药品生产企业相关人员对药品不良反应监测管理的质性研究  

Qualitative Research on the Monitoring and Management of Adverse Drug Reactions Among the Relevant Personnel in Pharmaceutical Enterprises

作　　者：陈孟基 陈家进 廖新兴 杨苗苗 唐少文[1] CHEN Mengji;CHEN Jiajin;LIAO Xinxing;YANG Miaomiao;TANG Shaowen(School of Public Health,Nanjing Medical University,Nanjing,Jiangsu,China 211166;Nanjing Tongrentang Pharmaceutical Co.,Ltd.,Nanjing,Jiangsu,China 211800;Huichuntang Pharmaceutical Co.,Ltd.,Loudi,Hunan,China 417000)

机构地区：[1]南京医科大学公共卫生学院,江苏南京211166 [2]南京同仁堂药业有限责任公司,江苏南京211800 [3]回春堂药业股份有限公司,湖南娄底417000

出　　处：《中国药业》2021年第9期8-11,共4页China Pharmaceuticals

基　　金：国家自然科学基金[82073614];江苏高校品牌专业建设工程资助项目[PPZY2015A067]。

摘　　要：目的为进一步改进药品不良反应(ADR)监测与上报工作提供参考。方法实施《关于药品上市许可持有人直接报告不良反应事宜的公告》(简称《公告》)后,对3家药品生产企的业管理者和ADR监测相关人员共56人以半结构式、一对一深入访谈的方式获取资料,采用QSR Nvivo 8.0软件和Colaozzi七步法进行分析、整理,提炼药品生产企业执行情况与执行效果,并分析存在的问题与挑战。结果药品生产企业对ADR监测与上报的重视程度显著提高,能针对性地梳理存在的问题,组建ADR监测体系,建立内部考核机制,定期评价药品的安全性,ADR监测效率明显提升。药品生产企业担心ADR会激发与患者的矛盾,导致运营成本上升,更加重视ADR监测与上报规范化管理。结论药品生产企业对《公告》的执行进一步强化了其主体责任意识,推动了ADR的上报工作,但国家需制定和完善ADR监测上报指南,并对患者进行安全用药知识普及,尽快建立ADR救济相关的法律法规;药品生产企业应加强人员的培训,确保持续性地做好ADR监测与上报工作。Objective To provide a reference for the further improvement of adverse drug reaction(ADR)monitoring and reporting.Methods The data were collected by semi-structured,one-on-one in-depth interviews with the managers and related personnel of ADR monitoring(a total of 56 people)in three pharmaceutical enterprises after the implementation of the Announcement on Direct Reporting of Adverse Drug Reactions by Marketing Authorization Holders(herein after referred to as the Announcement).The interview content was analyzed by using QSR Nvivo 8.0 software and Colaozzi seven step method to obtain the implementation situation and effect of pharmaceutical enterprises,as well as the existing problems and challenges.Results The pharmaceutical enterprises paid more attention to ADR monitoring and reporting,they had sort out the existing problems,established ADR monitoring system and internal assessment mechanism,regularly evaluated drug safety,and significantly improved ADR monitoring efficiency.Pharmaceutical enterprises paid more attention to the standardized management of ADR monitoring and reporting because they were worried that ADR would trigger conflicts with patients and lead to an increase of operating costs.Conclusion The implementation of the Announcement further strengthens the main responsibility consciousness of pharmaceutical enterprises and promotes ADR reporting.However,the state should formulate and improve the guidelines for ADR monitoring and reporting,popularize the knowledge of safe drug use for patients,and establish laws and regulations related to ADR relief as soon as possible.Pharmaceutical enterprises should also strengthen the training of ADR monitoring personnel to ensure the sustainability of ADR monitoring.

关 键 词：药品生产企业 药品不良反应监测 质性研究 

分 类 号：R95[医药卫生—药学]