《中国超药品说明书用药管理指南(2021)》推荐意见及要点解读

2022-11-15 中国医学科学院北京协和医院药剂科 协和医学杂志

我国第一个关于超药品说明书用药的管理指南,共确定9个问题,并形成了23条推荐意见。

中文标题:

《中国超药品说明书用药管理指南(2021)》推荐意见及要点解读

发布日期:

2022-11-15

简要介绍:

超药品说明书用药在某些情况下是诊疗的合理需求,但其面临潜在的用药安全和法律风险。对于如何指导中国的超药品说明书用药管理,至今尚无相关指南,故北京协和医院牵头,与兰州大学循证医学中心共同组织临床、药学、循证医学、法律和医院管理等多学科领域专家,根据《中华人民共和国医师法》关于超药品说明书用药的规定以及《世界卫生组织指南制定手册》相关指南制定方法,制定了《中国超药品说明书用药管理指南(2021)》。这是我国第一个关于超药品说明书用药的管理指南,共确定9个问题,并形成了23条推荐意见。指南的英文版本Management guideline for the off-label use of medicine in China (2021)已于2022年9月发表,本文对该指南要点进行全面解读,以期提高临床对该问题的认识,为超药品说明书用药建立标准化的管理程序提供参考和帮助。 

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  1. [GetPortalCommentsPageByObjectIdResponse(id=2104879, encodeId=d65d21048e932, content=zhegetaihaole , beContent=null, objectType=guider, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ace75432047, createdName=ms3000000961188933, createdTime=Thu Dec 08 08:44:00 CST 2022, time=2022-12-08, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=2108551, encodeId=6273210855180, content=实用,满满的干货, beContent=null, objectType=guider, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c2b84836234, createdName=147651877, createdTime=Mon Jan 02 21:40:41 CST 2023, time=2023-01-02, status=1, ipAttribution=广东省), GetPortalCommentsPageByObjectIdResponse(id=2107375, encodeId=f9f5210e375ec, content=很有帮助, beContent=null, objectType=guider, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=be728487913, createdName=ms5000000711393452, createdTime=Sun Dec 25 00:03:07 CST 2022, time=2022-12-25, status=1, ipAttribution=海南省), GetPortalCommentsPageByObjectIdResponse(id=2104878, encodeId=605b21048e89c, content=henxuyao, beContent=null, objectType=guider, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ace75432047, createdName=ms3000000961188933, createdTime=Thu Dec 08 08:43:42 CST 2022, time=2022-12-08, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=2102080, encodeId=4b2e210208079, content=这个对临床很有必要。, beContent=null, objectType=guider, channel=null, level=null, likeNumber=137, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=9dd11470443, createdName=fenghaorong, createdTime=Tue Nov 22 21:57:23 CST 2022, time=2022-11-22, status=1, ipAttribution=)]
    2022-12-08 ms3000000961188933 来自上海

    zhegetaihaole

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=2104879, encodeId=d65d21048e932, content=zhegetaihaole , beContent=null, objectType=guider, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ace75432047, createdName=ms3000000961188933, createdTime=Thu Dec 08 08:44:00 CST 2022, time=2022-12-08, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=2108551, encodeId=6273210855180, content=实用,满满的干货, beContent=null, objectType=guider, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c2b84836234, createdName=147651877, createdTime=Mon Jan 02 21:40:41 CST 2023, time=2023-01-02, status=1, ipAttribution=广东省), GetPortalCommentsPageByObjectIdResponse(id=2107375, encodeId=f9f5210e375ec, content=很有帮助, beContent=null, objectType=guider, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=be728487913, createdName=ms5000000711393452, createdTime=Sun Dec 25 00:03:07 CST 2022, time=2022-12-25, status=1, ipAttribution=海南省), GetPortalCommentsPageByObjectIdResponse(id=2104878, encodeId=605b21048e89c, content=henxuyao, beContent=null, objectType=guider, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ace75432047, createdName=ms3000000961188933, createdTime=Thu Dec 08 08:43:42 CST 2022, time=2022-12-08, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=2102080, encodeId=4b2e210208079, content=这个对临床很有必要。, beContent=null, objectType=guider, channel=null, level=null, likeNumber=137, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=9dd11470443, createdName=fenghaorong, createdTime=Tue Nov 22 21:57:23 CST 2022, time=2022-11-22, status=1, ipAttribution=)]
    2023-01-02 147651877 来自广东省

    实用,满满的干货

    0

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    2022-12-25 ms5000000711393452 来自海南省

    很有帮助

    0

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    2022-12-08 ms3000000961188933 来自上海

    henxuyao

    0

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    2022-11-22 fenghaorong

    这个对临床很有必要。

    0