OBJECTIVES: The European Commission has developed a new proposal for its pharmaceutical legislation framework, including an amendment to Article 51, classifying all antimicrobials as prescription-only medicines (POMs) to reduce antimicrobial resistance (AMR). This proposal is logical for antibiotics but risk of such in antivirals and antifungals is less obvious where resistance risk is mainly linked to high-dose, long-term, and systemic use in immunocompromised patients. In addition, economic impact on self-manageable conditions (athlete’s foot, cold sores, and vaginal thrush), currently treatable with topical OTCs has not been considered. This research evaluates the socioeconomic and health consequences of reclassifying OTC antifungal and antiviral.

METHODS: A decision tree model was developed using epidemiological and surveillance data, retail sales data, social media insights, patient surveys, and peer-reviewed literature. The model assumed that if the products were restricted to POMs patients would either do nothing, seek alternative treatments, or obtain a prescription through doctor’s appointments. The model estimated both direct and indirect costs, considering the impact on healthcare resources due to hospital visit, delayed treatment, and productivity losses across 19 European countries.

RESULTS: Around 48 million additional doctor's visits and 12 million emergency visits are estimated to occur in symptomatic individuals who rely on OTC antifungals and antivirals across 19 countries per year. Total cost is expected to increase by €13 billion from healthcare related spend (€10 billion) and Productivity loss (€3 billion). Patients with vaginal thrush would have the highest additional outpatient visits compared to other indications with total cost of €6 billion.

CONCLUSIONS: The proposed reclassification is expected to significantly increase healthcare costs and lead to worse health outcomes, as delayed treatment could exacerbate health conditions. A targeted approach with focus on reclassifying specific products which have an increased risk of AMR development while maintaining access to treatments for self-manageable conditions is recommended.