中国药物警戒 ›› 2011, Vol. 8 ›› Issue (1): 50-51.

• 药品不良反应监测 • 上一篇    下一篇

2009年度国家避孕药品不良反应报告质量评估

陈颖, 朱向, 李瑛   

  1. 国家人口计生委计划生育药具不良反应监测中心,江苏省计划生育科学技术研究所,江苏 南京 210036
  • 收稿日期:2010-07-23 出版日期:2011-01-10 发布日期:2015-08-24
  • 通讯作者: 李瑛,女,教授,博士研究生导师,药物流行病学。E-mail：liying2008@jsmail.com.cn
  • 作者简介:陈颖,女,药师,临床药学与不良反应监测。

The Quality Evaluation of State Contraceptives Adverse Reaction Reports in 2009

CHEN Ying, ZHU Xiang-jun, LI Ying   

  1. State Contraceptives Adverse Reaction Surveillance Center, Jiangsu Institute of Planned Parenthood Research, Jiangsu Nanjing 210036, China
  • Received:2010-07-23 Online:2011-01-10 Published:2015-08-24

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摘要： 目的 对国家人口计生委计划生育药具不良反应监测中心（以下简称：中心）的避孕药品不良反应报告进行质量评估。方法 对中心2009年收集的325例避孕药品不良反应报告表进行质量评分,对表格的真实性、规范性和完整性进行分析。结果 报告表评分在90分以上的占总数的58.46％。报告表主要存在的问题有：药品不良反应（ADR）过程描述不全、缺项漏项、ADR分析与关联性评价错误、未收到相关医学记录。结论 避孕药品不良反应报告表总体质量较高,但仍存在一些共性的质量问题,需在日后工作中有针对性地对基层报告人员加强培训,以进一步提高报告表质量。

关键词: 避孕药品, 药品不良反应, 质量评估

Abstract: Objective To evaluate the quality of the adverse drug reaction reports of the State Contraceptives Adverse Reaction Surveillance Center(SCARS). Methods 325 contraceptives adverse reaction(CAR) cases collected by SCARS in 2009 have been scored and analyzed from authenticity, normalization and integrality. Results There are 58.46％ reports score above 90. Mistakes that happened concentrate on the following items: adverse drug reaction(ADR) process description was incomplete, item vacancies, ADR analysis and evaluation opinion were incompatible, and haven't receive any relative medical reports. Conclusion Totally the quality of CAR reports are fine, but there are still a few quality problems in common. According to the above results, SCARS can elevate the quality of CAR reports by more training.

Key words: contraceptive drugs, adverse drug reaction(ADR), quality evaluation

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