Drug shortages: clinical implications and burdens - a trinational multiple-methods study including key stakeholders.

Abstract

Background: As the prevalence of drug shortages has markedly escalated in recent years, this study seeks to investigate the associated clinical implications and burdens in Austria, Germany and Kosovo where healthcare systems differ significantly.

Methods: The research was conducted as a trinational, multiple-methods study utilising questionnaires and in-depth interviews for different stakeholders, including patients, physicians, pharmacists and manufacturers. Descriptive statistics were applied to summarise and analyse the quantitative dataset, providing key insights into central tendencies and overall data distribution, while qualitative data were analysed using the summarising approach based on Mayring's qualitative content analysis.

Results: Manufacturers expressed concerns regarding the intense pressure on pricing amid global inflation. Proposed mitigation strategies were anticipated to incur higher costs, with increased stockpiling in one major country adversely affecting others. Pharmacists across all three nations reported significant disruptions to their clinical practice, with up to fifty per cent of patient encounters being affected by drug shortages, requiring considerable amounts of time to resolve. They expressed feelings of frustration and anger, citing bureaucratic obstacles and excessive regulation as impediments to effective problem-solving. Physicians reported similar challenges in their practice, often resorting to self-initiated solutions and advocating for improved information regarding drug availability. While most patients have been exposed to drug shortages, the majority of these issues were resolved with moderate interruptions to their therapy. The root causes of these problems were primarily attributed to political factors.

Conclusion: The results show that drug shortages have significantly disrupted clinical practice across all three countries, with pharmacists and physicians reporting major impacts on patient care and increased time spent resolving issues. Economic pressures, political factors and regulatory obstacles were identified as key causes exacerbating the crisis and highlighting the need for coordinated mitigation strategies.