海南省药品上市许可持有人药物警戒体系现状及改进研究

Current Status and Improvement Research of Pharmacovigilance System of Drug Marketing Authorization Holders in Hainan Province

目的为完善我国药品上市许可持有人(MAH)药物警戒体系提供参考。方法按照《海南省药品不良反应报告和监测检查要点》,2019年至2021年对省内MAH开展药品不良反应(ADR)专项检查。对检查中出现的缺陷项从MAH不符合项分布、具体问题等内容进行统计分析;梳理MAH药物警戒体系存在的问题,并提出对策建议。结果2019年至2021年,海南省共检查MAH 84家次,83家次发现不符合项目,不符合项数主要为1~5条(42.86%),其次为6~10条(26.19%);不符合项主要集中在质量管理体系、人员管理、组织机构3方面,共占总数的71.14%;有6项以上不符合项的MAH的占比,以及组织机构、质量管理体系、个例ADR报告方面不符合项占比均呈降低趋势,药品群体不良事件报告和评价与控制呈上升趋势。MAH在药物警戒体系建设方面主要存在体系构建不完善、MAH对ADR监测报告的重视力度不足、MAH风险评价与控制能力较弱等问题。结论目前,海南省MAH药物警戒体系的建设有待进一步加强,MAH应承担起药品全生命周期安全风险主体责任,加强科学化体系建设、制度落实及风险防范等环节的建设,以进一步完善药物警戒体系。

Objective To provide a reference for the improvement of pharmacovigilance system of drug marketing authorization holder(MAH)in China.Methods According to the Key Points for Adverse Drug Reaction(ADR)Reporting and Monitoring in Hainan Province,the special ADR inspection for MAH was carried out in Hainan Province from 2019 to 2021.The defects in the inspection were statistically analyzed from the distribution of MAH non-conformance(NCR)items and specific problems,the existing problems of MAH pharmacovigilance system were sorted out,countermeasures and suggestions were put forward.Results From 2019 to 2021,84 MAH cases were inspected in Hainan Province,and NCR items were found in 83 cases.The number of NCR items was mainly 1-5(42.86%),followed by 6-10(26.19%).NCR items were mainly concentrated in quality management system,personnel management and institution,accounting for 71.14%of the total.The proportion of MAH with more than six NCR items,the proportion of NCR items in the institution and quality management system,and individual ADR reports showed a downward trend,while the reporting,evaluation and control of adverse events of drug groups showed an upward trend.In terms of the construction of the MAH pharmacovigilance system,there were mainly problems such as imperfect system construction,insufficient attention paid by MAH to ADR monitoring report,and weak risk evaluation and control ability of MAH.Conclusion At present,the construction of the MAH pharmacovigilance system in Hainan Province needs to be further strengthened.MAH should assume the main responsibility of drug safety risk in the whole life cycle,and strengthen the construction of the scientific system,system implementation and risk prevention,so as to further improve the pharmacovigilance system.