安徽省药品不良事件聚集性信号分析
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摘要
目的探讨药品不良事件聚集性信号产生的规律和原因,分析药品使用环节潜在的风险和问题,为药品风险预警工作提供参考。方法对2014～2017年国家预警系统共享平台中安徽省产生的804条药品不良事件聚集性信号进行统计与分析。结果聚集性信号涉及的药品主要为注射剂和抗肿瘤药,其中严重报告产生的信号较多,信号主要集中在每年的第四季度,主要受预警规则、报告数量、报告习惯、报告质量等因素的影响。结论药品不良事件聚集性信号监测与处置工作的开展,能够及时发现药品上市后可能存在的风险和问题,提高药品安全事件的响应能力,有效发挥了风险防控的作用。
Objective To explore the regularity and cause of cluster signals of the adverse drug events and analyze the potential risks and problems in the use of drugs, so as to provide reference for the drug safety warning in the work.Methods Cluster signals of 804 cases of adverse drug events were summerized and analyzed from 2014 to 2017 in Anhui province. Results The mainly drugs involved in cluster signals were injections and antitumor drugs, in which more severe signals were reported. Distribution of events was concentrated in the fourth quarter of each year, the main factors were warning rules, number of reports, reporting habits, reporting quality and others. Conclusion The monitoring and handling of cluster signals of the adverse drug events can timely find the possible risk and problems.It also can improve the responsiveness of drug safety incidents, and effectively play the role of risk prevention and control.
Objective To explore the regularity and cause of cluster signals of the adverse drug events and analyze the potential risks and problems in the use of drugs, so as to provide reference for the drug safety warning in the work.Methods Cluster signals of 804 cases of adverse drug events were summerized and analyzed from 2014 to 2017 in Anhui province. Results The mainly drugs involved in cluster signals were injections and antitumor drugs, in which more severe signals were reported. Distribution of events was concentrated in the fourth quarter of each year, the main factors were warning rules, number of reports, reporting habits, reporting quality and others. Conclusion The monitoring and handling of cluster signals of the adverse drug events can timely find the possible risk and problems.It also can improve the responsiveness of drug safety incidents, and effectively play the role of risk prevention and control.
引文
[1]山东省食品药品监督管理局.山东省药品不良事件聚集性信号监测处置工作程序(暂行)[EB/OL].(2017-05-12)[2018-10-01].http://www.dyadr.org.cn/show/637.html.
[2]国家食品药品监督管理总局.国家药品不良反应监测年度报告(2014年)[EB/OL].(2015-07-17)[2018-10-01].http://www.sda.gov.cn/WS01/CL0078/124407.html.
[3]国家食品药品监督管理总局.国家药品不良反应监测年度报告(2015年)[EB/OL].(2016-07-13)[2018-10-01].http://www.sda.gov.cn/WS01/CL0844/158940.html.
[4]国家食品药品监督管理总局.国家药品不良反应监测年度报告(2016年)[EB/OL].(2017-04-28)[2018-10-01].http://www.sda.gov.cn/WS01/CL0844/172167.html.
[5]国家食品药品监督管理局.国家药品不良反应监测年度报告(2017年)[EB/OL].(2018-04-10)[2018-10-01].http://duyaonet.com/News/Detail/7886.
[6]冯红云,杨乐,宋秋洁,等.建设基于药品不良反应监测的聚集性不良事件预警体系的设想和实践[J].中国药物警戒,2015,12(11):665-668.
[7]冯红云,葛文超,夏旭东,等.聚集性药品不良事件预警系统共享平台的建设和实践[J].中国药物警戒,2015,12(12):727-730.
[8]冯红云,侯永芳,吴桂芝,等.药品不良事件聚集性信号预警系统的建立和运行[J].中国药物警戒,2012,9(12):745-748.
[9]中华人民共和国卫生部.药品不良反应报告和监测管理办法[S].中华人民共和国卫生部令第81号.2011-05-04.
[10]田春华,杜晓曦.论我国药品不良反应监测工作几点进展[J].药物流行病学杂志,2014,32(1):1-4.
[11]冯红云,刘佳,董铎,等.影响聚集性药品不良事件预警系统运行的风险因素分析及思考[J].中国药物警戒,2016,13(4):219-222.
[2]国家食品药品监督管理总局.国家药品不良反应监测年度报告(2014年)[EB/OL].(2015-07-17)[2018-10-01].http://www.sda.gov.cn/WS01/CL0078/124407.html.
[3]国家食品药品监督管理总局.国家药品不良反应监测年度报告(2015年)[EB/OL].(2016-07-13)[2018-10-01].http://www.sda.gov.cn/WS01/CL0844/158940.html.
[4]国家食品药品监督管理总局.国家药品不良反应监测年度报告(2016年)[EB/OL].(2017-04-28)[2018-10-01].http://www.sda.gov.cn/WS01/CL0844/172167.html.
[5]国家食品药品监督管理局.国家药品不良反应监测年度报告(2017年)[EB/OL].(2018-04-10)[2018-10-01].http://duyaonet.com/News/Detail/7886.
[6]冯红云,杨乐,宋秋洁,等.建设基于药品不良反应监测的聚集性不良事件预警体系的设想和实践[J].中国药物警戒,2015,12(11):665-668.
[7]冯红云,葛文超,夏旭东,等.聚集性药品不良事件预警系统共享平台的建设和实践[J].中国药物警戒,2015,12(12):727-730.
[8]冯红云,侯永芳,吴桂芝,等.药品不良事件聚集性信号预警系统的建立和运行[J].中国药物警戒,2012,9(12):745-748.
[9]中华人民共和国卫生部.药品不良反应报告和监测管理办法[S].中华人民共和国卫生部令第81号.2011-05-04.
[10]田春华,杜晓曦.论我国药品不良反应监测工作几点进展[J].药物流行病学杂志,2014,32(1):1-4.
[11]冯红云,刘佳,董铎,等.影响聚集性药品不良事件预警系统运行的风险因素分析及思考[J].中国药物警戒,2016,13(4):219-222.