北京市卫健委发文,抗肿瘤药物超说明书用药有了执行标准!

2022-03-27 北京市卫健委官网 北京市卫健委官网

严格管理抗肿瘤药物超说明书应用!

北京市卫健委日前发布《2022-2024年北京市肿瘤诊疗质量提升行动方案》(以下简称《行动方案》)。

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明确医疗机构在尚无更好治疗手段等特殊情况下,医师取得患者明确知情同意后,可使用药品说明书中未明确但具有循证医学证据的药品用法。医疗机构应制定相应管理制度,对抗肿瘤药物超说明书应用进行严格管理。

No.1  

形成北京市肿瘤诊疗检查项目分级管理目录

《行动方案》要求,有关部门要将肿瘤相关医疗检查作为重点,探索建立重点监控目录和超常预警制度,及时预警并纠正不合理医疗检查行为。对发现的违法违规行为,依法依规进行处理。

 各医疗机构应当依据有关诊疗指南(规范)、临床路径等,按照诊疗必需的原则为患者实施医疗检查。风险较大、缺乏诊疗指南(规范)或临床路径支持的医疗检查项目,应当有相关循证医学证据支持,并经科室讨论后实施。相关专业质控中心综合考虑风险、医疗费用、循证医学证据推荐级别等因素,制作检查项目分级管理目录,明确不同级别检查检验项目的具体管理要求。到2023年底,初步形成北京市肿瘤诊疗检查项目分级管理目录。

No.2  

严禁医务人员暗示患者到院外指定地点检查

接诊或收治患者的医疗机构无法开展的医疗检查项目,可通过医联体、委托第三方等方式实施。公立医疗机构委托第三方的,医疗检查相关费用应当由公立医疗机构收取。医疗机构、医务人员不得以任何形式诱导、暗示、强制患者到医疗机构外指定地点接受检查、治疗并从中谋取不正当利益。

No.3  

超说明书用药需有循证医学证据

抗肿瘤药物临床应用原则上须遵循临床应用指导原则、临床诊疗指南和药品说明书等。医疗机构在尚无更好治疗手段等特殊情况下,医师取得患者明确知情同意后,可使用药品说明书中未明确但具有循证医学证据的药品用法。医疗机构应制定相应管理制度,对抗肿瘤药物超说明书应用进行严格管理。

特殊情况下抗肿瘤药物使用采纳的证据级别依次是,其他国家或地区药品说明书中批准的用法、国际权威学协会或组织发布的诊疗规范、临床诊疗指南,国家级学协会发布的诊疗规范、临床诊疗指南和临床路径等。

No.4 

临床诊疗必需但未纳入医疗机构供应目录的药品,可以启动临时采购程序

临床诊疗必需但未纳入医疗机构供应目录的药品,应当按照规定程序纳入本机构目录采购使用。因特殊治疗需要,医疗机构确需使用本机构目录以外药品的,可以启动临时采购程序,由药学部门临时一次性购入使用。临床急需但短时间内无法采购的,临床科室应当组织讨论,报医疗机构有关部门批准后开具处方。同时要充分告知外购药品的必要性、医疗费用、医保政策、存在风险等,取得患者或家属书面同意。外购药品使用情况要记入病历。严禁医疗机构、医务人员以任何形式诱导、暗示、强制患者到医疗机构外指定地点购买药品并从中谋取不正当利益。

No.5  

首次应用的医疗技术,取得书面同意后进行

医疗机构要建立医疗技术临床应用论证和评估制度,拟首次应用的医疗技术,应当通过本机构技术能力和安全保障能力论证。对限制类医疗技术要进行重点评估,对患者实施前,临床科室应当组织讨论,必要时请有关科室会诊,充分告知必要性、医疗费用、医保政策、存在风险和替代方案等,取得书面同意后进行。

No.6  

医疗机构和医务人员要转变医学模式

医疗机构和医务人员要转变医学模式,关心患者心理变化,关注其心理社会需求,提供心理支持。鼓励有条件的医疗机构开展医务社工和志愿者服务,为有需求的患者争取社会资源提供帮助。

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    2022-03-28 ms4000000984858236

    学会了

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