从药用胶囊铬超标系列事件浅析如何建立我国药品安全快速预警与应急处置机制
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摘要
为进一步守住药品安全防线,做好药品安全事件快速预警和应急处置,有效防范和应对药品安全事件提供参考。回顾药用胶囊铬超标系列事件的处置过程,通过剖析药用胶囊铬超标系列事件的特点,探讨我国药品安全应急处置与预警机制。建立药品安全突发事件监测机制、风险分析与评估机制、程序启动机制、危机终止及善后评估机制、适当的舆情引导机制、明确药品安全突发事件处置中快速检测的法律地位是完善药品安全突发事件快速预警与应急处置的有效手段,可为我国的药品安全监管提供必要保障。
To further hold drug safety defense,rapid alert and emergency response should be done well for drug safety events in order to provide reference for effective prevention and response to drug safety incidents. The disposal process of the series events of medicinal capsules with excessive chromium was reviewed,and the features were analyzed to explore the emergency response and alert system for drug safety in China. To set up drug safety emergency monitoring mechanism,risk analysis and assessment mechanisms,procedures startup mechanism,crisis ending and follow-up assessment mechanism,appropriate public opinion guide mechanism,and a clear legal status of rapid test in the disposal of drug safety incidents are effective means to improve drug safety rapid alert and emergency response,which can provide necessary guarantees for drug safety and regulation.
To further hold drug safety defense,rapid alert and emergency response should be done well for drug safety events in order to provide reference for effective prevention and response to drug safety incidents. The disposal process of the series events of medicinal capsules with excessive chromium was reviewed,and the features were analyzed to explore the emergency response and alert system for drug safety in China. To set up drug safety emergency monitoring mechanism,risk analysis and assessment mechanisms,procedures startup mechanism,crisis ending and follow-up assessment mechanism,appropriate public opinion guide mechanism,and a clear legal status of rapid test in the disposal of drug safety incidents are effective means to improve drug safety rapid alert and emergency response,which can provide necessary guarantees for drug safety and regulation.
引文
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7 吴海生.食品药品安全应急处置技术支撑能力的建设与实践[J].时代教育,2015,(3):167
2 郑雅静.药品安全法律关系明晰——以药用胶囊铬超标事件为视角[J].法制与社会,2012,(10上):5-6
3编辑部.药用胶囊涉嫌铬超标[J].品牌与标准化,2012,(7):31-32
4许琳.“药用胶囊铬超标事件”被定性为劣药案[N].中国医药报,2014-04-23(001)
5 李静姿,江滨,李毅,等.药品安全预警理论研究[J].中国药房,2009,20(22):1684-1686
6 胡漾张欢之.欧美药品安全事件预警模式和我国药品安全预警工作现状[J].中国食品药品监管,2010,(12):71-72
7 吴海生.食品药品安全应急处置技术支撑能力的建设与实践[J].时代教育,2015,(3):167