陕西省医疗机构制剂发展现状及对策探析  

Current Situation and Countermeasures of the Development of Pharmaceutical Preparations Dispensed by Medical Institutions in Shaanxi Province

作　　者：张磊 曹涵博 赵馨韵 杨晓莉 ZHANG Lei;CAO Hanbo;ZHAO Xinyun;YANG Xiaoli(Shaanxi Provincial Drug Administration,Xi'an,Shaanxi,China 710065;Shaanxi Institute for Food and Drug,Xi'an,Shaanxi,China 710065;NMPA Key Laboratory for Testing Technology of Pharmaceutical Microbiology,Xi'an,Shaanxi,China 710065;Xi’an Gaohao Property Management Co.,Ltd.,Xi'an,Shaanxi,China 710065)

机构地区：[1]陕西省药品监督管理局,陕西西安710065 [2]陕西省食品药品检验研究院,陕西西安710065 [3]国家药品监督管理局药品微生物检测技术重点实验室,陕西西安710065 [4]西安高浩物业管理有限公司,陕西西安710065

出　　处：《中国药业》2021年第17期21-23,共3页China Pharmaceuticals

基　　金：国家药典委员会药品标准提高项目[2017-15]。

摘　　要：目的促进陕西省医疗机构制剂的规范化发展。方法结合现行法规,通过日常监管检查和调研部分医疗机构制剂的方式,分析陕西省医疗机构制剂发展中存在的问题,并提出建议。结果陕西省2014年至2019年医疗机构制剂新注册品种数大体呈下降趋势,再注册品种数整体呈平稳且轻微下降趋势。80%的医疗机构制剂配制时生产、检验条件均较差,制剂室人员不足(占药学部总人数的10%),质量管理理念落后,质量风险管控能力不足,制剂质量存在较大风险隐患,制剂生产、研发和二次开发能力低下,现行法规对其约束力度不够,药品质量安全的监管力度不足。结论建议加大注册申报管理力度,优化流程,统一标准,扩大医疗机构制剂室的发展规模和提高制剂质量,规范和约束医疗机构制剂的发展。Objective To promote the standardized development of pharmaceutical preparations dispensed by medical institutions in Shaanxi Province.Methods Based on the current laws and regulations,the problems existing in the development of the pharmaceutical preparations dispensed by medical institutions in Shaanxi Province were analyzed through the way of daily supervision,inspection and investigation of the pharmaceutical preparations dispensed by medical institutions,and the corresponding countermeasures were put forward.Results From 2014 to 2019,the number of newly registered varieties of pharmaceutical preparations dispensed by medical institutions in Shaanxi Province generally showed a downward trend,and the number of re-registered varieties showed a stable and slight downward trend.Precisely 80%of medical institutions had poor production and inspection conditions during preparation,insufficient personnel in the preparation room was understaffed(accounting for 10%of the total staff in the pharmacy department),backward quality management concepts,insufficient quality risk control capabilities,high-risk potential hazards in preparation quality,and low preparation production,research and secondary development capabilities.The current laws and regulations were not enough to restrict the pharmaceutical preparations dispensed by medical institutions,and the supervision of drug quality and safety was insufficient.Conclusion It is suggested to strengthen the management of registration and declaration,optimize the process,unify the standards,expand the development scale of preparation room in the medical institution and improve the quality of preparations to standardize and restrict the development of the pharmaceutical preparations dispensed by medical institutions.

关 键 词：医疗机构制剂 药品监管 对策 陕西省 

分 类 号：R95[医药卫生—药学]