Background: The increasing number of drug shortages (DSs) worldwide calls for more proactive solutions to prevent the negative impacts of DSs on patient care. Such solutions require in-depth knowledge about potential patient safety risks related to DSs, the processes of recognizing and managing DSs, the contextual setting in which DSs occur, and the actors involved.

Objective: The aim of the study is to use prospective risk assessment to identify patient safety risks in hospitals associated with the management of DSs among actors at national, regional and local level in Denmark.

Methods: Healthcare Failure Mode and Effect Analysis (HFMEA) was employed in composition with elements from the Systematic Human Error Reduction and Prediction Approach (SHERPA) and the Systems-Theoretic Accident Model and Processes (STAMP). Potential risks related to DS management across three actor levels (national, regional and local) in the Danish healthcare system were described. Each actor level consisted of six participants that were identified using a purposive sampling strategy. Processes and sub-processes related to managing critical DSs were outlined and the actors identified, prioritized and rated potential failure modes, causes and consequences related to the processes. Recommendations to mitigate failures were proposed for high risk failures modes.

Results: Overall, a total of 167 failure modes were identified across the three actor levels. At the national level, the process of DS management consisted of 17 sub-processes, from which 71 failure modes were identified. Nine of them were rated as high risk. At regional level, 7 sub-processes and 33 failure modes were identified, of which 9 were rated as high risk. At local level, 14 sub-processes and 63 failure modes were identified, of which 32 were rated as high risk. The high-risk failures were related to a lack of IT support in the medication modules, underestimation of patient safety aspects, and insufficient personnel training and patient information.

Conclusion: Exploring DS management failure modes across actor levels provided an overview of interrelated failures. Potential solutions related to high risk failures were developed to ensure that actors ensure patient safety related to DS in healthcare.