• Alok Kapoor, Parth Patel, Daniel Mbusa, Thu Pham, Carrie Cicirale, Wenisa Tran, Craig Beavers, Saud Javed, Joann Wagner, Dawn Swain, Sybil Crawford, Chad Darling, Mayuko ItoFuKunaga, David McManus, Kathleen Mazor, and Jerry Gurwitz.
• UMass Chan Medical School, Worcester, MA, USA. alok.kapoor@umassmemorial.org.
• J Gen Intern Med. 2023 Dec 1; 38 (16): 352635343526-3534.

BackgroundAnticoagulants 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.ObjectiveTo evaluate the effectiveness of a multicomponent intervention for reducing CIMEs.DesignRandomized controlled trial.ParticipantsAmbulatory patients initiating a DOAC or resuming one after a complication.InterventionPharmacist 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.ControlCoupons and assistance to increase the affordability of DOACs.Main MeasureAnticoagulant-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.AnalysisIncidence and incidence rate ratio (IRR) of CIMEs (intervention vs. control) using multivariable Poisson regression modeling.Key ResultsA 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).ConclusionA multi-component intervention in which clinical pharmacists implemented an evidence-based DOAC Checklist did not reduce CIMEs.Nih Trial NumberNCT04068727.© 2023. The Author(s), under exclusive licence to Society of General Internal Medicine.

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