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| 基于WHO概念框架视角的我国药物警戒体系现状分析 |
| Analysis of Pharmacovigilance System of China Based on a Perspective of WHO Pharmacovigilance System Framework |
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| DOI： |
| 中文关键词: 世界卫生组织 药物警戒体系 药品风险管理 安全文化 |
| 英文关键词:WHO Pharmacovigilance system Drug risk management Safety culture |
| 基金项目:国家自然科学基金项目(编号：71373089) |
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| 摘要点击次数: 1061 |
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| 中文摘要: |
| 摘 要 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。 |
| 英文摘要: |
| ABSTRACT Objective:To know and perfect the current pharmacovigilance system of China based on the framework of WHO pharmacovigilance system. Methods: Analyzing the framework and structure relationship and activity scope and intervention measures in the WHO pharmacovigilance system and comparing the differences between China and WHO. Results:Basic management structure system of pharmacovigilance in China is in line with WHO evaluation criteria. Most of current measures of ensuring the quality of drugs, monitoring of drug adverse reactions and major means of drug risk communication meet the requirements of the WHO. There are four main differences in China: ① The coordination mechanism of adverse drug reactions and clinical irrational drug use monitoring is lacking；② The pharmacovigilance system has not been standardized to minimize the risks of patient medication as the fundamental purpose；③ The monitoring system of medication errors imperfect； ④ Most of people lack the professional education of safety culture and awareness of drug risk control. Conclusion:Based on the pharmacovigilance system under the WHO framework, China was still the need for improving the existing system from many aspects of management scope， risk management procedure, law system of pharmacovigilance, risk communication means and education of drug safety culture, and promoting the engagement of drug safety system building. |
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