Assessing and further developing age-appropriate information for young people about reporting suspected Adverse Drug Reactions.

Adverse Drug Reactions, Pharmacovigilance, Paediatric Pharmacology, Yellow Card scheme Medicines Side Effects Young People

Journal

British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323

Informations de publication

Date de publication:
22 Nov 2023
Historique:
revised: 22 10 2023
received: 11 08 2023
accepted: 05 11 2023
medline: 22 11 2023
pubmed: 22 11 2023
entrez: 22 11 2023
Statut: aheadofprint

Résumé

The Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme (YCS) is the UK's system that collects spontaneous reports about suspected Adverse Drug Reactions (ADRs). Reporting of suspected ADRs by young people (<19y) in the UK is extremely uncommon, driving efforts to improve awareness and reporting. Quality improvement project, using an anonymous online survey about updated information for young people, distributed through school pupils (age 13-18) across the UK through the Alder Hey Research Ambassador programme. Research Ambassadors were recruited in 21 schools and colleges, generating 2933 responses (15/11/22 - 08/04/23). 6.3% of respondents had heard of the YCS, and 0.8% had previously reported a Yellow Card. Three hundred and seven suspected drug-event combinations were reported, 36 of which required attendance at hospital. The updated YCS reporting guide was understood by 92.8% of young people, and 90.8% reported knowing more about ADRs after reading the guide. The percentage of young people 'Not Comfortable' reporting a suspected ADR decreased from 13.3% (before reading) to 4.1% after reading (p<0.000001), and 84.5% of young people reported willingness to report a side effect in the future. The most common comments regarding further improvement of the information were content, or length of the text could be altered in some way (n = 543, 26.1%) and graphic design could be improved (n = 357, 17.2%). The age appropriate information provided met many of their needs, increasing willingness to report. Integration into existing education curricula in the UK would facilitate knowledge transfer and improve reporting.

Identifiants

pubmed: 37990602
doi: 10.1111/bcp.15971
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

This article is protected by copyright. All rights reserved.

Auteurs

Louis Bioletti (L)

Department of Women's and Children's Health, Institute of Life Course and Medical Sciences, University of Liverpool, UK.

Charlotte Woodward (C)

St Helens and Knowsley Teaching Hospital NHS Trust, Prescot, UK.

Mitul Jadeja (M)

Medicines and Healthcare products Regulatory Agency (MHRA), London, UK.

Daniel B Hawcutt (DB)

Department of Women's and Children's Health, Institute of Life Course and Medical Sciences, University of Liverpool, UK.
NIHR Alder Hey Clinical Research Facility, Liverpool, UK.

Classifications MeSH