文档介绍：华中科技大学
硕士学位论文
药品召回成本分析及管理研究
姓名:蒋兴隆
申请学位级别:硕士
专业:社会医学与卫生事业管理
指导教师:姜卫
2010-12
药品召回成本分析及管理研究
研究生:蒋兴隆
导师:姜卫副教授
摘要
药品是特殊商品,它既能防病治病,维护人们生命健康,也可能因毒副作用、
用药不当等原因对人体造成伤害,甚至死亡。近年来,药品不安全事件频繁发生,
越来越多的学者开始关注发达国家的药品监督管理机制。药品召回是生产企业对
已上市销售并存在安全隐患的缺陷药品的回收,能避免缺陷药品在市场上的继续
流通,减少其可能造成的健康损害。生产企业是药品召回实施的主体和召回成本
的承担者。面对巨额的药品召回成本,企业难免望而却步,而这将不利于药品召
回的发展与完善。因此,加强药品召回成本管理的研究具有重要的现实意义。
本论文从药品召回的概况切入,分析了药品召回的适用对象、特点;阐述了
召回对消费者、企业乃至整个医药产业的意义;剖析了召回过程中各个要素的作
用和相互关系及药品召回实施存在的障碍。药品召回成本分析是本论文的重点,
通过药品召回与汽车召回的比较分析,并结合笔者对药品召回成本的定义,提出
了药品召回成本构成的理论模型,并进一步探讨了缺陷药品基本情况、召回主体
的作为、消费者反应及召回效果对召回成本的影响。最后,结合我国药品召回的
现状提出了药品召回成本管理的策略与建议:多渠道筹资,分担企业药品召回成
本;加强药品研发生产质量管理,从源头把关;完善药品不良反应监测,及时发
现问题;保持药品信息顺畅,提高可追踪性;科学设计召回计划,合理组织药品
召回;做好企业危机公关,树立企业良好形象。
关键词:药品召回;成本分析;影响因素;成本管理
1
ABSTRACT
Drugs are special kind of products that can prevent and cure diseases, support
people's lives and health. In addition, they may cause injury and even death due to
side effects, inappropriate medication and other factors. In recent years, unsafe
medicines have happened frequently, more and more scholars begin to pay attention
to the drug regulatory mechanism of developed countries. Drug recall by
pharmaceutical manufacturers is a measure of recycling the drugs that have been
marketed and have safety problems, to avoid the defect drugs continue to circulate
in the market and reduce the potential health damage. Drug manufacturers are the
subject of recall and bearing the total recall costs. Facing massive cost of drug
recall, pharmaceutical manufacturers are discouraged inevitably, which will be
detrimental to the development and improvement of drug recall. Therefore, to
enhance cost management of drug recall has important practical significance.
This article cuts in from the general situation of drug recall, analyzing the
characteristics and object of drug recall, describing the meaning of recall for
consumers, companies and even the pharmaceut