Sr. Program Manager U.S. Food and Drug Administration Cranberry Township, United States
Background: Falsified pills—sometimes referred to by the public as fake, counterfeit, pressed, or laced—pose a tremendous public health risk, particularly pills containing illicitly manufactured fentanyl. America’s Poison Centers National Poison Data System (NPDS) is a near-real time surveillance system that may help understand the evolving role of falsified pills in the overdose crisis.
Objectives: To investigate falsified pill involvement in U.S. poison center (PC) cases and explore the utility of NPDS as a data resource for monitoring harms from falsified pills.
Methods: Using NPDS, we identified and manually reviewed case narratives from 200 randomly selected intentional abuse cases with medical outcomes of at least moderate effect, reported to involve oxycodone (N = 80), alprazolam (N = 80), or amphetamine (N = 40) from 6/1/2019 – 5/31/2022. Structured data and narrative text were abstracted to capture case characteristics and categorize cases by likelihood of falsified pill involvement: probable (documented suspicion of falsified pill), possible (no documented suspicion but noted non-prescription source, e.g., “street,” “party,”), unlikely (source was own or other’s prescription), or unknown (all other cases). Descriptive analyses were performed.
Results: We categorized 16% of oxycodone cases as probable falsified pill involvement, 5% as possible, 14% as unlikely, and 65% as unknown. For alprazolam, 4% were probable, 10% possible, 8% unlikely, and 79% unknown. Of the amphetamine cases, no cases were probable, 13% possible, 18% unlikely, and 70% unknown. Percent male ranged from 58% of unlikely cases to 71% of possible cases. Percent < 25 years old ranged from 33% (unlikely) to 65% (possible). Percent with inhalation or injection route ranged from 8% (unlikely) to 31% (probable). More than half of probable cases (56%) mentioned suspected fentanyl involvement. Polysubstance involvement ranged from 44% (probable) to 67% (unknown). Percent with major effect or death ranged from 29% (unlikely) to 44% (unknown). Overall, 26% of cases included information on drug source (e.g., own prescription, street). Toxicology lab data were limited and difficult to interpret.
Conclusions: This exploratory analysis of U.S. PC cases suggests potential for these data to contribute to our understanding of harms from falsified pills. NPDS enhancements, including structured data fields to document suspected falsified pill exposure, would increase value. Routine inquiry about drug source and suspected falsified pill exposure and expansion of toxicologic testing could also enhance surveillance and response to this tremendous public health threat.
