中国药物警戒 ›› 2016, Vol. 13 ›› Issue (6): 344-346.

• 法规与管理研究 • 上一篇    下一篇

基于报告数量和质量分析基层药品不良反应监测工作现状

班炳坤, 韦敬土, 李二平, 周黎, 孙蓉*   

  1. 黔南州药品不良反应监测与评价中心,贵州 都匀 558000
  • 收稿日期:2016-07-22 修回日期:2016-07-22 出版日期:2016-06-20 发布日期:2016-07-22
  • 通讯作者: 孙蓉,女,本科,副主任药师,药品不良反应监测与评价。 E-mail: sunrong423@163.com
  • 作者简介:班炳坤,女,硕士,主管药师,药品不良反应监测与评价。

Status Analysis of the Adverse Drug Reaction Monitoring Work Basing on the Quantity and Quality of ADR Reports

BAN Bing-kun, WEI Jing-tu, LI Er-ping, ZHOU Li, SUN Rong*   

  1. Center for ADR Monitoring of Qiannan, Guizhou Duyun 558000, China
  • Received:2016-07-22 Revised:2016-07-22 Online:2016-06-20 Published:2016-07-22

摘要: 目的 了解基层药品不良反应监测工作现状,为提高监测工作水平提供数据参考。方法 采用回顾性研究方法,对2015年度贵州省苗族布依族自治地区内收集的报告数量和质量进行分析,查找监测工作存在的问题。结果 报告数量、新的一般和严重报告数逐年增长,百万人口报告数达2 800份;月度报告均衡性、一般不良反应报告及时性、监测机构评价及时性较好,但报告来源结构欠佳、新的和严重报告平均上报时限不符合法规要求、新的报告类型判断准确率不高。结论 基层监测工作取得较大进展,监测体系基本健全,但报告质量仍存在诸多问题,药品不良反应监测工作还需向纵深发展。

关键词: 药品不良反应, 监测, 报告数量, 报告质量, 分析

Abstract: Objective To investigate the status of adverse drug reaction (ADR) at the grass-roots, so as to provide data reference for improving the level of monitoring work. Methods By adopting the method of retrospective study, the quantity and quality of ADR reports in 2015 from Miao and Buyi Autonomous Prefecture of Guizhou province were analyzed to find the problems in the monitoring work. Results The amount of ADR increased year by year, at the same time, the proportion of new and severe report has also increased, there are 2 800 reports per million population, the proportionality of monthly reports, the timeliness of general adverse reaction reports and evaluation of ADR are good, but the structure of the source of ADR is poor, the time of new and serious report did not conform to the regulations, the accuracy rate of the type of new report is not high in general. Conclusion The monitoring work of the region has made great progress and the monitoring system is basically sound, but the quality of report has many problems, so the adverse drug reaction monitoring work should be promoted.

Key words: adverse drug reaction, monitoring, report quantity, report quality, analysis

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