CAJ | 학술논문

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。
목적：료해화분석아성약품생산기업약품불량반응（ADR）감측화보고체계공작현상。방법채용분층추양，선취아성12개지시88가약품생산기업위연구현장，자행설계ADR감측화보고공작검사등계렬조사표대피추기업적부책인진행문권조사，획취유효문권88빈。결과88가약품생산기업균설립료ADR감측전문궤구급건립감측제도，67.05%적기업배비료전직인원，18.18%기업재상일년도진행과망락직보（공계65례보표），48.86%적기업개전료정기회총분석공작，39.77%기업개전료풍험평고공작，82.95%기업찬사료정기안전성경신보고。결론약품생산기업ADR감측공작체계축점완선，단감측공작불구심입，공작실효성교차。
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.