Article Text

Information for children and young people about reporting suspected adverse drug reactions
  1. Daniel B Hawcutt1,2,
  2. Mitul Jadeja3,
  3. NIkita Bhoombla4,
  4. Sophie Smith5,
  5. Stephen J McWilliam2
  1. 1 NIHR Alder Hey Clinical Research Facility, Liverpool, UK
  2. 2 Department of Women’s and Children’s Health, University of Liverpool, Liverpool, UK
  3. 3 Medicines and Healthcare Products Regulatory Agency, London, UK
  4. 4 Queen's Medical Centre, Nottingham, UK
  5. 5 Wirral Grammar School for Girls, Bebington, UK
  1. Correspondence to Dr Daniel B Hawcutt, NIHR Alder Hey Clinical Research Facility, Liverpool L12 2AP, UK; dhawcutt{at}liverpool.ac.uk

Abstract

Background When children and young people (CYP) report their own suspected adverse drug reactions (ADRs), different patterns of drugs and symptoms are noted. A new guide to reporting suspected ADRs using the Medicines and Healthcare Products Regulatory Agency (MHRA) Yellow Card scheme was developed by CYP, paediatric clinical pharmacology, Yellow Card Centres and the MHRA.

Methods An anonymous quality improvement project to assess the guide for CYP was undertaken (September 2020–February 2021).

Results The survey was completed by 234 CYP age 13–18 years. Within respondents, 68/226 (30.1%) were using medicines, 209/225 (92.9%) had used medicines previously, and 211/225 (93.8%) had heard of side effects. 79/225 (35.1%) believed they had experienced a side effect, with some requiring hospitalisation. Only 8/221 (3.6%) respondents were aware of the MHRA Yellow Card scheme.

Overall, 182/196 (92.9%) of CYP both understood the guide and felt more knowledgeable about how to report suspected side effects. CYP comfortable to report their own suspected ADR increased from 179/222 (80.6%) before reading guide, to 189/196 (96.4%) after reading the new CYP guide. In addition, 156/196 (79.6%) believed they would report a side effect from a medicine used in future. Over 360 free-text comments were also received, providing comments about what was good about the new guide and areas for improvement that could be made.

Conclusion The new guide for CYP to inform them about how to report a suspected ADR to the MHRA was well received and increased the knowledge, and confidence to report, in those who responded.

  • pharmacology
  • paediatrics
  • child health
  • therapeutics

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information. Not applicable.

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Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information. Not applicable.

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Footnotes

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  • Contributors DH and MJ conceived the project and cowrote the survey. SS, NB and SJM interpreted the data and edited the paper. DH is the guarantor for this manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Disclaimer The views expressed are those of the author(s) and not necessarily those of the National Health Service, the NIHR or the Department of Health.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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