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

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...

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

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 of smallscale manufacturers(53.57%)(P=0.01);the proportions of large-scale manufacturers(60.00%)and medium-scale manufacturers(50.00%),which had carried out risk management plans in the past five years,were higher than that of small-scale manufacturers(30.36%)(P=0.04);the proportion of large-scale manufacturers(50.00%),which adopted the measures in recent 5 year,was higher than medium-scale manufacturers(37.50%)and small-scale manufacturers(25.00%);the proportions of large-scale manufacturers(70.00%)and medium-scale manufacturers(59.38%),which carried out communication for pharmacists,were higher than small-scale manufacturers(32.14%)(P<0.01).Large-scale manufacturers outperformed small-and medium-scale manufacturers in terms of pharmacovigilance system,drug safety monitoring and drug risk management.Large-scale manufacturers had a certain degree of lack of initiative on performing risk management plans,medium-scale manufacturers on full-time staffs in charge,and small-scale manufacturers on pharmacovigilance system.So,it is recommended that large-scale manufacturers take effective control of variety risk as the goal and actively risk management;medium-scale manufacturers should continuously enhance the awareness of responsibility and improve the investment of resources on pharmacovigilance work;small-scale manufacturers should pay more attention to improving the pharmacovigilance system and the compliance of specific work.