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 r ecall in China

作　　者：宋明月 张冉 武志昂[1,2] SONG Mingyue;ZHANG Ran;WU Zhiang(College of Business Administration,Shenyang Pharmaceutical University,Shenyang Liaoning 110016,China;Beijing Yeedozencom Healthcare Science&Technology Co.,Ltd.,Beijing 100055,China)

机构地区：[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

出　　处：《中国药物警戒》2022年第10期1087-1090,共4页Chinese Journal of Pharmacovigilance

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。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.

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 

分 类 号：R954[医药卫生—药学]