首页|期刊导航|中国药业|2023年至2024年昆明市药品零售企业检查问题分析及规范发展优化建议

2023年至2024年昆明市药品零售企业检查问题分析及规范发展优化建议OA

Analysis of Inspection Issues and Optimization Suggestions for Standardized Development of Drug Retail Enterprises in Kunming from 2023 to 2024

中文摘要英文摘要

目的 为昆明市药品零售企业的规范发展提供参考.方法 共纳入 2023 年至 2024 年昆明市药品零售企业缺陷项目 9079 项,3193 例次,分析缺陷项目的主要分布情况,采用相关性分析和聚类分析方法识别药品零售企业规范管理的重点检查项目,探讨缺陷问题的产生原因及潜在影响,并提出改进建议.结果与结论 药品零售企业缺陷问题主要分布于药品质量管理和人员资质及培训两个方面;人员管理、质量管理与职责、文件 3 项为药品零售企业质量管理规范的关键因素;缺陷问题的主要成因是企业自身体系发展不足,监管体系不完善及行业竞争困境,影响患者用药安全和行业可持续发展.加强企业自身质量管理体系建设、完善监管机制与责任落实、规范行业竞争秩序,并通过多方协同合作,促进昆明市药品零售企业的规范发展.

Objective To provide a reference for the standardized development of drug retail enterprises in Kunming.Methods A total of 9 079 defect items and 3 193 cases from drug retail enterprises in Kunming from 2023 to 2024 were included.The main distribution of defect items was analyzed,and correlation analysis and cluster analysis methods were used to identify key inspection items for standardized management of drug retail enterprises.The causes and potential impacts of defect problems were explored,and improvement suggestions were proposed.Results and Conclusion The defects from drug retail enterprises were mainly distributed in two aspects:drug quality management,personnel qualifications and training;personnel management,quality management and responsibilities,and document management were the key factors for standardizing quality management of drug retail enterprises;the main causes of defect problems were insufficient development of the own system of enterprise,imperfect regulatory system,and industry competition difficulties,which affected the medication safety of patients and the sustainable development of the industry.Strengthening the construction of quality management of enterprises,improving regulatory mechanisms and responsibility implementation,standardizing the industry competition order,and through multi-party collaboration and cooperation to promote the standardized development of drug retail enterprises in Kunming.

田小权;曾文辉;黄文平

云南省昆明市药品不良反应与药物滥用监测中心·云南省昆明市食品药品认证审评中心,云南 昆明 650000江西省药品检查员中心·江西省疫苗检查中心,江西 南昌 330001江西中医药大学中药固体制剂制造技术国家工程研究中心,江西 南昌 330006

医药卫生

药品零售企业检查缺陷规范发展改进建议

drug retail enterpriseinspection for defectstandardized developmentimprovement suggestion

《中国药业》 2026 (2)

23-27,5

江西省药品监督管理局科研项目[2023G225、2022JS31].

10.3969/j.issn.1006-4931.2026.02.005

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