【摘要】：藥品不良反應(yīng)監(jiān)測(cè)是各國藥品監(jiān)督主管部門的重要職責(zé),是一項(xiàng)利國利民的社會(huì)公益事業(yè),是確保藥品安全、保障公眾健康的重要手段。隨著醫(yī)學(xué)、藥學(xué)科學(xué)技術(shù)的發(fā)展,人們對(duì)生活質(zhì)量的要求越來越高,藥品的安全性也越來越受到人們的重視,藥品不良反應(yīng)問題成為全球關(guān)注的重點(diǎn)問題,世界各國也紛紛采取措施控制和解決藥品不良反應(yīng)問題。但由于我國該項(xiàng)工作起步較晚,工作體制運(yùn)行也不夠順暢,工作開展面臨諸多困難。因此,如何采取有效措施開展好莊河市藥品不良反應(yīng)監(jiān)測(cè)工作,對(duì)其他縣級(jí)地區(qū)推進(jìn)監(jiān)測(cè)工作具有一定的實(shí)踐意義。 本文在文獻(xiàn)綜述的基礎(chǔ)上,緊密聯(lián)系自身實(shí)際工作,采用了文獻(xiàn)調(diào)查、比較分析、調(diào)查研究等方法,首先論述了藥品不良反應(yīng)監(jiān)測(cè)工作的背景和意義,介紹了當(dāng)前國內(nèi)外學(xué)者如何研究藥品不良反應(yīng)監(jiān)測(cè)工作,并對(duì)其觀點(diǎn)進(jìn)行了闡述,對(duì)藥品不良反應(yīng)監(jiān)測(cè)等相關(guān)關(guān)鍵詞進(jìn)行了釋義；其次,分析了莊河市藥品不良反應(yīng)監(jiān)測(cè)工作現(xiàn)狀,指出了莊河市藥品不良反應(yīng)監(jiān)測(cè)工作在監(jiān)測(cè)機(jī)構(gòu)、涉藥單位、社會(huì)公眾等方面主要存在機(jī)構(gòu)掛靠、監(jiān)督機(jī)制不健全、專業(yè)技術(shù)人員缺乏、責(zé)任心不強(qiáng)、公眾參與度低等諸多問題,并對(duì)成因進(jìn)行深入剖析；然后在借鑒國內(nèi)外先進(jìn)經(jīng)驗(yàn)的基礎(chǔ)上,論證從機(jī)構(gòu)設(shè)置、監(jiān)督機(jī)制構(gòu)建、人員素質(zhì)提高、信息系統(tǒng)建設(shè)4個(gè)方面對(duì)藥品不良反應(yīng)監(jiān)測(cè)工作進(jìn)行改進(jìn),并結(jié)合業(yè)務(wù)流程再造理論、信息不對(duì)稱理論提出組建專門科室、構(gòu)建監(jiān)督機(jī)制、實(shí)施分類管理、加強(qiáng)信息系統(tǒng)建設(shè)等具體的改進(jìn)方案；最后針對(duì)改進(jìn)方案提出了加強(qiáng)組織保障、完善相關(guān)制度、擴(kuò)大參與范圍等保障措施。 本文提出嘗試對(duì)莊河市藥品不良反應(yīng)報(bào)告上報(bào)單位實(shí)施分類管理,并提出建立莊河市藥品不良反應(yīng)補(bǔ)償機(jī)制,以打消莊河市相關(guān)單位上報(bào)藥品不良反應(yīng)的顧慮和保障公眾的合法權(quán)益,應(yīng)該能夠積極推進(jìn)莊河市藥品不良反應(yīng)監(jiān)測(cè)工作。
[Abstract]:Adverse drug reaction monitoring is an important responsibility of drug supervision departments in various countries, a social public welfare cause that benefits the country and the people, and an important means to ensure drug safety and public health. With the development of medicine and pharmaceutical science and technology, people have higher and higher requirements for quality of life, and the safety of drugs has been paid more and more attention. Adverse drug reactions (ADR) have become the focus of global attention. Countries all over the world have also taken measures to control and solve the problem of adverse drug reactions. However, due to the late start of the work in our country, the operation of the work system is not smooth enough, and the work is facing many difficulties. Therefore, how to take effective measures to carry out the monitoring of adverse drug reactions in Zhuanghe City has certain practical significance for other county-level areas to promote the monitoring work. On the basis of literature review, this paper closely links with its own practical work, adopts the methods of literature investigation, comparative analysis, investigation and research, and first discusses the background and significance of adverse drug reaction monitoring. This paper introduces how to study the monitoring of adverse drug reactions (ADR) by scholars at home and abroad, expounds its viewpoint, and interprets the related keywords such as ADR monitoring. Secondly, the present situation of adverse drug reaction monitoring in Zhuanghe City is analyzed, and it is pointed out that the monitoring work of adverse drug reaction in Zhuanghe City is mainly linked to the monitoring institutions, drug-related units, the public and so on, and the supervision mechanism is not perfect. Lack of professional and technical personnel, weak sense of responsibility, low public participation and many other problems, and in-depth analysis of the causes; Then, on the basis of drawing lessons from the advanced experience at home and abroad, this paper demonstrates that the monitoring of adverse drug reactions will be improved from four aspects: institutional setting, construction of supervision mechanism, improvement of personnel quality and construction of information system, and combined with the theory of business process reengineering. The theory of information asymmetry puts forward some concrete improvement schemes, such as setting up special departments, constructing supervision mechanism, implementing classified management, strengthening the construction of information system and so on. Finally, aiming at the improvement scheme, this paper puts forward some safeguard measures, such as strengthening the organizational guarantee, perfecting the relevant system, expanding the scope of participation and so on. This paper puts forward an attempt to carry out classified management of the reporting units of adverse drug reactions in Zhuanghe City, and puts forward the establishment of a compensation mechanism for adverse drug reactions in Zhuanghe City. In order to dispel the concerns of the relevant units in Zhuanghe City and protect the legitimate rights and interests of the public, we should be able to actively promote the monitoring of adverse drug reactions in Zhuanghe City.
【學(xué)位授予單位】：大連理工大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：R95

【參考文獻(xiàn)】

相關(guān)期刊論文 前2條

1 余健華;;開展藥品不良反應(yīng)監(jiān)測(cè)的意義[J];社區(qū)醫(yī)學(xué)雜志;2007年01期

2 梁海月;劉玉菲;;煙臺(tái)市縣級(jí)藥品不良反應(yīng)監(jiān)測(cè)機(jī)構(gòu)建設(shè)的現(xiàn)狀[J];藥學(xué)研究;2013年02期

相關(guān)博士學(xué)位論文 前6條

1 胡愛敏;歐盟多層治理框架內(nèi)歐洲公民社會(huì)組織的政治參與[D];山東大學(xué);2010年

2 齊曉霞;藥害事故防范與救濟(jì)制度研究[D];復(fù)旦大學(xué);2011年

3 張芬;藥品不良反應(yīng)損害補(bǔ)償制度研究[D];華中科技大學(xué);2009年

4 馮變玲;基于數(shù)據(jù)挖掘技術(shù)的心腦血管用藥ADR關(guān)聯(lián)模型構(gòu)建研究[D];天津大學(xué);2012年

5 于培明;藥品安全性問題研究[D];沈陽藥科大學(xué);2007年

6 游述華;藥物政策學(xué)理論探討[D];沈陽藥科大學(xué);2007年

，

本文編號(hào)：2473102