药品安全与风险管理

Drug Safety and Drug Risk Management

目的:保障用药安全,降低用药风险。方法:根据风险管理的基本原理,借鉴欧美实践,对药品风险管理的内容、药品安全与药品风险的关系和药品风险因素的类型等进行分析,并提出建议。结果与结论:引入风险管理可促进我国药品全过程安全管理的规范化与标准化,最大化药品的收益,最小化药品的风险。

OBJECTIVE： To ensure drug use safety and lower druginduced risks. METHODS： Based on risk management theory and USA-EU drug risk management system, we analyzed the contents of drug risk management, the relationship between drug safety and drug risk, and the classification of drug - risk factors etc. And some suggestions were put forward. RESULT ＆ CONCLUSION： The introduction of drug - risk management system can help facilitate the normalization and standardization of drug safety control, maximize drug benefit and minimize drug risk.