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Under-reporting of gastrointestinal bleeding associated with anticoagulant use using the UK Yellow Card Scheme

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Abstract

Background

The Yellow Card Scheme was created in 1964 to oversee new and existing medicines and medical devices, and act as an early warning system for unexpected adverse drug reactions (ADRs). Under-reporting within the system is a known issue, estimated to be as high as 94% in a 2006 systematic review. Anticoagulants are often prescribed in the UK to prevent stroke in patients with atrial fibrillation but can be associated with gastrointestinal bleeding as a common ADR.

Aim

The study aimed to investigate the incidence of suspected DOAC-related GI bleeds at a North-West England hospital and explore the volume of these incidents reported through the MHRA Yellow Card Scheme, over a 5-year period.

Method

Hospital coding data was used to identify patient records with GI bleeding and cross-referenced with electronic prescribing records for anticoagulant usage. Additionally, pharmacovigilance reporting activity for the Trust was obtained from the MHRA Yellow Card Scheme.

Results

For the period investigated, the Trust recorded 12,013 GI bleed related emergency admissions. Of these admissions, 1058 patients were taking a DOAC. During the same time period, a total of 6 DOAC-related pharmacovigilance reports were made by the trust.

Conclusion

Utilisation of the Yellow Card System for reporting potential ADR is poor, leading to under-reporting of ADRs.

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Acknowledgements

The authors would like to thank the MHRA Yellow Card Centre North West for their assistance.

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

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Authors and Affiliations

  1. Department of General Surgery, Stockport NHS Foundation Trust, Stockport, SK2 7JE, UK

    Paul Shuttleworth & Edwin Clark

  2. Pharmacy Department, Stockport NHS Foundation Trust, Stockport, SK2 7JE, UK

    James Baker

Authors
  1. Paul Shuttleworth
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  2. James Baker
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  3. Edwin Clark
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Correspondence to Paul Shuttleworth.

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Shuttleworth, P., Baker, J. & Clark, E. Under-reporting of gastrointestinal bleeding associated with anticoagulant use using the UK Yellow Card Scheme. Int J Clin Pharm 45, 1014–1018 (2023). https://doi.org/10.1007/s11096-023-01601-0

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  • DOI: https://doi.org/10.1007/s11096-023-01601-0

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