UMass Chan Medical School, Worcester, MA, USA.
UMass Memorial Medical Center, Worcester, MA, USA.
J Gen Intern Med. 2023 Dec;38(16):3526-3534. doi: 10.1007/s11606-023-08315-z. Epub 2023 Sep 27.
Anticoagulants including direct oral anticoagulants (DOACs) are among the highest-risk medications in the United States. We postulated that routine consultation and follow-up from a clinical pharmacist would reduce clinically important medication errors (CIMEs) among patients beginning or resuming a DOAC in the ambulatory care setting.
To evaluate the effectiveness of a multicomponent intervention for reducing CIMEs.
Randomized controlled trial.
Ambulatory patients initiating a DOAC or resuming one after a complication.
Pharmacist evaluation and monitoring based on the implementation of a recently published checklist. Key elements included evaluation of the appropriateness of DOAC, need for DOAC affordability assistance, three pharmacist-initiated telephone consultations, access to a DOAC hotline, documented hand-off to the patient's continuity provider, and monitoring of follow-up laboratory tests.
Coupons and assistance to increase the affordability of DOACs.
Anticoagulant-related CIMEs (Anticoagulant-CIMEs) and non-anticoagulant-related CIMEs over 90 days from DOAC initiation; CIMEs identified through masked assessment process including two physician adjudication of events presented by a pharmacist distinct from intervention pharmacist who reviewed participant electronic medical records and interview data.
Incidence and incidence rate ratio (IRR) of CIMEs (intervention vs. control) using multivariable Poisson regression modeling.
A total of 561 patients (281 intervention and 280 control patients) contributed 479 anticoagulant-CIMEs including 31 preventable and ameliorable ADEs and 448 significant anticoagulant medication errors without subsequent documented ADEs (0.95 per 100 person-days). Failure to perform required blood tests and concurrent, inappropriate usage of a DOAC with aspirin or NSAIDs were the most common anticoagulant-related CIMEs despite pharmacist documentation systematically identifying these issues when present. There was no reduction in anticoagulant-related CIMEs among intervention patients (IRR 1.17; 95% CI 0.98-1.42) or non-anticoagulant-related CIMEs (IRR 1.05; 95% CI 0.80-1.37).
A multi-component intervention in which clinical pharmacists implemented an evidence-based DOAC Checklist did not reduce CIMEs.
NCT04068727.
包括直接口服抗凝剂（DOACs）在内的抗凝剂是美国风险最高的药物之一。我们推测，在门诊环境中，临床药师对开始或重新使用 DOAC 的患者进行常规咨询和随访，将减少临床重要的药物错误（CIMEs）。
评估多组分干预措施减少 CIMEs 的效果。
随机对照试验。
开始使用 DOAC 或在出现并发症后重新开始使用 DOAC 的门诊患者。
基于最近发表的检查表进行药师评估和监测。关键要素包括 DOAC 使用的适宜性评估、DOAC 可负担性援助的必要性、三次药师发起的电话咨询、获取 DOAC 热线、向患者的连续性提供者进行记录交接以及监测后续实验室检查。
优惠券和增加 DOAC 可负担性的援助。
DOAC 相关的 CIME（抗凝相关 CIMEs）和 DOAC 开始后 90 天内的非抗凝相关 CIME；通过盲法评估过程识别 CIME，包括两名医师对药师提出的事件进行判断，而药师与参与研究的药师不同，药师审查了参与者的电子病历和访谈数据。
使用多变量泊松回归模型分析 CIME（干预组与对照组）的发生率和发生率比（IRR）。
共有 561 名患者（281 名干预组和 280 名对照组患者）出现 479 例抗凝相关 CIME，包括 31 例可预防和可改善的 ADE 和 448 例无后续记录的 ADE 的严重抗凝药物错误（每 100 人-天 0.95 例）。尽管药师在记录中系统地识别了这些问题，但未能进行所需的血液检查以及同时使用 DOAC 与阿司匹林或 NSAIDs 是最常见的抗凝相关 CIME。干预组的抗凝相关 CIME 发生率（IRR 1.17；95%CI 0.98-1.42）或非抗凝相关 CIME 发生率（IRR 1.05；95%CI 0.80-1.37）均无降低。
临床药师实施基于证据的 DOAC 检查表的多组分干预并未减少 CIMEs。
NCT04068727。
