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The FDA and the Next Wave of Drug Abuse — Proactive Pharmacovigilance
The New England Journal of Medicine ( IF 158.5 ) Pub Date : 2018-07-19 , DOI: 10.1056/nejmp1806486
Douglas C. Throckmorton 1 , Scott Gottlieb 1 , Janet Woodcock 1
Affiliation  

In response to the opioid crisis, the Food and Drug Administration (FDA) has taken action on multiple fronts. We have approved better measures for treating opioid use disorder and preventing deaths from overdose, have launched efforts to inform more appropriate prescribing as a way to limit clinical exposure to opioids, have taken actions to reduce the excess opioids available for abuse, and are working to facilitate development of new therapeutics that can effectively and safely help patients suffering from pain. Going forward, the FDA needs to remain vigilant to recognize shifting trends in the addiction landscape. Taking a systematic approach to monitoring such trends should allow us to intervene promptly and appropriately and protect the public from associated risks.

中文翻译:

FDA和下一波药物滥用浪潮-主动药物警戒

为了应对阿片类药物危机,美国食品药品监督管理局(FDA)已在多个方面采取了行动。我们已经批准了更好的措施来治疗阿片类药物使用障碍并防止因服用过量而导致死亡,并已开始努力告知更适当的处方,以限制临床上对阿片类药物的接触,并已采取措施减少可用于滥用的过量阿片类药物,并且正在努力促进新疗法的开发,这些疗法可以有效,安全地帮助遭受痛苦的患者。展望未来,FDA必须保持警惕,以认识到成瘾态势的变化趋势。采取系统的方法来监测此类趋势应使我们能够及时,适当地进行干预,并保护公众免受相关风险的影响。
更新日期:2018-07-19
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