基于行政处罚案例的互联网药品销售安全风险识别与评价研究OA
Research on safety risk identification and evaluation of internet-based pharmaceutical sales based on administrative penalty cases
目的 为药品监管部门针对互联网药品销售实施精准监管提供数据支持和理论参考.方法 以"互联网药品销售""网络售药"等为关键词,检索人民政府、药品监管部门官方网站以及北大法宝等数据库,收集2014年1月至2024年6月与互联网药品销售相关行政处罚的典型案例、公示信息.基于事故致因理论,采用文本挖掘方法从人的不安全行为、物的不安全状态、环境因素、安全管理4个维度识别风险因素,采用灰色关联度分析法定量评价并筛选关键风险因素,进而提出针对性治理建议.结果 共纳入617个行政处罚案例.自2018年起案例数量增幅明显;地区间案例数量呈现"东高西低"的分布特征;违法环节主要集中在经营资质审查方面;违法主体以药品网络零售企业为主.本研究形成了包含4个一级风险因素、17个二级风险因素、56个三级风险因素的互联网药品销售安全风险因素识别体系.经灰色关联度分析,筛选出未做好票据管理、药品广告内容违法等37个关键三级风险因素(多为安全管理维度的风险因素),以及药品广告宣传违规、药品储存不规范等12个关键二级风险因素.结论 从业人员能力不足和合规意识薄弱、药品广告违法、药品储存和运输不规范、药品网络销售企业和第三方平台的质量管理体系不健全,是互联网药品销售安全的突出风险因素.建议加强从业人员资质审查与能力培训、规范药品信息展示与广告宣传、完善药品仓储物流管理体系、细化关键环节制度要求,以提升互联网药品销售监管效能.
OBJECTIVE To provide data support and theoretical reference for drug-regulatory authorities to implement targeted supervision over internet-based pharmaceutical sales.METHODS Using keywords such as"internet-based pharmaceutical sales"and"online drug sales",the official websites of the People's Government,drug-regulatory authorities and databases including PKULaw and others were searched,so as to collect typical cases and public disclosure information of administrative penalties related to internet-based pharmaceutical sales from January 2014 to June 2024.Guided by accident-causation theory,the text-mining method was adopted to identify risk factors from four dimensions:human unsafe behaviors,unsafe state of substances,environmental factors and safety management.Grey relational analysis was performed to quantitatively evaluate and screen key risk factors,and targeted governance suggestions were subsequently put forward.RESULTS A total of 617 administrative penalty cases were included.The number of cases increased significantly since 2018.The regional distribution of cases presented a characteristic of"high in the east and low in the west".Violations were mainly concentrated in the business qualification examination link,and online pharmaceutical retail enterprises were the dominant law-breaking subjects.A risk identification system for internet-based pharmaceutical sales was constructed,covering 4 primary-level,17 secondary-level and 56 tertiary-level risk factors.Through grey relational analysis,37 key tertiary-level risk factors(most of which belonged to the safety-management dimension)including inadequate bill management and illegal drug-advertising content,as well as 12 key secondary-level risk factors such as drug-advertising violations and non-standard drug storage,were screened out.CONCLUSIONS Inadequate capabilities and weak compliance awareness of practitioners,illegal drug advertising,non-standard drug storage and transportation,and imperfect quality-management systems of online-drug-sales enterprises and third-party platforms are prominent safety risk factors for internet-based pharmaceutical sales.It is recommended to strengthen qualification examination and competency training for practitioners,standardize drug-information display and drug advertising,improve the management system of drug warehousing and logistics,and refine institutional requirements for key links,so as to improve the supervision efficiency of internet-based pharmaceutical sales.
蒋蓉;蒙文鑫;杨帆;佟婳;吴利雅
海军军医大学药学系,上海 200433海口市市场监督管理局,海口 570100南京医科大学医政学院,南京 211166国际关系学院经济金融学院,北京 100091中国药品监督管理研究会,北京 100082
医药卫生
互联网药品销售行政处罚案例风险识别风险评价
internet-based pharmaceutical salesadministrative penalty casesrisk identificationrisk evaluation
《中国药房》 2026 (17)
2224-2228,5
国家自然科学基金项目(No.72304280)中国药品监督管理研究会2026年度立项课题(No.2026-Y-Y-014)
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