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research-article2013

AOPXXX10.1177/1060028013508643Tedders et alTedders et al

Research Report

Evaluation of Pharmacist-Managed Dabigatran in an Inpatient Setting

Annals of Pharmacotherapy 47(12) 1649­–1653 © The Author(s) 2013 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1060028013508643 aop.sagepub.com

Kristen M. Tedders, PharmD1, Michael F. Lucey, PharmD1, and Stephanie B. Edwin, PharmD, BCPS1

Abstract Background: Although therapeutic drug monitoring is not required for patients receiving dabigatran to determine therapeutic efficacy, there are a number of other factors to consider. Currently, there are no studies evaluating pharmacistled management of dabigatran. Objective: The role of inpatient pharmacists related to the management of dabigatran was evaluated. Methods: All adult patients who received at least 1 dose of dabigatran with a length of stay greater than 24 hours in a single-center, community hospital between May 2011 and August 2012 were retrospectively reviewed (n = 176). Results: Almost half of the patients (46%) required pharmacist intervention related to dabigatran management during hospital admission. Of patients receiving dabigatran prior to hospital admission, 18.4% were admitted on an inappropriate home dose. Transitioning between dabigatran and alternative anticoagulants accounted for the majority of pharmacist interventions (74.2%), with patients transitioning from unfractionated heparin to dabigatran occurring most frequently. Renal impairment requiring dose adjustment or drug discontinuation occurred in 6.3% of patients, whereas 6.8% of patients required pharmacist intervention for procedural anticoagulation. Inpatient therapy was determined to be relatively safe, with few patients (1.7%) requiring permanent discontinuation of dabigatran as a result of a bleeding complication. Conclusion: Pharmacists significantly contributed to the safe and appropriate use of dabigatran during hospitalization. Keywords anticoagulation, dabigatran, pharmacist, intervention

Background Long-term anticoagulation therapy has historically centered on warfarin, a complex drug known for its narrow therapeutic index, need for frequent monitoring, interpatient variability, and numerous food and drug interactions. Significant variation exists related to attainment of a therapeutic international normalized ratio (INR). Despite previous literature citing time within therapeutic range as high as 77%, one study evaluating patients admitted to the emergency department noted that only 28% of warfarin patients were within goal INR range.1,2 This degree of variation places patients at a higher risk of bleeding and thrombotic adverse events. Dabigatran etexilate (Pradaxa), a direct thrombin inhibitor, was approved by the Food and Drug Administration (FDA) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in October 2010.3,4 The most recent CHEST guidelines for the treatment of atrial fibrillation suggest the use of dabigatran 150 mg twice daily over dose-adjusted warfarin for many patient populations with a CHADS2 score ≥1 because of lower rates of stroke and systemic embolism with dabigatran

versus warfarin in the RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy) trial.5,6 Dabigatran offers other benefits compared with warfarin, including lack of therapeutic dose monitoring and fewer drug-drug interactions. The Joint Commission National Patient Safety Goal 03.05.01 was developed to reduce patient harm resulting from anticoagulation.7 Anticoagulants account for an increased frequency of emergency hospitalizations in older adults because of adverse effects.8 This National Patient Safety Goal encourages the use of approved protocols for the initiation and maintenance of anticoagulant therapy and for education to be provided to patients and their families. To improve patient safety and satisfy the Joint Commission requirement of protocolized management, many hospitals 1

St John Hospital and Medical Center, Detroit, MI, USA

Corresponding Author: Kristen M. Tedders, PharmD, St John Hospital and Medical Center, 22101 Moross Road, Detroit, MI 48236, USA. Email: [email protected]

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have engaged pharmacists in anticoagulation management programs. Previous literature pertaining to pharmacist warfarin management has documented improved attainment of therapeutic INR values within 5 days, fewer supratherapeutic levels during titration, reduced time to therapeutic INR, reduced length of stay after warfarin was started, and fewer outpatient dosage adjustments following discharge compared with usual physician management.9-11 Although therapeutic drug monitoring is not required for patients receiving dabigatran to determine therapeutic efficacy, there are a number of other factors to consider when maximizing the efficacy of anticoagulation while minimizing the risk of bleeding: renal function, invasive procedures, concomitant medications, and transitions between different anticoagulants. Because many of these factors can occur simultaneously during an inpatient hospital admission, it was hypothesized that monitoring of inpatients prescribed dabigatran by pharmacists would reduce the risk of patient harm. Currently, there are no studies evaluating pharmacistled inpatient management of dabigatran. At our institution, pharmacists manage inpatient anticoagulation therapy, including intravenous heparin, enoxaparin, warfarin, argatroban, and novel oral anticoagulants. At the time of P&T approval, a protocol was developed requiring pharmacist management of patients receiving dabigatran. All pharmacists within the department participate in the anticoagulation service, with 24/7 coverage being provided for patients at our institution. Training for dabigatran management was provided to pharmacists at the time of the protocol implementation, which included an in-service conducted by a pharmacy clinical specialist and competency assessment. Pharmacists are responsible for ensuring appropriateness of the indication, dosing, periprocedural anticoagulation, and transitioning between dabigatran and other anticoagulants. Furthermore, pharmacists are also responsible for monitoring signs or symptoms of bleeding and renal function throughout the course of therapy. Prior to hospital discharge, pharmacists provide patient education regarding dabigatran to patients and families. The purpose of this study was to evaluate the role of inpatient pharmacists in the management of dabigatran.

Methods Participants and Design This retrospective, observational study was performed at St John Hospital and Medical Center (SJHMC), a 772-bed hospital in Detroit, Michigan. Institutional review board approval was granted prior to the start of data collection. Adult patients who received at least 1 dose of dabigatran with a length of stay greater than 24 hours between May 2011 and August 2012 met inclusion criteria for this study.

Patients were excluded if they were pregnant at the time of admission.

Pharmacist-Managed Dabigatran Protocol All patients admitted to SJHMC have dabigatran managed by the pharmacy anticoagulation service. Prescribers are responsible for placing an initial order for “dabigatran dosing by pharmacy,” which delegates authority to the pharmacist for further management. The pharmacist has the responsibility to verify an appropriate indication for therapy, ensure lack of contraindications, order necessary baseline laboratory tests, order the appropriate dabigatran dose, and provide patient education and follow-up daily. Daily follow-up consists of the pharmacist monitoring renal function, signs or symptoms of bleeding, concomitant medications, and for scheduled procedures that may necessitate drug discontinuation. The pharmacist is responsible for changing the dabigatran dose with changes in renal function or drug interactions. The pharmacist also has the responsibility of contacting the prescriber if any contraindications are present to discuss alternative anticoagulation strategies. An initial progress note is written by the pharmacist and documented in the patient’s electronic medical record. Follow-up progress notes are written at minimum every 3 days or if any changes were made by the pharmacist.

Data Collection A list of eligible patients was generated from the hospital pharmacy information system (n = 176). Baseline demographic and laboratory data collected for each patient included age, gender, race, admission and discharge date, initial serum creatinine, initial creatinine clearance (CrCl), and CHADS2 score. Dabigatran indication, presence of valve disease, dose prior to admission, and discharge dose were collected to determine appropriateness of therapy. Data regarding contraindications to therapy, which included a CrCl

Evaluation of pharmacist-managed dabigatran in an inpatient setting.

Although therapeutic drug monitoring is not required for patients receiving dabigatran to determine therapeutic efficacy, there are a number of other ...
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