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. 2023 Dec;38(16):3526-3534.
doi: 10.1007/s11606-023-08315-z. Epub 2023 Sep 27.

Multicomponent Pharmacist Intervention Did Not Reduce Clinically Important Medication Errors for Ambulatory Patients Initiating Direct Oral Anticoagulants

Alok Kapoor  1   2 , Parth Patel  3 , Daniel Mbusa  3 , Thu Pham  3 , Carrie Cicirale  4 , Wenisa Tran  5 , Craig Beavers  6 , Saud Javed  3   5 , Joann Wagner  3 , Dawn Swain  7   8 , Sybil Crawford  9 , Chad Darling  3   5 , Mayuko ItoFuKunaga  3   5 , David McManus  3   5 , Kathleen Mazor  3 , Jerry Gurwitz  3
Affiliations

Multicomponent Pharmacist Intervention Did Not Reduce Clinically Important Medication Errors for Ambulatory Patients Initiating Direct Oral Anticoagulants

Alok Kapoor et al. J Gen Intern Med. 2023 Dec.

Abstract

Background: 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.

Objective: To evaluate the effectiveness of a multicomponent intervention for reducing CIMEs.

Design: Randomized controlled trial.

Participants: Ambulatory patients initiating a DOAC or resuming one after a complication.

Intervention: 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.

Control: Coupons and assistance to increase the affordability of DOACs.

Main measure: 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.

Analysis: Incidence and incidence rate ratio (IRR) of CIMEs (intervention vs. control) using multivariable Poisson regression modeling.

Key results: 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).

Conclusion: A multi-component intervention in which clinical pharmacists implemented an evidence-based DOAC Checklist did not reduce CIMEs.

Nih trial number: NCT04068727.

Keywords: adverse events; ambulatory care; epidemiology and detection; medication safety; pharmacists; transitions in care.

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Conflict of interest statement

Dr. Kapoor has received research grant support from Pfizer through its Independent Grants for Learning and Change funding mechanism and from Bristol Myers Squibb for independent medical education grants. Recently, he has received research grant support through a competitive process adjudicated and funded by the alliance, which is formed by both Pfizer and Bristol Myers Squibb. He has also been awarded a grant by Pfizer to examine conversations between patients and providers. Dr. McManus has received sponsored research support from Bristol Myers Squibb, Boehringer Ingelheim, Pfizer, Biotronik, and Philips Healthcare and has consulted for Bristol Myers Squibb, FlexCon, Samsung, Philips, and Pfizer. Dr. McManus has equity in Mobile Sense Technologies, LLC. Drs. Crawford, Mazor, and Gurwitz have also received research grant support from Bristol Meyers Squibb in the past 3 years (as coinvestigators on the grants secured by Dr. Kapoor). Dr. Gurwitz also serves as a consultant to United Healthcare.

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