Severe and life-threatening hemorrhage in patients receiving anti-FXa DOACs is unusual; especially for the most-feared bleeding complication, ICH, events are significantly less common than for patients on vitamin K antagonists (VKA). Still, these events occur, and there is a need for specific, timely, evidence-guided, and multimodal management of DOAC-treated patients with hemorrhage to avoid worsening morbidity, excessive cost and length of stay, and mortality. Hospital pharmacists play a key role in the management of these emergency cases, often serving as the most knowledgeable resource on hand for the use of reversal and repletion agents. Hospital pharmacists also often develop, oversee, and monitor institutional protocols for the management of DOAC-associated hemorrhage. Finally, hospital pharmacists are often responsible for educating front-line physicians on best practice in managing these challenging patients within the capabilities and confines of the individual facility.
Our expert faculty will review the latest data, specialty society guidelines recommendations, and ongoing trials in this challenging therapeutic area. They will also address best processes for developing an institutional protocol for the streamlines and consistent management of anti-FXa-DOAC-associated hemorrhage.
Hospital pharmacists (with special focus on clinical pharmacists in the ED or ICU) who are involved in the management of patients with acute hemorrhage associated with anti-FXa-DOAC anticoagulation, including evaluation the risks and benefits of reversal/repletion therapy
I. Introduction and Welcome, Review Objectives
II. What Is the Difference Between “Reversal” and “Repletion”?
III. Summary of Current Society Guidelines Recommendations for Management of Anti-FXa-DOAC-Associated Hemorrhage
IV. Case Vignettes Demonstrating the Pharmacist’s Optimal Multi-Modal Management of Hemorrhage in Anti-FXa-DOAC-Treated Patients:
a. Acute ICH
b. Acute Severe GI Bleed with Unstable Vital Signs
c. Multisystem Trauma with Unstable Vital Signs
V. Developing Institutional Pathways for Managing Anti-FXa-DOAC-Associated Hemorrhage
VI. Faculty Panel Discussion
- Review the pharmacology and mechanisms of action of andexanet alfa and 4-factor PCC in the management of anti-FXa-DOAC-associated hemorrhage
- Review the latest clinical trial data on reversal/repletion as part of multi-modal management of both ICH and non-ICH events in patients taking anti-FXa DOACs.
- Review the most current society guidelines addressing management of anti-FXa-DOAC-associated hemorrhage.
- Improve competence and confidence in the hospital and ED/ICU pharmacist’s role in address and/or lead development of an institutional multi-specialty protocol for the optimal, streamlined management of anti-FXa-DOAC-associated hemorrhage
John Fanikos, RPh, MBA (Course Chair)
Assistant Professor of Clinical Pharmacy Practice
Massachusetts College of Pharmacy
Director of Pharmacy Business and Financial Services
Brigham and Women’s Hospital
Robert DiDomenico, PharmD, BCPS-AQ Cardiology, FCCP, HFSA, FACC
Associate Professor, Department of Pharmacy Practice
Cardiovascular Clinical Pharmacist
University of Illinois Hospital & Health Sciences System
Disclosures of Relevant Financial Relationships
It is the policy of AcademicCME that all faculty, instructors, and planners disclose relevant financial relationships relating to the topics of this educational activity. Any relevant financial relationships are mitigated via a content review by planning committee members and faculty with no relevant financial relationships.
The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CE activity:
|Faculty||Relationship Identified With:|
|John Fanikos, RPh, MBA||Consultant/Advisor: AstraZeneca; Boehringer Ingelheim International GmbH; Heron Therapeutics, Inc.; Mallinckrodt Pharmaceuticals; Pfizer Inc.; PhaseBio Pharmaceuticals, Inc. Vifor Pharma|
|Robert DiDomenico, PharmD
|Consultant/Advisor: Abiomed; PhaseBio Pharmaceuticals, Inc.
Research/Grant Support: CSL Limited
|Paul P. Dobesh, PharmD
|Consultant/Advisor: AstraZeneca; Bristol-Myers Squibb Company; Janssen Pharmaceuticals; Pfizer Inc.|
Planners and Peer Reviewers
Timothy Hayes, MD, PhD; Kim Cheramie, MSN, RN-BC, Nicole McMenamin and Chelsey Benedek hereby state that they or their spouse/life partner do not have any relevant financial relationships to products or devices with any commercial interests related to the content of this activity of any amount during the past 12 months.
In support of improving patient care, AcademicCME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Credit Designation Statements
AcademicCME designates this continuing education activity for 1.25 CPE Contact Hours (0.125 CEUs) of continuing pharmacy education credit (UAN# JA4008190-0000-22-024-H01-P).
Clinicians should claim only the credit commensurate with the extent of their participation in the activity.
This activity has been supported by an independent educational grant from AstraZeneca.
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. AcademicCME and AstraZeneca do not recommend the use of any agent outside of the labeled indications.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
Method of Participation
In order to claim credit, participants must complete the following:
- Read the learning objectives, accreditation information and faculty disclosures at the beginning of this activity.
- Complete the Pre-Activity Questions
- Read or Review the activity content.
- Complete the Post-Activity Test Questions and Evaluation.
- Learners who receive a grade of 66% or better on the Post-Activity Test Questions and complete the Evaluation will receive appropriate credit as indicated (CME, CNE, and/or CPE credit).
- CME and CNE credit will be issued appropriate certificate of completion.
- Others may request a “certificate of completion”.
- Learners should claim only the credit commensurate with the extent of their participation in the activity.
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