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Structural Patterns of Antibiotic Shortages: A Cross-National Analysis of Systemic Antibacterials
Oana-Teodora Chirac1, Adriana-Elena Tăerel2, Mihaela Dinu1
1Department of Pharmaceutical Botany and Cell Biology, Faculty of Pharmacy, "Carol Davila" University of Medicine and Pharmacy, 050474 Bucharest, Romania.
Antibiotics (Basel, Switzerland)
|June 26, 2026
Summary
Drug shortages, particularly for systemic antibiotics, frequently impact multiple countries simultaneously. Critical medicines designated by the European Medicines Agency (EMA) are disproportionately affected, highlighting global supply chain vulnerabilities.
Area of Science:
- Pharmacoeconomics and Health Policy
- Global Health Security
- Pharmaceutical Supply Chain Management
Background:
- Drug supply disruptions are a growing global health concern, with systemic antibiotics frequently experiencing shortages.
- Existing research lacks simultaneous, multi-country analyses of antibiotic shortage patterns.
- Regulatory bodies have repeatedly flagged the risk of drug shortages.
Purpose of the Study:
- To conduct a cross-sectional comparative analysis of systemic antibiotic shortages across seven international jurisdictions.
- To assess the association between a drug's critical status (EMA list) and the multinational recurrence of shortages.
- To identify structural fragilities in international antibiotic supply chains.
Main Methods:
- Comparative analysis of public national shortage registries from Belgium, France, Germany, Romania, Spain, the USA (FDA), and Saudi Arabia.
- Extraction and harmonization of records for systemic antibiotics (ATC group J01), with active substance (INN) as the unit of analysis.
- Statistical assessment using chi-square tests, Mann-Whitney U test, and multivariate logistic regression, including sensitivity analysis.
Main Results:
- 350 shortage records identified for 64 unique active pharmaceutical ingredients, with an average of 3.48 jurisdictions affected per substance.
- Macrolides (J01F) and quinolones (J01M) showed the widest geographic spread of shortages.
- European Medicines Agency (EMA)-designated critical medicines were significantly more prone to multinational shortages (82.86% vs. 37.14%; p < 0.001), remaining an independent predictor (OR = 8.29; p < 0.001).
Conclusions:
- Systemic antibiotic shortages exhibit a multinational, simultaneous pattern, indicating shared vulnerabilities.
- Drugs classified as critical by the EMA are disproportionately affected by these widespread shortages.
- The findings underscore the need for international collaboration in monitoring and managing essential antibiotic availability due to structural weaknesses in global supply chains.
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