jiadan;CHEN Yongqing;MENG Long;LU Jin;LUO Zilang;QIU Feng;ZHEN Jiancun(Department of Pharmacy,the First Affiliated Hospital of Chongqing Medical University,Chongqing 400016,China;Department of Pharmacy,China-Japan Friendship Hospital,Beijing 100029,China;Pharmaceutical Specia-lized Committee,Chinese Hospital Association,Beijing 100035,China;Department of Pharmacy,Beijing Jishuitan Hospital,Capital Medical University,Beijing 100035,China)

机构地区：[1]重庆医科大学附属第一医院药学部,重庆400016 [2]中日友好医院药学部,北京100029 [3]中国医院协会药事专业委员会,北京100035 [4]首都医科大学附属北京积水潭医院药学部,北京100035

出　　处：《医药导报》2025年第5期708-711,共4页Herald of Medicine

基　　金：重庆市卫生适宜技术推广项目(2025cgjstg-001)。

摘　　要：药品质量问题严重威胁患者的生命健康。药品质量问题处置是医疗机构药事管理的重要内容,加强医疗机构药品质量问题处置管理能为患者的用药安全提供有力保障。《药品质量问题处置标准》由中国医院协会药事专业委员会牵头编制,编制方法及流程包括问题梳理、框架建立、初稿撰写、意见征集、专家论证审议和标准形成。《药品质量问题处置标准》规范了医疗机构药品质量问题处置工作中的基本要求、应对策略、质量控制与持续改进各要素。该文对《药品质量问题处置标准》的制订方法和内容进行阐述,以期为医疗机构进行药品质量问题处置工作提供参考。Drug quality problems seriously threaten the life and health of patients,drug quality problems handling is an important part of pharmaceutical management in medical institutions,and strengthening the management of drug quality problems in medical institutions can provide a strong guarantee for drug safety of patients.This standard was compiled by the Pharmaceutical Affairs Commission of the Chinese Hospital Association,and the process included problems identification,framework development,manuscript writing,opinions gathering,expert argumentation and deliberation,and standards development.The standard regulates the basic requirements,coping strategies,quality control and continuous improvement of drug quality problems handling in medical institutions.This article elaborates on the methods and contents of formulating standards for drug quality problems handling,to provide reference and inspiration for medical institutions to carry out drug quality problems handling.

关 键 词：药品质量问题处置 药事管理 标准制订 标准解析 

分 类 号：R951[医药卫生—药学]