【作者】 李旭；

【导师】 宋悦华；

【作者基本信息】 大连理工大学 ， 公共管理（MPA）（专业学位）， 2017， 硕士

【摘要】 药品质量安全问题是重大的民生问题,我国政府高度重视药品质量安全问题,近年来,我国药品监管体系基本建立,药品供应体系基本健全,药品法律体系不断完善,经过几十年的不懈努力,我国基本解决了用药难问题。但在对占药品销售终端85%以上市场份额的医疗机构药品使用监管还存在“市场失灵”等问题。本文从盘锦市医疗机构药品使用监管的实际出发,对药品使用监管现状进行探究分析,分析问题和成因,为盘锦市药品使用监管提供解决方案及对策建议,助推盘锦市食品药品安全放心城市创建,也为完善我国医疗机构药品使用监管工作提供参考。本文通过文献研究法、问卷调查法和统计分析法,对国内外药品监管相关文献进行分析研究,对药品使用监管体制机制、法律法规、药品使用人员情况进行调查研究;对盘锦市医疗机构分布、药品使用管理规范化状况、药品管理从业人员、药品用设施设备、药品使用计算机化系统管理等进行调查研究。通过上述研究,基本分析了盘锦市医疗机构药品使用监管存在的问题及成因。药品使用监管存在部门间职责边界不清问题;存在药品使用监管人员流动大专业技能不熟问题;存在药品使用监管不规范,医疗机构药品使用质量管理水平低,药品使用质量风险管理工作滞后问题。主要原因是药品使用监管法律法规不健全,药品监管体制不稳定无专职药品监管人员,药品使用监管制度不完善,药品使用质量管理标准不统一,药品使用计算机化管理水平低。在上述研究分析的基础上,通过文献研究法,借鉴国内外药品监管经验,本文提出了监管部门+医疗机构双推进改进方案,通过完善盘锦市医疗机构药品使用监管制度,加强盘锦市药品使用监管人员队伍建设,提升盘锦市医疗机构药品使用质量管理水平,建立盘锦市医疗机构药品使用风险管理体系,推进盘锦市医疗机构药品使用监管社会共治,全面提升盘锦市医疗机构药品使用监管水平,切实保障人民群众用药安全。更多还原

【Abstract】 The drug quality safety is a major livelihood issues,the Chinese government attaches great importance to the quality and safety of drugs,in recent years,China’s drug regulatory system basically established,the drug supply system is basically sound,and constantly improve the legal system of medicine,after decades of unremitting efforts,China has basically solved the difficult problem of medication.However,there are also problems such as "market failure" in the regulation of drug use in medical institutions that account for more than 85% of the market share of drug sales terminals.Based on the practice of the medical institutions of Panjin City drug use monitoring,drug use supervision status inquiry analysis,analysis of problems and causes,provide solutions and suggestions for the supervision of drug use in Panjin City,Panjin City,boosting food and drug safety assured City,also provides the reference for the improvement of China’s medical institutions drug use monitoring work.In this paper,through literature research,questionnaire survey and statistical analysis,analysis of the domestic and foreign research and drug supervision literature,investigation and Research on drug use supervision system,laws and regulations and the use of pharmaceutical personnel;distribution of medical institutions in Panjin city medicine to regulate the use of management status,practitioners,drug administration,drug use of facilities and equipment,and drug use of computerized system management research.Through the above research,the problems and causes of drug use supervision in Panjin medical institutions are analyzed.Drug use supervision responsibilities between departments unclear problems exist;drug use monitoring the movement of large professional skills with the drug problem;do not regulate the use of drugs in medical institutions use supervision,quality management level is low,the drug use of quality risk management work lag problem.The main reason is the use of drug control laws and regulations are not perfect,the drug regulatory system is not stable and no full-time drug supervision personnel,drug use monitoring system is not perfect,the use of drug quality management standards are not unified,drug use Management low level of computer.On the basis of the above analysis,through literature research,draw lessons from domestic and foreign experience in drug supervision,this article proposes the supervision departments and medical institutions to promote double improvement,through the improvement of medical supervision system,strengthen supervision of drug use construction personnel,improve medical institutions drug use quality management level,the establishment of medical institutions and drug use the risk management system,promote the supervision of the use of drugs in medical institutions of social governance,to enhance the drug use in medical institutions of Panjin City,the level of supervision,and effectively protect people’s drug safety.更多还原