2SPD-019 Hospital pharmacists addressing medication shortages in the European Union: a comparative analysis of causes and solutions in Bulgaria and the EU

<h3>Background and Importance</h3> Medication shortages have emerged as a critical public health issue throughout the European Union (EU), impacting patient care, treatment continuity, and the efficacy of healthcare systems. The shortages, intensified by the COVID-19 pandemic and regulatory complexity, have increased the necessity for integrated efforts to manage pharmaceutical supply chains. <h3>Aim and Objectives</h3> The objective of this study is to examine the factors contributing to medicine shortages inside the EU, particularly in Bulgaria, and their association with the hospital pharmacist’s role. The study aims to identify critical areas for enhancement by analysing national and EU-level data on supply chain disruptions, regulatory frameworks, and treatment deficiencies. The objectives encompass identifying the therapeutic areas most adversely affected, evaluating the implications for public health, and recommending evidence-based methods to alleviate future shortages. <h3>Material and Methods</h3> A mixed-methods approach was utilised to examine drug shortages, incorporating both quantitative and qualitative data. Information regarding medicine shortages was obtained from official reports and registers issued by the European Medicines Agency (EMA), the Bulgarian Drug Agency, and several national health authorities within the EU. The quantitative research encompassed the frequency, duration, and severity of shortages, while the qualitative methods employed theme analysis of regulation documents and expert perspectives. A comparison analysis was performed between Bulgaria and other EU nations, concentrating on drug classifications, therapeutic domains, and supply chain weaknesses. <h3>Results</h3> The study revealed 61 drugs in short supply in Bulgaria, many of which are critical for managing chronic conditions such as hypertension, diabetes, and cancer. Cancer and immunotherapy are the areas of therapy most affected by the lack of important drugs, such as chemotherapeutic and immunomodulatory therapies. Contributing variables encompass restricted production capacities, heightened demand, and regulatory challenges in medicine pricing and approval procedures. <h3>Conclusion and Relevance</h3> Medication shortages in Bulgaria and throughout the EU represent a substantial risk to public health and a challenge for hospital pharmacists. Mitigating these shortages necessitates synchronised regulatory actions, bolstered supply chain robustness, and greater communication among pharmaceutical companies, healthcare practitioners, and regulatory agencies. EMA and national agencies have enacted emergency solutions, including digital tracking systems and regulation modifications, shortages continue to challenge hospital pharmacies. <h3>References and/or Acknowledgements</h3> EMA reports Bulgarian Drug Agency reports <h3>Conflict of Interest</h3> No conflict of interest