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A Mixed-Methods Analysis of Medication Safety Incidents Reported in Neonatal and Children's Intensive Care
Anwar A Alghamdi1,2, Richard N Keers3,4, Adam Sutherland3,5
1Centre for Pharmacoepidemiology and Drug Safety, Division of Pharmacy and Optometry, School of Health Sciences, Manchester Academic Health Science Centre, University of Manchester, Manchester, M13 9PT, UK. nloalgamdi7@kau.edu.sa.
Insights
Critically ill children, especially neonates, face significant medication safety risks in intensive care units (ICUs). Addressing staffing, system design, and anti-infective use can help reduce these medication errors.
Area of Science:
- Pediatric critical care medicine
- Patient safety research
- Medication safety science
Background:
- Critically ill neonates and children in intensive care units (ICUs) are at higher risk for medication-related safety incidents.
- Understanding these incidents is crucial for improving pediatric patient safety.
Purpose of the Study:
- To investigate the nature and contributing factors of medication-related safety incidents in neonatal and pediatric ICUs.
- To analyze reported incidents over a nine-year period to identify trends and root causes.
Main Methods:
- A mixed-methods analysis of anonymized medication safety incidents reported to the National Reporting and Learning System.
- Involved children aged 18 years or younger admitted to ICUs in England and Wales from 2010-2018.
- Descriptive analysis of data and qualitative examination of free-text descriptions for contributory factors.
Main Results:
- Over 25,000 medication-related incidents were analyzed, with most occurring during administration (53.5%) and prescribing (29%).
- Common errors included drug omissions (18.8%) and dosing errors (17.5%). Neonates were frequently involved (47.9%), particularly with anti-infectives (25.4%).
- Harmful incidents (12.2%) often involved neonates, with staff-related factors (68.7%), system design, and inadequate guidelines as key contributors.
Conclusions:
- Neonates are disproportionately affected by medication safety incidents in pediatric ICUs.
- Improving staffing, workload management, system/process design, and anti-infective medication protocols can mitigate risks.
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.
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Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...