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Japan essential medicine list and medicine supply issues: a cross-sectional study
Camila Heredia1, Hayase Hakariya2, Akihiko Ozaki3,4
1MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.
Background:
Essential medicines lists aim to improve access, affordability, and quality of medicines, though their impact on pricing and supply varies. Japan's universal coverage addresses key EML policy areas but faces drug shortages linked to generic drug promotion. This cross-sectional analysis of secondary data explores EML inclusion in the context of medicine supply issues in Japan.
Methods:
We analysed Japan's 2024 EML using data from the April 2024 Pharmaceutical Supply Survey. Unique medicines were defined by active ingredient and route. Duplicates, combinations, and non-essential categories were excluded. Supply issues were counted per medicine, but for total supply issue analysis, each medicine was counted only once.
Results:
We analysed 1107 unique medicines from Japan's 2024 pharmaceutical supply survey. Of these, 401 (36.2%) had shipping or supply issues. Among 167 medicines listed in Japan's 2024 EML, 80 (47.9%) had shipping issues. Most medicines with or without issues were not on the EML. A total of 847 entries described supply limitations for the 401 affected medicines. Causes included drug price deletion, quality issues, manufacturing problems, increased demand, and raw material shortages. For example, widely used essential medicines like amlodipine and metformin, not on Japan's EML, also had reported supply issues.
Conclusions:
One-third of medicines analysed had shipping issues, affecting nearly half of those on Japan's 2024 EML. Shipping issues spanned therapeutic areas, with antibiotics most affected. This aligns with global findings linking essential medicine status and shortages, though our findings describe shipping issue patterns at a single point in time. Factors include low pricing and quality issues. Ongoing updates to the EML and a national strategy are essential to ensure availability of priority medicines.
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