摘要
目的以我国药品不良反应信息通报制度建立为背景,结合药品不良反应监测工作的阶段特点,重点分析被通报品种的监管历程,并从具体实施的行政举措展示药品风险管理的效应。方法以被通报的具体品种为线索,重点采用文献调研、系统分析的方法进行论述性阐述。结果对被通报品种在不同阶段所采取的风险管理措施与当时社会、政策以及工作背景密切相关。结论药品风险管理是一个复杂、艰巨和渐进性的工作。
Objective Combining with the characteristics of the work of ADR monitoring in different historic period, this article analyzes the process of surveillance on the background of establishing the system of ADlk Information Bulletin. And it shows the results of risk management by specific administrative measures on every drug. Methods The drugs in the Information Bulletin are as the clue, the article does to discuss the issued drugs and risk management by literature review and systematic analysis. Results The measures of risk management on issued drugs are highly relative with the society, policy and monitoring background at that time. Conclusion Drugs risk management is a complicated and tough protracted work.
出处
《中国药物警戒》
2008年第5期261-264,共4页
Chinese Journal of Pharmacovigilance
关键词
药品
不良反应
信息通报
风险管理
drugs
adverse reaction
information bulletin
risk management
