ArticleInternational journal of clinical pharmacy2023
Under-reporting of gastrointestinal bleeding associated with anticoagulant use using the UK Yellow Card Scheme.
Article in International journal of clinical pharmacy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.
- Triggers for identifying anticoagulation-associated adverse drug events in hospitalized patients: a systematic review and meta-analysis.International journal of clinical pharmacy · 2025Pooled it
- Reducing Adverse Drug Reactions for Older People in the Community: Evaluating the Validity and Reliability of the ADRe Profile.Journal of nursing management · 2025Trial
- Reporting of suspected adverse drug reactions: a systematic review comparing clinical settings and pharmacovigilance systems.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Cancer-Therapy-Induced Cardiotoxicity: Results of the Analysis of the UK Yellow Card Adverse Drug Reaction (ADR) Reporting.Cancers · 2024Article
- Accuracy in patient-reported adverse drug reactions and their recognition: a mixed-methods study.International journal of clinical pharmacy · 2024Article
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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.
aimThe 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.
methodHospital 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.
resultsFor 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.
conclusionUtilisation of the Yellow Card System for reporting potential ADR is poor, leading to under-reporting of ADRs.
Indexed as
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Registered trials
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