Pharmaceutical Quality and Accessibility of Emergency Contraceptive Levonorgestrel Tablets via Personal Importation in Japan

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INTRODUCTION: Levonorgestrel (LNG) tablets are used for emergency contraception and must be taken within 72 h after unprotected intercourse. In Japan, access had historically been restricted, although it has improved with the introduction of over-the-counter LNG tablets. However, barriers such as cost and convenience might still lead some individuals to obtain LNG through personal importation websites. We assessed the accessibility, regulatory compliance, and pharmaceutical quality-specifically, content assay and content uniformity-of LNG products obtained through these unregulated online pathways. METHODS: We identified nine personal importation websites through a Google search and purchased one LNG product from each site, assessing characteristics such as price, delivery time, packaging method, and insert availability. We evaluated pharmaceutical quality through quantitative analysis and content uniformity testing. RESULTS: Imported LNG tablets were cheaper than those available through official channels (mean: ¥1835/dose in 2022). However, the mean delivery time through personal importation was 19 d, making these products unsuitable for urgent use. Moreover, we observed missing instructions and foreign-language labeling. Quality testing revealed that five of the nine products were out of specification for the United States Pharmacopeia assay, and eight of the nine failed to meet the Japanese Pharmacopoeia XVIII content uniformity criteria. DISCUSSION: Although recent regulatory changes have allowed LNG tablet purchases from pharmacies without a prescription, structural and regulatory barriers to timely access remain-specifically, prohibitive costs compared to other nations and limited pharmacy access. These barriers potentially lead individuals to rely on personal importation, posing public health concerns. Ensuring equitable and prompt access to emergency contraception through appropriate regulatory frameworks and information is essential.

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