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Castelli et al
(ACTS), rivaroxaban has been associated with a lower medical burden, higher perceived benefits, and improved treatment
satisfaction by patients when compared with treatment involving a combination of low molecular weight heparin (LMWH)
and VKA.5-7
Although the short onset and offset of action is often considered one of the greatest benefits of rivaroxaban, it may
also pose a risk. Patients must remain adherent to the intended
dosing regimen to remain fully anticoagulated.4 With a halflife of 5 to 9 hours in healthy adults, one missed dose could
result in loss of anticoagulation and subsequently increase
the patient's risk for a thrombotic event.4 In addition, the
combination of a short half-life and the change of medication
dosage and frequency required on day 22 may increase the
likelihood for patient error, especially in patients with limited health literacy. An error made during this critical transition phase may increase the risk of patients to experience a
recurrent VTE or major bleed. Although the literature examining adherence to NOACs for treatment of VTE is lacking,
it is hypothesized that factors related to NOAC nonadherence include increased number and severity of comorbid
conditions, lack of access to resources, low degree of patient
education, and negative patient perceptions of drug therapy.8
One recent cohort study found that, when compared with
pooled data of patients prescribed dabigatran, rivaroxaban,
and apixaban, initiation of warfarin was associated with a
lower probability of adhering to anticoagulation in patients
with atrial fibrillation (P < .001).9 Consistent monitoring and
follow-up are vital to ensure continued compliance and beneficial clinical outcomes. With nearly 36% of adults in the
United States proposed to have limited health literacy,
improved patient education for this high-risk medication is
critical to allow ample opportunity for beneficial clinical
outcomes.10
Although not specific to rivaroxaban and not statistically
significant, a study by Shore and colleagues showed that pharmacist-led adverse event and adherence monitoring was associated with improved dabigatran adherence (RR, 1.25; 95%
confidence interval [CI], 1.11-1.41, p > 0.05).11 Collaboration
with physicians to tailor monitoring to manage nonadherent
patients was associated with higher adherence rates (RR 1.31;
95% CI, 1.16-1.47, p > 0.05). This finding suggests that multidisciplinary clinics with close monitoring and patient specific follow-up can improve medication adherence regardless
of patient factors that may be nonmodifiable.11
The Rivaroxaban Patient Assistance Kit (R-PAK) trial
was designed to measure the ability of a novel discharge
strategy to enhance the dose transition period and improve
medication adherence, patient safety and satisfaction.
Methods
not-for-profit, community-teaching hospital in patients with
confirmed symptomatic DVT and/or PE who were prescribed rivaroxaban. After obtaining informed consent,
patients who met inclusion/exclusion criteria were assigned
to either the standard rivaroxaban group with no discharge
kit or to the rivaroxaban discharge kit (R-PAK) group. On
the day of discharge, all patients received standardized verbal education by a pharmacist on rivaroxaban including
indication, dosing regimen, administration, common adverse
effects, and required monitoring. Patients were also given a
written educational handout titled "A Patient's Guide to
Rivaroxaban." Patients assigned to the R-PAK group were
additionally given a rivaroxaban discharge kit, which consisted of a pillbox to organize medication doses based on the
date of drug initiation and hospital discharge as well as a
dose transition card.
Assignments were randomly allocated in blocks of 10 and
investigators were blinded to the treatment group until the
patient was enrolled. The study was supported by an internal
institutional research fund. The investigators coordinated the
trial and performed all statistics independently from the
sponsors.
The investigators had final responsibility for the study
design, clinical protocol, study oversight, and data verification and analyses. The protocol was reviewed and approved
by all affiliated institutional review boards. Written informed
consent was obtained from all patients. The data were collected and securely maintained by the investigators. The
investigators wrote the manuscript and vouch for the accuracy and completeness of the reported data and analyses and
the fidelity of the study to the protocol.
Recruitment
Using the electronic medical record and reporting system, a
daily report was generated to identify patients diagnosed
with a current VTE and prescribed rivaroxaban twice daily.
An investigator confirmed all inclusion criteria were met and
screened for exclusion criteria.
Study Subjects
Patients 18 years of age at the time of diagnosis, with one or
more newly diagnosed acute VTE(s) treated with rivaroxaban were included in this study. Patients who met criteria and
consented to participation for study entry were screened for
health literacy using a single item-screening tool (Figure 1).
Patients were screened for drug interactions and needed to
consent to an outpatient follow-up phone call. Patients being
discharged to long-term care facilities or skilled nursing
facilities or on rivaroxaban prior to admission were excluded.
Study Design and Oversight
Intervention
This is a prospective, randomized, single-center, activetreatment trial conducted at an 859-bed, comprehensive,
Patients were randomized to receive verbal education by a
pharmacist plus the R-PAK or to a control group to receive
Table of Contents for the Digital Edition of Hospital Pharmacy - July/August 2017
The Evolution of Drug Information Centers and Specialists
Letter: Sodium Phosphates Injection—Osmolarity Labeling Correction
ISMP Adverse Drug Reactions
Drug Monographs: Avelumab and Ribociclib
Formulary Drug Review: Naldemedine
Chimeric Antigen Receptor T-Cell Therapy for Lymphomas: A Review of a Drug Class or Therapeutic Class in a Late Stage of Clinical Development
International Mentoring Programs: Leadership Opportunities to Enhance Worldwide Pharmacy Practice
Compounded Apixaban Suspensions for Enteral Feeding Tubes
Impact of Developing Adult Ketamine Order Panels for the Emergency Department
Critical Appraisal of Biomedical Literature With a Succinct Journal Club Template: The ROOTs Format
Effect of a Rivaroxaban Patient Assistance Kit (R-PAK) for Patients Discharged With Rivaroxaban: A Randomized Controlled Trial
Examining the Use of Sodium Nitroprusside in Coronary Artery Bypass Grafting: Is the Benefit Worth the Cost?
