中国药物警戒 ›› 2015, Vol. 12 ›› Issue (3): 175-177.

• 药械安全性研究 • 上一篇    下一篇

2013年度中山市药品不良反应报告表质量分析

李亮华,温润龙* ,罗万婷   

  1. 中山市药品不良反应监测中心，广东 中山 528437
  • 收稿日期:2014-12-01 出版日期:2015-03-08 发布日期:2015-07-28
  • 通讯作者: 温润龙，男，硕士，医师，药械安全性监测。
  • 作者简介:李亮华，男，硕士，主治医师，药械安全性监测。

Quality Analysis of Adverse Drug Reactions Reports in Zhongshan in 2013

LI Liang-hua,WEN Run-long*,LUO wan-ting   

  1. 1Adverse Drug Reaction Monitoring Center of Zhongshan, Guangdong Zhongshan 528437, China
  • Received:2014-12-01 Online:2015-03-08 Published:2015-07-28

PDF (PC)

187

摘要： 目的 通过对2013年度中山市药品不良反应（ADR）报告表进行质量评估，以期提高ADR报告和评价能力。方法 采用回顾性研究方法 ，随机抽取2013年度中山市18家监测单位报告的155份ADR报告表开展质量评估。包括现场核查ADR报告表的原始资料和按《药品不良反应病例报告质量评估评分标准》进行质量评分。结果 所有监测单位建立了ADR报告和监测制度，部分单位未及时更新和落实不到位。ADR报告表信息可追溯，未发现虚假报告。ADR报告表质量评分总体良好，在报告时限、ADR过程描述、用药信息等方面仍需改进。结论 定期开展ADR报告表质量评估是市级监测机构一项重要工作，提高ADR报告表的数量和质量，为药品风险监测提供科学依据。

关键词: 药品不良反应, 质量评估, 核查, 监测

Abstract: Objective To analyze the quality of adverse drug reaction(ADR) reports in Zhongshan in 2013, so as to improve the ability of ADR reporting and assessment. Methods By using the method of retrospective study, 155 ADR reports in 18 monitoring units were chosen at random to evaluate the authenticity, integrity and accuracy. We verified the original data of ADR reports on site and gave a mark according to the scoring criteria to assess the quality of ADR reports. Results All monitoring units established the ADR system of reporting and monitoring, some of which did not update and put it in place. All of ADR reports could be traced and proved to be true. The quality score of ADR reports was generally good, but it needs to be improved in reporting time, ADR process description, drug information and so on. Conclusion Regular quality evaluation of ADR reports is an important job for municipal monitoring organization. Improving the quantity and quality of ADR reports can provide the scientific basis for drug risk monitoring.

Key words: adverse drug reactions(ADR), quality assessment, verification, monitoring

中图分类号: