Medication Safety in Neonatal and Children’s Intensive Care

Abstract

Aims: This thesis aimed to understand the frequency, nature and underlying contributory factors of medication errors (MEs) and preventable adverse drug events (ADEs) in children admitted to paediatric and neonatal intensive care units (PICUs and NICUs) in order to generate recommendations for strategies that promote the safe use of medications in this vulnerable patient group. Methods: A systematic review was first conducted to identify and critically evaluate the published peer reviewed evidence on the prevalence and nature of MEs and preventable ADEs in PICUs and NICUs in hospitals worldwide. A subsequent prospective observational cohort study was conducted across three English PICUs to assess the incidence, nature, preventability and severity of ADEs. A mixed methods analysis was then carried out to understand the nature and contributory factors of medication-related safety incidents reported from children’s intensive care settings in England and Wales to the National Reporting and Learning System (NRLS) during 2010-2018. This included a descriptive analysis of reported incidents and content analysis of harmful incidents. Results: Thirty-five studies were identified for inclusion in the systematic review. In PICUs, the median rate of MEs was 14.6 per 100 medication orders (interquartile range 5.7–48.8%, n=3 studies) and between 6.4 and 9.1 per 1000 patient-days (n=2). In NICUs, ME rates ranged from 4 to 35.1 per 1000 patient-days (n=2) and from 5.5 to 77.9 per 100 medication orders (n=2). In both settings, prescribing and medication administration errors were found to be the most common MEs. Preventable ADE rates were reported in three PICU studies as 2.3 per 100 patients (n=1) and 21–29 per 1000 patient-days (n=2). In NICUs, preventable ADE rates from three studies were 0.86 per 1000 doses (n=1) and 0.47–14.38 per 1000 patient-days (n=2). Anti-infective medications were commonly involved with MEs/preventable ADEs in both settings. The systematic review identified a lack of evidence concerning the burden of ADEs in these settings from the United Kingdom. Of 302 patients included in the subsequent observational cohort study involving three PICUs in England, one or more ADEs was detected in 47 (15.6%) patients. A total of 62 ADEs were identified, with an estimated incident rate of 20.5 per 100 patients (95% CI, 15.3-27.5) and 16.7 per 1000 patient-days (95% CI, 9.3-29.9). The majority of ADEs were considered preventable (36/62, 58.1%). Most ADEs caused temporary harm and were associated with problems with prescribing medicines. Medications for the central nervous system, infections and cardiovascular system were commonly implicated with ADEs. Patients with a PICU stay of seven or more days (OR 6.29, 95% CI, 2.42-16.32) were more likely to experience an ADE compared to patients with a stay of one to six days. Following examination of a total of 25,567 medication-related incidents reported to the NRLS, incidents were commonly reported to occur during medicines administration and prescribing stages. Anti-infectives were the medications most commonly associated with reported incidents and incidents that were reported to have caused patient harm accounted for 12.2% (3,129/25,567) of the total. Neonates were involved in 47.9% of all incidents, half (50.2%) of harmful incidents and 64.1% of anti-infective incidents. Common contributing factors to harmful incidents comprised staff-related factors such as failure to follow protocols or errors in documentation, which were associated often with challenging working conditions, inadequate guidelines, and design of systems and protocols. Conclusions: This programme of research has found that MEs and related ADEs are common in children’s intensive care settings and may lead to serious harm in critically ill children. Based on the in-depth understanding of these events that was generated b