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滥用防范阿片类药物制剂:预防阿片灾难的关键因素?

Abuse-Deterrent Opioid Formulations: A Key Ingredient in the Recipe to Prevent Opioid Disasters?

机构信息

Department of Pharmacy Practice, Gatton College of Pharmacy, East Tennessee State University, Johnson City, TN, USA.

Department of Pharmaceutical Sciences, Gatton College of Pharmacy, East Tennessee State University, Box 70594, Johnson City, TN, 37614-1708, USA.

出版信息

Clin Drug Investig. 2018 Jul;38(7):573-577. doi: 10.1007/s40261-018-0651-3.

Abstract

The US Food and Drug Administration (FDA) is encouraging the innovation of long-acting opioid formulations that are manipulation-resistant. The purpose of this commentary is to assess the benefits and limitations of abuse-deterrent opioid formulations (ADFs) and discuss their role in mitigating the current opioid epidemic. ADFs have been created with chemical properties that make it difficult for people who non-medically use prescription drugs to crush and dissolve opioid tablets, as well as by combining opioids with antagonists such as naloxone or naltrexone, which are released only when the dosage form has been manipulated or the drug is taken by a non-intended route. Despite these and other technologies, consensus regarding the effectiveness of these formulations in preventing non-medical use is lacking given the difficulty in obtaining post-marketing data. Researchers also question if the creation of abuse-deterrent drugs will have a positive effect on those struggling with a severe opioid-use disorder, fearing that current opioid users will simply find a new - perhaps more dangerous - drug of choice. Abuse-deterrent opioids are still opioids, and although they may make manipulation more difficult than non-ADF formulations, they are not "abuse proof." The introduction of ADFs could provide a false sense of security among prescribers and dispensers, and we fear that ADFs may have a minimal impact on non-medical use of prescription opioids. Further epidemiological studies will be required to determine the large-scale impact of abuse-deterrent opioids in preventing opioid use disorder and its downstream consequences.

摘要

美国食品和药物管理局(FDA)正在鼓励开发长效阿片类药物制剂,这些制剂应具有抗操纵性。本文旨在评估滥用防御型阿片类药物制剂(ADF)的益处和局限性,并讨论它们在减轻当前阿片类药物流行方面的作用。ADF 的化学性质使其难以被非医疗用途处方药物的人粉碎和溶解阿片类药物片剂,并且通过将阿片类药物与纳洛酮或纳曲酮等拮抗剂结合使用,这些拮抗剂仅在剂型被操纵或药物被非预期途径使用时才会释放。尽管有这些和其他技术,但鉴于难以获得上市后数据,对于这些制剂在预防非医疗使用方面的有效性,尚未达成共识。研究人员还质疑,是否创建滥用防御性药物会对那些与严重阿片类药物使用障碍作斗争的人产生积极影响,担心当前的阿片类药物使用者会简单地找到一种新的——也许更危险的——药物选择。滥用防御型阿片类药物仍然是阿片类药物,尽管它们可能使操纵比非 ADF 制剂更困难,但它们并非“防滥用”。ADF 的引入可能会使处方者和配药者产生一种虚假的安全感,我们担心 ADF 可能对预防处方类阿片类药物的非医疗使用影响有限。需要进一步开展流行病学研究,以确定滥用防御型阿片类药物在预防阿片类药物使用障碍及其下游后果方面的大规模影响。

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