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目的:基于WHO构建的药物警戒体系视角,分析我国的药物警戒体系状况,为完善我国药物警戒体系提供参考建议。方法:通过分析WHO药物警戒的框架体系的构成要素、结构关系、范围和干预措施等内容,比较分析我国目前药物警戒体系的现状和差异。结果:我国药物警戒的管理结构体系基本符合WHO的评价标准,目前采取的药品质量保证、不良反应监测和主要的药品风险交流的措施大部分符合WHO的要求。然而,我国的药物警戒体系在以下方面存在不足:1缺乏对药品不良反应和临床不合理用药的监测协调机制;2我国药物警戒规范体系还尚未把最小化患者用药风险作为根本目的;3用药差错的监测体系不完善;4用药安全文化教育缺乏,药品风险控制意识弱。结论:通过对比WHO框架下的药物警戒体系,我国目前还需要从警戒管理范围、风险管理流程、预警法律体系、风险交流方式和用药安全文化教育等方面进行完善,促进主动参与式的药品安全保障体系的建设。
OBJECTIVE: To analyze the status of drug alert system in China based on the perspective of drug alert system constructed by WHO, and to provide reference for improving the alert system in China. Methods: By analyzing the components, structure, scope and interventions of the WHO Pharmacovigilance Framework, the status quo and differences of the current drug vigilance system in our country are comparatively analyzed. Results: The system of drug alert management in our country basically conformed to the evaluation criteria of WHO. At present, most of the measures taken to ensure drug quality assurance, adverse reaction monitoring and major drug risk exchange meet WHO requirements. However, the system of drug alert in our country is deficient in the following aspects: 1, there is a lack of coordination mechanism for the monitoring of adverse drug reaction and clinical irrational drug use; 2 the drug risk regulatory system in our country has not yet taken the minimum risk of drug administration as the fundamental purpose; 3, The monitoring system is imperfect; 4 drug safety culture and lack of education, awareness of drug risk control is weak. Conclusion: By comparing the drug alert system under the WHO framework, our country still need to improve from the aspects of alert management scope, risk management process, early warning legal system, risk communication mode and drug safety culture education so as to promote active participatory drug safety and security System construction.