药品生产企业直接报告不良反应能力调查研究

Investigation of Pharmaceutical Manufacturers’ Ability of Direct Reporting of Drug Adverse Reactions

目的调查我国制药行业药品不良反应监测工作现状及存在问题,提出提高药品生产企业不良反应报告能力的措施。方法采取定性和定量相结合的调查方法。定性调查包括座谈会和实地考察;定量调查为向全国16个省份的药品生产企业发放问卷进行调查。结果我国药品生产企业在不良反应监测体系建设、不良反应收集报告、分析评价和风险控制方面都存较多问题,技术监督和行政监管也存在需要改进的地方。结论药品生产企业、药品不良反应监测机构、药品监督管理部门应认真落实《国家药品监督管理局关于药品上市许可持有人直接报告不良反应事宜的公告》,采取有效措施从整体上提高我国制药行业药品安全性意识和不良反应监测工作水平。

Objective To investigate the status quo of and existing problems with ADR monitoring in the pharmaceutical industry in China,so as to propose measures to improve the ADR reporting ability of manufacturers.Methods Personnel interviews and questionnaires were used.Personnel interviews were conducted in the form of symposiums and on-the-spot investigation,using qualitative analysis method.Questionnaire surveys were conducted among more than 1000 manufacturers in 16 provinces,using qualitative analysis method.Results There were many problems with the construction of ADR monitoring systems as well as with the collection,reporting,analysis and evaluation,and control of ADRs by drug manufacturers.Technical supervision and administrative supervision needed to be improved.Conclusion Drug manufacturers,ADR monitoring centers and drug regulatory authorities should implement the Notice of the NMPA on Direct Reporting Adverse Reactions by MAHs to the letter so as to improve the awareness of safety and the level of ADR monitoring in the pharmaceutical industry as a whole.