药品风险管理手段在阿洛司琼案例中的应用  

Management measures of drug risk and its application in the case of Lotronex

作　　者：魏晶[1,2] 潘卫三[3] 杨悦[1] 

机构地区：[1]沈阳药科大学工商管理学院,沈阳110016 [2]辽宁省食品药品监督管理局技术审评中心,沈阳110003 [3]沈阳药科大学药学院,沈阳110016

出　　处：《中国新药杂志》2009年第13期1189-1192,共4页Chinese Journal of New Drugs

摘　　要：通过回顾阿洛司琼由上市到撤市,再重返市场以及随后的风险干预过程,总结阿洛司琼案例中采取的各种风险管理手段。阿洛司琼是一个风险管理的典型案例,一般监管及特殊监管甚至撤市等监管的极端手段均被采用,对我国建立风险管理制度有借鉴作用。Through reviewing the case of Lotronex that has undergone approval of marketing, withdrawal from market, return to the market and subsequent risk intervention, we summarized various risk management instruments in this case. In this representative case, the risk management, general supervision, special supervision and extremely rigorous methods, such as withdrawal, were used without exception. The management measures of drug risk will be a reference for the establishment of management system for drug risk.

关 键 词：阿洛司琼 药品风险管理 风险管理措施 

分 类 号：R95[医药卫生—药学]