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

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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

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Funding

The Agency for Healthcare Research and Quality funded this study.

Author information

Authors and Affiliations

  1. UMass Chan Medical School, Worcester, MA, USA

    Alok Kapoor MD, MSc, Parth Patel BS, Daniel Mbusa BS, Thu Pham BS, Saud Javed MD, Joann Wagner MSW, Chad Darling MD, Mayuko ItoFuKunaga MD, David McManus MD, Kathleen Mazor EdD & Jerry Gurwitz MD

  2. UMass Memorial Medical Center, Worcester, MA, USA

    Alok Kapoor MD, MSc, Wenisa Tran PharmD, Saud Javed MD, Chad Darling MD, Mayuko ItoFuKunaga MD & David McManus MD

  3. Barnes-Jewish Hospital, One Barnes Jewish Hospital Plaza, St. Louis, MO, USA

    Carrie Cicirale PharmD

  4. University of Kentucky, Lexington, KY, USA

    Craig Beavers PharmD

  5. Bouve College of Health Sciences, Northeastern University , Boston, MA, USA

    Dawn Swain PharmD

  6. Beverly Hospital, Beverly, MA, USA

    Dawn Swain PharmD

  7. Tan Chingfen Graduate School of Nursing, UMass Chan Medical School, Worcester, MA, USA

    Sybil Crawford PhD

Authors
  1. Alok Kapoor MD, MSc
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  2. Parth Patel BS
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  16. Jerry Gurwitz MD
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Corresponding author

Correspondence to Alok Kapoor MD, MSc.

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Conflict of Interest

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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Kapoor, A., Patel, P., Mbusa, D. et al. Multicomponent Pharmacist Intervention Did Not Reduce Clinically Important Medication Errors for Ambulatory Patients Initiating Direct Oral Anticoagulants. J GEN INTERN MED 38, 3526–3534 (2023). https://doi.org/10.1007/s11606-023-08315-z

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