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湖南省工业和信息化厅等三部门关于印发《湖南省常态短缺药品储备管理办法(2024年修订)》的通知

湖南省工业和信息化厅等三部门 2024/10/16 15:31

各市州工信局、财政局、卫生健康委:

深化医药卫生体制改革,加强短缺药品监测保供,更好满足人民群众用药需求,省工业和信息化厅、省财政厅、省卫生健康委共同研究修订了《湖南省常态短缺药品储备管理办法》,现印发给你们,请认真贯彻执行。

 

湖南省工业和信息化厅

湖南省财政厅

湖南省卫生健康委员会

2024911


湖南省常态短缺药品储备管理办法

2024年修订)

 

第一章 总 则

第一条 为深化医药卫生体制改革,构建机制健全、渠道通畅、反应迅速、管理规范的全省常态短缺药品储备管理体系,加强短缺药品监测保供,满足我省医疗机构对常态短缺药品的临床需求,最大程度保证群众用药,根据《国家医药储备管理办法》要求,制定本办法。

第二条 本办法所称常态短缺药品是指临床必需、疗效确切、供应困难的药品。

第三条 常态短缺药品储备遵循企业储备、政府补贴、盈亏自负的原则,作为我省医药储备的重要组成部分。

第四条 省工业和信息化厅牵头组织全省常态短缺药品储备工作,会同省财政厅、省卫生健康委下达常态短缺药品储备计划,负责常态短缺药品储备日常管理。

省财政厅负责会同省工业和信息化厅做好常态短缺药品储备补助资金筹措和下达,参与常态短缺药品储备计划制定和承储企业遴选工作。

省卫生健康委负责提出全省常态短缺药品目录和年度储备数量建议,参与常态短缺药品承储企业的遴选,指导医疗机构合理使用常态短缺储备药品。

承储企业具体负责常态短缺药品的采购、调运、储存和轮换,对其所承储常态短缺药品的数量、质量和安全负责。

 

第二章 储备品种、数量

第五条 根据常态短缺药品特征和临床作用范围,省级常态短缺药品分为五类:临床抢救药品、中毒解救特效药品、传染病治疗药品、突发灾情应对药品和临床必需药品。

第六条 省卫生健康委负责收集整理全省医疗机构临床短缺药品信息,于每年一季度提出本年度全省常态短缺药品储备品种、剂型、数量建议。根据省卫生健康委提出的建议,省工业和信息化厅会同省财政厅、省卫生健康委共同组织研究确定年度全省常态短缺药品储备计划。

第七条 常态短缺药品储备计划根据医疗机构需求数量变化、可能出现的疫情及突发公共卫生事件情况进行动态调整,原则上可每年调整一次。

 

第三章 储备企业、方式

第八条 常态短缺药品承储企业原则上从有意愿承担常态短缺药品储备任务的药品流通骨干企业和能够生产常态短缺药品的医药生产企业中公开遴选。

第九条 省工业和信息化厅会同省财政厅、省卫生健康委制定承储企业的遴选方案并公告。申请承储企业必须是近三年连续盈利的医药商业企业或者医药生产企业。在企业自愿申请基础上,由省工业和信息化厅会同省财政厅、省卫生健康委按照企业的规模、市场覆盖率、经营管理水平等遴选承储企业。

第十条 承储企业原则上每3年公开遴选一次,遇特殊情况可根据需要及时遴选调整承储企业。

第十一条 承储企业的职责:

(一)建章立制。建立常态短缺药品储备管理领导小组,建立健全仓储、调用、配送、财务、值班值守、应急等管理制度,明确责任到人。

(二)落实任务。足量落实储备计划安排,确保常态短缺药品储备品种实物在库、质量良好、储存安全。加强信息化管理,建立储备药品进销存及配送台账,保证常态短缺药品储备的正常调用和来源去向清晰。

(三)有效轮换。根据具体承储品种的有效期采取滚动轮换方式对储备药品进行适时轮换,保证储备常态短缺药品质量有效期限在半年以上。

(四)配合管理。接受政府主管部门对常态短缺药品储备执行情况的监督检查,发现问题及时整改,切实做好常态短缺药品储备管理工作。

第十二条 常态短缺药品储备采用以实物储备方式为主、定点生产等其它方式为辅,实行品种控制、总量平衡的动态储备模式。

 

第四章 药品调用、管理

第十三条 常态短缺药品储备实行有偿调用。医疗机构可根据临床紧迫的用药需要,向承储企业直接联系,进行紧急配送。遇到灾情疫情或突发重大事故需要动用常态短缺药品时,按照《湖南医药储备应急预案》相关要求,组织调用常态短缺药品储备。承储企业在常态短缺储备药品调出后的30天内,应按储备计划及时补齐储备药品。

第十四条 承储企业应建立常态短缺药品应急配送机制,根据医疗机构用药需求,及时配送常态短缺药品,并做好调用配送记录台账。

第十五条 承储企业必须建立常态短缺药品台账管理制度,每月对库存进行盘点,对有效期接近半年的常态短缺储备药品,承储企业应及时向省工业和信息化厅、省财政厅、省卫生健康委报告。每年度1月份向省工业和信息化厅、省财政厅、省卫生健康委及时上报上年度承储及调用工作总结。

第十六条 省卫生健康委、省工业和信息化厅及时面向医疗机构发布省级常态短缺药品储备品种目录以及承储企业采购部门联系方式等信息。

第十七条 省工业和信息化厅会同省财政厅、省卫生健康委不定期开展常态短缺药品储备工作检查,督促指导承储企业落实和改进储备管理工作。

第十八条  承储企业如出现未建立完善的储备管理制度,或落实储备任务不到位,或未对储备药品进行有效轮换,或不配合主管部门工作,或其他违反本办法规定的情形,由省工业和信息化厅责令其限期整改。整改后仍未到位的,由省工业和信息化厅商省财政厅、省卫生健康委后取消其承储资格。

如出现以下情形,由省工业和信息化厅商省财政厅、省卫生健康委后直接取消企业承储资格:

(一)企业被暂停或吊销药品生产、经营有关许可;

(二)企业或其法定代表人发生重大违法事项;

(三)企业或其法定代表人发生重大负面舆情事件;

(四)企业不具备承担储备任务资格的其他情形。

 

第五章 储备补助

第十九条 储备补助包含药品储备补贴和过期损耗补偿两种。按要求做好常态短缺药品储备管理工作的承储企业,享有储备补助权利。被取消承储资格的企业不享有储备补助权利。

第二十条 承储企业药品储备补贴根据实物储备常态短缺药品所需资金的贷款利息、仓储保管费用、周转、存储损耗以及应急配送等因素综合考虑,每年核定一次。根据储备工作落实情况,按储备常态短缺药品金额的20%-30%给予承储企业补贴。

第二十一条 因执行政府特殊指令造成常态短缺药品储备过期损耗的,承储企业向省工业和信息化厅递交过期损耗补偿申请报告并附有关证明资料。经审核同意后按过期药品的进货价格给予50%的补偿。

第二十二条 承储企业的药品储备补贴和过期损耗补偿核定工作由省工业和信息化厅会同省财政厅、省卫生健康委实施。承储企业补助实行后补助,每年补助一次。

第二十三条 承储企业补助资金从省先进制造业高地建设专项中列支,按年度及时拨付给承储企业,不得截留、挪用。

 

第六章 附 则

第二十四条 本办法自公布之日起施行,有效期五年。