江苏省药品生产企业药物警戒工作现状抽样调查研究

Sampling Investigation of Current Situalion of Pharmacovigilance in Pharmaceutical Manufacturers in Jiangsu Province

目的本文立足于药品不良反应监测工作向药物警戒过渡的发展阶段,调查分析江苏省药品生产企业药物警戒工作的现状,为提升药品生产企业药物警戒工作能力提供依据与建议。方法采用问卷调查法,选取江苏省内药品生产企业代表,对其在药物警戒体系、药品安全性监测、药品风险管理等方面的工作现状进行调查,运用SPSS 22.0软件进行数据录入和统计。结果问卷调查覆盖各种类型药品生产企业共计108家,调查结果显示,大部分药品生产企业已初步建立药物警戒体系,在药品安全性监测方面的投入与成效日渐增加,但在药品风险管理方面相对薄弱。结论建议企业从提高重视程度、加强药物警戒体系建设、提升重点及薄弱环节工作有效性等方面加以完善,并建议监管部门及监测机构及时做好指南及培训相关配套。

Objective To investigate the status quo of pharmacovigilance by drug manufacturers in Jiangsu Province,and to offer recommendations on how to improve pharmacovigilance by manufacturers amid the transition from monitoring of adverse drug reactions to pharmacovigilance.Methods After representatives of drug manufacturers in Jiangsu Province were selected,a questionnaire survey was conducted regarding the pharmacovigilance system,drug safety monitoring and risk management.SPSS 22.0 software was used for data entry and statistics.Results The survey covered 108 drug manufacturers of different types.The results indicated that most of the enterprises had established basic pharmacovigilance systems.Although the input into and effectiveness of ADR monitoring systems are increasing among those manufacturers,the level of risk management is relatively low.Conclusion It is recommended that manufacturers improve their awareness of drug safety,strengthen their pharmacovigilance systems,overcome their weaknesses,and that regulatory authorities and agencies provide related support in a timely manner.