中美药品风险沟通应用的对比分析——基于罗格列酮案例  

Comparison of the application of drug risk communication between America and China based on the case of rosiglitazone

作　　者：朱虹[1] 刘兰茹[1] 兰恭赞[2] 张小波[3] 韩月[1] 

机构地区：[1]哈尔滨医科大学人文社会科学学院,哈尔滨150086 [2]哈尔滨医科大学药学院,哈尔滨150086 [3]哈尔滨医科大学附属第四医院老年病科,哈尔滨150001

出　　处：《中国新药杂志》2016年第10期1089-1094,共6页Chinese Journal of New Drugs

基　　金：黑龙江省教育厅2013年度人文社会科学面上项目:药品不良反应损害法律救济的探索与研究(12532215)

摘　　要：罗格列酮与心血管损伤的安全性问题广受关注。本文通过回顾中美两国药品监督管理部门对罗格列酮的风险管理事件,收集并整理罗格列酮风险信息、风险管理及风险沟通等信息,对比两国药品风险沟通应用的差异。两国在沟通主体及对象、沟通方式、沟通内容三方面均存在差异。我国应当以美国药品风险沟通应用为借鉴,积极关注并正确宣导药品的风险和效益信息,基于循证结果,确定风险沟通决策及内容,鼓励制药企业主动参与,合理实施风险沟通的措施,保障公众用药安全。The attention has been paid widely to the safety issues on rosiglitazone and cardiovascular damage. To analyze post-marketing risk management of rosiglitazone in America and China,the information about rosiglitazone＇s risk,risk management and risk communication was collected,and the application of drug risk communication between two countries was compared. There were some differences in the three aspects of communication,namely subjects,objects and manners,and contents. We should pay positive attention to and correct information of the drug risks and benefits,and make decision based on data and evidence. Pharmaceutical companies should be encouraged to actively participate in risk communication,and make the reasonable implementation of risk communication to ensure the safety of drug use in public. American drug risk communication application was used as the reference.

关 键 词：罗格列酮 风险沟通 风险效益 风险管理 

分 类 号：R95[医药卫生—药学]