药品质量管理及控制标准制订与解析  

Formulation and Analysis on the Standard of Drug Quality Management and Control

作　　者：胡琴 刘韶[1,2] 黄品芳 陆进[4] 罗平[1,2] 曾大勇 龚志成[1,2] 甄健存[5,6] HU Qin;LIU Shao;HUANG Pinfang;LU Jin;LUO Ping;ZENG Dayong;GONG Zhicheng;ZHEN Jiancun(Department of Pharmacy,Xiangya Hospital,Central South University,Changsha 410000,China;National Clinical Research Center for Geriatric diseases(Xiangya);Department of Pharmacy,the First Affiliated Hospital of Fujian Medical University,Fuzhou 350004,China;Department of Pharmacy,China-Japan Friendship Hospital,Beijing 100029,China;Department of Pharmacy,Beijing Jishuitan Hospital,Capital Medical University,Beijing 100035,China;Pharmaceutical Specialized Committee,Chinese Hospital Association,Beijing 100035,China)

机构地区：[1]中南大学湘雅医院药学部,长沙410000 [2]国家老年疾病临床医学研究中心(湘雅),长沙410000 [3]福建医科大学附属第一医院药学部,福州350004 [4]中日友好医院药学部,北京100029 [5]首都医科大学附属北京积水潭医院药学部,北京100035 [6]中国医院协会药事专业委员会,北京100035

出　　处：《医药导报》2023年第10期1469-1472,共4页Herald of Medicine

基　　金：湖南省自然科学基金联合基金项目(2022JJ80045)。

摘　　要：药品质量管理及控制是医疗机构药事管理的重要内容,加强医疗机构药品质量管理及控制有助于提升医疗质量,从而为患者的用药安全提供有力的保障。为实施同质化的药品质量管理及控制,编制团队以科学性、通用性、指导性和可操作性为编写原则,通过梳理问题、征集意见、专家论证审议,最终形成国内首部对药品质量管理及控制全过程进行规范的团体标准。该文阐述药品质量管理及控制标准制订过程,并对标准内容进行解析,以期为各级各类医疗机构开展药品质量管理及控制提供建议和指导。Drug quality management and control is an important part of hospital pharmacy administration.Strengthening drug quality management and control in medical institutions can help improve medical quality and provide strong guarantees for patient medication safety.In order to implement homogeneous drug quality management and control,we sorted out problems,solicited opinions,and convened expert argumentation meetings,finally formed the first group standard in China to regulate the entire process of drug quality management and control adhered to the principles of scientificity,universality,guidance,and operability.This article elaborates on the process of formulating drug quality management and control standards,and analyzes the content of the standards in order to provide suggestions and guidance for various medical institutions at all levels to carry out drug quality management and control.

关 键 词：药品质量 药事管理 药品质量管理及控制 

分 类 号：R951[医药卫生—药学]