Pharmaceutical product shortages and its challenges

Abstract

Background: Pharmaceutical product shortages are a complex and multifactorial challenge that arise when a demand of a medicinal product exceeds the available supply. Shortages may be attributed to manufacturing interruptions and delays, limited production capacity, quality defects, logistics issues such as supply chain vulnerabilities and procurement challenges. Regulatory constraints such as lengthy approval timelines and limited regulatory flexibilities during supply emergency may contribute to delays in market availability leading to shortages. The study aimed to evaluate factors associated with pharmaceutical shortages by identifying key drivers, assessing stakeholder experiences and exploring potential strategies to mitigate and prevent shortages. Method: An evidence-based approach was employed to develop the guidance document for shortage prevention and the action plan for managing active shortages. A scoping literature review was conducted to identify existing regulatory frameworks and international shortage prevention plans, focusing on plans from Canada, European Medicines’ Agency guidance and England’s National Health Services (NHS) guidance. These documents were validated in a focus group discussion for relevance, clarity and practical applicability. Questionnaires were also distributed electronically to healthcare professionals (HCPs) and pharmaceutical suppliers to capture stakeholder perspectives on shortages. A thematic synthesis integrating findings from the literature and questionnaire responses was undertaken to identify key themes related to shortage drivers, impacts, and mitigation strategies. Results: A structured guidance document and action plan were developed to address pharmaceutical product shortages. The guidance document was organised into key sections including risk identification, early identification and notification of supply risk, supply chain monitoring, regulatory flexibilities, and stakeholder communication, with an emphasis on proactive shortage prevention. The action plan was designed as a stepwise, operational framework activated during active shortage, outlining clear escalation pathways, coordination mechanisms, and mitigation strategies. A RACI (Responsible, Accountable, Consulted, Informed) matrix was incorporated within the action plan to clearly define stakeholder roles and responsibilities across regulators, suppliers, and healthcare professionals, ensuring coordinated and efficient response. Together, these outputs provide a structured and context-specific approach to both the prevention and management of medicine shortages. Questionnaire findings highlighted that pharmaceutical product shortages are frequently encountered by both HCPs and suppliers and have a significant impact on patient care and an increase workload, treatment delays and the need to switch to alternative therapies. Although awareness of current mitigation strategies varies across stakeholders, there was an agreement that an improved communication, enhanced coordination and a greater adoption of digital tools, including artificial intelligence to support supply chain logistics and shortage prediction and management is required. Conclusion: Shortages remain a significant and multifactorial challenge impacting both patients and supply chains alike. The study highlights the need for s structured, proactive and coordinated approach to both the prevention and management of shortages. Both the guidance and action plan provide a practical and context-specific framework to enhance supply chain resilience.