从美国处置来氟米特看我国药品风险管理现状

美国药品风险管理模式是一个围绕风险与利益评估、风险最小化以及利益最大化的重复过程，连续贯穿于一个产品的周期之中。通过剖析美国对来氟米特的风险管理过程，从法律法规、技术监测水平、国产药品现状等方面，阐述我国药品风险管理的现状，提出开展药品风险管理必须从宏观和微观上下功夫，宏观上要抓紧法律法规的建设和完善，撑起法律的空间；微观上，在现有药品不良反应监测工作基础上，从流行病学研究角度，不断细化和规范各项操作规程，统一标准，使药品风险管理科学化、法制化。

Analysis on the Status Quo of Drug Risk Management in China from the Leflunomide Event

As we all know,the model of drug risk management in USA is a repeating process which includes risk/benefit ratio,minimized risk and maximized benefit. And it permeates through the life cycle of drug. This article analyzed the status quo (SQ) of drug risk management in China in terms of legislations,regulations,monitoring level and SQ of drug from the leflunomide event. The conclusion is that drug risk management includes macroscopical and microscopical sides: one side,the legislations and regulations should be consummated as early as possible; on the other hand,based on the existing ADR monitoring system,zooming and standardizing the regulations on pharmacoepidemiology to make drug risk management scientific and jural.