医疗机构制剂论文：山东省医疗机构制剂现状与监督管理对策研究

1、 医疗机构制剂论文：山东省医疗机构制剂现状与监督管理对策研究【中文摘要】医疗机构制剂具有普通药品不可替代的优势,其一,它是针对特定的疾病、特定的人群,对疾病的治疗更具有针对性,更利于病人康复；其二,对于一些临床疑难杂症、特殊的慢性疾病,医疗机构制剂(尤其是中药类)比上市的同类药品有更好的疗效；其三,医疗机构制剂一般还具有价格优势,有利于缓解新阶段医疗改革中“看病贵”的问题。另外,手足口病、H1N1流感等类似突发性群体事件中,医疗机构制剂也可以发挥重要作用。因此,医疗机构制剂在卫生事业的发展中具有非常重要的作用。但是医疗机构制剂由于各种原因,近年来存在萎缩现象,因此研究医疗机构制剂的现状和监督管

2、理对策非常有必要。研究方法本文以山东省医疗机构制剂为研究对象,通过文献和政策研究,相关医疗机构制剂许可、批准文号发放等数据库的分析,以及对119家各类医疗机构进行的调查和访谈,研究山东省医疗机构制剂发展的历史背景以及现状。主要研究结果本文第一部分对我国医疗机构制剂的发展演变,以及山东省医疗机构制剂的发展过程进行了分析,获得了山东省医疗机构制剂发展的背景信息。第二部分首先通过对数据库的分析,获取了山东省医疗机构制剂许可证和批准文号发放数量、剂型、区域分布情况；其次通过对调查问卷的分析,获取了山东省医疗机构制剂收入、硬件设施、人力资源等方面的情况；最后通过对访谈资料的整理明确了医疗机构和市级药品监

3、督管理局相关人员对山东省医疗机构制剂发展过程的认知程度。第三部分,本文首先通过SWOT-PEST方法梳理了历史研究和现状调查中的相关资料,在此基础上从医疗机构自身、社会监督和药品监督管理机构三个角度总结了存在的问题,并提出了相关的对策建议。结论与政策建议本文认为山东省医疗机构制剂发展必须结合医疗机构自身的自律、社会监督和药品监督管理机构的监督管理等多种形式,才能保证医疗机构制剂的稳定、健康发展,单独采取任何一种形式的管理方法,都不会达到最优的监督管理效果。【英文摘要】Medical institutional preparations have irreplaceable advantages

4、 over the marketing Pharmaceuticals. First, these preparations are designed for specific diseases and specific groups of people, and which is also easy to integrate into clinical practice. Second, medical preparations (especially traditional Chinese medicines) have shown more effective than the mark

5、eting pharceutical counterparts for the treatment of a number of clinical chronic diseases. Third, the low cost of many medical preparations can alleviate the emerged “high cost of medical treatment” issues during the current health care reform process. Moreover, medical preparations have play impor

6、tant roles in preventing and curing sudden group diseases such as “hand, foot and mouth” disease and H1N1 influenza. The great beneficial effect of medical preparations in clinical practice has been manifested for hundreds of years, however, the production of medical preparations has been shrinked f

7、or various reasons in recent years. Therefore, it is important to study the current situation and regulation countermeasure of medical preparation.Data and MethodsThe data set of this study is generated from published or unpublished literature, policy analysis, medical preparation database and insti

8、tutional survey. To better understand the current situation and regulation countermeasure of medical preparations in Shandong Province, the institution survey was conducted which covered 119 reprentative medical institutions.Main resultsIn the first part, the policy evolution of medical preparations

9、 in China and Shandong Province and the problems faced by the development of medical preparation in Shandong province was reviewed. In the second part, the number, formulations and region distribution of “Preparation Certificate for Medical Institutions” and “Medical preparations Approval Number” we

10、re analyzed based on the medical preparations database. The information of medical preparations revenue, infrastructure, human resources and other aspects of sample medical institutions were also investigated in this part. In the last part, the history and current situation of medical preparations e

11、mployed SWOT-PEST were studied. Finally, this study summarized the problems and provides relevant suggestions for the further development of medical preparations from the point of medical institution, social surveillance and regulation agency.Conclusions and policy suggestionThis study indicates tha

12、t the integrated regulation from self-discipline of medical institution, social supervision and regulation of Food and Drug Administration agency is essential for the development of medical preparations, and this cooperative management from all of these three sides is the key to reach the optimal ef

13、fectiveness of medical preparations.【关键词】医疗机构制剂 现状 监督管理 对策 政策建议【英文关键词】medical preparations current situation regulation and management countermeasure policy suggestion【目录】山东省医疗机构制剂现状与监督管理对策研究摘要10-11Abstract11-12第一章 前言13-221.1 核心概念的界定13-161.1.1 医疗机构13-141.1.2 医疗机构制剂141.1.3 医师处方、协定处方和法定处方14-151.1.4 医疗

14、机构制剂监督管理15-161.2 研究背景及目标16-191.2.1 研究背景16-171.2.2 研究现状17-191.2.3 研究目标191.3 研究对象与内容191.4 研究框架(见图1-1)19-201.5 资料来源与研究方法20-211.5.1 文献查阅201.5.2 定量调查201.5.3 定性调查20-211.5.4 资料处理与统计分析211.6 创新与研究不足21-22第二章 医疗机构制剂发展和监督管理的历史演变22-382.1 医疗机构制剂的发展历史22-242.1.1 医疗机构制剂的雏形期222.1.2 西医的传入及医疗机构制剂的炮制222.1.3 中华人民共和国成立后医疗

15、机构制剂的发展22-232.1.4 改革开放后医疗机构制剂的进一步发展232.1.5 新药品管理法颁布以来的医疗机构制剂情况23-242.2 医疗机构制剂的监督管理历史24-282.3 我国现行医疗机构制剂监督管理的制度安排28-312.3.1 医疗机构制剂的监督管理组织机构28-292.3.2 医疗机构制剂的各种制度29-312.4 山东省医疗机构制剂监督管理发展的演变31-382.4.1 山东省医疗机构制剂监督管理的发展过程31-342.4.2 山东省医疗机构制剂监督管理的特点34-38第三章 山东省医疗机构制剂现状分析38-623.1 山东省医疗机构制剂的总体情况分析38-423.1.1

16、 山东省医疗机构制剂许可证总体情况38-403.1.2 山东省医疗机构制剂批准文号总体情况40-423.2 山东省医疗机构制剂的抽样结果分析42-533.2.1 调查对象的基本情况42-443.2.2 被调查医疗机构制剂现状分析44-533.3 被调查医疗机构和市级药品监督管理部门对制剂现状的认知情况53-623.3.1 “医疗机构制剂研发水平”的认知情况分析53-553.3.2 “实施医疗机构制剂配制质量管理规范”认知情况分析55-563.3.3 “医疗机构制剂样品检验能力”认知情况分析56-583.3.4 “对设立制剂区域性配制中心看法”的认知情况分析58-593.3.5 “医疗机构制剂各环节存在的问题及影响因素”的认知情况分析59-603.3.6 “医疗机构制剂未来发展及影响因素”的认知情况分析603.3.7 “医疗机构制剂未来发展对策”的认知情况分析60-62第四章 山东省医疗机构制剂现状SWOT-PEST分析及监管对策62-714.1 SWOT-PEST分析方法概述62-634.2 山东省医疗机构制剂发展的内部环境分析63-664.2.1 山东省医疗机构制剂发展