Research on safety risk identification and evaluation of internet-based pharmaceutical sales based on administrative penalty cases
- VernacularTitle: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
- Author:
Rong JIANG
1
;
Wenxin MENG
2
;
Fan YANG
3
;
Hua TONG
4
;
Liya WU
5
Author Information
1. School of Pharmacy，Naval Medical University，Shanghai 200433，China
2. Haikou Municipal Administration for Market Regulation，Haikou 570100，China
3. School of Health Policy and Management，Nanjing Medical University，Nanjing 211166，China
4. School of Economics and Finance，University of International Relations，Beijing 100091，China
5. China Society for Drug Regulation，Beijing 100082，China
- Publication Type:Journal Article
- Keywords:
administrative penalty cases;
risk identification;
risk evaluation
- From:
China Pharmacy
2026;37(17):2224-2228
- CountryChina
- Language:Chinese
-
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.
