摘要
目的对国家药品不良反应监测中心已发布的22期《药品不良反应信息通报》警戒信息中涉及的品种及风险点进行了梳理,并对我国已尝试开展的药品风险控制措施进行了系统分析。方法探讨了针对药品风险因素我国从药品生命周期不同阶段和药品风险效益评估两个不同角度已采取的多种药品风险控制模式,提出积极开展药品上市后研究并制定相关技术指南、出台上市后评价法规并制定技术评价规范、制定相对统一共同遵循的风险控制原则和尺度。结果与结论逐步建立符合我国国情的药品风险管理模式是今后药品风险管理研究的内容及方向。
Objective To promote the establishment of risk management of medicines with China＇s national conditions. Methods This Article reviewed the varieties and risks presented in the 22 issues of published ADVERSE DRUG REACTION INFORMATION BULLETIN, systematically analyzed the drug risk management in China and discussed two different patterns of drug risk control according to the stages of life period and benefit evaluation of medicine. Results and Conclusions We propose a model of gradual establishment of the medical risk management pattern that fits to the situation of China, including the development of post marketed study and concerning guidelines, evolutional technological protocols and standardized common principles.
出处
《中国药事》
CAS
2009年第8期735-739,751,共6页
Chinese Pharmaceutical Affairs
关键词
药物警戒
信息通报
风险管理
上市后评价
pharmacovigilance
information bulletin
risk management
post--marketed evaluation
