Children’s Hospital Adverse drug reaction Reporting Tool
Research type
Research Study
Full title
Assessing understanding of a tool used to improve reporting of suspected adverse drug reactions from hospitalised children and young people
IRAS ID
350105
Contact name
Dan Hawcutt
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
This study aims to assess hospitalised children and young people's understanding of a tool used to improve reporting of their adverse drug reactions (ADRs), which are unintended and sometimes harmful effects of medications. Examples range from mild issues like a rash to severe complications like heart problems. ADR reporting is essential to make medicines safer, but young people rarely report their experiences. This gap limits understanding of how medications affect children and young people specifically.
The study will evaluate a tool designed to help children understand ADRs and report them through the Yellow Card Scheme, a national system for monitoring medicine safety. Previously, young people in the community helped develop and test this age-appropriate information, but it hasn’t been tested with hospitalised children, who often take different medicines and may experience unique side effects.
Children aged 9-17 years old who are inpatients at Alder Hey Children’s Hospital will be eligible to participate. They will be asked to complete a questionnaire about their experiences with medications, whether they understand the information provided about ADRs, and their willingness to report future ADRs. Participants will receive study information, tailored to their reading level, and will have at least 24 hours to decide whether to take part. Consent will be obtained from parents (if under 12), from parents or patients (12-15) or the participants themselves (if aged 16 or 17).
The study will run for six months, from February to July 2025, on Alder Hey’s medical and surgical wards. The findings will identify how well hospitalised children understand the ADR tool and suggest improvements to make it more effective.
The research is sponsored by the University of Liverpool, with results shared publicly and with the Medicines and Healthcare products Regulatory Agency (MHRA) to inform future ADR reporting efforts and improve medication safety for children.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
25/SW/0031
Date of REC Opinion
23 Apr 2025
REC opinion
Further Information Favourable Opinion