本文選題：藥品不良反應(yīng) + 藥品不良反應(yīng)報(bào)告��； 參考：《鄭州大學(xué)》2014年碩士論文

【摘要】：藥品不良反應(yīng)報(bào)告和監(jiān)測(cè)工作在盡早發(fā)現(xiàn)藥品不良反應(yīng)和藥品不良事件以及避免藥害事件重復(fù)發(fā)生和蔓延等方面發(fā)揮著重要的作用，我國(guó)國(guó)家食品藥品監(jiān)管總局對(duì)此項(xiàng)工作高度重視，將其列為藥品上市后監(jiān)管的主要內(nèi)容之一，并不斷加強(qiáng)法規(guī)和監(jiān)測(cè)體系建設(shè)。1984年《藥品管理法》規(guī)定將不良反應(yīng)監(jiān)測(cè)列為藥品監(jiān)管的重要內(nèi)容，標(biāo)志著不良反應(yīng)監(jiān)測(cè)法制化的開(kāi)始。1999年原國(guó)家藥品監(jiān)督管理局和衛(wèi)生部聯(lián)合頒發(fā)了《藥品不良反應(yīng)監(jiān)測(cè)管理辦法（試行）》，結(jié)束了多年以來(lái)藥品不良反應(yīng)監(jiān)測(cè)工作無(wú)章可循的局面。2001年修訂的《中華人民共和國(guó)藥品管理法》第71條規(guī)定“國(guó)家實(shí)行藥品不良反應(yīng)報(bào)告制度”。從此ADR監(jiān)測(cè)制度走上了法律軌道；2004年，CFDA和衛(wèi)生部聯(lián)合頒布了《藥品不良反應(yīng)報(bào)告和監(jiān)測(cè)管理辦法》(以下簡(jiǎn)稱04版《辦法》)，將法律層級(jí)由規(guī)范性文件提升為部門規(guī)章；2011年衛(wèi)生部發(fā)布了修訂后的《藥品不良反應(yīng)報(bào)告和監(jiān)測(cè)管理辦法》（以下簡(jiǎn)稱11版《辦法》），進(jìn)一步推動(dòng)了ADR監(jiān)測(cè)體系的開(kāi)展。11版《辦法》的出臺(tái)，為藥品不良反應(yīng)監(jiān)測(cè)和藥品安全性監(jiān)管提供了一個(gè)良好的發(fā)展契機(jī)，但同時(shí)在實(shí)施過(guò)程中也存在一些問(wèn)題；例如，醫(yī)療機(jī)構(gòu)上報(bào)的積極性不高、報(bào)告質(zhì)量不高、藥品生產(chǎn)企業(yè)ADR監(jiān)測(cè)工作開(kāi)展不力、公眾對(duì)ADR的認(rèn)知度較低、對(duì)ADR知識(shí)缺乏、懲罰力度不夠等；所以本課題希望通過(guò)實(shí)地調(diào)研，借鑒國(guó)外的先進(jìn)方法和理念，去探究一個(gè)科學(xué)合理的《藥品不良反應(yīng)報(bào)告和監(jiān)測(cè)管理辦法》，為更好的實(shí)施和完善我國(guó)的《藥品不良反應(yīng)報(bào)告和監(jiān)測(cè)管理辦法》提供一些建議和參考。 本課題采用的研究方法有文獻(xiàn)研究，對(duì)比研究，現(xiàn)狀研究及借鑒研究等方法，對(duì)我國(guó)《辦法》的發(fā)展進(jìn)行了較為系統(tǒng)的探討；其中文獻(xiàn)研究主要針對(duì)2009年到2013年間國(guó)內(nèi)藥品不良反應(yīng)監(jiān)測(cè)文獻(xiàn)的內(nèi)容進(jìn)行分析，對(duì)比研究主要是將我國(guó)2個(gè)版本的《辦法》在結(jié)構(gòu)框架、每章節(jié)的內(nèi)容予以對(duì)比，現(xiàn)狀研究涉及河南省生產(chǎn)企業(yè)、醫(yī)療機(jī)構(gòu)及藥品監(jiān)管部門對(duì)11版《辦法》的實(shí)施情況，借鑒研究主要對(duì)ICH以及美國(guó)在藥品不良反應(yīng)監(jiān)測(cè)工作方面的方法進(jìn)行探討。 