Analysis of medicinal product shortages in Bulgarian hospital settings in 2023: addressing procedures and unmet needs

Objective: This study aims to examine the national landscape of medicine shortages in Bulgaria, with an emphasis on the supply and procurement of medicines requested by hospital facilities due to their absence from the domestic market.

Materials and methods: A mixed-method approach was employed, combining regulatory and real-world data analysis. European and national legislation governing the supply of unavailable medicines in Bulgaria, including the Medicinal Products in Human Medicine Act and Ordinance No. 10, were reviewed. Data on unavailable medicinal products imported into Bulgaria in 2023 were obtained from the Bulgarian Drug Agency. These data were categorized into therapeutic classes, dosage forms, and regulatory pathways, with additional analysis of price regulation and World Health Organization Essential Medicines List status.

Results: In 2023, Bulgaria imported 165 INNs that were unavailable through the standard supply chain and reimbursement system due to their absence from the local market. Of these, 35% were procured under the regulatory framework established by Article 266a of the Medicinal Products in Human Medicine Act. These imports comprised 1,996 deliveries to hospital facilities nationwide. The analysis identified significant shortages in key therapeutic areas, including oncology, cardiovascular care, and critical care. The imported products were predominantly opioid analgesics, anticoagulants, anticancer medications, and diagnostic tools. Notably, several of these medicines are listed in the World Health Organization Essential Medicines List, underscoring their critical importance in addressing unmet healthcare needs.

Conclusion: Medicine shortages in Bulgaria present substantial challenges to healthcare delivery, further complicated by complex regulatory, economic, and market dynamics. Legislative mechanisms could not ensure the availability of some essential medicines. This study highlights the need for comprehensive national strategies to address shortages effectively, drawing on best practices from other European Union Member States. Future research should focus on expanding the assessment of shortages to enhance healthcare resilience and ensure continuous access to essential treatments.