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

项目总结 非药物芬太尼和其他新型合成阿片类药物(NSO)对 美国服药过量死亡率上升假药供应迅速增加 标志着NSO传播的新浪潮，它给广泛的 用户数量。迫切需要更多的研究来表征其毒理学特征和引发 与使用仿制假药有关的途径、使用模式和过量危险行为 处方类阿片类药物、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， 在不断演变的NSO疫情的新一波浪潮中，被描述为“零起点”。这项研究建立在 与索诺兰预防工场的合作伙伴关系，索诺兰预防工场是#年领先的基层减少伤害组织 AZ.拟议研究的总体目的是描述吸毒经历和过量用药的特征。 与迅速增长的假药(阿片类药物、苯二氮卓类药物)相关的风险 在亚利桑那州蔓延。这项研究将在亚利桑那州凤凰城大都会地区招募60名个体，分成两组 按目前(过去7天)非处方药用阿片类药物和/或假冒阿片类药物的使用情况分组 非处方苯二氮卓类和/或假冒苯二氮卓类药丸(n=30)。我们将致力于与 少数族裔群体以确定族裔/种族差距和与脆弱性相关的可获得性激增 亚利桑那州的假药。具体目标是：目标1：描述当地毒品市场状况、个人 脆弱性以及更广泛的社会和结构因素影响吸毒经历和过量用药风险 与假冒阿片类药物和苯二氮卓类药物使用有关的深入定性访谈 在亚利桑那州凤凰城使用非法药物者(N=60人)。目标2：使用液体-进行尿毒学分析 基于LC-MS/MS的方法鉴定芬太尼，芬太尼类似物， 其他非政府组织、设计的苯二氮卓类药物和其他处方药和非法药物，并评估与 自行报告这些药物的使用情况(N=60)。目标3：确定优先干预和政策应对战略，以 通过与关键利益攸关方(N=20)的焦点小组减少与假药过量有关的风险，包括 减少伤害协调员、吸毒者基层组织、治疗提供者和 政策制定者。这项研究意义重大，因为它将为日益增长的假冒产品提供及时的数据 美国的药物使用。拟议的研究具有创新性，因为：a)跨学科 与基层减少危害组织建立方法和伙伴关系，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用药风险 假冒阿片类药物和假冒苯二氮卓类药物的使用。D)评估两国之间可能存在的重叠 新型合成阿片类药物和设计型苯二氮卓类药物的爆发。

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.