摘要
为提高试验用药品的管理水平,应用7S管理模式规范本院中心药房试验用药品的管理。区域划分明确,分验收区、保存区和退回区,保存区分常温区、阴凉区和冷藏区。设置专业药品管理员,实行专项专册专人管理试验用药品,试验用药品统一接收,严格区分机构、专业存放试验用药品。严格落实日常维护和定期保养工作。加强药品管理员培训,增强GCP意识,提高药品管理能力。购置自动化温度、湿度监控设备,实现全天候温度、湿度监控。缩减管理环节,降低管理成本。7S管理模式的应用使本院中心药房分区更趋合理,人员设置与职责分工更明确,试验用药品的管理更科学、规范。
In order to improve the management level of clinical trial drugs, 7 S management was referred to standardize the management of clinical trial drugs in the central pharmacy of our hospital. The division of the central pharmacy was clean, which contained acceptance area, storage area and return area. The storage area consisted of normal storage, shaded storage and cold storage. The professional pharmaceutical administrator was newly set, who actively fulfilled his tasks in accordance with one folder correspondence to one project and strictly did routine and regular maintenance of clinical trial drugs. Clinical trial drugs were primarily received and strictly distinguished in the central pharmacy. The pharmaceutical administrators were trained in order to enhance good clinical practice awareness and management capability. The automatic temperature and humidity monitoring equipment was introduced, and the all-day temperature and humidity of the central pharmacy were monitored. The clinical trial drugs management links and costs were largely reduced. Referring to 7 S management, the partition is more reasonable, and the staff setting and division of responsibilities are clearer.Moreover, the management of clinical trial drugs is more scientific, standardized and efficient.
作者
赵想玲
夏勇
闵捷
汪亦奇
李刚
郭飘飘
ZHAO Xiang-ling;XIA Yong;MIN Jie;WANG Yi-qi;LI Gang;GUO Piao-piao(Drug Clinical Tried Institution,the Third Hospital of Nanchang,Nanchang JIANGXI 330009,China)
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2019年第3期144-147,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
7S管理
临床试验
药房
药物贮藏
7S management
clinical trial
pharmacies
drug storage
作者简介
赵想玲,女,初级药师,硕士,主要从事药物临床试验药品管理的研究,E-mail:408605446@qq.com;夏勇,男,副主任药师,硕士,主要从事药物临床试验管理的研究,E-mail:3136710384@qq.com.