發(fā)布時(shí)間：2018-04-20 03:13

  本文選題：藥品不良反應(yīng) + 損害��； 參考：《山東大學(xué)》2014年碩士論文

【摘要】：藥品作為治療疾病必不可少的一種手段,其不良反應(yīng)也是如影隨形。本文討論的藥品不良反應(yīng)是指由合格藥品引起的,在正常用法用量下出現(xiàn)的與用藥目的無(wú)關(guān)的有害反應(yīng)。 近幾十年來(lái)藥品不良反應(yīng)造成損害的事件頻頻出現(xiàn)在人們視線中,例如反應(yīng)停事件、DES事件、“斯蒙病”事件等,這使人們認(rèn)識(shí)到了藥品在帶給人們健康的同時(shí)也可能帶來(lái)災(zāi)難,而不良反應(yīng)造成的后果往往很嚴(yán)重,輕者致殘、致畸,重者要付出生命的代價(jià),這使得建立健全藥品不良反應(yīng)損害救濟(jì)制度具有極強(qiáng)的必要性和緊迫性。 在認(rèn)識(shí)到這些情況之后,我國(guó)相繼制定了一系列法律對(duì)藥品質(zhì)量嚴(yán)格把關(guān),例如《疫苗流通和預(yù)防接種管理?xiàng)l例》和《藥品管理法》。《藥品不良反應(yīng)報(bào)告和檢測(cè)管理辦法》也加強(qiáng)了藥品不良反應(yīng)的監(jiān)測(cè)工作,起到了一定的預(yù)防作用。然而,我國(guó)藥品不良反應(yīng)救濟(jì)制度卻是一片空白。反觀國(guó)外及我國(guó)臺(tái)灣地區(qū),美國(guó)對(duì)制藥企業(yè)苛以嚴(yán)格的產(chǎn)品責(zé)任來(lái)救濟(jì)受害者,德國(guó)和瑞典構(gòu)建了與其社會(huì)保障制度相配套的保險(xiǎn)制度,日本和我國(guó)臺(tái)灣地區(qū)則建立了較為完善的基金救濟(jì)制度。 本文通過(guò)了解藥品不良反應(yīng)的概念,分析我國(guó)藥品不良反應(yīng)救濟(jì)制度的現(xiàn)狀及存在的問(wèn)題,剖析建立藥品不良反應(yīng)損害救濟(jì)制度的重大意義,結(jié)合對(duì)美國(guó)、德國(guó)、瑞典、日本以及我國(guó)臺(tái)灣地區(qū)的藥品不良反應(yīng)損害救濟(jì)制度的比較分析,總結(jié)相關(guān)經(jīng)驗(yàn)教訓(xùn)。在此基礎(chǔ)上探索適合我國(guó)現(xiàn)階段國(guó)情的藥品不良反應(yīng)損害救濟(jì)制度,提出可行性建議。
[Abstract]:Drugs as an essential means of treatment of disease, its adverse reactions are also accompanied. The adverse drug reactions discussed in this paper refer to harmful reactions caused by qualified drugs and not related to the purpose of drug use. In recent decades, adverse drug reactions have frequently caused damage to people's eyes, such as the "des" incident, the "Smon disease" event, etc., which make people realize that drugs not only bring people health, but also bring disaster. However, the consequences of adverse reactions are often very serious, the light people are disabled, teratogenic, and the heavy ones have to pay the cost of their lives, which makes it necessary and urgent to establish and improve the relief system of adverse drug reactions damage. In recognition of these circumstances, China has formulated a series of laws to strictly control the quality of drugs. For example, the regulations on the Administration of Vaccine Circulation and Preventive vaccination and the Law on Drug Administration. The methods for reporting and detecting adverse Drug reactions have also strengthened the monitoring of adverse drug reactions and played a preventive role. However, the relief system of adverse drug reactions in China is a blank. On the other hand, in foreign countries and Taiwan, the United States has imposed strict product liability on pharmaceutical companies to help the victims. Germany and Sweden have established insurance systems that complement their social security systems. Japan and Taiwan have established more perfect fund relief system. Through understanding the concept of adverse drug reactions, this paper analyzes the present situation and existing problems of the relief system of adverse drug reactions in China, analyzes the great significance of establishing the system of adverse drug reaction damage relief, and combines with the United States, Germany, Sweden, the United States, Germany, Sweden, the United States, Germany, Sweden, The comparative analysis of adverse drug reaction (ADR) damage relief system in Japan and Taiwan is carried out, and the relevant experiences and lessons are summarized. On this basis, this paper explores the relief system of adverse drug reaction damage suitable for the present situation of our country, and puts forward some feasible suggestions.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類號(hào)】：D923;D922.16;D922.294

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