中国药物警戒 ›› 2018, Vol. 15 ›› Issue (4): 226-229.

• 法规与管理研究 • 上一篇    下一篇

我国药品不良反应报告质量的影响因素分析

包慧玲, 李江帆, 武志昂*   

  1. 沈阳药科大学工商管理学院,辽宁 沈阳 110016
  • 收稿日期:2018-05-29 修回日期:2018-05-29 出版日期:2018-04-20 发布日期:2018-05-29
  • 通讯作者: 武志昂,男,教授·博导,药品不良反应监测与药品注册管理。E-mail:wuerla501@126.com
  • 作者简介:包慧玲,女,在读硕士,药事管理。

Analysis on Influencing Factors of Quality of Adverse Drug Reaction Reports in China

BAO Hui-ling, LI Jiang-fan, WU Zhi-ang*   

  1. School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2018-05-29 Revised:2018-05-29 Online:2018-04-20 Published:2018-05-29

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摘要： 目的 通过对药品不良反应报告质量的影响因素进行筛选和重要性排序,以期为监管部门完善不良反应报告制度提供参考。方法 运用全面质量管理理论、“人机料法环”五因素理论和层次分析法进行分析。结果 药品不良反应报告质量影响因素的重要性排序依次是人员因素、方法规章因素、软硬件因素、材料因素、环境因素。结论 影响因素的重要性排序结果可作为监管部门完善不良反应报告制度的参考与依据。

关键词: 药品不良反应报告, 质量管理, 影响因素, 层次分析法

Abstract: Objective To screen and rank factors affecting quality of adverse drug reaction(ADR) reports, provide a reference for improving the reporting system for adverse drug reactions. Methods The theory of total quality management, "4M1E" five factors theory and analytic hierarchy process(AHP) were used to analyze influencing factors. Results The ranking of importance of factors affecting the quality of ADR reports is personnel, method and regulation, software and hardware, material and environmental factors in order. Conclusion The ranking of importance of influencing factors can be used as a reference for improving the reporting system for ADR.

Key words: adverse drug reaction reports, quality management, influencing factors, analytic hierarchy process

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