Regulatory gaps in over-the-counter antifungal access for vulvovaginal candidiasis in Uganda: A policy analysis framework.

Objectives: Vulvovaginal candidiasis (VVC) affects approximately 75% of women globally, with a particularly high prevalence (30-45%) among women of reproductive age in Uganda. Over-the-counter (OTC) antifungal medications are a critical access point for treatment in resource-limited settings; however, their unregulated availability raises important questions regarding appropriate use, diagnostic accuracy, and antimicrobial stewardship. We aimed to analyze Uganda's regulatory framework governing OTC antifungal medications for VVC management, identify key policy gaps, and develop an evidence-based framework to balance accessibility with appropriate use. Methods: This study employed a documentary analysis of Ugandan pharmaceutical policy documents (2000-2025) combined with a systematic review of the published literature on medication regulation and self-medication practices. A structured policy analysis framework was applied to examine the classification systems, implementation mechanisms, and provision of oversight for antifungal medications. Results: Uganda's current regulatory framework increases antifungal accessibility through liberal OTC classification but neglects complementary measures to ensure appropriate use and safety. Five critical policy gaps were identified: (i) diagnostic accuracy: no provisions ensure proper differentiation of VVC from other conditions; (ii) treatment completion: no mechanisms ensure adherence to recommended treatment durations; (iii) safety screening: absence of pregnancy screening requirements for contraindicated fluconazole; (iv) personnel training, inadequate VVC-specific training for drug shop operators; and (v) product regulation: insufficient oversight of combination products. These gaps exist within the healthcare context, where 62% of antimicrobials are supplied by private vendors with minimal oversight. We propose an evidence-based framework that balances accessibility with appropriate use. Conclusions: The identified policy gaps potentially compromise women's health outcomes through inappropriate treatment, incomplete therapy courses, preventable medication risks, and conditions that favor the development of antifungal resistance. The policy tensions between accessibility and appropriate use highlight the need for gender-sensitive pharmaceutical regulations that maintain access while implementing targeted safeguards for improved health outcomes and antimicrobial stewardship.