某院重大公共卫生事件捐赠药品风险管理策略  

Risk management strategies of donated drugs for major public health eventsat a hospital

作　　者：王欣 陈捷 张静 WANG Xin;CHEN Jie;ZHANG Jing(Department of Pharmacy,Lu'an Hospital,Anhui Medical University,Anhui Lu'an 237000,China)

机构地区：[1]安徽医科大学附属六安医院药学部,安徽六安237000

出　　处：《中国医院药学杂志》2021年第18期1911-1916,共6页Chinese Journal of Hospital Pharmacy

基　　金：2020年度六安市科技计划项目(六科创[2020]74号,编号:2020laskt13)。

摘　　要：目的:探讨重大公共卫生事件下,引入风险管理方法规范管理医疗机构接受的捐赠药品。方法:按照风险管理基本步骤,利用危害分析与关键控制点法的原理和步骤,对医院接受捐赠药品所存在的风险进行评估,使用逻辑树法确定关键控制点,制订危害分析与关键控制点的实施计划。结果:成立医院捐赠药品风险管理小组,绘制接受捐赠药品流程图,拟定危害分析单,结合医院管理实际,确定6个关键控制点,即捐赠药品品种不在医院应急药品目录范围内、效期较近、与捐赠主体签订协议不完善、混发错发、超说明书使用、不合理用药,根据关键控制点,分别列出关键限值,拟定出捐赠药品风险管理实施计划。结论:引入风险管理理念,合理选择风险评估工具,科学管理重大公共卫生事件下医院接受的捐赠药品,有助于医院规范、合法、有序、安全地使用捐赠药品,充分发挥其治疗作用和社会作用的双重价值。OBJECTIVE To explore the implementation of risk management methods to regulate the management of donated drugs accepted by medical institutions during major public health events.METHODS In accordance with basic steps of risk management, the principles and steps of hazard analysis and critical control point method were applied for evaluating the risks of donated drugs accepted by hospital.Logic tree method was employed for determining the critical control point and formulating the implementation plan for hazard analysis and critical control point.RESULTS A risk management team was assembled for donated drugs in the hospital.And a flow chart was plotted for donated drugs, a hazard analysis sheet formulated and six key control points determined for actual management of hospital.The donated drugs were no longer within the scope of hospital’s emergency drug list, validity period was relatively short, imperfect agreements with donors, mixed or wrong delivery, off-label use and irrational use of drugs.Based upon key control points, key limits were listed separately and implementation plans formulated for the risk management of donated drugs.CONCLUSION The introduction of risk management concepts, reasonable selection of risk assessment tools and scientific management of donated drugs accepted by hospitals during major public health events will assist hospitals use donated drugs in a standardized, legal, orderly and safe manner so as to achieve the drugs’ therapeutic and social benefits.

关 键 词：重大公共卫生事件 捐赠药品 风险管理 危害分析与关键控制点 

分 类 号：R952[医药卫生—药学]