Counterfeit Pharmaceuticals: Increased Risks in the Era of Novel Synthetic Opioids and Other Designer Drugs

项目摘要 非药物芬太尼和其他新型合成阿片类药物（NSO）为前所未有的 美国过量死亡率的增加假冒药品的供应迅速激增 标志着新一波的NSO传播，它提出了独特的挑战，并增加了广泛的风险， 用户的人口。迫切需要更多的研究来表征毒理学特征和启动 途径，使用模式，以及与使用假冒药丸有关的过量风险行为 处方阿片类药物、苯二氮卓类药物和其他药物。该研究将在亚利桑那州（AZ）进行， 在新一波不断演变的国家统计局流行病方面，被称为“归零地”。这项研究建立在 与索诺兰预防工程，一个领先的基层减少危害组织， AZ.拟议研究的总体目的是描述药物使用经历和过量的特征 与快速增长的假冒药品（阿片类药物、苯二氮卓类药物）有关的风险 分布在AZ。该研究将在亚利桑那州凤凰城市区招募60名样本，分为两组。 按当前（过去7天）使用a）非处方药用阿片类药物和/或假冒阿片类药物分列的 药丸; 2）非处方苯二氮卓类和/或假冒苯二氮卓类药丸（n=30）。我们将致力于 少数民族群体，以确定族裔/种族差异和脆弱性有关的激增提供 假冒伪劣药品具体目标是：目标1：描述当地药品市场状况、个人 脆弱性以及更广泛的社会和结构性因素影响吸毒经历和过量风险 与假冒阿片类药物和苯二氮卓类药物使用相关的研究， 在亚利桑那州凤凰城使用非法药物的人（N=60）。目的2：使用液体进行尿液毒理学分析 基于色谱-串联质谱（LC-MS/MS）的方法来鉴定芬太尼，芬太尼类似物， 其他国家统计局、特制苯二氮卓类药物以及其他处方药和非法药物，并评估与 自我报告使用这些药物（N=60）。目标3：确定优先干预和政策应对战略， 通过与关键利益相关者（N=20）的焦点小组，降低与假药过量相关的风险，包括 减少危害协调员、吸毒者基层组织、治疗提供者，以及 政策制定者。这项研究非常重要，因为它将提供有关日益增长的假冒伪劣产品的及时数据。 该研究具有创新性，因为：a）跨学科 方法和与基层减少危害组织的伙伴关系，B）整合定性访谈 数据和毒理学分析，c）比较和对比药物使用经验和相关的过量风险 使用假冒阿片类药物和苯二氮卓类药物（d）评估两个组织之间可能的重叠 新型合成阿片类药物和设计师苯二氮卓类药物爆发。

PROJECT SUMMARY Non-pharmaceutical fentanyl and other novel synthetic opioids (NSO) have contributed to unprecedented increases in overdose mortality in the U.S. A rapid surge in the availability of counterfeit pharmaceutical drugs signals a new wave of the NSO spread, and it presents unique challenges and increased risks to a broad population of users. More research is urgently needed to characterize the toxicological features and the initiation pathways, patterns of use, and overdose risk behaviors related to the use of counterfeit pills that mimic prescription opioids, benzodiazepines, and other drugs. The study will be conducted in Arizona (AZ), characterized as a “ground zero” in terms of the new waves of the evolving NSO epidemic. The study builds on a collaborative partnership with Sonoran Prevention Works, a leading grassroots harm reduction organization in AZ. The overall purpose of the proposed study is to characterize drug use experiences and overdose risks associated with the rapidly growing counterfeit pharmaceutical drug (opioids, benzodiazepines) spread in AZ. The study will recruit a sample of 60 individuals in the Phoenix, AZ metro area, stratified into two groups by their current (past 7 days) use of a) non-prescribed pharmaceutical opioids and/or counterfeit opioid pills; 2) non-prescribed benzodiazepine and/or counterfeit benzodiazepine pills (n=30). We will aim to engage ethnic minority groups to identify ethnic/racial disparities and vulnerabilities related surging availability of counterfeit drugs in AZ. The Specific Aims are: Aim 1: Characterize how local drug market conditions, individual vulnerabilities, and broader social and structural factors influence drug use experiences and overdose risks associated with counterfeit opioid and benzodiazepine pill use through in-depth qualitative interviews with persons who use illicit drugs (N=60) in Phoenix, AZ. Aim 2: Conduct urine toxicology analysis using liquid- chromatography-tandem mass spectrometry (LC-MS/MS)-based methods to identify fentanyl, fentanyl analogs, other NSOs, designer benzodiazepines, and other prescription and illicit drugs and assess the concordance with self-reported use of these drugs (N=60). Aim 3: Identify priority intervention and policy response strategies to reduce overdose-related risks of counterfeit pills through focus groups with key stakeholders (N=20), including harm reduction coordinators, grassroots organizations of persons who use drugs, treatment providers, and policymakers. The study is highly significant because it will provide timely data on the growing counterfeit pharmaceutical drug use in the U.S. The proposed research is innovative because of: a) interdisciplinary approach and partnership with a grassroots harm reduction organization, b) integration of qualitative interview data and toxicological analyses, c) compare and contrast drug use experiences and overdose risks associated with the counterfeit opioid and counterfeit benzodiazepine use. d) assessment of potential overlap between the novel synthetic opioid and designer benzodiazepine outbreaks.