Introduction:

Anticoagulants are associated with significant harm when used in error, but there are limited data on potential harm of inappropriate treatment with direct oral anticoagulants (DOACs). We conducted a matched case-control study among atrial fibrillation (AF) patients admitting the hospital with a chronic treatment with DOACs, in order to assess factors associated with the risk of major bleeding.

Methods:

Patient data were documented using hospital’s computerized provider order entry system. Patients identified with major bleeding were defined as cases and were matched with controls based on the duration of treatment with DOACs and number of chronic medications. Appropriateness of prescribing was assessed based on the relevant clinical guidelines. Conditional logistic regression was used to evaluate the potential impact of safety-relevant prescribing errors with DOACs on major bleeding.

Results:

A total number of 509 eligible admissions were detected during the study period, including 64 cases of major bleeding and 445 controls. The prevalence of prescribing errors with DOACs was 33%. Most prevalent prescribing errors with DOACs were “drug dose too low” (16%) and “non-recommended combination of drugs” (11%). Safety-relevant prescribing errors with DOACs were associated with major bleeding [adjusted odds ratio (aOR) 2.17, 95% confidence interval (CI) 1.14-4.12].

Conclusion:

Prescribers should be aware of the potential negative impact of prescribing errors with DOACs and understand the importance of proper prescribing and regular follow-up.

中文翻译：

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直接口服抗凝剂的处方错误及其对心房颤动患者出血风险的影响

介绍：

错误使用抗凝剂会带来重大危害，但关于直接口服抗凝剂 (DOAC) 治疗不当的潜在危害的数据有限。我们在入院接受 DOACs 长期治疗的心房颤动 (AF) 患者中进行了一项匹配的病例对照研究，以评估与大出血风险相关的因素。

方法：

使用医院的计算机化供应商订单输入系统记录患者数据。确定有大出血的患者被定义为病例，并根据 DOAC 治疗的持续时间和慢性药物的数量与对照组进行匹配。根据相关临床指南评估处方的适当性。条件逻辑回归用于评估 DOAC 的安全相关处方错误对大出血的潜在影响。

结果：

研究期间共检测到 509 名符合条件的入院患者，包括 64 例大出血病例和 445 例对照。DOAC 处方错误的发生率为 33%。DOAC 最普遍的处方错误是“药物剂量过低”（16%）和“不推荐的药物组合”（11%）。DOAC 的安全相关处方错误与大出血相关 [调整优势比 (aOR) 2.17, 95% 置信区间 (CI) 1.14-4.12]。

结论：

处方者应了解 DOAC 处方错误的潜在负面影响，并了解正确处方和定期随访的重要性。