江苏省不同规模药品生产企业药物警戒工作现状对比研究  

Comparative Study on the Current Situation of Pharmacovigilance in Pharmaceutical Manufacturers of Different Scales in Jiangsu Province

作　　者：王佳域[1] 柳鹏程[2] 陈巧云 李明[1] 黄倩倩 陈锦敏 孙骏[1] WANG Jiayu;LIU Pengcheng;CHEN Qiaoyun;LI Ming;HUANG Qianqian;CHEN Jinmin;SUN Jun(Jiangsu Province Drug Adverse Reaction Monitoring Center,Nanjing 210002,China;School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,China;Jiangsu Drug Administration,Nanjing 210000,China)

机构地区：[1]江苏省药品不良反应监测中心,南京210002 [2]中国药科大学国际医药商学院,南京211198 [3]江苏省药品监督管理局,南京210000

出　　处：《中国药房》2020年第17期2070-2075,共6页China Pharmacy

基　　金：江苏省食品药品监督管理局科研项目(No.20170103);中国药科大学“双一流”学科创新团队建设项目(No.CPU2018GY43)。

摘　　要：目的:研究江苏省大、中、小型药品生产企业的药物警戒工作现状,为不同规模企业的药物警戒工作开展提供参考。方法:通过问卷调查及检索相关网站,对江苏省内108家企业的药物警戒工作现状进行考察,调查不同规模企业的药物警戒情况(组织机构、人员及培训、药物警戒文件、计算机系统)、药品安全性监测情况(个例报道、定期安全性更新报告、上市后安全性研究)和药品风险管理情况(信号管理、风险管理计划、风险控制措施、药品安全性沟通),并分别提出建议。结果与结论:不同规模企业在组织机构设置(独立设置专门机构)方面无显著差异(P=0.60),大部分企业在独立设置药物警戒专门机构上的比例均不足五成,在人员及培训(负责人专职情况、专职人员数、其中医学及临床药学类人员数)、文件(制定培训管理制度、委托管理与重点监测相关规程)和计算机系统3个方面存在显著差异(P<0.05);不同规模企业在个例报告的主要收集途径上无显著差异,但大型企业2019年自主报告数量(P<0.01)、针对定期安全性更新报告设有质量控制流程的比例(P=0.01)、近5年开展过上市后安全性研究的比例(P<0.01)均显著高于中、小型企业;大型企业(70.00%)和中型企业(84.38%)认为"缺乏技术指导原则"是影响信号管理的重要因素的比例高于小型企业(53.57%)(P=0.01);大型企业(60.00%)和中型企业(50.00%)在近5年内开展过风险管理计划的比例高于小型企业(30.36%)(P=0.04);大型企业(50.00%)在近5年内采取过说明书修订措施的比例高于中型企业(37.50%)和小型企业(25.00%)(P=0.05);大型企业(70.00%)和中型企业(59.38%)针对药店药师实施沟通活动的比例高于小型企业(32.14%)(P<0.01)。整体而言,大型企业在药物警戒体系、药品安全性监测、药品风险管理等方面优于中、小型企业。大型企业在主动开展风险管理计划方面、OBJECTIVE:To study the current situation of pharmacovigilance work in large,medium and small-scale pharmaceutical manufacturers in Jiangsu Province,and to provide reference for the pharmacovigilance development of drug manufacturers with different scales.METHODS:The situation of pharmacovigilance work in 108 manufacturers in Jiangsu province was investigated through a questionnaire survey and related websites.The pharmacovigilance work(organization,personnel and training,document,computer system),drug safety monitoring(case report,regular safety update report,post-marketing safety research)and drug risk management(signal management,risk management plan,risk control measures,drug safety communication)of different manufacturers were investigated to put forward the suggestions.RESULTS&CONCLUSIONS:There was no significant difference in the organizational structure(independently established specialized agencies)among manufacturers of different scales(P=0.60).Most of the manufacturers had less than 50%of the proportion in the independent establishment of specialized institutions for pharmacovigilance.There was significant difference in personnel and training(situation and number of full-time staff in charge,medical and clinical pharmacy personnel number),document(formulating training management system,entrusted management and key monitoring procedures),computer system(P<0.05).There was no difference in the main collection ways of case reports among manufacturers of different scales;however,the number of independent reports in 2019(P<0.01),the proportion of quality control process for regular safety update reports(P=0.01),and the proportion of carrying out postmarketing safety research in recent five years(P<0.01)in large-scale manufacturers were all significantly higher than small-and medium-scale manufacturers.The proportions of large-scale manufacturers(70.00%)and medium-scale manufacturers(84.38%),which considered"lack of technical guidelines"as an important factor affecting signal management,were higher than that o

关 键 词：药物警戒 药品上市许可持有人 药品生产企业 企业规模 现状 

分 类 号：R951[医药卫生—药学]