Medication Safety Failures and the 2022 Paediatric Acute Kidney Injury Epidemic in The Gambia: A Systems-Based Analysis

Abstract Background Medication-related harm remains a major and preventable contributor to child mortality in low- and middle-income countries (LMICs). In 2022, The Gambia experienced a fatal outbreak of pediatric acute kidney injury (AKI) linked to contaminated paracetamol and cough syrups, exposing critical weaknesses in medicine regulation, pharmacovigilance, and health system preparedness. This epidemic provides an important policy-relevant case for examining medication safety within the framework of the World Health Organization’s (WHO) Global Patient Safety Action Plan (2021–2030) and the Global Medication Safety Challenge: Medication Without Harm. Methods A descriptive, systems-based case analysis was conducted using secondary data sources, including peer-reviewed literature, WHO medical product alerts, and national investigation reports. Established safety and human factors models the Swiss Cheese, SHELL, SHEEP, and Endsley’s Situational Awareness models were applied to examine failures across the medicine lifecycle, from importation and regulation to clinical use and public health response. Results The analysis identified aligned failures across multiple defensive layers. Weak import regulation and absence of routine quality testing allowed contaminated paediatric medicines to enter the formal supply chain. Passive pharmacovigilance delayed recognition of early AKI clusters, while deficits in situational awareness, fragmented communication, and limited paediatric renal care capacity constrained timely response. These interacting failures transformed toxic exposure into widespread and preventable child mortality. Conclusion The Gambian AKI epidemic illustrates how medication safety failures can rapidly escalate into national patient safety crises when governance, surveillance, and preparedness systems are weak. Aligning national reforms with WHO patient safety strategies through strengthened regulatory oversight, active pharmacovigilance, workforce capacity building, improved situational awareness, and integration of medication safety into emergency preparedness offers a practical policy roadmap for preventing similar events and protecting children in resource-constrained settings.