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

Area of Science:

• Pharmacovigilance and Drug Safety
• Gastroenterology
• Cardiology

Background:

• The Yellow Card Scheme, established in 1964, monitors medicines and medical devices for adverse drug reactions (ADRs).
• Under-reporting of ADRs is a persistent challenge, with estimates suggesting up to 94% of incidents go unreported.
• Anticoagulants, commonly prescribed for atrial fibrillation to prevent stroke, carry a risk of gastrointestinal bleeding.

Purpose of the Study:

• To determine the incidence of suspected direct oral anticoagulant (DOAC)-related gastrointestinal (GI) bleeds in a North-West England hospital.
• To assess the reporting rate of these suspected DOAC-related GI bleeds through the MHRA Yellow Card Scheme over a five-year period.

Main Methods:

• Utilized hospital coding data to identify patients with GI bleeding.
• Cross-referenced GI bleed records with electronic prescribing data to identify anticoagulant use, specifically DOACs.
• Obtained pharmacovigilance reporting data for the Trust from the MHRA Yellow Card Scheme.

Main Results:

• Over the study period, 12,013 GI bleed-related emergency admissions were recorded.
• Of these, 1,058 patients were identified as taking a DOAC.
• During the same period, only 6 DOAC-related pharmacovigilance reports were submitted by the Trust.

Conclusions:

• The utilization of the Yellow Card System for reporting potential adverse drug reactions (ADRs) is notably poor.
• This leads to significant under-reporting of ADRs, particularly for medications like DOACs associated with serious events such as GI bleeds.