中国药品安全的伦理学研究

发布时间：2018-01-06 09:17

本文关键词：中国药品安全的伦理学研究　出处：《中南大学》2013年博士论文　论文类型：学位论文

【摘要】：本文是有关药品安全伦理问题的研究型论文。本文首次联合药学伦理、科研伦理和商业伦理三个方面指出我国药品安全存在的伦理问题,并提出解决的对策和措施,为保障我国药品安全提供参考意见。药品是关系到公众身体健康的一种特殊商品。药品安全监管始终贯穿着药品的研制与开发、生产与销售、使用与管理的全过程。药品特殊性被忽视必然伴随着各种药品安全事件的出现,而药品安全事件对人类的生存与发展构成重大的危害。因此,药品研制、生产、流通和使用各环节漠视药品特殊性折射的是对生命的漠视和伦理的践踏。药学事业的发展是药学伦理与商业伦理形成的基础,反过来药学伦理与商业伦理会指导人类药学事业进一步发展。违背药学伦理与商业伦理必然导致会各类药品安全事件的发生,严重阻碍药学事业的正常发展,因此,我们在药学事业的发展中必须注意药学伦理与商业伦理问题。药品临床试验是新药上市前最重要的研究环节之一,有必要从科研伦理角度探讨找出我国药品临床试验中可能出现的伦理问题,如知情同意不规范、侵犯受试者生命和健康利益、伦理委员会成员伦理相关培训不足等。我国医药流通领域中常见的问题,涵盖生产企业的药品质量、营销企业的营销手段、药品的价格保障与药品供应、药品零售终端医院和药店在药物使用、销售过程中存在的种种问题,如药品质量不合格、销售假药、商业贿赂、虚假药品广告宣传、网络销售假药、药品价格不合理、滥用药物等。我们分析发现,药学伦理、商业伦理道德的缺失与不足在医药领域并非鲜见,而是呈普遍缺失的状态。(这就是为什么各种规范不错,而严格执行规范错失。) 我国医药行业同其它行业一样,普遍存在伦理道德缺失,这是引发各类药品安全事件的重要原因。学校应该从学历教育开始重视学生的伦理教育。医药行业从业人员的入职教育应将职业的伦理教育作为培训的重要内容；在医药行业发展的过程中必须主动、及时地进行伦理的继续再教育。只有这样才能让医药相关的从业人员在从业过程中按正确的价值标准塑造自我的品德,从而有计划、有组织地对医药活动施加伦理道德的影响,提高从业人员在医药活动中的自律能力,规范医药从业人员的行为。
[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.

【学位授予单位】：中南大学
【学位级别】：博士
【学位授予年份】：2013
【分类号】：R95;R-052

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