학술논문
Assessing and further developing age-appropriate information for young people about reporting suspected adverse drug reactions.
Document Type
Academic Journal
Author
Bioletti L; Department of Women's and Children's Health, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK.; Woodward C; St Helens and Knowsley Teaching Hospital NHS Trust, Prescot, UK.; Jadeja M; Medicines and Healthcare products Regulatory Agency (MHRA), London, UK.; Hawcutt DB; Department of Women's and Children's Health, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK.; NIHR Alder Hey Clinical Research Facility, Liverpool, UK.
Source
Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 7503323 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2125 (Electronic) Linking ISSN: 03065251 NLM ISO Abbreviation: Br J Clin Pharmacol Subsets: MEDLINE
Subject
Language
English
Abstract
Aims: The Medicines and Healthcare products Regulatory Agency 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 (age <19 years) in the UK is extremely uncommon, driving efforts to improve awareness and reporting.
Methods: Quality improvement project, using an anonymous online survey about updated information for young people, distributed through school pupils (age 13-18 years) across the UK through the Alder Hey Research Ambassador programme.
Results: Research Ambassadors were recruited in 21 schools and colleges, generating 2933 responses (15 November 2022-08 April 2023); 6.3% of respondents had heard of the YCS, and 0.8% had previously reported a Yellow Card. There were 307 suspected drug-event combinations 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 < .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%).
Conclusions: 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.
(© 2023 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)
Methods: Quality improvement project, using an anonymous online survey about updated information for young people, distributed through school pupils (age 13-18 years) across the UK through the Alder Hey Research Ambassador programme.
Results: Research Ambassadors were recruited in 21 schools and colleges, generating 2933 responses (15 November 2022-08 April 2023); 6.3% of respondents had heard of the YCS, and 0.8% had previously reported a Yellow Card. There were 307 suspected drug-event combinations 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 < .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%).
Conclusions: 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.
(© 2023 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)