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全国医疗机构制剂现状调研及问题分析
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| 篇名： | 全国医疗机构制剂现状调研及问题分析 |
| TITLE： | CHINA PH ARMACY Volume 33，Number 5，March 15，2022 Semimonthly Table of Contents Nationwide investigation and problems analysis of pharmaceutical preparations in medical institutions |
| 摘要： | 目的 了解我国医疗机构制剂的发展现况，促进医疗机构制剂持续健康发展。方法在国家药事管理专业质控中心的组织下，采用网络调查的形式，对各省（区、市）和新疆生产建设兵团的二级及以上综合医院填报的2019年全国医疗机构制剂相关指标数据进行统计分析。结果在全国4639家医院中，具有制剂批准文号的医院占9.36％，设立制剂室的医院占8.15％。医疗机构制剂生产/获批比（常规生产制剂品种数与具有制剂批准文号制剂品种数的比值）的平均值为0.72，有41.52％的医院该比值集中于1～0.9。医疗机构制剂的主要生产方式为医院自产，且医院级别越高，其自产与委托加工相结合的生产方式占比越高，委托加工的占比越低。在有制剂批准文号的医院中，拥有中药制剂的占比最高（73.66％），其次为普通化学制剂（69.93％）。从医疗机构制剂年产值看，三级医院高于二级医院，民营医院高于公立医院，且其与医疗机构制剂生产方式、生产品种以及医院是否设立制剂室有关。医疗机构制剂在区域发展上呈现出华中、华北、华南地区高于东北、西北、西南地区的趋势。结论目前我国医疗机构制剂以医院自产为主，制剂类型较单一，且存在各级别各地区医疗机构制剂发展不平衡、制剂规模缩小的问题。建议医院重视医疗机构制剂创新，尤其是疗效确切的特色制剂的发展，充分发挥其“拾遗补缺”的作用；同时，要加强对制剂调拨的政策支持、重视区域制剂中心的建立。 |
| ABSTRACT： | OBJECTIVE To investigate the situation of pharmaceutical pr eparations in medical institutions （hereinafter refer to hospital preparations ），and to promote the sustained and healthy development of hospital preparations. METHODS Under the organization of National Pharmacy Administration & Quality Control Center ，internet survey was adopted to statistically analyze the data of hospital preparations in 2019 that was completed and reported by the secondary general hospitals and above in provinces （cities，districts）and Xinjiang Production and Construction Corps. RESULTS Among the 4 639 hospitals，9.36％ had drug approval numbers and 8.15％ had preparation laboratories. The average ratio of the number of hospital preparations in production to the number of preparations approved was 0.72，and that of 41.52％ hospital was concentrated in 1-0.9. Self-produced by hospital was the main production mode of hospital preparations ；the higher hospital level was ，the higher the proportion of self-production combined with commissioned processing ，while the lower the proportion of commissioned processing only. In hospitals with preparation approval numbers ，the proportion of owning TCM preparations was the highest （73.66％），followed by common chemical preparations （69.93％）. From perspective of annual output value of hospital preparations ，tertiary hospitals were higher than secondary hospitals ，and private hospitals were higher than public hospitals ；it was related to the production mode ，varieties of hospital preparations and the establishment of the preparation laboratories. There was a trend that the development of hospital preparations in C entral China ，North China and South China was better than that in the Northeast China ，Northwest China and Southwest China. CONCLUSIONS At present ，hospital preparations in China are mainly made in medical institutions ， com and the types are relatively limited. The regional developmentis unbalanced and the scale of hospital preparations is reduced.It is suggested that medical institutions should pay attention to the innovation of hospital preparations ，especially to deve lopment of characteristic preparations with definite curative effect ，so as to give full play to their role of “shortage make-up ”. Great importance also should be paid to the policy support of dispensing and the establishment of regional dispensing centers. |
| 期刊： | 2022年第33卷第05期 |
| 作者： | 蔡明远，张翠莲，周亮，颜青，左玮 |
| AUTHORS： | CAI Mingyuan ，ZHANG Cuilian ，ZHOU Liang，YAN Qing，ZUO Wei |
| 关键字： | 医疗机构制剂；制剂批文；公立医院；民营医院；制剂室；发展现状 |
| KEYWORDS： | pharmaceutical preparations ；formulation approval ；public hospital ；private hospital ；preparation laboratory ； |
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