Abstract
Background Critically ill neonates and paediatric patients may be at a greater risk of medication-related safety incidents than those in other clinical areas. Objective This study aimed to examine the nature of, and contributory factors associated with, medication-related safety incidents reported in neonatal and paediatric intensive care units (ICUs). Methods We carried out a mixed-methods analysis of anonymised medication safety incidents reported to the National Reporting and Learning System that involved children (aged <= 18 years) admitted to ICUs across England and Wales over a 9-year period (2010-2018). Data were analysed descriptively, and free-text descriptions of harmful incidents were examined to explore potential contributory factors associated with incidents. Results In total, 25,567 eligible medication-related incident reports were examined. Incidents commonly occurred during the medicines administration (n = 13,668 [53.5%]) and prescribing stages (n = 7412 [29%]). The most commonly implicated error types were drug omission (n = 4812 [18.8%]) and dosing errors (n = 4475 [17.5%]). Neonates were commonly involved in reported incidents (n = 12,235 [47.9%]). Anti-infectives (n = 6483 [25.4%]) were the medications most commonly associated with incidents and commonly involved neonates. Incidents that were reported to have caused patient harm accounted for 12.2% (n = 3129) and commonly involved neonates (n = 1570/3129 [50.2%]). Common contributing factors to harmful incidents included staff-related factors (68.7%), such as failure to follow protocols or errors in documentation, which were often associated with working conditions, inadequate guidelines, and design of systems and protocols. Conclusions Neonates were commonly involved in medication-related incidents reported in children's intensive care settings. Improvements in staffing and workload, design of systems and processes, and the use of anti-infective medications may reduce this risk.