Medication errors and their reporting : an insight into the acute hospital setting

Abstract

Medication errors represent a significant global public health concern, contributing substantially to preventable morbidity and mortality. Medication errors have far-reaching consequences, affecting patients, family members, healthcare professionals, and the wider healthcare organisations. Despite increasing efforts to put medication safety to the forefront, progress in this area has been limited. This dissertation, therefore, sought to explore the causes of medication errors and their reporting practices in the acute care setting in Malta. The study utilised an explanatory-sequential mixed methods design. The initial quantitative phase involved a retrospective analysis of Individual Case Safety Reports (ICSRs) from the EudraVigilance database between 2022 and 2025. These findings then informed the qualitative phase, which sought to augment and interpret the quantitative results. Semi-structured interviews were conducted with front-line healthcare professionals, including a mix of doctors, nurses and pharmacists, working within two local acute hospital settings, as well as with select key players within the field of medication and patient safety. The qualitative analysis was informed by Reason’s Accident Causation Model to classify the causes and contributory factors of medication errors, and by the Theoretical Domains Framework to explore the barriers and facilitators to reporting. The most notable finding from the quantitative phase was the absence of medication error reports originating from Malta during the study period. Using the international ICSRs from this database, the most common stages associated with medication errors were prescribing (27.2%) and administration (24.4%), with anti- infectives (23.1%) and nervous system agents (22.8%) being the most frequently implicated medication classes. Statistically significant associations (p < 0.01) were identified between error seriousness and both patient age group and reporter type. The qualitative phase identified key causes and contributory factors to medication errors. While active failures such as selecting the wrong medication, incorrect dose calculations or deviations from hospital protocols emerged, errorprovoking conditions, including heavy workload, time pressures, staff shortages, fatigue, the effect of look-alike and sound-alike medications and communication issues, were identified as the predominant factors leading to medication errors. Latent failures, linked to inadequate training and supervision, issues with staff allocation and roles, and problems with the quality of procured medications were also commonly cited. The main barriers to error reporting included hospital culture, fear of professional repercussions, insufficient awareness of reporting systems, and the timeconsuming nature of reporting. The qualitative insights from healthcare professionals’ interviews gave insight into the lack of reporting shown by the EudraVigilance data. The findings aligned with international literature on both the underlying causes and the barriers to medication error reporting. These findings highlighted how medication errors often stem from complex, multi-factorial causes, where gaps in defences align to allow for an error to occur. The barriers to reporting identified by front-line healthcare professionals provided crucial insight into potential reasons behind the significant underreporting locally and underscored the need for urgent action. Various recommendations from the study findings emerged and were categorised into micro (individual), meso (organisational) and macro (regulatory) level interventions. These included improving training and education on medication safety, fostering and sustaining an open patient safety hospital culture, implementing digital tools for medication use and addressing key issues such as procurement practices and staff shortages In conclusion, medication errors are an important public health concern in Malta, necessitating urgent measures to address their widespread causes and the evident barriers leading to their current under-reporting.