北京市医疗机构制剂研发现状调研与对策分析

发布时间：2018-01-12 18:04

本文关键词：北京市医疗机构制剂研发现状调研与对策分析　出处：《北京中医药大学》2015年硕士论文　论文类型：学位论文

【摘要】：20世纪50年代至今,医疗机构制剂发展经历漫长的变化和改革,从产生、发展到萎缩,展示我国医疗机构制剂行业发展的整体态势。医疗机构制剂作为市售药品的补充,具有安全有效、价格低廉等特点,在疾病治疗方面发挥不可替代的作用。在国家政策要求以及社会关注下,监管部门对医疗机构制剂严格控制,确保使用安全有效,这将使医疗机构制剂呈现出新的发展特点。本研究采用文献梳理、问卷调查和实地走访方式对北京市具有制剂批准文号的医疗机构开展调研。本次调研覆盖130家具有制剂批准文号的医疗机构,占全市具有制剂批准文号的医疗机构93.5%。共回收问卷数量117份,回收率达到90%。调研出北京市具有批准文号制剂品种2317个,占全市总品种的67.2%。本研究在阐述北京市医疗机构制剂整体现状基础上,对医疗机构制剂配制、研发及监管现状开展定性和定量研究。首先,针对北京市医疗机构制剂整体现状开展调查研究,以全市具有制剂批准文号品种的医疗机构作为研究对象,了解医院性质、医院级别以及经济效益、配制条件等材料；其次,针对具有批准文号制剂品种的配制情况、生产情况以及科室分布情况等进行定量研究；再次,针对北京市医疗机构制剂研制开发状况,深入挖掘影响医疗机构制剂研发的因素；最后,通过SWOT-PEST分析得出北京市医疗机构制剂发展存在问题,并提出相应解决方案及对策。通过本研究得出北京市医疗机构制剂现状概括如下：医疗机构制剂发展呈现萎缩态势,批准文号数量以及许可证数量逐年下滑；医疗机构制剂软硬件投入不足,制剂室设备条件较差,人员数量偏低,专业素质不高；医疗机构缺乏制剂研发动力,积极性不高；医疗机构制剂发展受经济效益影响较大,多数制剂存在价格与成本倒挂现象；医疗机构制剂发展得到监管部门的支持,在制剂质量和安全性方面均有提高；医疗机构制剂监管法律法规体系初步形成,需要进一步落实完善。本研究从监管层面、医疗机构层面和社会层面分别提出相关政策建议如下：医疗机构制剂监管部门需要加大监管力度,严格把控制剂配制、审批及使用等多个环节,充分整合资源为制剂发展提供支持；医疗机构要重视制剂发展,加大制剂科研投入,为新药研发提供基础；从社会角度建立制剂区域配制中心,利于节约资源,形成规模效益。
[Abstract]:Since 1950s, the development of medical institutions has undergone a long period of changes and reforms, from production, development to atrophy. To show the overall situation of the development of the pharmaceutical industry of medical institutions in China. As a supplement of the drugs sold in the market, the preparations of medical institutions have the characteristics of safety, efficiency, low price and so on. In the treatment of diseases play an irreplaceable role. In the national policy requirements and social concern, the regulatory authorities of medical institutions to strictly control the preparation, to ensure the use of safe and effective. This will make the preparation of medical institutions present new characteristics of development. Questionnaires and field visits to Beijing with the preparation approval number of medical institutions to carry out research. This survey covers 130 medical institutions with preparation approval number. Accounting for the whole city with the preparation approval number of medical institutions 93.510. A total of 117 questionnaires were recovered, the recovery rate reached 90. The survey shows that Beijing has 2317 kinds of approved preparation. This study on the basis of explaining the overall status of the preparation of medical institutions in Beijing, the preparation of medical institutions, research and development and regulatory status of qualitative and quantitative research. First of all. According to the status quo of the preparation of Beijing medical institutions, the authors investigated and studied the status quo of the preparations in the whole city, and took the medical institutions with the preparation approval number as the research object to understand the nature of the hospital, the hospital level and the economic benefits. Preparation conditions and other materials; Secondly, quantitative research is carried out on the preparation, production and distribution of approved preparations. Thirdly, according to the status of research and development of preparations in Beijing medical institutions, the factors that affect the research and development of preparations in medical institutions are deeply explored. Finally, through SWOT-PEST analysis, the development of medical institutions in Beijing has problems. And put forward the corresponding solutions and countermeasures. Through this study, the status quo of preparation in Beijing medical institutions is summarized as follows: the development of medical institutions is shrinking, the number of approved document number and the number of licenses decline year by year; The medical organization preparation hardware and software investment is insufficient, the preparation room equipment condition is poor, the personnel quantity is on the low side, the specialized quality is not high; Medical institutions lack the motivation of research and development of preparations, and their enthusiasm is not high; The development of preparation in medical institutions is greatly affected by economic benefits, and most of the preparations have the phenomenon of price and cost upside down. The development of preparation in medical institutions has been supported by the supervision department, and the quality and safety of preparations have been improved. The legal and regulatory system of pharmaceutical preparation regulation in medical institutions is initially formed and needs to be further improved. This study is from the level of supervision. Medical institutions and social level respectively put forward the relevant policy recommendations as follows: the pharmaceutical regulatory authorities of medical institutions need to strengthen supervision, strictly control the preparation of agents, examination and approval and use of a number of links. Fully integrate resources to provide support for formulation development; Medical institutions should attach importance to the development of preparations, increase the investment in research and development of new drugs, and provide the basis for the research and development of new drugs. The establishment of regional preparation center from a social point of view is beneficial to the conservation of resources and the formation of economies of scale.
【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R95

【相似文献】