Department of General Surgery, Stockport NHS Foundation Trust, Stockport, SK2 7JE, UK.
Pharmacy Department, Stockport NHS Foundation Trust, Stockport, SK2 7JE, UK.
Int J Clin Pharm. 2023 Aug;45(4):1014-1018. doi: 10.1007/s11096-023-01601-0. Epub 2023 Jun 3.
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.
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.
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.
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.
Utilisation of the Yellow Card System for reporting potential ADR is poor, leading to under-reporting of ADRs.
黄卡计划于 1964 年成立，旨在监督新的和现有的药物和医疗器械，并作为药物不良反应（ADR）的早期预警系统。该系统的低报告率是一个已知问题，在 2006 年的一项系统评价中估计高达 94%。在英国，抗凝剂通常被开给患有心房颤动的患者，以预防中风，但可能会出现胃肠道出血等常见的 ADR。
本研究旨在调查英格兰西北部一家医院疑似 DOAC 相关胃肠道出血的发生率，并探讨在 5 年期间通过 MHRA 黄卡计划报告的这些事件的数量。
医院编码数据用于识别有胃肠道出血的患者记录，并与抗凝剂使用的电子处方记录进行交叉参考。此外，还从 MHRA 黄卡计划获得了信托基金的药物警戒报告活动。
在所调查的期间，该信托机构记录了 12013 例与胃肠道出血相关的紧急入院。在这些住院患者中，有 1058 名患者正在服用 DOAC。在同一时期，该信托总共提交了 6 份与 DOAC 相关的药物警戒报告。
黄卡系统用于报告潜在 ADR 的使用率很低，导致 ADR 报告不足。
