| 引用本文：邵蓉, 唐吉锋.我国药品不良反应监测体系实施效果评价[J].中国卫生政策研究,2014,7(8):29-36 |
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| 我国药品不良反应监测体系实施效果评价 |
| 投稿时间：2014-07-21 修订日期：2014-08-10 PDF全文浏览 HTML全文浏览 |
| 邵蓉1,2, 唐吉锋1 |
1. 中国药科大学国际医药商学院 江苏南京 211198;
2. 国家药物政策与医药产业经济研究中心 江苏南京 211198 |
| 摘要:本文搜集1998—2013年我国药品不良反应数据，同时运用文献分析法探究我国药品不良反应监测效果的内涵，以过程、产出、结果指标体系构建药品不良反应监测体系实施效果评价概念框架。研究认为我国药品不良反应监测体系已在近几年取得了快速的发展，一定程度上运作良好，监测网络建设、审核评价效率、每百万人口报告数等效果参数表现优异，而风险控制措施、严重不良反应报告比率、不良反应报告质量、生产企业报告比等表现较差，有待进一步完善提高。 |
| 关键词:药品不良反应 药品安全性监测 效果评价 |
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| The effect evaluation of adverse drug reaction monitoring system in China |
| SHAO Rong1,2, TANG Ji-feng1 |
1. School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing Jiangsu 211198, China;
2. The Research Center of National Drug Policy & Ecosystem, Nanjing Jiangsu 211198, China |
| Abstract:The Literature analysis method was adopted to evaluate the adverse drug reaction(ADR) monitoring system in China. The conceptual framework was built including process, output and outcome. ADR data from 1998 to 2013 were collected from the National ADR Information Bulletin and Annual Report of National ADR Monitoring. China's ADR monitoring system had achieved rapid progress in recent years and functioned well to some extent. Some parameters such as monitoring network construction, efficiency of evaluation and ADR reports per million populations showed outstanding performance. Others such as risk control measures, the ratio of serious ADR reports, and quality of ADR reports showed poor effects, which needed further improvements. |
| Key words:Adverse drug reactions Drug safety monitoring Effect evaluation |
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