抵制阿片类药物滥用 美国正在行动

2017-07-21 常 路 环球医学

在美国,阿片类药物滥用导致的死亡人数一直在迅速上升。一份于7月13日由美国国家科学院、工程院和医学院公布的报告中,专家组建议美国食品和药物管理局(FDA)在批准上市前后,应显着扩大从公司获得的证据,以证明其阿片类药物是安全且有效的。

在美国,阿片类药物滥用导致的死亡人数一直在迅速上升。一份于7月13日由美国国家科学院、工程院和医学院公布的报告中,专家组建议美国食品和药物管理局(FDA)在批准上市前后,应显着扩大从公司获得的证据,以证明其阿片类药物是安全且有效的。

阿片类药物是包括例如羟考酮、二氢可待因和吗啡等处方药以及非法毒品海洛因在内的一类药物。很大程度上由处方阿片类药物以及像海洛因和非法制造的芬太尼这类非法毒品驱动的药物过量死亡,在美国已超越车祸成为伤害致死的首要原因。

事实上,FDA已经采取了一系列动作抵制阿片类药物成瘾。FDA新任局长Dr. Scott Gottlieb上任后将FDA首要目标锁定在遏制阿片药物的滥用,并在FDA官方网站上发表了相关声明。今年6月,它要求某制药企业从市场上撤回其长效止痛药盐酸氢羟吗啡酮,因为发现这种新配方导致静脉注射滥用增加。近日,该机构宣布,它将让更广泛的阿片类药物受到《风险评估和应对策略》要求的约束,其中包括要求公司在教育其医师关于相关风险和开药实践方面做更多事情。

哈佛大学公共卫生政策专家、起草阿片类药物新报告的专家组成员之一Aaron Kesselheim说,甚至需要更广泛的彻底检查。他表示:“我们在请FDA采取一种‘阿片例外论’的姿态,即FDA需要将阿片类药物和其他药物区别考虑……在药物批准和其他有关市场监管决策方面从公共健康角度出发。这是基于FDA已经采取的行动,尽管在其他领域的作用要有限得多。”

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    2017-08-28 zchen
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    2017-07-23 lhlxtx
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    2017-07-21 hhh678

    henhao

    0

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