Medication-related Harms to Paediatric Patients in Primary Care

[Speaker] David M Reith:1
[Co-author] Susan M Dovey:1, Sharon Leitch:1, Katharine A Wallis:2, Kyle S Eggleton:2, Andrew W Mcmenamin:3, Wayne K Cunningham:4, Martyn I Williamson:1, Steven Lillis:2, Murray W Tilyard:1
1:Dunedin School of Medicine, University of Otago, New Zealand, 2:University of Auckland, New Zealand, 3:Te Ngae Medical Centre, New Zealand, 4:Royal College of Surgeons in Ireland - Medical University of Bahrain, Bahrain

Background: Safety incidents in a primary care setting occur in approximately 2.2% of patient contacts, and 1 in 4 of these incidents have effects on patients, with hospital admission in approximately 3% of incidents (1). Available data indicate that, in pediatric patients, vaccines and medicines are the leading source of harm. Children are at particular risk for medication incidents because of the complexity of dosing, lack of suitable formulations and errors in administration. The rate of harm in children, in standard practice, is unknown because most of the data come from spontaneous reporting.
Methods: The SHARP study is a stratified, 2-level cluster, retrospective records review study to identify and describe patient harms (2). "Harm" was defined as disease, injury, disability, suffering, and death, arising from the health system. Categorization of patient harm (including type, preventability, severity, and outcome) was coded using the Medical Dictionary for Regulatory Activities (MedDRA) 18.0. The age group for the purposes of the study was <20 years age. The data were further analysed by 5-year age groups.
Results: There were 195 patient harms in children: 3 (1.5%) in the <2 years age group, 68 (34.9%) in the 2 to <6 years age group, 39 (20.0%) in the 6 to <12 years, 59 (30.3%) in the 12 to <18 years and 26 (13.3%) in the 18 to <21 years. 109 (55.9%) occurred in females and 86 (44.1%) in males. 46 (23.6%) were related to antibiotics. 16 (8.2%) were related to immunisations. Three of the occasions were not related to medications or vaccinations.
Conclusions: Most treatment related harms, in standard care, in children are related to medications, with antibiotics and immunisations the most commonly associated treatments.
1. Gaal S, Verstappen W, Wolters R, Lankveld H, van Weel C, Wensing M. Prevalence and consequences of patient safety incidents in general practice in the Netherlands: a retrospective medical record review study. Implementation Science. 2011;6(37).
2.. Dovey SM, Leitch S, Wallis KA, Eggleton KS, Cunningham WK, Williamson MI, et al. Epidemiology of Patient Harms in New Zealand: Protocol of a General Practice Records Review Study. JMIR research protocols. 2017;6(1):e10.
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