The clinical burden associated with unregulated access to short-acting β2-agonists in patients with asthma: Findings from the SABINA III study

Introduction: The SABINA III study reported that 18% of patients with asthma across 24 countries purchased short-acting β2-agonists (SABAs) over-the-counter (OTC);1 however, the clinical burden of unregulated access to SABA remains unknown. Therefore, we examined the association of SABA prescriptions and SABA OTC purchase with asthma-related outcomes. Methods: This post-hoc analysis of SABINA III included patients with asthma (≥12 years) with SABA prescriptions and self-reported OTC SABA purchase (canisters/year). The association of SABA prescriptions (≥3 vs 1‒2) and SABA OTC purchase with asthma-related outcomes was evaluated by performing four analyses using multivariable regression models; patients with 0 SABA prescriptions were excluded* (Table 1 A–D). Results: Of the 4,556 patients (mean age, 48.9 years) analysed, 75.7% received SABA prescriptions only, with 24.3% both prescribed and purchasing SABA OTC. Overall, 2,810 patients (61.7%) were overprescribed SABAs (≥3 canisters/year), of whom 27.6% also purchased ≥1 SABA canisters OTC. The highest disease burden was observed in the subset of patients who were prescribed ≥3 SABA canisters and purchased ≥1 SABA OTC, with 73.2% experiencing ≥1 severe exacerbations (mean, 2.1 severe exacerbations†) in the preceding 12 months and 55.7% reporting uncontrolled asthma at baseline. Prescription of ≥3 vs 1‒2 SABA canisters was consistently associated with an increased risk of severe exacerbations and lower odds of having at least partly controlled asthma‡ (Table 1A‒C). However, asthma outcomes were worse in patients with ≥3 SABA prescriptions and ≥1 SABA OTC purchase vs those with 1‒2 SABA prescriptions (without SABA OTC purchase; Table 1D). Discussion: Prescription of ≥3 vs 1‒2 SABA canisters/year was consistently associated with poor treatment outcomes. Notably, patients who were overprescribed SABAs and purchased ≥1 SABA OTC experienced the greatest disease burden. These findings underscore the need to implement evidence-based interventions to reduce the burden of unregulated access to SABA OTC without a prescription.