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原标题:短缺药供应保障有了时间表
本报北京6月28日讯 记者吴佳佳报道:国家卫生计生委、国家发展改革委、工信部、国家食药监管总局等9部门日前联合下发《关于改革完善短缺药品供应保障机制的实施意见》。《意见》提出,到今年年底,要建立短缺药品信息收集和汇总分析机制,完善短缺药品监测预警和清单管理制度,初步建成基于大数据应用的国家药品供应保障综合管理平台和短缺药品监测预警信息系统,健全部门会商联动机制,初步建立国家、省、地市、县四级监测预警机制和国家、省两级应对机制;到2020年,实现药品供应保障综合管理和短缺监测预警信息资源的共享共用,建立成熟稳定的短缺药品实时监测预警和分级应对体系,构建短缺药品信息收集、汇总分析、部门协调、分级应对、行业引导的工作格局,形成短缺药品供应保障制度。
《意见》明确,在目前每个省份布局不少于15个监测哨点的基础上,逐步扩大监测范围,联通药品研发注册、生产流通、采购使用等重点环节,实现短缺药品信息监测全覆盖;实行监测信息每月零报告制度,建立四级监测网络体系和预警机制;建设基于大数据应用的监测预警信息系统。
在部门联动、分级应对方面,《意见》强调由国家卫生计生委、国家发改委、工信部、财政部、人社部、商务部、国资委、国家工商总局、国家食药监管总局等组成国家短缺药品供应保障工作会商联动机制,突出跨领域、多部门政策统筹、协作配合、有效联动,明确工作规则和任务分工。国家层面重点组织开展短缺药品及其原料药生产供应保障能力评估,协调解决跨省短缺问题,统筹建设短缺药品监测预警信息系统、国家和省两级短缺药品多元信息采集和供应业务协同应用平台;省级层面同样建立部门会商联动机制,重点强化省、市、县三级监测,综合评估辖区内药品短缺信息和应对建议,解决局部性短缺问题。
《意见》明确,通过实施定点生产,协调应急生产和进口,加强供需对接、协商调剂,完善短缺药品储备,打击违法违规行为,健全罕见病用药政策等多种措施,实现短缺药品供应保障分类精准施策。综合临床必需、用量小或交易价格偏低、企业生产动力不足等因素,遴选定点生产品种,招标确定定点生产企业,直接挂网采购,保障区域合理供应。针对药品相关标准变化、认证改造等导致企业停产及临床需求突然增加等情况,协调有资质的企业应急生产或加快进口。注重掌握药品生产流通企业和医疗卫生机构实际库存,推进供需对接,避免供需信息沟通不畅导致短缺。根据临床实际需求,筛选短缺药品储备品种(含原料药),建立中央和地方两级常态短缺药品储备。
(责编:朱江、伍振国)
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