Page 17 - 《中国药房》2025年4期

·药事管理·

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 Δ

＊
王木兰 ，林 鹏，涂司武，陈珍珍，王洪桥（江西省药品检查员中心，南昌 330029）

中图分类号 R952 文献标志码 A 文章编号 1001-0408（2025）04-0395-06
DOI 10.6039/j.issn.1001-0408.2025.04.02

摘 要 目的 调研直接面向患者（DTP）药房冷链药品质量管理现状并提出风险管理前置化措施，为做好冷链药品质量管理提供
参考。方法 基于国家相关法规要求，采用调查问卷、电话采访、实地访问的方式，于2023年11月－2024年2月对我国J省的DTP
药房冷链药品收货、储存、发货、配送环节中的质量管理情况进行调研，找出冷链药品经营过程中质量管理的常见问题，分析原因
并提出可行的风险管理前置化措施。结果与结论 122家DTP药房参与了问卷调查，30家DTP药房的负责人参与了实地访问和电
话访问。部分DTP药房存在人员配备或培训不足、质量体系文件制定不全面或执行不充分、冷链设施设备配备或管理不到位、冷
链药品储存与配送不规范等问题，冷链药品的经营质量管理存在一定风险。建议DTP药房采取加强人员配备和培训工作、完善
质量体系文件、强化设施设备的配备与管理、规范储运操作并强化监督考核等前置化措施，社会各方也应从保障冷链药品储运安
全出发协同治理，以减少冷链药品经营过程中质量安全问题的发生，保障患者用药安全有效。
关键词 直接面向患者药房；冷链药品；质量管理；风险管理；前置化管理

Exploring the current status of quality management of cold chain medicines in DTP pharmacies and the
measures for pre-emptive risk management
WANG Mulan，LIN Peng，TU Siwu，CHEN Zhenzhen，WANG Hongqiao（Jiangxi Drug Inspection Center，
Nanchang 330029， China）

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.
KEYWORDS DTP pharmacies； cold chain medicines； quality management； risk management； pre-emptive management

随着我国医疗改革的持续深入，“两票制”、医院“药
Δ 基金项目 江西省药品监督管理局科研项目（No.2023GL22，No.
占比”控制、疾病诊断相关分组（diagnosis related groups，
2024GL14）
DRG）付费、国家医保谈判药品“双通道”管理等政策的
＊ 第一作者 副 主 任 药 师 。 研 究 方 向 ：药 品 监 管 。 E-mail：
wzj1005@163.com 逐步落地，大大促进了医院处方外流，部分规模较大、管

中国药房 2025年第36卷第4期 China Pharmacy 2025 Vol. 36 No. 4 · 395 ·