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. 2024 Mar;90(3):863-870.
doi: 10.1111/bcp.15971. Epub 2023 Dec 18.

Assessing and further developing age-appropriate information for young people about reporting suspected adverse drug reactions

Louis Bioletti  1 ; Alder Hey Research Ambassadors; Charlotte Woodward  2 , Mitul Jadeja  3 , Daniel B Hawcutt  1   4
Collaborators, Affiliations
Free article

Assessing and further developing age-appropriate information for young people about reporting suspected adverse drug reactions

Louis Bioletti et al. Br J Clin Pharmacol. 2024 Mar.
Free article

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.

Keywords: Yellow Card scheme; adverse drug reactions; medicines; paediatric pharmacology; pharmacovigilance; side effects; young people.

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References

REFERENCES

    1. Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol. 2007;63(2):148-156. doi:10.1111/j.1365-2125.2006.02746.x
    1. Mclernon DJ, Bond CM, Hannaford PC, et al. Adverse drug reaction reporting in the UK a retrospective observational comparison of yellow card reports submitted by patients and healthcare professionals. Drug Saf. 33(9):775-788. doi:10.2165/11536510-000000000-00000
    1. Thiesen S, Conroy EJ, Bellis JR, et al. Incidence, characteristics and risk factors of adverse drug reactions in hospitalized children-a prospective observational cohort study of 6,601 admissions. BMC Med. 2013;11(1):237. doi:10.1186/1741-7015-11-237
    1. Gallagher RM, Mason JR, Bird KA, et al. Adverse drug reactions causing admission to a paediatric hospital. PLoS ONE. 2012;7(12):e50127. doi:10.1371/journal.pone.0050127
    1. Heeley E, Riley J, Layton D, Wilton LV, Shakir SAW. Prescription-event monitoring and reporting of adverse drug reactions. Lancet. 2001;358(9296):1872-1873. doi:10.1016/S0140-6736(01)06898-2