對(duì)比研究表明，11版《辦法》由04版《辦法》的六章33條增加到八章67條，，增加了藥品重點(diǎn)監(jiān)測(cè)和信息管理兩個(gè)章節(jié)；11版《辦法》規(guī)范了報(bào)告程序，增加了對(duì)嚴(yán)重ADR、群體藥品不良事件調(diào)查核實(shí)評(píng)價(jià)的要求，增加了“藥品重點(diǎn)監(jiān)測(cè)的要求”，并對(duì)生產(chǎn)企業(yè)開(kāi)展ADR監(jiān)測(cè)工作提出了更多更高的要求。 現(xiàn)狀研究表明，河南省的ADR監(jiān)測(cè)工作在11版《辦法》實(shí)施之后取得了很大的突破，例如報(bào)告數(shù)量逐年增長(zhǎng)，報(bào)告質(zhì)量也得到了提高，河南省藥品監(jiān)測(cè)部門針對(duì)報(bào)告收集過(guò)程中出現(xiàn)的問(wèn)題，對(duì)醫(yī)療機(jī)構(gòu)、生產(chǎn)企業(yè)及民眾采取了有效的措施，使得近幾年來(lái)河南省收集到的不良反應(yīng)報(bào)告在數(shù)量及質(zhì)量上都取得了顯著的成效；河南省監(jiān)監(jiān)測(cè)機(jī)構(gòu)收集到的ADR應(yīng)報(bào)告數(shù)據(jù)絕大多數(shù)來(lái)自醫(yī)療機(jī)構(gòu)，河南省生產(chǎn)企業(yè)報(bào)告ADR的主動(dòng)性也不高，這與CFDA在2012年ADR年度報(bào)告上報(bào)道的是一致的， 借鑒研究表明，我國(guó)關(guān)于藥品不良反應(yīng)監(jiān)管的法律法規(guī)日趨成熟,但與美國(guó)、歐盟及ICH的相關(guān)法律法規(guī)相比：我國(guó)還存在制度上的不健全，例如由于監(jiān)管需求和監(jiān)管形勢(shì)的不斷變化和發(fā)展出現(xiàn)了監(jiān)管法律滯后、與現(xiàn)實(shí)脫節(jié)的新情況,藥品不良反應(yīng)監(jiān)管法規(guī)位階不高，相關(guān)配套法規(guī)不完善，不良反應(yīng)受害人難以獲得救濟(jì)等。 文獻(xiàn)研究表明，我國(guó)在實(shí)施2011版《辦法》過(guò)程中存在諸多問(wèn)題，例如報(bào)告質(zhì)量不高，企業(yè)報(bào)告率太低，《辦法》可操作性不強(qiáng)，與辦法相配套的法律法規(guī)缺失等。 結(jié)論：應(yīng)該完善我國(guó)ADR監(jiān)測(cè)工作相關(guān)的法律法規(guī)，提高醫(yī)療機(jī)構(gòu)ADR報(bào)告的質(zhì)量，增強(qiáng)監(jiān)測(cè)技術(shù)部門的監(jiān)測(cè)水平，強(qiáng)化監(jiān)管部門對(duì)有關(guān)藥品安全風(fēng)險(xiǎn)警示信息的發(fā)布；因此，我國(guó)ADR監(jiān)測(cè)工作應(yīng)該借鑒國(guó)外先進(jìn)經(jīng)驗(yàn)并結(jié)合我國(guó)實(shí)際，來(lái)探究一個(gè)科學(xué)的合理的藥品不良反應(yīng)報(bào)告和監(jiān)測(cè)管理辦法。
[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.
【學(xué)位授予單位】：鄭州大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：R95

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