Oral Presentation: Analysis of Medication Errors in Children and Adolescents Reported to HALMED

• Published in: Drug safety Vol. 45; no. 10; pp. 1116 - 1117
• Main Authors: Pavičič, M, Skvrce, N M, Kulis, I, Miletic, L, Tomic, S
• Format: Journal Article
• Language: English
• Published: Auckland Springer Nature B.V 01.10.2022
• Subjects: Adolescents; Age; Analgesics; Children; Dosage; Drug dosages; Drugs; Errors; Health care; Medical errors; Optimization; Overdose; Paracetamol; Patients; Pharmacists; Risk analysis; Risk factors; Salbutamol; Syrup; Teenagers; Valproic acid
• ISSN: 0114-5916; 1179-1942

Introduction: A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient [1]. Use of medicinal products in children is identified as a risk factor for occurrence of medication errors [2, 3]. Objective: Aim of this study is to describe medication errors and identify causes of medication errors in children and adolescents spontaneously reported to HALMED, in order to propose and implement appropriate risk minimisation measures. Methods: We performed a search of HALMED's adverse drug reaction database using Standardised MedDRA Query (SMQ): Medication errors (Broad) with data lock point April 30th 2022. Cases in which medication errors occurred in patients up to 18 years of age were analysed according to the patient's age and gender, Preferred Terms (PTs) reported and root causes of medication errors. Results: Out of 8603 cases in patients up to 18 years of age, 1684 cases included terms pertaining to SMQ: Medication errors (Broad). Medication errors were most frequently reported for male patients (54%) and in the age group 2-11 years (67%). The most commonly reported PTs for medication errors were Accidental exposure to product by child (65%) and Accidental overdose (19%). Grouping of cases was observed for the following pharmaceutical formulations of the active substances: salbutamol nebuliser solution, paracetamol solution for infusion, valproate oral solution and syrup and cholecalciferol oral drops, solution. Identified root causes for medication errors were the following: misinterpretation of prescribed dosage due to very small volume resulting in 10 times higher administered dose (e.g. 3 ml instead of 0.3 ml) for salbutamol; confusion between units millilitres and milligrams resulting in overdose for paracetamol; interchange between medicinal products due to primary package similarities resulting in overdose for cholecalciferol (e.g. swapping with simethicone, dimetindene, bromhexidine); interchange between oral solution and syrup resulting in overdose for valproate. Conclusion: Medication errors were reported in 20% of all cases in patients up to 18 years of age, which highlights the importance of medication errors prevention in children and adolescents. Review of root causes for medication errors led to implementation of further risk minimisation measures, namely notifications for healthcare professionals (salbutamol and valproate), additional risk minimisation measures i.e. poster and dosage card (paracetamol) and workshops for healthcare professionals (salbutamol, valproate, paracetamol, cholecalciferol). Following implementation of risk minimisation measures, it is concluded there is a further need for evaluation or their effectiveness.