Sustaining pharmaceutical supply: strategies for mitigating and managing drug shortages
Turbucz Béla
Pharmaceutical Sciences
Dr. Zelkó Romána
Semmelweis Egyetem Hőgyes Előadóterem
2025-07-22 14:00:00
Modern Trends in Pharmaceutical Scientific Research
Dr. Antal István
Dr. Hankó Balázs
Dr. Lám Judit
Dr. Vida Róbert György
Dr. Szökő Éva
Dr. Lengyel Miléna Bea
Dr. Vecsernyés Miklós
This dissertation addresses the global challenge of drug shortages, which can disrupt healthcare delivery, compromise patient safety, and place additional burdens on the entire pharmaceutical supply chain. The lack of essential medicines has the largest impact on treatment outcomes, so their shortages constitute a particular threat. Understanding the root causes of drug shortages and how to mitigate them, as well as identifying best practices among shortage management strategies are critical for improving healthcare resilience and safeguarding patient outcomes. A mixed-methods approach was chosen, combining quantitative and qualitative analyses. The quantitative analysis compares drug shortages across six countries—Hungary, Belgium, Spain, Switzerland, Australia, and the United States. It examines the frequency and severity of shortages, particularly in four therapeutic categories most affected by critical shortages. Findings reveal substantial disparities in shortage rates and reporting systems, with European countries experiencing higher proportions of critical shortages per population. Anti-infectives and nervous system drugs appear to be particularly affected, as they demonstrate a higher proportion of critical shortages compared to other ATC groups. The qualitative analysis explores the root causes of shortages, with business and economic issues, requirements of mature quality management systems, and logistical and regulatory challenges being the three main categories of root causes. It is also discussed how each of these causes can be addressed, so shortages are prevented or mitigated early on. Furthermore, shortage management strategies are also studied. Best practices are identified both among centrally managed measures for regulatory bodies and locally managed measures for healthcare professionals. The dissertation concludes with recommendations for addressing pharmaceutical shortages through a combination of harmonized international practices and adaptable local solutions. Standardized definitions and reporting systems, and clear collaborative frameworks would enable stakeholders to reduce the number of shortages. Together, these measures can help health systems maintain access to essential medicines while also increasing resilience against future supply chain challenges.
