2024年山东省药品经营使用单位延伸检查缺陷项目分析  

Analysis of Extended Inspection Defects of Drug Dealers and Users in Shandong Province in 2024

作　　者：杨成勇 张娇 侯玉磊 张艳 李海峰 庄辉 YANG Cheng-yong;ZHANG Jiao;HOU Yu-lei;ZHANG Yan;LI Hai-feng;ZHUANG Hui(Shandong Center for Food and Drug Evaluation&Inspection)

机构地区：[1]山东省食品药品审评查验中心

出　　处：《中国食品药品监管》2025年第1期120-125,共6页China Food & Drug Administration Magazine

摘　　要：目的:分析2024年山东省药品经营使用单位延伸检查过程中发现的问题,为药品监管部门科学监管与药品经营使用单位持续提升质量管理水平提供参考。方法:统计2024年山东省药品经营使用单位延伸检查中发现的缺陷项目,分析主要缺陷项目和高频次缺陷问题。结果:药品零售企业延伸检查常见问题主要集中在人员及制度管理、经营场所管理、储存陈列、处方药管理等方面;药品使用单位延伸检查常见问题主要集中在药品保管养护制度及安全设施、药品储存、拆零管理等方面。结论:建议药品监管部门在日常监管中对高频次缺陷问题予以重点关注;药品经营使用单位应提高全员参与质量管理意识,严格按照规章制度履行职责,保障公众用药安全有效可及。Objective:This study aims to analyze the issues identified during the 2024 extended inspection of drug dealers and users in Shandong Province and to provide references for drug regulators to implement scientific supervision and for drug dealers and users to continuously improve quality management.Methods:The defects found in the extended inspection of drug distribution and usage units in Shandong Province in 2024 were compiled,and the causes of these issues were analyzed.Results:Common issues in the extended inspection of drug retail enterprises mainly focused on personnel and system management,business premises management,storage and display,and prescription drug management.For drug usage units,the most frequent issues were associated with the drug storage and maintenance system,safety facilities,drug storage,and split-batch management.Conclusion:It is suggested that drug regulatory authorities focus on addressing high-frequency defects during daily supervision.Drug dealers and users should raise awareness of comprehensive participation in quality management,strictly adhere to regulations,and perform their responsibilities to ensure the safety,efficacy,and accessibility of drugs for the public.

关 键 词：药品经营 药品使用 延伸检查 缺陷项目 分析 

分 类 号：R95[医药卫生—药学]