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全国范围内开展药品零售企业执业药师 “挂证”行为整治

2019-03-19 佚名 国家药监局综合司

各省、自治区、直辖市药品监督管理局,新疆建设兵团市场监督管理局:3月15日晚,中央广播电视总台曝光了重庆市部分药品零售企业执业药师“挂证”、不凭处方销售处方药等问题,造成了恶劣社会影响。为全面落实药品监管“四个最严”要求,严厉打击执业药师“挂证”行为,现决定在全国范围内开展为期6个月的药品零售企业执业药师“挂证”行为整治。现将有关工作要求通知如下:一、整治目标通过整治,查处并曝光一批违法违规的药品

各省、自治区、直辖市药品监督管理局,新疆建设兵团市场监督管理局:

3月15日晚,中央广播电视总台曝光了重庆市部分药品零售企业执业药师“挂证”、不凭处方销售处方药等问题,造成了恶劣社会影响。为全面落实药品监管“四个最严”要求,严厉打击执业药师“挂证”行为,现决定在全国范围内开展为期6个月的药品零售企业执业药师“挂证”行为整治。现将有关工作要求通知如下:

一、整治目标

通过整治,查处并曝光一批违法违规的药品零售企业和从业人员,有效遏制“挂证”行为,形成严查重处的高压态势和强大威慑,进一步规范药品经营秩序和执业药师执业行为,切实保障人民群众用药安全有效。

二、整治内容

在2017年部署开展的城乡接合部和农村地区药店诊所药品质量安全集中整治基础上,各地要进行“回头看”,并按照《国家药监局关于加强2019年药品上市后监管工作的通知》(国药监药管〔2019〕7号)要求,组织对药品零售企业开展监督检查,重点查处执业药师“挂证”等违法违规经营行为。要将药品零售企业“挂证”整治与规范进货渠道、严格票据管理等日常监督检查内容相结合,督促药品零售企业提高质量管理和药学服务水平。

三、工作安排

(一)自查整改阶段

所有药品零售企业对照《药品流通监督管理办法》《药品经营质量管理规范》要求开展自查,对执业药师配备不到位、不凭处方销售处方药等问题,采取切实有效措施主动进行整改。企业自查整改情况应于2019年4月30日前报属地市(或县)级负责药品监管的部门。

所有注册执业在药品零售企业的执业药师亦须一并开展自查,凡是存在“挂证”行为、不能在岗服务的执业药师,应立即改正或于2019年 4月30日前主动申请注销《执业药师注册证》。

(二)监督检查阶段

自2019年5月1日起,各省级局组织对行政区域内的药品零售企业开展监督检查,并按照以下要求处理:

1.凡检查发现药品零售企业存在“挂证”执业药师的,按严重违反《药品经营质量管理规范》情形,撤销其《药品经营质量管理规范认证证书》。

2.凡检查发现药品零售企业未按规定配备执业药师的,按照《中华人民共和国药品管理法》第七十八条规定依法查处;同时,将该企业列入年度重点检查对象,进行跟踪检查或飞行检查。

3.凡检查发现药品零售企业未按规定销售处方药的,依据《药品流通监督管理办法》第三十八条规定予以处罚。

4.凡检查发现存在“挂证”行为的执业药师,撤销其《执业药师注册证》,在全国执业药师注册管理信息系统进行记录,并予以公示;在上述不良信息记录撤销前,不能再次注册执业。

四、有关要求

(一)广泛宣传引导。各省级局要借助媒体曝光的契机,积极组织开展社会宣传,为整治工作营造良好舆论氛围。要提升全行业对执业药师配备政策要求的认识,主动开展自查整改;要提升全社会对执业药师在保障用药安全、提升质量管理方面重要性的认识,强化社会监督。

(二)严格监督检查。各省级局要督促行政区域内各级监管部门高度重视,加强属地药品经营企业日常监管,严厉查处药品零售企业执业药师“挂证”等行为。市(或县)级负责药品监管的部门要对新开办药品零售企业严格审核把关,不具备条件的,不得核发《药品经营许可证》。

(三)推动社会共治。各市(或县)级负责药品监管的部门要结合全国执业药师注册管理信息系统的执业注册信息,提高监督检查针对性和实效性。对于查实药品零售企业存在执业药师“挂证”的,应通报当地医保管理等部门,取消其医保定点资格,形成部门联合惩戒机制。对于查实的“挂证”执业药师,撤销其《执业药师注册证》,并对外公示。要将“挂证”执业药师纳入信用管理“黑名单”,积极探索多部门联合惩戒、共同打击的长效机制。

(四)落实监管责任。各省级局对整治工作进行督查督办,落实属地监管责任,一级抓一级,层层抓落实。要强化调查研究,有针对性地加强指导、督促和检查,确保整治工作取得实效。对工作推动不力、整治效果不佳的地区,予以通报批评。

各省级局于2019年9月30日前,对行政区域内执业药师“挂证”整治工作进行总结,报国家药监局药品监管司。

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    2019-05-29 维他命
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    2019-03-21 hyf030
  5. [GetPortalCommentsPageByObjectIdResponse(id=1646351, encodeId=1b9416463512d, content=<a href='/topic/show?id=080d5469e79' target=_blank style='color:#2F92EE;'>#执业#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54697, encryptionId=080d5469e79, topicName=执业)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=95a523305089, createdName=维他命, createdTime=Wed May 29 01:41:00 CST 2019, time=2019-05-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1971994, encodeId=20a519e199452, content=<a href='/topic/show?id=0ce58e51574' target=_blank style='color:#2F92EE;'>#药品零售#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87515, encryptionId=0ce58e51574, topicName=药品零售)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=236b481, createdName=anan, createdTime=Tue Nov 12 00:41:00 CST 2019, time=2019-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1411929, encodeId=1a79141192999, content=<a href='/topic/show?id=f52f54e225f' target=_blank style='color:#2F92EE;'>#执业药师#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54722, encryptionId=f52f54e225f, topicName=执业药师)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cac32820101, createdName=3631174, createdTime=Thu Mar 21 05:41:00 CST 2019, time=2019-03-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1456241, encodeId=c8d31456241c6, content=<a href='/topic/show?id=3cdb2563088' target=_blank style='color:#2F92EE;'>#企业#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25630, encryptionId=3cdb2563088, topicName=企业)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=0a765759005, createdName=hyf030, createdTime=Thu Mar 21 05:41:00 CST 2019, time=2019-03-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1593820, encodeId=e800159382011, content=<a href='/topic/show?id=1fc056381fb' target=_blank style='color:#2F92EE;'>#挂证#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=129, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56381, encryptionId=1fc056381fb, topicName=挂证)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=880318165283, createdName=yourmama, createdTime=Thu Mar 21 05:41:00 CST 2019, time=2019-03-21, status=1, ipAttribution=)]
    2019-03-21 yourmama

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