中国药房2026，Vol.37Issue(17)：2224-2228,5.DOI:10.6039/j.issn.1001-0408.2026.17.02
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
Research on safety risk identification and evaluation of internet-based pharmaceutical sales based on administrative penalty cases
摘要
Abstract
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.关键词
互联网药品销售/行政处罚案例/风险识别/风险评价Key words
internet-based pharmaceutical sales/administrative penalty cases/risk identification/risk evaluation分类
医药卫生引用本文复制引用
蒋蓉,蒙文鑫,杨帆,佟婳,吴利雅..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[J].中国药房,2026,37(17):2224-2228,5.基金项目
国家自然科学基金项目(No.72304280) （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) （No.2026-Y-Y-014）
