医院药品不良反应集中监测与评价系统的研发与应用
发布时间：2018-08-20 20:00
【摘要】：药品不良反应(Adverse Drug Reaction,简称ADR)是指在按规定剂量正常应用药品的过程中产生的有害而非所期望的、与药品应用有因果关系的反应,药品不良反应一般可分为副作用、毒性反应、过敏反应和继发感染四大类,在现实生活中,药品不良反应的发生率是相当高的,特别是在长期使用或用药量较大时,情况更为严重甚至出现严重的毒副反应,ADR报告和监测是指药品不良反应的发现、报告、评价和控制的过程,国际上ADR监测的主要方法有自发呈报系统(SRS)、处方事件监测(PEM)及医院集中监测系统等三种。 本文针对我国目前ADR监测自发呈报模式存在的漏报率高、计算ADR发生率困难、报告随意性强、报告信息不完整难以确定因果关系等问题和局限性,结合国家药监部门对上市后药品安全监管的需求,研究开发“医院药品不良反应集中监测与评价系统”,通过与协作医院HIS系统的信息集成,实现医疗机构内部ADR信息管理、重点监测药品安全性再评价管理、ADR处方事件监测管理及与广东省ADR信息管理系统的信息智能交换管理等功能,从而为探索我国医院ADR信息及重点监测药品信息的自动采集、分析、评价、预警、反馈及服务的有效方法进行有益地尝试。 本文研究开发工作在探索适合我国国情的药品ADR医院集中监测、处方事件监测与自发呈报监测等方法有机结合与应用方面有所创新,研究成果将为我国逐步建设和推广应用兼顾药品ADR监测、重点药品安全性再评价及区域药物流行病学研究等功能的综合服务平台打下良好基础,从而为我省乃至我国全面提升上市后药品安全监管能力和有效促进医疗机构安全合理用药服务。
[Abstract]:Adverse Drug Reaction (ADR) refers to the adverse reactions produced in the course of normal use of drugs according to the prescribed dosage rather than expected, which are causal to the use of drugs. ADR can be generally divided into four categories: side effects, toxic reactions, allergic reactions and secondary infections. In real life, drugs ADR reporting and monitoring refers to the process of discovery, reporting, evaluation and control of adverse drug reactions. The main methods of ADR monitoring in the world are spontaneous reporting system (SRS), prescription event monitoring. There are three kinds of measurement system (PEM) and centralized hospital monitoring system.
Aiming at the problems and limitations of the current spontaneous reporting mode of ADR monitoring in China, such as high rate of omission, difficulty in calculating the incidence of ADR, strong randomness in reporting, incomplete information in reporting, and difficulty in determining the causality, this paper studies and develops the "centralized monitoring of adverse drug reactions in hospitals" according to the requirements of the state drug regulatory department for drug safety supervision after listing. Through information integration with HIS system of cooperative hospital, the functions of ADR information management in medical institutions, drug safety reappraisal management, ADR prescription event monitoring management and intelligent information exchange management with ADR information management system of Guangdong Province are realized, so as to explore ADR information and key monitoring of hospitals in China. Effective methods for automatic collection, analysis, evaluation, early warning, feedback and service of drug information are beneficial attempts.
The research and development work in this paper has made some innovations in exploring the organic combination and application of drug ADR hospital centralized surveillance, prescription event surveillance and voluntary reporting surveillance. The research results will give consideration to drug ADR surveillance, key drug safety reassessment and regional drug epidemic in China. The comprehensive service platform of research and other functions lays a good foundation for our province and even our country to comprehensively enhance the post-marketing drug safety supervision ability and effectively promote the safe and rational drug use service of medical institutions.
【学位授予单位】：广东工业大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95
本文编号：2194824
[Abstract]:Adverse Drug Reaction (ADR) refers to the adverse reactions produced in the course of normal use of drugs according to the prescribed dosage rather than expected, which are causal to the use of drugs. ADR can be generally divided into four categories: side effects, toxic reactions, allergic reactions and secondary infections. In real life, drugs ADR reporting and monitoring refers to the process of discovery, reporting, evaluation and control of adverse drug reactions. The main methods of ADR monitoring in the world are spontaneous reporting system (SRS), prescription event monitoring. There are three kinds of measurement system (PEM) and centralized hospital monitoring system.
Aiming at the problems and limitations of the current spontaneous reporting mode of ADR monitoring in China, such as high rate of omission, difficulty in calculating the incidence of ADR, strong randomness in reporting, incomplete information in reporting, and difficulty in determining the causality, this paper studies and develops the "centralized monitoring of adverse drug reactions in hospitals" according to the requirements of the state drug regulatory department for drug safety supervision after listing. Through information integration with HIS system of cooperative hospital, the functions of ADR information management in medical institutions, drug safety reappraisal management, ADR prescription event monitoring management and intelligent information exchange management with ADR information management system of Guangdong Province are realized, so as to explore ADR information and key monitoring of hospitals in China. Effective methods for automatic collection, analysis, evaluation, early warning, feedback and service of drug information are beneficial attempts.
The research and development work in this paper has made some innovations in exploring the organic combination and application of drug ADR hospital centralized surveillance, prescription event surveillance and voluntary reporting surveillance. The research results will give consideration to drug ADR surveillance, key drug safety reassessment and regional drug epidemic in China. The comprehensive service platform of research and other functions lays a good foundation for our province and even our country to comprehensively enhance the post-marketing drug safety supervision ability and effectively promote the safe and rational drug use service of medical institutions.
【学位授予单位】：广东工业大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95
【引证文献】
相关期刊论文 前2条
1 李丽娅;;基层医院药品不良反应监测中存在的问题探讨[J];世界最新医学信息文摘;2016年94期
2 谢莹霞;刘源;;利用医院集中监测药物不良反应管理系统适时监测药物性肝损害[J];中国卫生产业;2016年29期
相关硕士学位论文 前1条
1 陆文乔;区域食品安全检测及风险预警系统设计与实现[D];广东工业大学;2015年
，本文编号：2194824
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