Over-the-counter naloxone sales and pricing variability in North Carolina following FDA approval

Access to naloxone, an opioid overdose reversal medication traditionally available only by prescription, has expanded through different policies. The most recent policy change occurred in March 2023 when the United States Food and Drug Administration (FDA) approved naloxone for over-the-counter (OTC) use. Although intended to broaden access, no study has evaluated OTC sales trends. This study aimed to examine geographic and racial variations in OTC naloxone sales and cost in North Carolina.

This repeated cross-sectional study used Nielsen IQ Retail Scanner Data to assess naloxone sales from retail outlets between September 2023 and November 2024. We aggregated OTC sales by quarter and linked to geographic identifiers called Precision IDs, which combine ZIP Code Tabulation Areas (ZCTAs) into larger geographic areas. We assigned racial composition and rurality to each Precision ID using the American Community Survey and USDA Rural-Urban Commuting Area (RUCA) codes. We used generalized estimating equations (GEE) to model changes in naloxone units sold and price per unit over time; racial composition and rurality were included as covariates.

A total of 5734 naloxone units were sold over the study period. Sales declined by about 2% per quarter (IRR = 0.98, 95% CI: 0.95, 1.00; p = 0.0488) and were lower in non-metropolitan areas (p = 0.0082). Sales were higher in areas that had more stores (p < 0.0001) and lower in areas with higher proportions of Black populations (p = 0.0172). The average cost per unit was $44.72 (SD = 2.11), with a significant decline of US$0.49 per quarter (β = -0.489, 95% CI: -0.60, -0.37); p < 0.0001). Higher prices were observed in areas with higher proportions of American Indian/Alaska Native (AIAN) populations (p = 0.0004). Prices were significantly lower in non-metropolitan areas (p = 0.0145).

Differences in OTC naloxone sales and cost existed, with sales and average prices declining over the study period. Sales were lower in non-metropolitan areas and Black communities, while higher prices were observed in AIAN communities. Structural and geographic barriers may limit OTC naloxone sales in areas that could benefit from low-cost naloxone availability. Monitoring changes in sales and prices can inform targeted policy and outreach efforts to promote equitable access to OTC naloxone.