【摘要】：上市后藥品的安全性事關(guān)每一個人,我國藥品生產(chǎn)企業(yè)在改革開放的市場經(jīng)濟中蓬勃發(fā)展,為臨床提供了大量物美價廉的藥品,跨國藥品生產(chǎn)企業(yè)踴躍入華,帶來了臨床急需的創(chuàng)新藥,這些藥品是我國的健康事業(yè)不可或缺的,其為保障人民健康提供了重要物質(zhì)支撐。然而,是藥三分毒,經(jīng)批準上市藥品的安全性是相對的,藥品在治療疾病的同時也可能會給人們帶來與治療無關(guān)的有害反應(yīng),這就是藥品不良反應(yīng)。因此,藥品安全是世界各國藥品監(jiān)管部門追求的共同目標,開展藥品不良反應(yīng)監(jiān)測成為藥品安全監(jiān)管部門管控上市后藥品安全性的重要手段,構(gòu)建藥品不良反應(yīng)監(jiān)測體系是政府在藥品安全這一重要的公共安全領(lǐng)域必須履行的責任和義務(wù)。本文從藥物的本質(zhì)出發(fā),對藥品安全問題及藥品不良反應(yīng)監(jiān)測的國內(nèi)外歷史、現(xiàn)狀進行了闡述；并論述了藥品安全的公共產(chǎn)品屬性,從經(jīng)濟學角度分析了藥品安全的市場失靈因素；以福建省藥品不良反應(yīng)監(jiān)測工作的實踐為例說明了我國基層藥品不良反應(yīng)監(jiān)測體系的特點,分析了體系建設(shè)過程中遇到的困境,并從宏觀上提出了當前藥品不良反應(yīng)監(jiān)測體系構(gòu)建中應(yīng)重點關(guān)注的問題和因應(yīng)之策。本文認為,構(gòu)建和完善包括藥品不良反應(yīng)損害賠償法在內(nèi)的藥品不良反應(yīng)相關(guān)法律法規(guī)、強化衛(wèi)生行政部門和醫(yī)療機構(gòu)在藥品不良反應(yīng)監(jiān)測體系中的責任和地位、完善藥品不良反應(yīng)監(jiān)測技術(shù)體系、努力實現(xiàn)監(jiān)測成果最大限度和最大范圍的有效利用、加強藥品不良反應(yīng)監(jiān)測管理機制建設(shè)是當前藥品不良反應(yīng)監(jiān)測體系構(gòu)建中的當務(wù)之急。
[Abstract]:The safety of drugs after going on the market has a bearing on everyone. The pharmaceutical manufacturing enterprises of our country have developed vigorously in the market economy of reform and opening up, providing a large number of high-quality and inexpensive drugs for clinical practice, and multinational drug manufacturing enterprises have enthusiastically entered China. These drugs are indispensable to the health of our country and provide important material support for the protection of people's health. However, the safety of the approved drugs is relative, and the drugs may bring non-toxic reactions to people while treating diseases, which is called adverse drug reactions. Therefore, drug safety is a common goal pursued by drug regulatory authorities in the world, and monitoring of adverse drug reactions has become an important means for drug safety supervision and control after marketing. It is the responsibility and obligation of the government to establish an adverse drug reaction monitoring system in the field of drug safety, which is an important field of public safety. Starting from the essence of drugs, this paper expounds the history and present situation of drug safety problems and adverse drug reaction monitoring at home and abroad, and discusses the public product attributes of drug safety. This paper analyzes the market failure factors of drug safety from the angle of economics, takes the practice of monitoring adverse drug reactions in Fujian Province as an example to illustrate the characteristics of the monitoring system of adverse drug reactions at the grass-roots level in China, and analyzes the difficulties encountered in the process of building the system. At the same time, the author puts forward the problems and countermeasures in the construction of the current ADR monitoring system from the macro point of view. In this paper, we construct and perfect the laws and regulations related to adverse drug reactions, including the law of compensation for adverse drug reactions, and strengthen the responsibility and position of the administrative departments of health and medical institutions in the monitoring system of adverse drug reactions. It is urgent to perfect the technical system of adverse drug reaction monitoring, to realize the most effective use of the monitoring results and to strengthen the management mechanism of adverse drug reaction monitoring system.
【學位授予單位】：廈門大學
【學位級別】：碩士
【學位授予年份】：2014
【分類號】：F203;F426.72

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