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Article History

Received: 4 July 2025

Accepted: 15 September 2025

First Online: 7 October 2025

Declarations

:

: Richard O. Day is an Editorial Board member of Drug Safety. He was not involved in the selection of peer reviewers for the manuscript nor in any of the subsequent editorial decisions. The authors have no additional relevant financial or non-financial interests to disclose.

: The data that support the findings of this study are not openly available owing to reasons of sensitivity and are available from the corresponding author upon reasonable request. Data are located in a controlled-access data storage at Macquarie University.

: The research was approved by the Human Research Ethics Committee of the Sydney Children’s Hospitals Network (HREC/15/SCHN/370) and by Macquarie University. The research was conducted in accordance with the Australian National Statement on Ethical Conduct in Human Research.

: We were granted a waiver of participant (or their parent or legal guardian) consent for patient data collection. Case studies presented to harm panels did not include any patient identifiers such as name, date of birth or medical record number. All nurses observed during the administration data collection provided consent and were de-identified.

: All authors have approved the final draft and consent to publication. We were granted a waiver of participant (or their parent or legal guardian) consent for the publication of de-identified patient data. All nurses observed during the study consented to publication of the results in the consent form.

: Not applicable.

: Virginia Mumford, Johanna I Westbrook, Magdalena Z. Raban and Ling Li designed the harm assessment process. Erin Fitzpatrick and Amanda Woods collected the error data and created the error classification process. Les White, Richard O. Day, Geoffrey Ambler, Luciano Dalla-Pozza, Madlen Gazarian, Peter Barclay and Alan Gardo were members of the harm assessment panels and helped design the panel assessment process. Virginia Mumford, Erin Fitzpatrick, Amanda Woods and Alison Merchant prepared the case studies. Ling Li, Tim Badgery-Parker, Magdalena Z. Raban and Virginia Mumford analysed the results. All authors provided input on the interpretation of findings. Virginia Mumford prepared the first draft of the manuscript, and all authors contributed to and approved the final version.