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