药品上市许可持有人药物警戒外包的风险因素分析

Analysis of Risk Factors of MAH Pharmacovigilance Outsourcing

目的:分析药品上市许可持有人(MAH)药物警戒外包的风险因素并提出风险管控策略,为MAH顺利实施药物警戒外包和监管部门制定相应监管策略提供参考。方法:基于委托-代理理论和头脑风暴法初步确定风险因素,并设计调查问卷,采用随机抽样的方式对广东省内200家MAH的药物警戒工作人员进行问卷调查。采用因子分析法对问卷数据进行统计分析,归纳得出综合性风险因素并计算其评分。结果与结论:共发放调查问卷200份,回收有效问卷154份,问卷有效回收率为77.00%。因子分析结果显示,MAH药物警戒外包活动涉及的综合性风险因素主要有4个,按其影响程度由高到低分别为服务提供商与外包管理因素(3.792分)、MAH因素(3.766分)、法规因素(3.626分)和市场因素(3.610分)。针对上述影响因素,建议MAH在开展药物警戒外包时,应重视完善外包合同、与服务提供商建立信息沟通机制、加强审计与管理工作、强化自身药物警戒能力及人才建设、明确适宜的药物警戒外包业务内容、充分做好对服务提供商的事前调查工作;建议相关部门应尽快制定药物警戒委托质量管理规范或指南,并加强对服务提供商的监管;建议尝试成立药物警戒外包行业协会,并通过充分发挥协会的影响力来规范行业行为,进而避免外包风险的发生。

OBJECTIVE:To analyze the risk factors of marketing authorization holder(MAH)pharmacovigilance outsourcing and propose risk management and control strategies,and to provide reference for MAH to successfully implement pharmacovigilance outsourcing and regulatory authorities to formulate corresponding regulatory strategies.METHODS:Based on the principal-agent theory and brainstorming method,the risk factors were preliminarily determined,and a questionnaire was designed.The questionnaire survey was carried out among pharmacovigilance staff of 200 MAH in Guangdong province by random sampling.The factor analysis method was used to statistically analyze the questionnaire data,and the comprehensive risk factors and their respective factor scores were summarized.RESULTS&CONCLUSIONS:A total of 200 questionnaires were distributed,and 154 valid questionnaires were returned,with effective recovery rate of 77.00%.The results of factor analysis method showed that there were 4 comprehensive risk factors involved in MAH pharmacovigilance outsourcing activities,which were service providers and outsourcing management factor(3.792 score),MAH factor(3.766 score),regulations factor(3.626 score)and market factor(3.610 score)from high to low.In view of the above factors,it is suggested that MAH should focus on improving outsourcing contract,establishing information communication mechanism with service providers,strengthening auditing and management,strengthening pharmacovigilance ability and personnel building,defining appropriate pharmacovigilance outsourcing business contents,and fully doing pre-service investigation of service providers,when MAH conducts outsourcing of pharmacovigilance.It is suggested that relevant departments should formulate pharmacovigilance entrusted quality management specifications or guidelines as soon as possible and strengthen the supervision of service providers.It is suggested to try to establish a pharmacovigilance outsourcing industry association,and standardize the industry behavior by giving full play to the influence of the association,so as to avoid the outsourcing risk.