| 2013～2016年国家药品不良反应监测年度报告统计分析 |
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| 引用本文： | 张彦昭,文占权,刘传绪,曹常影.2013～2016年国家药品不良反应监测年度报告统计分析[J].药物流行病学杂志,2017(11):763-765. |
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| 作者姓名： | 张彦昭 文占权 刘传绪 曹常影 |
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| 作者单位： | ①北京中医药大学管理学院（北京 100029） |
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| 摘 要： | 摘 要 目的：了解我国近年来药品不良反应/事件监测情况，分析其原因，提出建议，为加强药品不良反应/事件监测、降低药品质量风险、保障公众安全用药提供参考。方法：收集2013～2016年《国家药品不良反应监测年度报告》，对我国药品不良反应/事件报告的总体情况、基本药物监测情况、抗感染药物监测情况以及中药注射剂监测情况进行统计分析。结果：药品不良反应监测网络覆盖率逐年增加；收集的不良反应/事件报告数量也逐年增多；医疗机构是药品不良反应/事件报告的主要来源；抗感染药物不良反应报告数量仍居首位。结论：药品不良反应/事件监测事业的稳定运行是公众安全用药的有力保障，应当形成全员参与的意识，药品生产经营企业提高对上市药品的不良反应/事件监测力度；重视抗感染药物和中药注射剂的药品不良反应；关注老年人和儿童用药不良反应。
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| 关 键 词： | 药品不良反应 监测 报告 安全用药 |
Statistical Analysis of Annual Report on National Adverse Drug Reactions in 2013-2016 |
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| Zhang Yanzhao,Wen Zhanquan,Liu Chuanxu,Cao Changying.Statistical Analysis of Annual Report on National Adverse Drug Reactions in 2013-2016[J].Chinese Journal of Pharmacoepidemiology,2017(11):763-765. |
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| Authors: | Zhang Yanzhao Wen Zhanquan Liu Chuanxu Cao Changying |
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| Affiliation: | College of Management, Beijing University of Chinese Medicine, Beijing 100029, China |
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| Abstract: | ABSTRACT Objective:To analyze the situation of adverse drug reaction / event monitoring in recent years, analyze the reasons and make suggestions, then provide references for strengthening drug adverse reaction / event supervision, reducing drug quality risk and safeguarding public safety medication. Methods: The annual report on the monitoring of adverse drug reactions in China was collected from 2013 to 2016, and to analyze the overall situation, the monitoring of essential drugs, the monitoring of anti infective drugs and the monitoring of traditional Chinese medicine injections in China.Results:The number of adverse reactions/event reports increased year by year; medical institutions were the main source of adverse drug reactions/event reports; the number of anti infective drug adverse reaction reports was still the highest.Conclusion:The stable operation of drug adverse reaction / event monitoring is a strong guarantee for public safety. It should form a sense of full participation. The pharmaceutical production and operation enterprises should improve the adverse reaction / event monitoring of listed drugs; attach importance to anti infective drugs and traditional Chinese medicine injections of adverse drug reactions; concern for the elderly and children with adverse drug reactions. |
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| Keywords: | Adverse drug reaction Monitoring Report Safe medication |
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