我国药品不良反应监测体系的现状、问题与对策研究

发布时间：2018-10-08 10:02

【摘要】：上市后药品的安全性事关每一个人,我国药品生产企业在改革开放的市场经济中蓬勃发展,为临床提供了大量物美价廉的药品,跨国药品生产企业踊跃入华,带来了临床急需的创新药,这些药品是我国的健康事业不可或缺的,其为保障人民健康提供了重要物质支撑。然而,是药三分毒,经批准上市药品的安全性是相对的,药品在治疗疾病的同时也可能会给人们带来与治疗无关的有害反应,这就是药品不良反应。因此,药品安全是世界各国药品监管部门追求的共同目标,开展药品不良反应监测成为药品安全监管部门管控上市后药品安全性的重要手段,构建药品不良反应监测体系是政府在药品安全这一重要的公共安全领域必须履行的责任和义务。本文从药物的本质出发,对药品安全问题及药品不良反应监测的国内外历史、现状进行了阐述；并论述了药品安全的公共产品属性,从经济学角度分析了药品安全的市场失灵因素；以福建省药品不良反应监测工作的实践为例说明了我国基层药品不良反应监测体系的特点,分析了体系建设过程中遇到的困境,并从宏观上提出了当前药品不良反应监测体系构建中应重点关注的问题和因应之策。本文认为,构建和完善包括药品不良反应损害赔偿法在内的药品不良反应相关法律法规、强化卫生行政部门和医疗机构在药品不良反应监测体系中的责任和地位、完善药品不良反应监测技术体系、努力实现监测成果最大限度和最大范围的有效利用、加强药品不良反应监测管理机制建设是当前药品不良反应监测体系构建中的当务之急。
[Abstract]:The safety of drugs after going on the market has a bearing on everyone. The pharmaceutical manufacturing enterprises of our country have developed vigorously in the market economy of reform and opening up, providing a large number of high-quality and inexpensive drugs for clinical practice, and multinational drug manufacturing enterprises have enthusiastically entered China. These drugs are indispensable to the health of our country and provide important material support for the protection of people's health. However, the safety of the approved drugs is relative, and the drugs may bring non-toxic reactions to people while treating diseases, which is called adverse drug reactions. Therefore, drug safety is a common goal pursued by drug regulatory authorities in the world, and monitoring of adverse drug reactions has become an important means for drug safety supervision and control after marketing. It is the responsibility and obligation of the government to establish an adverse drug reaction monitoring system in the field of drug safety, which is an important field of public safety. Starting from the essence of drugs, this paper expounds the history and present situation of drug safety problems and adverse drug reaction monitoring at home and abroad, and discusses the public product attributes of drug safety. This paper analyzes the market failure factors of drug safety from the angle of economics, takes the practice of monitoring adverse drug reactions in Fujian Province as an example to illustrate the characteristics of the monitoring system of adverse drug reactions at the grass-roots level in China, and analyzes the difficulties encountered in the process of building the system. At the same time, the author puts forward the problems and countermeasures in the construction of the current ADR monitoring system from the macro point of view. In this paper, we construct and perfect the laws and regulations related to adverse drug reactions, including the law of compensation for adverse drug reactions, and strengthen the responsibility and position of the administrative departments of health and medical institutions in the monitoring system of adverse drug reactions. It is urgent to perfect the technical system of adverse drug reaction monitoring, to realize the most effective use of the monitoring results and to strengthen the management mechanism of adverse drug reaction monitoring system.
【学位授予单位】：厦门大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：F203;F426.72

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