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

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.

Safety of Inpatient Dofetilide Initiation per Cardiology Services: A Retrospective Review.

INTRODUCTION: Dofetilide is an antiarrhythmic medication that has the potential to cause life threatening arrhythmias, such as Torsade de pointes. The 2014 ACC/AHA/HRS guidelines for the management of patients with atrial fibrillation state that patients need to meet certain criteria to be initiated on dofetilide. Patients who are not initiated on this therapy according to the guideline criteria are likely to be at higher risk of adverse reactions. METHODS: This is a single center, retrospective chart review of patients who were initiated on dofetilide from July 2016-December 2019. Patients included in the study were initiated on dofetilide as a new antiarrhythmic and monitored inpatient for 3 days. The primary outcome was a composite of incidence of cardiac arrhythmias, cardiac arrest, cardiac death, and cardiac related hospital readmission. RESULTS: There were 224 patients included in the analysis: 190 patients who were initiated on dofetilide inappropriately and 34 that were initiated appropriately. The primary outcome (composite of cardiac arrhythmia, cardiac arrest, cardiac death, and hospital readmission) was statistically significant with more patients experiencing an outcome in the group initiated inappropriately. CONCLUSIONS: Patients are placed at a higher risk of adverse reactions when this potentially dangerous antiarrhythmic medication is not used according to the protocol set forth by the guidelines. Practitioners should use caution when prescribing dofetilide. Other antiarrhythmic medications or non-pharmacologic options should be considered due to the incidence of these dangerous adverse reactions.