我省药品生产企业药品不良反应监测和工作体系分析  

Analysis of Adverse Drug Reaction Monitoring andInspection System for Drug Manufacturers in Our Province

作　　者：田克仁 高菁 缪健 万凯化 余超 周鹃 徐瑾 李穗 

机构地区：[1]江西省食品药品监督管理局,江西南昌330029 [2]江西省药品不良反应监测中心,江西南昌330046 [3]江西省卫生学会办公室,江西南昌330046

出　　处：《中国药物警戒》2014年第5期285-287,290,共4页Chinese Journal of Pharmacovigilance

基　　金：江西省软科学研究计划项目(20122BBA10109)

摘　　要：目的了解和分析我省药品生产企业药品不良反应(ADR)监测和报告体系工作现状。方法采用分层抽样,选取我省12个地市88家药品生产企业为研究现场,自行设计ADR监测和报告工作检查等系列调查表对被抽企业的负责人进行问卷调查,获取有效问卷88份。结果 88家药品生产企业均设立了ADR监测专门机构及建立监测制度,67.05%的企业配备了专职人员,18.18%企业在上一年度进行过网络直报(共计65例报表),48.86%的企业开展了定期汇总分析工作,39.77%企业开展了风险评估工作,82.95%企业撰写了定期安全性更新报告。结论药品生产企业ADR监测工作体系逐渐完善,但监测工作不够深入,工作实效性较差。Objective To understand and analyze status of adverse drug reaction（ADR） monitoring and inspection system for drug manufacturers. Methods Using stratified sampling method, 88 drugmanufacturers of 12 cities in Jiangxi province were extracted. We designed the ADR monitoring and reporting questionaires, and 88 effective questionnaires were returned. Results 88 drug manufacturers all have set up branches of ADR monitoring, and established a ADR-monitoring system. 67.25%manufacturers have full-time personnel, 18.18%manufacturers have reported directly through the network（a total of 65 cases）, 48.86%manufacturers have carried regular pooled analytical work, 39.77%have worked on risk assessment, 48.86% manufacturers have written Periodic Safety Update Report（PSUR）. Conclusion The work system of ADR monitoring for drug manufacturers has been perfected more and more, but the monitoring has not been widely spreaded, the effect of ADR monitoring is low.

关 键 词：药品生产企业 药品不良反应监测 体系检查 

分 类 号：R95[医药卫生—药学]