Successful Implementation of an Antimicrobial Stewardship Program at an Academic Medical Center
Hospital Pharmacy - July/August 2017 - 445
Hospital Pharmacy - July/August 2017 - 446
Hospital Pharmacy - July/August 2017 - 447
Hospital Pharmacy - July/August 2017 - 448
Hospital Pharmacy - July/August 2017 - 449
Hospital Pharmacy - July/August 2017 - 450
Hospital Pharmacy - July/August 2017 - 451
Hospital Pharmacy - July/August 2017 - The Evolution of Drug Information Centers and Specialists
Hospital Pharmacy - July/August 2017 - 453
Hospital Pharmacy - July/August 2017 - Letter: Sodium Phosphates Injection—Osmolarity Labeling Correction
Hospital Pharmacy - July/August 2017 - ISMP Adverse Drug Reactions
Hospital Pharmacy - July/August 2017 - 456
Hospital Pharmacy - July/August 2017 - 457
Hospital Pharmacy - July/August 2017 - 458
Hospital Pharmacy - July/August 2017 - Drug Monographs: Avelumab and Ribociclib
Hospital Pharmacy - July/August 2017 - 460
Hospital Pharmacy - July/August 2017 - 461
Hospital Pharmacy - July/August 2017 - 462
Hospital Pharmacy - July/August 2017 - 463
Hospital Pharmacy - July/August 2017 - Formulary Drug Review: Naldemedine
Hospital Pharmacy - July/August 2017 - 465
Hospital Pharmacy - July/August 2017 - 466
Hospital Pharmacy - July/August 2017 - 467
Hospital Pharmacy - July/August 2017 - 468
Hospital Pharmacy - July/August 2017 - Chimeric Antigen Receptor T-Cell Therapy for Lymphomas: A Review of a Drug Class or Therapeutic Class in a Late Stage of Clinical Development
Hospital Pharmacy - July/August 2017 - 470
Hospital Pharmacy - July/August 2017 - International Mentoring Programs: Leadership Opportunities to Enhance Worldwide Pharmacy Practice
Hospital Pharmacy - July/August 2017 - 472
Hospital Pharmacy - July/August 2017 - 473
Hospital Pharmacy - July/August 2017 - 474
Hospital Pharmacy - July/August 2017 - 475
Hospital Pharmacy - July/August 2017 - 476
Hospital Pharmacy - July/August 2017 - 477
Hospital Pharmacy - July/August 2017 - Compounded Apixaban Suspensions for Enteral Feeding Tubes
Hospital Pharmacy - July/August 2017 - 479
Hospital Pharmacy - July/August 2017 - 480
Hospital Pharmacy - July/August 2017 - 481
Hospital Pharmacy - July/August 2017 - 482
Hospital Pharmacy - July/August 2017 - Impact of Developing Adult Ketamine Order Panels for the Emergency Department
Hospital Pharmacy - July/August 2017 - 484
Hospital Pharmacy - July/August 2017 - 485
Hospital Pharmacy - July/August 2017 - 486
Hospital Pharmacy - July/August 2017 - 487
Hospital Pharmacy - July/August 2017 - Critical Appraisal of Biomedical Literature With a Succinct Journal Club Template: The ROOTs Format
Hospital Pharmacy - July/August 2017 - 489
Hospital Pharmacy - July/August 2017 - 490
Hospital Pharmacy - July/August 2017 - 491
Hospital Pharmacy - July/August 2017 - 492
Hospital Pharmacy - July/August 2017 - 493
Hospital Pharmacy - July/August 2017 - 494
Hospital Pharmacy - July/August 2017 - 495
Hospital Pharmacy - July/August 2017 - Effect of a Rivaroxaban Patient Assistance Kit (R-PAK) for Patients Discharged With Rivaroxaban: A Randomized Controlled Trial
Hospital Pharmacy - July/August 2017 - 497
Hospital Pharmacy - July/August 2017 - 498
Hospital Pharmacy - July/August 2017 - 499
Hospital Pharmacy - July/August 2017 - 500
Hospital Pharmacy - July/August 2017 - 501
Hospital Pharmacy - July/August 2017 - Examining the Use of Sodium Nitroprusside in Coronary Artery Bypass Grafting: Is the Benefit Worth the Cost?
Hospital Pharmacy - July/August 2017 - 503
Hospital Pharmacy - July/August 2017 - 504
Hospital Pharmacy - July/August 2017 - 505
Hospital Pharmacy - July/August 2017 - 506
Hospital Pharmacy - July/August 2017 - 507
Hospital Pharmacy - July/August 2017 - Successful Implementation of an Antimicrobial Stewardship Program at an Academic Medical Center
Hospital Pharmacy - July/August 2017 - 509
Hospital Pharmacy - July/August 2017 - 510
Hospital Pharmacy - July/August 2017 - 511
Hospital Pharmacy - July/August 2017 - 512
Hospital Pharmacy - July/August 2017 - 513
Hospital Pharmacy - July/August 2017 - 514
Hospital Pharmacy - July/August 2017 - 515
Hospital Pharmacy - July/August 2017 - 516
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