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李克强发话!一夜之间,白血病廉价药又回来了
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Topic: 李克强发话!一夜之间,白血病廉价药又回来了 (Read 119 times)
xnf201
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李克强发话!一夜之间,白血病廉价药又回来了
December 03, 2017, 03:39:32 PM
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浙北药业已经取得巯嘌呤片新车间的GMP证书。 浙北药业供图原标题:白血病儿救命药短缺,国家卫计委、食药监总局已协调恢复供应用不上救命药巯嘌呤的白血病儿童,很快就能摆脱困境。11月20日,澎湃新闻从国家卫计委获悉,经国家卫计委、食药监总局两部门与有关企业多次会商协调,加快GMP认证审批程序。近日,浙江浙北药业已恢复巯嘌呤生产供应,第一批295万片(约可满足临床一年用量)已完成生产检验并做好了发货准备。国家卫计委近日还下发了《关于切实做好临床短缺药品巯嘌呤采购配送工作的通知》,要求各地高度重视,抓紧协调组织做好巯嘌呤的采购配送工作,减少中间环节,直接挂网采购,及时配送,确保供应。儿童白血病患者的救命药巯嘌呤片,2015年前后在全国各地陆续出现短缺问题,2016年底起,上海陆续断药。境外代购药物,成为不少白血病患儿家长的无奈之举。巯嘌呤片贯穿于ALL(儿童急性淋巴细胞白血病)患儿的整个治疗过程。如果在维持期治疗内停止服用这一药物,将大大影响这些患儿的长期生存效果。澎湃新闻日前报道这一救命药断货的情况后,李克强总理作出批示,要求有关部门切实加大国产廉价药生产供应保障力度。白血病患儿缺药将使这些家庭雪上加霜,要将心比心,高度重视所反映问题,抓紧采取有效措施,特事特办,切实加大国产廉价药生产供应保障力度,切实缓解患儿家庭的‘用药之痛’。总理在批示中说。按照今年6月底国家卫生计生委等9部门联合印发的《关于改革完善短缺药品供应保障机制的实施意见》,卫计部门近两年建立的短缺药品监测网络前期已经监测到巯嘌呤的短缺风险预警。今年8月份,国家重点监测的130多个短缺药品中就有巯嘌呤。国家卫生计生委会同食药监总局等部门对巯嘌呤的短缺情况立即开展了相关信息核查。目前,国内有巯嘌呤原料药批准文号生产企业3家,但仅1家实际在产;制剂生产企业6家,但仅2家企业近两年实际在产。2016年下半年,在产的1家企业因原料药价格上涨过快采购困难停产;2017年上半年,在产的另1家企业因GMP认证停产,导致巯嘌呤出现供应较大程度短缺。巯嘌呤每年全国临床用量约300万片(总价约300万元),临床用量小,利润不高,生产供应不充分。国家卫计委还表示,近期正在开展短缺药品市场撮合试点,卫计委会同发改、工信、国资委和食药监等部门,委托卫计委具管理中心组织辽宁、上海、浙江、山东等12个省份和生产企业,开展了临床必需、市场供应短缺药品鱼精蛋白和青霉胺的市场撮合。经供需双方商议和努力促成,12个省份与生产企业达成了协商一致。企业承诺从今年7月至明年12月,对青霉胺,以79.0元/瓶的价格稳定供货(撮合前各地实际采购价格在80;95元/瓶之间);对鱼精蛋白,以45元/支的价格稳定供货(撮合前各地实际采购价格在45;75元/支之间)。鱼精蛋白是开展心脏外科手术等必须备用的药品,此前一度出现短缺。国家卫计委还透露,通过开展短缺药品基础信息调查核实并推进分类解决,近段时间卫计委会同食药监总局、工信部、国资委等部门,已经一揽子解决了监测到130多个药品中的大部分品种短缺问题。此外,工信部、国家卫计委、国家发改委、食药监总局4部门正在加快研究制定文件,以支持引导行业企业有序生产供应临床必需、用量小的小品种短缺药品,推进小品种(短缺药)集中生产基地建设。国家卫计委还表示,下一步将进一步完善短缺药品监测预警体系,建立国家、省两级短缺药品清单管理制度,加强原料药供应跟踪监测,及时应对;加大违法违规行为打击力度,维护市场秩序,对于价格的确偏低的,引导形成合理供应价格,同时加大对哄抬价格和垄断等各类违法违规行为的打击力度,维护市场秩序,确保公平竞争。
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李克强发话!一夜之间,白血病廉价药又回来了
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