中国药物警戒 ›› 2020, Vol. 17 ›› Issue (3): 148-153.
DOI: 10.19803/j.1672-8629.2020.03.04

• 法规与管理研究 • 上一篇    下一篇

我国药品不良反应个例报告质量评估方法研究

陈俐烨, 安连宇, 石萍, 王淑玲*   

  1. 沈阳药科大学工商管理学院,辽宁 沈阳 110016
  • 收稿日期:2020-03-17 修回日期:2020-03-17 出版日期:2020-03-15 发布日期:2020-03-17
  • 通讯作者: *王淑玲,女,硕士,副教授,研·导,医药流通法规与质量控制。E-mail：lingyi@163.com
  • 作者简介:陈俐烨,女,硕士,医药流通法规。

Methods for Quality Evaluation of Individual Case Reports of Adverse Drug Reactions in China

CHEN Liye, AN Lianyu, SHI Ping, WANG Shuling*   

  1. College of Business Administration, Shenyang Pharmaceutical University, Shenyang Liaoning 110016, China
  • Received:2020-03-17 Revised:2020-03-17 Online:2020-03-15 Published:2020-03-17

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摘要： 目的 探索一种便于长期运用的药品不良反应个例报告质量评估方法,对个例报告进行更加科学的评估。方法 通过文献分析法,借鉴国内外已有的评价方法,运用专家咨询法确立指标权重,运用层次分析法构建药品不良反应个例报告质量评估体系。结果 通过对某三甲医院40份药品不良反应报告的评估验证,该评价体系具有合理性。结论 经检验,以乘法计算特征建立的药品不良反应个例评估体系是科学合理的,便于对不良反应报告内容的动态管理,并可以进一步建立高效的科学评估。

关键词: 药品不良反应, 个例报告质量, 评估方法

Abstract: Objective To seek a long-term method for evaluating the quality of individual case reports of adverse drug reactions so as to evaluate case reports more accurately. Methods By analyzing literature, looking at current evaluation methods at home and abroad, and consulting experts, the weight of indicators was determined. AHP was used to establish the quality evaluation system of individual case reports on ADRs. Results This evaluation system was well-designed as evidenced by the evaluation of 40 ADR reports from a big A hospital. Conclusion The evaluation system of individual ADR cases based on characteristics of multiplication calculation is scientific and well-grounded, which can facilitate the dynamic management of the content of ADR reports and improve the efficiency of evaluation.

Key words: adverse drug reaction, quality of individual case report, evaluation method

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