Drug shortages in Italy: strategic insights and empirical evidence from the Italian pharmaceutical market.

Drug shortages disrupt healthcare delivery and pose a critical challenge to the resilience of pharmaceutical supply chains. This study investigates the drivers of drug shortages in Italy - Europe's leading pharmaceutical producer - to identify the factors associated with supply disruptions and inform evidence-based health policy. Using national data from 2018 to 2023, we analysed 17,619 drugs across 3,013 groups of substitutes, covering community, dual-dispensed, and hospital distribution channels. Generalised linear mixed models were employed to assess how drug characteristics, market dynamics, and regulatory features influence shortage risk. Shortages were most prevalent among community drugs, where high market fragmentation and low-profit margins contributed to supply instability. Patent protection was associated with lower shortage risk for non-sterile drugs, while sterile drugs remained vulnerable regardless of patent status, likely due to manufacturing complexity. Notably, price effects were age-dependent: higher prices mitigated shortage risk, particularly for older drugs. This study offers a comprehensive evaluation of shortage patterns in a key pharmaceutical market, identifying structural risk factors and market vulnerabilities. The findings provide actionable insights for policymakers aiming to design targeted interventions, strengthen supply chain resilience, and ensure continuous access to essential medicines.