Exploring the current status of quality management of cold chain medicines in DTP pharmacies and the measures for pre-emptive risk management
- VernacularTitle:DTP药房冷链药品质量管理现状及风险管理前置化措施探讨
- Author:
Mulan WANG
1
;
Peng LIN
1
;
Siwu TU
1
;
Zhenzhen CHEN
1
;
Hongqiao WANG
1
Author Information
1. Jiangxi Drug Inspection Center，Nanchang 330029，China
- Publication Type:Journal Article
- Keywords:
DTP pharmacies;
cold chain medicines;
quality management;
risk management;
pre-emptive management
- From:
China Pharmacy
2025;36(4):395-400
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To investigate the current status of quality management of cold chain medicines in direct-to-patient （DTP） pharmacies and propose measures for pre-emptive risk management， providing references for the quality risk management of cold chain medicines. METHODS Based on the requirements of national regulations， a survey was conducted on the quality management of cold chain medicines in DTP pharmacies of J Province from November 2023 to February 2024， focusing on the receipt， storage， distribution， and delivery processes， using questionnaires， telephone interviews， and on-site visits. Common quality management issues in the operation of cold chain medicines were identified， and the causes of these issues were analyzed to propose feasible pre-emptive risk management measures. RESULTS & CONCLUSIONS A total of 122 DTP pharmacies participated in the questionnaire survey， and personnel from 30 DTP pharmacies participated in on-site and telephone interviews. Typical problems were identified in some DTP pharmacies， including insufficient personnel allocation or training， incomplete or inadequate implementation of quality system documentation， inadequate provision or management of cold chain facilities and equipment， and non-compliant storage and distribution of cold chain medicines. These issues posed certain risks to the quality management of cold chain medicines. It is recommended that DTP pharmacies strengthen personnel allocation and training， improve quality system documentation， enhance the provision and management of facilities and equipment， standardize storage and transportation operations， and strengthen supervision and assessment as pre-emptive measures. In addition， all sectors of society should also collaborate in governance from the perspective of ensuring the safety of cold chain drug storage and transportation， in order to mitigate the risk of quality and safety issues during the distribution of cold chain drugs and guarantee the safe and effective use of medications for patients.
