【作者】 林自葵；

【导师】 汝宜红；

【作者基本信息】 北京交通大学 ， 管理科学与工程， 2011， 博士

【摘要】 药品是用于预防、治疗和诊断人体疾病,保证人民群众身体健康的特殊商品,关系国计民生。药品的质量安全关乎人民群众的健康,然而药品安全事件却在我国频频发生,引起了人民群众的普遍关注,产生了较大的消极影响。保障药品安全的关键是强化药品流通监管,但是,目前我国药品流通监管采用的投诉举报机制、抽查检验机制和监督检查机制存在发现问题不及时、监管人员劳动强度大等问题,药品流通监管的方法和技术手段需要改进和完善才能更好的适应当前监管形势的需要。在此背景下,本文在国家科技支撑计划项目课题——“药品安全追溯管理射频识别技术研究”(2008BA155807)的基础上进行了延伸,提出了药品物流系统网络流量监管的概念,并综合运用政府规制理论、物流系统理论等多学科理论与方法,将定性分析和定量研究、理论研究和仿真/实证分析相结合,立足我国实际情况,对我国药品流通监管的现状进行了分析,研究了药品物流系统网络流量监管的机理,并对药品物流系统网络流量实时监控、网络流量异常点追溯、异常点隔离后网络重构等问题进行了建模、仿真/实证研究,从而为我国药品流通监管机构提供了一套事前控制、实时自动且高效的药品流通监管方法。本文完成的主要研究工作如下：(1)在国内外学者研究的基础上,本文对药品物流系统的内涵进行了界定,并通过分析药品物流系统和药品流通之间的关系,提出了“药品物流系统网络流量监管”的概念。药品物流系统网络流量监管为我国药品流通监管工作提供了一种全新的思路。(2)通过整理相关政策文件、引用国家食品药品监督管理局和国家统计局公布的统计数据,本文对我国药品流通监管的体制、法制和机制情况进行了系统的梳理,用详实的数据说明了我国药品流通监管取得的成就及存在的问题。(3)应用物流系统理论、政府规制理论和控制论,本文对我国药品物流系统的主体、网络结构、客体、流量特性等进行了分析,设计了药品物流系统网络流量监管的过程,并分别论述了药品物流系统网络流量的实时监控、物流系统中流量异常点的追溯、流量异常点隔离后的网络重构的机理。(4)依据药品物流系统网络流量监管的机理,本文建立了药品物流系统网络流量实时监控模型、药品物流系统网络流量异常点追溯模型、异常点隔离后的物流网络重构模型,并依据模型各自的特点分别采用仿真或实证的方法进行了验证。更多还原

【Abstract】 Drugs are special goods for preventing, treating and diagnosing disease in order to assure people’s health. The quality of drug is directly related to people’s health. However, the frequent events of quack and inferior remedies happening recently in China have caused great attention and negative effect. The regulation in drug circulation channel is the key to prevent those events. However, the complaint reporting mechanism, medicines sampling inspection mechanism and supervision mechanism, which are commonly used in drug circulation regulation now, can cause untimely trace and heavy workload for regulator. So the regulation methods and technology of drug circulation have to be improved in order to better meet the requirements of current regulation situations.With the background mentioned above, the dissertation makes further research on the basis of National Science and Technology Supporting Project, which is Drug Safety Retrospective Management Project using RFID Technology with Project N.O. 2008BAI55B07. We put forward a new concept, which is Monitoring and Management of Drug Logistics System Network Flows. With the government regulation theory and logistics system theory, we combine qualitative analysis, quantitative research, theory research and simulation analysis together. Based on the actual situation in China, the current regulation status in drug circulation process is analyzed and the network flows regulation mechanism of drug logistics system is proposed. Then the dissertation makes modeling, simulation and case research on several topics, which can be network flows real-time monitoring of drug logistics system, abnormal points tracking of network flows and network redesign after abnormal points being kept apart. These researches can provide a new set of advance controlled drug regulation method, which has the characteristics of being dynamic, real-time and effective, for relevant department.The innovations of this dissertation are indicated as follows:(1) On the basis of academic research at home and abroad, the dissertation makes the definition of Drug Logistics System. Then through analysis of relationship between drug logistics system and drug circulation, we put forward the concept of Monitoring and Management of Drug Logistics System Network Flows, which offers a new idea for drug circulation regulation in China.(2) With the reference to the relevant policy documents and statistics data from State Food and Drug Administration and State Statistics Bureau, the dissertation summarizes the organization, legal system and mechanism of drug circulation regulation in China, and illustrates the achievement and problem of drug circulation regulation with detailed data.(3) On the basis of logistics systems theory, government regulation theory and controlling theory, the dissertation analysis the subject, network structure, object and flow characteristics of drug logistics system in China, designs the process of Monitoring and Management of Drug Logistics System Network Flows and describes separately real-time monitoring, abnormal points’trace of drug logistics system and network redesign after abnormal points’disposal.(4) Based on the Monitoring and Management mechanism of Drug Logistics System Network Flows, the dissertation establishes network flows real-time monitoring model, network flows abnormal points trace model and network redesign model of drug logistics system. Due to the characteristics of different models, the dissertation uses the different verification methods to verify their feasibility.更多还原