使用英国黄卡计划,与使用抗凝剂相关的胃肠道出血报告不足
Paul Shuttleworth1, James Baker2, Edwin Clark3
1Department of General Surgery, Stockport NHS Foundation Trust, Stockport, SK2 7JE, UK. paul.shuttleworth@nhs.net.
International journal of clinical pharmacy
|June 3, 2023
概括
通过黄卡计划报告药物不良反应 (ADR) 的情况显著不足. 这项研究发现,尽管有已知的风险,但与直接口服抗凝剂 (DOAC) 相关的胃肠道出血报告非常少.
科学领域:
- 药监和药物安全 药监和药物安全
- 胃肠病学 胃肠病学
- 心脏病学 心脏病学
背景情况:
- 1964年成立的黄卡计划,监测药物和医疗器械的药物不良反应 (ADRs).
- 报道不足的副作用是一个持续的挑战,估计高达94%的事件没有被报告.
- 抗凝药,通常用于心房来预防中风,携带胃肠道出血的风险.
研究的目的:
- 为了确定疑似与直接口服抗凝剂 (DOAC) 相关的胃肠道 (GI) 出血的发生率,在西北英格兰的一家医院.
- 在五年内通过MHRA黄卡计划评估这些疑似DOAC相关的胃肠道出血的报告率.
主要方法:
- 利用医院编码数据来识别胃肠道出血的患者.
- 与电子处方数据交叉引用GI出血记录,以确定抗凝剂的使用,特别是DOACs.
- 从MHRA黄卡计划获得了信托机构的药监报告数据.
主要成果:
- 在研究期间,记录了12013例与肠道出血相关的紧急住院病例.
- 其中,1,058名患者被确定为服用DOAC.
- 在同一时期,信托基金只提交了6份与DOAC相关的药监报告.
结论:
- 黄卡系统用于报告潜在的药物不良反应 (ADRs) 的利用特别差.
- 这导致对ADR的报道显著不足,特别是在与严重事件 (如胃肠道出血) 相关的DOAC等药物中.
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