中国现行药品监管体制下的药品安全问题研究

发布时间：2018-11-19 07:40

【摘要】： 1998年以来,我国药品监管体制主要经历了两轮较大的改革,改变了我国药品、医疗器械监管长期存在的政出多门、监管乏力的局面,基本上实现了由多头分散向统一集中的转变,一定程度上优化了行政资源配置,提高了监管效率。然而,我国的药品安全问题并未因此得到有效的解决,特别是近期以来,出现了接二连三的药品安全问题及相关案件,这些药品大案要案波及范围极广、影响极坏。同时,药品监管高层人员相继落马又造成了整个药监系统和监管体制的震荡与失信,加之药品虚假广告泛滥成灾、屡禁不止,整个药品市场特别是农村药品市场相当混乱,药价虚高不下和各级医患关系空前紧张等,医疗保健体系和药品安全问题便成为当今世人关注的焦点和政府头痛的问题,成为民生的“一座大山”,也成为构建社会主义和谐社会的一大障碍。药品安全问题集中暴露了药品监督管理体制所存在的问题。药品监管机构职能定位的不准确、机构设置的不合理、制度设计的不完善、决策机制的不科学等因素的综合作用是引发问题的深层次制度性原因。本文共四个部分。导言部分提出了研究问题、政府和主管部门对我国药品安全问题的态度,并对国内学者的研究成果进行了综合阐述;第二部分对我国药品安全领域的主要问题进行了总结和分析;第三部分探讨了引发药品安全问题的深层次体制性原因,第四部分是完善药品监管体制、解决药品安全问题的对策性思考。
[Abstract]:Since 1998, China's drug regulatory system has mainly undergone two rounds of major reforms, which have changed the situation of China's drug and medical device supervision, which has existed for a long time. It basically realizes the transformation from multi-head dispersion to unified centralization, optimizes the allocation of administrative resources to a certain extent, and improves the efficiency of supervision. However, the problem of drug safety in our country has not been solved effectively, especially in recent years, there have been one after another drug safety problems and related cases. At the same time, the fall of the top officials in drug supervision has also caused the shock and discredit of the whole drug supervision system and the supervision system, coupled with the flood of false advertisements of drugs, repeated prohibitions, and the confusion in the whole drug market, especially in the rural drug market. As the prices of medicines are high and the relations between doctors and patients at all levels are unprecedented, the issue of medical care system and drug safety has become the focus of the world's attention and the headache of the government, and has become a "big mountain" for people's livelihood. It has also become a major obstacle to the construction of a socialist harmonious society. Drug safety problems have exposed the problems existing in the drug supervision and administration system. The inaccuracy of the function orientation of the drug regulatory agency, the unreasonable setting of the institution, the imperfect design of the system, the unscientific decision-making mechanism and other factors are the deep-seated institutional reasons that lead to the problem. There are four parts in this paper. In the introduction part, the author puts forward the research problems, the attitude of the government and the competent department to the drug safety problem of our country, and comprehensively expounds the research results of the domestic scholars. The second part summarizes and analyzes the main problems in the field of drug safety in China. The third part discusses the deep institutional causes of drug safety problems. The fourth part is to perfect the drug supervision system and solve the drug safety problems.
【学位授予单位】：北京师范大学
【学位级别】：硕士
【学位授予年份】：2008
【分类号】：F203

【相似文献】