药品风险控制中风险沟通的研究  

Study on Risk Communication in Drug Risk Control

作　　者：葛楠 向玉梅 罗兴洪[2] GE Nan;XIANG Yu-mei;LUO Xing-hong(Hainan Simcere Pharmaceutical Co.,Ltd.;Jiangsu Simcere Pharmaceutical Co.,Ltd.State Key Laboratory of Translational Medicine and Innovative Drug Development)

机构地区：[1]海南先声药业有限公司 [2]江苏先声药业有限公司转化医学与创新药物国家重点实验室

出　　处：《中国食品药品监管》2023年第6期54-59,共6页China Food & Drug Administration Magazine

摘　　要：药品风险管理是一个动态管理过程,贯穿于药品全生命周期。对于已识别出的风险或可能严重危害公众健康的潜在风险,应当采取适宜的风险控制措施。风险控制措施包括常规风险控制措施和特殊风险控制措施。本文重点描述特殊风险控制措施中的风险沟通,介绍和分析风险沟通相关法规、指南及我国风险沟通的现状,探讨以更好的方式,最大程度地保障公众用药安全。Drug risk management is a dynamic management process that runs through the entire life cycle of drugs.Appropriate risk control measures should be implemented for identified risks or potential risks that may seriously endanger public health.Risk control measures encompass both conventional and special risk control measures.This paper focuses on risk communication in special risk control measures,analyzes relevant regulations,guidelines,and the status quo of risk communication in China.The aim is to explore more effective ways to maximize patient safety in medication usage.

关 键 词：药品风险控制 风险沟通 风险管理 用药安全 

分 类 号：R95[医药卫生—药学]