本文關(guān)鍵詞：中國藥品安全的倫理學(xué)研究　出處：《中南大學(xué)》2013年博士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 藥品安全 藥學(xué)倫理 科研倫理 商業(yè)倫理

【摘要】：本文是有關(guān)藥品安全倫理問題的研究型論文。本文首次聯(lián)合藥學(xué)倫理、科研倫理和商業(yè)倫理三個(gè)方面指出我國藥品安全存在的倫理問題,并提出解決的對(duì)策和措施,為保障我國藥品安全提供參考意見。 藥品是關(guān)系到公眾身體健康的一種特殊商品。藥品安全監(jiān)管始終貫穿著藥品的研制與開發(fā)、生產(chǎn)與銷售、使用與管理的全過程。藥品特殊性被忽視必然伴隨著各種藥品安全事件的出現(xiàn),而藥品安全事件對(duì)人類的生存與發(fā)展構(gòu)成重大的危害。因此,藥品研制、生產(chǎn)、流通和使用各環(huán)節(jié)漠視藥品特殊性折射的是對(duì)生命的漠視和倫理的踐踏。 藥學(xué)事業(yè)的發(fā)展是藥學(xué)倫理與商業(yè)倫理形成的基礎(chǔ),反過來藥學(xué)倫理與商業(yè)倫理會(huì)指導(dǎo)人類藥學(xué)事業(yè)進(jìn)一步發(fā)展。違背藥學(xué)倫理與商業(yè)倫理必然導(dǎo)致會(huì)各類藥品安全事件的發(fā)生,嚴(yán)重阻礙藥學(xué)事業(yè)的正常發(fā)展,因此,我們?cè)谒帉W(xué)事業(yè)的發(fā)展中必須注意藥學(xué)倫理與商業(yè)倫理問題。藥品臨床試驗(yàn)是新藥上市前最重要的研究環(huán)節(jié)之一,有必要從科研倫理角度探討找出我國藥品臨床試驗(yàn)中可能出現(xiàn)的倫理問題,如知情同意不規(guī)范、侵犯受試者生命和健康利益、倫理委員會(huì)成員倫理相關(guān)培訓(xùn)不足等。 我國醫(yī)藥流通領(lǐng)域中常見的問題,涵蓋生產(chǎn)企業(yè)的藥品質(zhì)量、營銷企業(yè)的營銷手段、藥品的價(jià)格保障與藥品供應(yīng)、藥品零售終端醫(yī)院和藥店在藥物使用、銷售過程中存在的種種問題,如藥品質(zhì)量不合格、銷售假藥、商業(yè)賄賂、虛假藥品廣告宣傳、網(wǎng)絡(luò)銷售假藥、藥品價(jià)格不合理、濫用藥物等。我們分析發(fā)現(xiàn),藥學(xué)倫理、商業(yè)倫理道德的缺失與不足在醫(yī)藥領(lǐng)域并非鮮見,而是呈普遍缺失的狀態(tài)。(這就是為什么各種規(guī)范不錯(cuò),而嚴(yán)格執(zhí)行規(guī)范錯(cuò)失。) 我國醫(yī)藥行業(yè)同其它行業(yè)一樣,普遍存在倫理道德缺失,這是引發(fā)各類藥品安全事件的重要原因。學(xué)校應(yīng)該從學(xué)歷教育開始重視學(xué)生的倫理教育。醫(yī)藥行業(yè)從業(yè)人員的入職教育應(yīng)將職業(yè)的倫理教育作為培訓(xùn)的重要內(nèi)容；在醫(yī)藥行業(yè)發(fā)展的過程中必須主動(dòng)、及時(shí)地進(jìn)行倫理的繼續(xù)再教育。只有這樣才能讓醫(yī)藥相關(guān)的從業(yè)人員在從業(yè)過程中按正確的價(jià)值標(biāo)準(zhǔn)塑造自我的品德,從而有計(jì)劃、有組織地對(duì)醫(yī)藥活動(dòng)施加倫理道德的影響,提高從業(yè)人員在醫(yī)藥活動(dòng)中的自律能力,規(guī)范醫(yī)藥從業(yè)人員的行為。
[Abstract]:This article is about the ethical problems of drug safety research. This paper first joint pharmaceutical research ethics, ethics and business ethics three aspects pointed out the ethical problems of drug safety in China, and puts forward the countermeasures and measures, and provide reference for the protection of drug safety in China.
The drug is a special commodity related to public health. Research and development of drug safety supervision has always been permeated with drugs, production and sales, the whole process of the management and use of special drugs. Neglected must be accompanied by the emerging drug safety events, and drug safety to human survival and development pose a major harm. Therefore, drug research, production, circulation and use of all aspects of disregard of drug specificities reflects the trampling disregard for life and ethics.
The development of pharmacy is the foundation for the pharmaceutical ethics and business ethics, ethics and business ethics in turn pharmacy will further guide the development of human medicine career. Contrary to pharmaceutical ethics and business ethics will inevitably lead to all kinds of drug safety incidents occur, seriously hinder the normal development of the pharmaceutical industry, therefore, we must pay attention to pharmaceutical ethics and business ethics in the development of pharmacy in clinical trials of drugs is one of the most important links listed before the new drug, it is necessary to find out possible ethical problems of clinical drug trials in China from the perspective of research ethics, such as informed consent is not standardized, infringement subjects of life and health benefits, the ethics committee members lack of ethical training.
The common problems in the field of Chinese medicine distribution, covering the quality of pharmaceutical production enterprises and their marketing means, the price of drugs and drug supply security, drug retail terminal hospitals and pharmacies in drug use, problems in the sales process, such as drug quality, sales of counterfeit drugs, commercial bribery, false drug advertising network promotion, sales of counterfeit drugs, drug prices unreasonable, drug abuse and so on. Our analysis shows that pharmacy ethics, business ethics and moral deficiencies and shortcomings in the field of medicine is not uncommon, but a lack of state. (this is why various norms and strict implementation of norms is good, miss.)
China's pharmaceutical industry with other industries, widespread lack of ethics and morality, which is an important cause of drug safety events. All kinds of schools should begin to pay attention to ethics education from the academic education of students. Vocational education of the pharmaceutical industry practitioners should be an important part of ethics education as the occupation training must be active in the course of development of medicine; in the industry, timely ethics of continuing education. The only way to let the medical staff in the relevant working process according to the correct values to cultivate self character, thus planned, organized to exert influence on medical ethics activities, improving personnel in medical activities in self-discipline, standardize the medical staff's behavior.

【學(xué)位授予單位】：中南大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2013
【分類號(hào)】：R95;R-052

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