我国药品召回质量风险管理影响因素研究

doi:10.19803/j.1672-8629.20210304

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (10): 1087-1090.
DOI: 10.19803/j.1672-8629.20210304

我国药品召回质量风险管理影响因素研究

宋明月¹, 张冉¹, 武志昂^1,2,*

¹沈阳药科大学工商管理学院,辽宁沈阳 110016;
²北京亦度正康健康科技有限公司,北京100055

收稿日期:2021-04-08 出版日期:2022-10-15 发布日期:2022-10-17
通讯作者: ^*武志昂,男,教授·博导,药事管理。E-mail: wuerla501@126.com
作者简介:宋明月,女,硕士,药事管理。

Influencing factors of quality risk management of drug recall in China

SONG Mingyue¹, ZHANG Ran¹, WU Zhiang^1,2,*

¹College of Business Administration, Shenyang Pharmaceutical University, Shenyang Liaoning 110016, China;
²Beijing Yeedozencom Healthcare Science & Technology Co., Ltd., Beijing 100055, China

Received:2021-04-08 Online:2022-10-15 Published:2022-10-17

摘要/Abstract

摘要： 目的通过对我国药品召回质量风险影响因素的提取与重要性排序,为提高我国药品召回质量提供建议。方法以风险管理理论为指导,基于文献研究,采用李克特量表法、层次分析法,提取及修正我国药品召回质量风险影响因素,并确定其权重。结果与结论 构建我国药品召回质量风险指标体系,结合药品召回风险要素的重要性,针对性地提出控制我国药品召回质量风险的建议。

关键词: 药品召回, 质量风险管理, 层次分析法, 药品上市许可持有人

Abstract: Objective To provide suggestions for improving the quality of defective drug recalls through the extraction and importance ranking of risk factors affecting the quality of drug recalls in China. Methods Factors affecting the quality of drug recalls in China are extracted, revised, and weighted guided by risk management theory, based on literature research, using Likert scale method and analytic hierarchy process. Results and Conclusion Constructing China's drug recall quality risk index system, combining the importance of drug recall risk elements, and putting forward recommendations to control the quality risk of China's drug recalls.

Key words: drug recall, quality risk management, analytic hierarchy process, drug marketing authorization holder

中图分类号:

R954

宋明月, 张冉, 武志昂. 我国药品召回质量风险管理影响因素研究[J]. 中国药物警戒, 2022, 19(10): 1087-1090.

SONG Mingyue, ZHANG Ran, WU Zhiang. Influencing factors of quality risk management of drug recall in China[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1087-1090.

参考文献

[1] National Medical Products Administration. Measures for the administration of drug recalls (Bureau Order No. 29) [EB/OL]. (2007-12-10) [2021-03-25]. https://www.nmpa.gov.cn/xxgk/fgwj/bmgzh/20071210000001620.html.
[2] National Medical Products Administration. Measures for the administration of drug recalls (Draft for Solicitation of Comments) [EB/OL]. (2020-10-23) [2021-03-25]. https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20201013104036103.html.
[3] JIN QY.Studies on the Project Risk Management of the R&D of New Medicines[D]. Shenyang: Shenyang Pharmaceutical University, 2006.
[4] YU YH.The Study of Biosimilars R&D Risk Management[D]. Jinan: Shandong University, 2014.
[5] SHI Y.Quality Risk Management in Pharmaceutical Cold Chain Logistics of the New GSP[D]. Jinan: Shandong University, 2014.
[6] QIAO XF.Analysis on the current situation and improvement measures of drug recall management in China[J]. Mechanical and Electrical Information(机电信息), 2018, 560(26): 12-15.
[7] National Medical Products Administration. Good manufacturing practice for drugs (Revised in2010) [EB/OL]. (2011-01-17) [2021-03-25]. https://www.nmpa.gov.cn/xxgk/fgwj/bmgzh/20110117120001434.html.
[8] BAI JF, ZHANG Z, SUN H, et al.Analysis on risk factors and preventive measures of ADR monitoring[J]. China Medicine and Pharmacy(中国医药科学), 2019, 9(18): 250-252.
[9] CAI JJ, WU QY, CHEN Q, et al.Analysis on current situation and existing problems of drug recall in China based on official website information[J]. China Pharmacy(中国药房), 2016, 27(13): 1742-1745.
[10] WENG XL, XIE RX.Practice of drug risk management in our hospital[J]. China Pharmacy(中国药房), 2015(20): 3118-3121.
[11] ZHAO JF, WANG HY, GUO Y, et al.On problems and countermeasures of the drug-recall process[J]. Chinese Pharmaceutical Affairs(中国药事), 2016, 30(1): 50-53.
[12] LI TT, WEN YL, XU J. A preliminary study on drug recall management in pharmaceutical enterprises[J]. China Market(中国市场),2015(41):108, 148.
[13] QI LB.Statistical analysis and fuzzy comprehensive evaluation of Likert scale[J]. Shandong Science(山东科学), 2006, 19(2): 18-23.
[14] XUE JZ.Research on Methods and Applications of Group Decision Making Based on Analytic Hierarchy Process[D]. Harbin: Harbin Institute of Technology, 2012.
[15] DONG XW.The Study of Municipal Solid Waste Disposal Techniques'Optimizing Based on Group Decision AHP in Chongqing city[D]. Chongqing: Chongqing University, 2016.

我国药品召回质量风险管理影响因素研究

Influencing factors of quality risk management of drug recall in China

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