Root cause analysis of medication errors of the most frequently involved active substances in paediatric patients.

BACKGROUND: Use of medicinal products in paediatric patients is identified as a risk factor for the occurrence of medication errors. OBJECTIVES: To describe and identify root causes of medication errors in children and adolescents spontaneously reported to Agency for Medicinal Products and Medical Devices of Croatia (Agency). METHOD: Agency's adverse drug reaction database was searched by using the Standardised MedDRA Query: medication errors (Broad) with data lock point set at 30th June 2022. Cases in which medication errors occurred in patients up to 18 years of age were analysed according to the patients' age group and gender, reporter's qualification, seriousness, reported preferred terms and active substances. For the first 30 most frequently reported active substances, an in-depth analysis was performed to identify the root cause of medication errors. RESULTS: Altogether, 6254 reports were spontaneously reported to the Agency, out of which 1947 (31 %) contained at least one preferred term belonging to Standardised MedDRA Query medication errors. More than half of patients experiencing medication errors belonged to the age group 2-11 years (66 %) and male gender (53 %). The most frequently reported ME PTs included accidental exposure to product by a child (64 %) and accidental overdose (17 %). Medication error root causes for the first 30 most frequently involved active substances included misinterpretation of prescribed dosage due to a very small volume resulting in salbutamol overdose; replacing millilitre and milligram units resulting in paracetamol solution overdose; interchange between medicinal products due to primary package similarities resulting in cholecalciferol overdose and interchange between oral solution and syrup resulting in valproate overdose. CONCLUSIONS: Healthcare professionals should counsel caregivers about the importance of keeping medicinal products out of children's reach and provide detailed instructions on how to appropriately use medicinal products.

The readiness of the spontaneous reporting system for COVID-19 vaccines safety monitoring in Croatia.

We aimed to identify whether a spontaneous reporting system (SRS) in Croatia could timely identify and confirm signals for COVID-19 vaccines. Post-marketing spontaneous reports of adverse drug reactions (ADRs) following COVID-19 immunisation reported to the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) were extracted and analysed. 6624 cases reporting 30 655 ADRs following COVID-19 immunisation were received from 27th December 2020 to 31st December 2021. Available data in those cases were compared with data available to the EU network at the time when signals were confirmed and minimisation measures were implemented. 5032 cases, reporting 22 524 ADRs, were assessed as non-serious, and 1,592 cases, reporting 8,131 ADRs as serious. The most reported serious ADRs, which were listed in the MedDRA Important medical events terms list, were syncope (n = 58), arrhythmia (n = 48), pulmonary embolism (n = 45), loss of consciousness (n = 43), and deep vein thrombosis (n = 36). The highest reporting rate had Vaxzevria (0.003), followed by Spikevax and Jcovden (0.002), and Comirnaty (0.001). Potential signals were identified, however, they couldn't be timely confirmed solely on cases retrieved by SRS. In order to overcome the limitations of SRS, active surveillance and post-authorisation safety studies of vaccines should be implemented in Croatia.