基于实证分析的江苏省医疗机构制剂现状研究

发布时间：2018-03-28 08:04

本文选题：医疗机构　切入点：医疗机构制剂　出处：《南京中医药大学》2014年硕士论文

【摘要】：医疗机构制剂是我国特有的概念,其产生与发展的原因与我国的基本国情息息相关。在建国初期缺医少药的大背景下,医疗机构制剂对维护国民健康、支持我国医疗卫生事业发展做出的贡献不容置疑。经过建国以来60多年的发展,我国的医药工业已经焕然一新,药品供应体系也已经基本建立。但是医疗机构制剂治疗疾病方面仍起着不可取代的作用。在社会大众对药品安全性关注日益提高的大背景下,国家法律法规对其的要求也越来越严格,这也使得新时期我国医疗机构制剂的发展出现了新特点。本研究在阐述江苏省医疗机构制剂发展和监管历史的基础上,对医疗机构制剂配制、使用和监管现状开展定性研究和定量研究。首先,选取江苏省具有制剂许可证的医疗机构作为研究对象,搜集制剂配制许可证、医疗机构制剂批准文号以及医疗机构制剂再注册等有关材料；其次,对江苏省医疗机构制剂基本情况进行调研,并对医疗机构制剂安全性监测现状进行专家访谈；最后,通过SWOT-PEST分析得出江苏省医疗机构制剂现状存在问题以及监管中的不足,并进而提出相关的对策建议。通过本研究可以得出目前江苏省医疗机构制剂的一般结果：医疗机构制剂室数量在逐年减少,逐渐趋于合理；医疗机构制剂批准文号数量在大幅度减少,基本符合医疗机构制剂定位；医疗机构制剂室人员数量不足,专业素质普遍不高；医疗机构制剂研发资金投入少,研发水平不高；医疗机构制剂不良反应率逐渐降低,但不良反应监测和再评价仍需加强；医疗机构中药制剂委托加工应加强管理；医疗机构制剂加入医保范围仍需加大；医疗机构制剂配制质量管理规范的实施,制剂质量与安全性得到了提高；医疗机构制剂原料检验远远达不到要求；医疗机构制剂监督管理体系仍需完善。
[Abstract]:Medical institution preparation is a unique concept in our country, and the reasons for its emergence and development are closely related to the basic conditions of our country. In the background of lack of medical and minor medicine in the early days of the founding of the people's Republic of China, medical institution preparations have a great impact on the maintenance of national health. The contribution of supporting the development of medical and health care in our country is beyond doubt. After more than 60 years of development since the founding of the people's Republic of China, the pharmaceutical industry in our country has taken on a new look. The drug supply system has also been basically established. But medical institutions still play an irreplaceable role in the treatment of diseases. Against the background of increasing public concern about drug safety, The requirements of national laws and regulations are more and more strict, which makes the development of medical institutions in our country appear new characteristics in the new period. On the basis of expounding the history of preparation development and supervision of medical institutions in Jiangsu Province, this study carries out qualitative and quantitative studies on the present situation of preparation, use and supervision of formulations in medical institutions. Selecting the medical institutions with preparation license in Jiangsu Province as the research object, collecting the preparation license, the approval number of the preparation of the medical institution and the re-registration of the preparation of the medical institution. Secondly, To investigate the basic situation of medical institutions in Jiangsu Province, and to conduct expert interviews on the status quo of safety monitoring of medical institutions. Finally, through SWOT-PEST analysis, we can conclude that the current situation of medical institutions in Jiangsu Province has problems and deficiencies in supervision. And then put forward the relevant countermeasures and suggestions. Through this study, we can get the general results of the preparation of medical institutions in Jiangsu Province: the number of preparation rooms in medical institutions is decreasing year by year, and gradually tending to be reasonable, and the number of approved documents for medical institutions is greatly reduced. It is basically in line with the orientation of medical institutions; the number of personnel in the preparation rooms of medical institutions is insufficient, and the professional quality is generally not high; the investment in R & D of medical institutions is low, and the level of R & D is not high; the adverse reaction rate of medical institutions is gradually decreasing. However, the monitoring and re-evaluation of adverse reactions should be strengthened; the commissioning and processing of traditional Chinese medicine preparations in medical institutions should be strengthened; the scope of medical institutions' preparations added to medical insurance still need to be enlarged; and the implementation of quality management norms for the preparation of medical institutions' preparations, The quality and safety of the preparation have been improved; the raw material inspection of the preparation in medical institutions is far from meeting the requirements; the supervision and management system of the preparation in the medical institutions still needs to be improved.
【学位授予单位】：南京中医药大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95

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