【作者】 邵华；

【导师】 林德明；

【作者基本信息】 大连理工大学 ， MPA（专业学位）， 2014， 硕士

【摘要】 药品不良反应监测是各国药品监督主管部门的重要职责,是一项利国利民的社会公益事业,是确保药品安全、保障公众健康的重要手段。随着医学、药学科学技术的发展,人们对生活质量的要求越来越高,药品的安全性也越来越受到人们的重视,药品不良反应问题成为全球关注的重点问题,世界各国也纷纷采取措施控制和解决药品不良反应问题。但由于我国该项工作起步较晚,工作体制运行也不够顺畅,工作开展面临诸多困难。因此,如何采取有效措施开展好庄河市药品不良反应监测工作,对其他县级地区推进监测工作具有一定的实践意义。本文在文献综述的基础上,紧密联系自身实际工作,采用了文献调查、比较分析、调查研究等方法,首先论述了药品不良反应监测工作的背景和意义,介绍了当前国内外学者如何研究药品不良反应监测工作,并对其观点进行了阐述,对药品不良反应监测等相关关键词进行了释义；其次,分析了庄河市药品不良反应监测工作现状,指出了庄河市药品不良反应监测工作在监测机构、涉药单位、社会公众等方面主要存在机构挂靠、监督机制不健全、专业技术人员缺乏、责任心不强、公众参与度低等诸多问题,并对成因进行深入剖析；然后在借鉴国内外先进经验的基础上,论证从机构设置、监督机制构建、人员素质提高、信息系统建设4个方面对药品不良反应监测工作进行改进,并结合业务流程再造理论、信息不对称理论提出组建专门科室、构建监督机制、实施分类管理、加强信息系统建设等具体的改进方案；最后针对改进方案提出了加强组织保障、完善相关制度、扩大参与范围等保障措施。本文提出尝试对庄河市药品不良反应报告上报单位实施分类管理,并提出建立庄河市药品不良反应补偿机制,以打消庄河市相关单位上报药品不良反应的顾虑和保障公众的合法权益,应该能够积极推进庄河市药品不良反应监测工作。更多还原

【Abstract】 Adverse drug reaction monitoring as the significant responsibility for drug monitoring departments in almost every country all over the world, is the main method of guaranteeing the drug safety and the public health. With the development of medical and pharmaceutical science and technology, people have more and more requirements on the life quality and have paid more and more attention to the drug safety. Adverse drug reaction has become an important problem worldwide and measures have been applied to control and solve the adverse drug reaction problem. However, adverse drug reaction monitoring started relatively late in our country and the system did not work smoothly with numerous difficulties. Therefore, how to take effective measures to develop adverse drug reaction monitoring in Zhuanghe City has a definitely practical significance on improving the monitoring in the other counties.This paper applies the methods, like literature survey, comparative analysis, investigations, on the basis of literature review, closely connected with the practical work, which firstly to describe the background and significance of adverse drug monitoring, introduce the research situation and comment on adverse drug reaction monitoring by the scholarships domestic and overseas. Also this paper summarizes the related key words of the adverse drug reaction monitoring. Secondly, this paper analyzes the current situation of the adverse drug monitoring in Zhuanghe Municipality and the problems and causes analysis are put forward in the adverse drug monitoring in Zhuanghe Municipality in the field of monitoring organs, drug related units and social cognition:the problems including institutions affiliated, imperfect supervision system, lack of professionals, low responsibilities of the staff, low public involvement and so on. Then, referring to the advance experience from domestic and abroad, this paper demonstrates solutions from four aspects, such as institution setting, construction of supervision system, improvement of staff qualities, construction of information system, in order to improve adverse drug reaction monitoring. Combining business process reengineering and asymmetric information theories, specific improvement projects have been put forward, which include construction of specific departments and supervision system, application of classification management and construction of information system. At last, according to the improvement projects, supporting measures are put forward, which are to strengthen the organization guarantee, complete the relative systems and enlarge the participation range and so on.This paper aims to carry out the classification management on the departments which submit the report of adverse drug reaction and puts forward the compensation mechanism of adverse drug reaction in order to dispel the worries of the departments on the reports and guarantee the legal interest of the public, which should improve the adverse drug reaction monitoring in Zhuanghe Municipality positively.更多还原