《药品不良反应报告和监测管理办法》的发展研究

发布时间：2018-06-07 11:42

本文选题：药品不良反应 + 药品不良反应报告　；参考：《郑州大学》2014年硕士论文

【摘要】：药品不良反应报告和监测工作在尽早发现药品不良反应和药品不良事件以及避免药害事件重复发生和蔓延等方面发挥着重要的作用，我国国家食品药品监管总局对此项工作高度重视，将其列为药品上市后监管的主要内容之一，并不断加强法规和监测体系建设。1984年《药品管理法》规定将不良反应监测列为药品监管的重要内容，标志着不良反应监测法制化的开始。1999年原国家药品监督管理局和卫生部联合颁发了《药品不良反应监测管理办法（试行）》，结束了多年以来药品不良反应监测工作无章可循的局面。2001年修订的《中华人民共和国药品管理法》第71条规定“国家实行药品不良反应报告制度”。从此ADR监测制度走上了法律轨道；2004年，CFDA和卫生部联合颁布了《药品不良反应报告和监测管理办法》(以下简称04版《办法》)，将法律层级由规范性文件提升为部门规章；2011年卫生部发布了修订后的《药品不良反应报告和监测管理办法》（以下简称11版《办法》），进一步推动了ADR监测体系的开展。11版《办法》的出台，为药品不良反应监测和药品安全性监管提供了一个良好的发展契机，但同时在实施过程中也存在一些问题；例如，医疗机构上报的积极性不高、报告质量不高、药品生产企业ADR监测工作开展不力、公众对ADR的认知度较低、对ADR知识缺乏、惩罚力度不够等；所以本课题希望通过实地调研，借鉴国外的先进方法和理念，去探究一个科学合理的《药品不良反应报告和监测管理办法》，为更好的实施和完善我国的《药品不良反应报告和监测管理办法》提供一些建议和参考。本课题采用的研究方法有文献研究，对比研究，现状研究及借鉴研究等方法，对我国《办法》的发展进行了较为系统的探讨；其中文献研究主要针对2009年到2013年间国内药品不良反应监测文献的内容进行分析，对比研究主要是将我国2个版本的《办法》在结构框架、每章节的内容予以对比，现状研究涉及河南省生产企业、医疗机构及药品监管部门对11版《办法》的实施情况，借鉴研究主要对ICH以及美国在药品不良反应监测工作方面的方法进行探讨。对比研究表明，11版《办法》由04版《办法》的六章33条增加到八章67条，，增加了药品重点监测和信息管理两个章节；11版《办法》规范了报告程序，增加了对严重ADR、群体药品不良事件调查核实评价的要求，增加了“药品重点监测的要求”，并对生产企业开展ADR监测工作提出了更多更高的要求。现状研究表明，河南省的ADR监测工作在11版《办法》实施之后取得了很大的突破，例如报告数量逐年增长，报告质量也得到了提高，河南省药品监测部门针对报告收集过程中出现的问题，对医疗机构、生产企业及民众采取了有效的措施，使得近几年来河南省收集到的不良反应报告在数量及质量上都取得了显著的成效；河南省监监测机构收集到的ADR应报告数据绝大多数来自医疗机构，河南省生产企业报告ADR的主动性也不高，这与CFDA在2012年ADR年度报告上报道的是一致的，借鉴研究表明，我国关于药品不良反应监管的法律法规日趋成熟,但与美国、欧盟及ICH的相关法律法规相比：我国还存在制度上的不健全，例如由于监管需求和监管形势的不断变化和发展出现了监管法律滞后、与现实脱节的新情况,药品不良反应监管法规位阶不高，相关配套法规不完善，不良反应受害人难以获得救济等。文献研究表明，我国在实施2011版《办法》过程中存在诸多问题，例如报告质量不高，企业报告率太低，《办法》可操作性不强，与办法相配套的法律法规缺失等。结论：应该完善我国ADR监测工作相关的法律法规，提高医疗机构ADR报告的质量，增强监测技术部门的监测水平，强化监管部门对有关药品安全风险警示信息的发布；因此，我国ADR监测工作应该借鉴国外先进经验并结合我国实际，来探究一个科学的合理的药品不良反应报告和监测管理办法。
[Abstract]:The report and monitoring of adverse drug reactions (ADR) play an important role in detecting adverse drug reactions and adverse drug events as soon as possible and avoiding the repeated occurrence and spread of drug damage events. The State Food and drug administration has attached great importance to this work and listed it as one of the main contents of post market supervision. In the period of.1984, the law of drug management was set up as an important content of drug regulation, which marks the beginning of the.1999 year of the National Drug Supervision Administration and the Ministry of health of the National Drug Administration Bureau and the Ministry of public health, which issued the method of monitoring and management of adverse drug reactions (Trial) for many years. The situation of drug ADR monitoring has no rules to follow. The seventy-first article of the People's Republic of China drug management law revised in the year.2001 amended the state to implement the report system on adverse drug reactions in the state. Since then, the ADR monitoring system has been on the legal track; in 2004, the CFDA and the Ministry of Health jointly promulgated the report on adverse drug reactions and monitoring management office of the Ministry of health. Law > (hereinafter referred to as the 04 edition < method >), the legal hierarchy is upgraded from a normative document to a departmental regulation. In 2011, the Ministry of Health issued a revised "adverse drug reaction report and monitoring management method >" (hereinafter referred to as the 11 Edition), which further promoted the introduction of the.11 edition of the ADR monitoring system for the monitoring of adverse drug reactions and the monitoring of adverse drug reactions. Drug safety regulation provides a good opportunity for development, but at the same time, there are also some problems in the process of implementation. For example, the enthusiasm of the medical institutions is not high, the quality of the report is not high, the ADR monitoring work of the pharmaceutical production enterprises is ineffective, the public awareness of the ADR is low, the knowledge of ADR is lacking, and the punishment is not enough, and so on. This project hopes to explore a scientific and reasonable "adverse drug reaction report and monitoring management method" by using the advanced methods and ideas of foreign countries, and to provide some suggestions and references for the better implementation and improvement of China's "adverse drug reaction report and monitoring management method".
