摘要
药品现在已经成为居民生活中必备品之一,其质量直接关系到人们的生命安全,例如2003年发生的鱼腥草注射液事件、2006年发生的“欣弗”、“齐二药”事件,以及最近的“华联制药”等一系列事件使公众对药品生产工艺和用药安全产生了不同程度的质疑。由于国内的药品监督管理还缺少有效的信息回馈和管理机制,因此当重大药品事故发生一段时间后,其它地区、部门才采取措施,信息相对滞后。基于RFID的药品监督管理重构了传统的药品监督管理流程,增进了药监各部门之间信息的沟通,能够有效的阻止假药流入市场,维护正常的药品市场秩序,提高市场的灵敏度。
本文总结了国内外药品监督管理的发展和现状,分析了新的识别技术—RFID无线射频技术以及其在药品监督管理中的应用;研究了分布式数据库技术的性能和工作方式,构建了以分布式数据库为基础的多层药监框架。
以现有的药品监督管理方面的法律法规为依据,结合药品RFID标签,以管制类药品为例,对目前的药品购销、使用流程进行了重新的设计,建立了以RFID为药品信息载体的购销流程。
以RFID标签和药品流通信息中的各项属性值为依据,对药品监督管理中涉及到的主要问题—药品本身具有毒副作用、药品变质、药品过期、实到药品与所购药品不一致、生产许可证过期、被吊销—设计了具体的解决方案,实现了对单个药品进行监督管理的目的。
根据国家法律法规对药品标签内容的要求,对Mifare卡中用户数据区进行了重新的划分,实现了对药品标签信息的存储。
Drugs have become essential for the lives of the residents. Its quality has the direct relationship to the people's lives and safety. For example, in 2003, the Yu Xing Cao injection and in 2006, the "Xin Fu" and "Qi medicine" and a series of incident make the public have varying degrees of doubt of the drug production and drug safety. Due to the lack of effective management of information and management of feedback mechanism, major drugs accident occurred for a period of time until the other areas and departments started to take measures. The information is comparatively lagging behind. A comprehensive drug supervision and management can effectively prevent fake drugs into the market, maintain normal order of the pharmaceutical market and improve the sensitivity of the market.
This dissertation summarizes the development and the status of the pharmaceutical supervision and management domestic and abroad, analyzes the new recognition technology-RFID radio frequency technology, and its applications in pharmaceutical supervision and management; studies the performance and working methods of distributed database technology, builds a framework of multi-storey Drug Administration based on the distribution Database.
With the existing laws and regulations on drug supervision and administration, we use drug RPID tags, take the controlled drugs as an example, re-design the current drugs buying and selling process, set up a drug buying and selling drugs process based on the RFID.
Based on the values of RPID tags, we design the specific solution for each main question of the drug supervision and administration, such as, drugs with toxic side effects of their own, drugs eradicating corruption, drugs expired, the drug is not the one wanted, production permit expired, been cancelled.
According to state laws and regulations on drug label content requirements, we re-design the Mifare card user data areas, and fulfill the drug label information storage.
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