The research methods used in this study include literature research, comparative study, current situation research and reference research methods, and systematically discuss the development of China's "method >". The literature research mainly analyzes the internal capacity of the domestic drug adverse reaction monitoring literature from 2009 to 2013, and the comparative study is mainly the 2 in China. The contents of each chapter are compared in the structure framework. The current research involves the implementation of the 11 edition of the "11 edition" by the production enterprises of Henan Province, the medical institutions and the drug regulatory departments, and the study mainly on the methods of adverse drug reaction monitoring in the United States.
The comparative study showed that the 11 edition of the 11 edition was increased to eight chapters and 67 articles from the 04 edition of the method to eight chapters and 67, and increased the two chapters of the drug key monitoring and information management; the 11 edition of the method standardized the reporting procedure, increased the requirements for the verification and evaluation of the serious ADR, the group drug adverse events investigation, and increased the "requirements for drug key monitoring", and Production enterprises have put forward more and more requirements for ADR monitoring.
The present situation research shows that the ADR monitoring work in Henan province has made great breakthroughs after the implementation of the 11 edition of the "method >". For example, the number of reports has increased year by year, and the quality of the report has been improved. The drug monitoring department of Henan province has taken effective measures to the medical machinery, production enterprises and the public in view of the problems arising in the report collection process. In recent years, the reports of adverse reactions collected by Henan province have achieved remarkable results in quantity and quality; most of the ADR reports collected by Henan provincial monitoring agencies are from the medical institutions, and the initiative of the production enterprises in Henan province reports ADR is not high, which is consistent with the report of the 2012 ADR report in 2012.
The study shows that the laws and regulations on ADR supervision in China are increasingly mature, but compared with the relevant laws and regulations of the United States, the European Union and the ICH, our country still has the unsound system. For example, the new situation that the regulatory law is lagging behind because of the constant change and development of supervision demand and supervision situation and the new situation that disjoins with reality. Adverse drug reaction regulation regulation is not high, the relevant supporting laws and regulations are not perfect, and the victims of adverse reactions are hard to get relief.
The literature research shows that there are many problems in the implementation of the 2011 edition of the "method" in China, such as the poor quality of the report, the low reporting rate of the enterprise, the low operability of the method and the lack of laws and regulations to match the measures.
Conclusion: we should improve the relevant laws and regulations of ADR monitoring work in our country, improve the quality of the ADR report of medical institutions, strengthen the monitoring level of the monitoring technical department and strengthen the release of the warning information about the risk of drug safety by the regulatory authorities. Therefore, the ADR monitoring work in our country should learn from the advanced foreign experience and combine the reality of our country. A scientific and rational management method for adverse drug reaction reporting and monitoring.
【学位授予单位】：郑州大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95

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