Case 360⁰™: Clinical Challenges Associated with the Monitoring of Extended Half-Life (EHL) rFVIII Concentrates in People with Hemophilia A

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Release Date: April 5, 2019
Expiration Date: April 5, 2020
Estimated Time to Complete Activity:
1.0 hours
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Target Audience
This on-line CME activity is designed to meet the educational needs of HEM, HEM/ONC, Pediatric HEM/ONC and other physicians/PAs; nurse practitioners/APRNs, nurse coordinators, staff nurses; coagulation laboratory professionals, as well as other HCPs who treat hemophilia, or manage and counsel persons with hemophilia and their families/caregivers.

Statement of Need/Program Overview
Prophylactic and on-demand use of recombinant Factor VIII (rFVIII) has greatly improved management, outcomes and quality of life for people with hemophilia A. Diagnosis and severity classification are determined by standard laboratory FVIII activity assays. The same standard assays are widely used for establishing potency of rFVIII replacement products, clinical monitoring of rFVIII trough levels, and testing for FVIII inhibitors. However, it is now widely recognized that modifications of EHL rFVIII products can influence the accuracy of activity measurements using standard FVIII assays. With increasing adoption of EHL-FVIII products, challenges for post-infusion monitoring are increasingly encountered by both hemophilia treaters and coagulation laboratory specialists.

This educational activity will examine the multidisciplinary and complex challenge of EHL-rVIII monitoring and discuss strategies for improvement.
 

Educational Objectives
After participating in this activity, the participant should be better able to:

  • Review key clinical and coagulation laboratory issues and challenges associated with the post-infusion monitoring of extended half-life rFVIII concentrate therapy
  • Assess the strengths and weaknesses of both one-stage (OSA) and chromogenic (CSA) assays to determine assay choice and interpretation of results in a variety of clinical scenarios
  • Identify and implement effective communication strategies between the hemophilia treatment team and the coagulation laboratory about monitoring extended half-life rFVIII products to optimize care.

Faculty Chair
Robert Sidonio Jr, MD
Robert Sidonio Jr., MD
Associate Director of Hemostasis and Thrombosis
Comprehensive Bleeding Disorder Center
Emory University and Children’s Healthcare of Atlanta
Atlanta, GA

Faculty Presenters
Stefan Tiefenbacher, PhD
Stefan Tiefenbacher, PhD
Vice President, Laboratory Corporation of America® Holdings
Technical Director of Colorado Coagulation, A Labcorp Specialty Testing Group
Englewood, CO

Chris Guelcher, RN-BC, MS, PPCNP-BC
Chris Guelcher, RN-BC, MS, PPCNP-BC
Lead Advanced Practice Provider
Center for Cancer and Blood Disorders, Children’s National Health System
Washington, DC

Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and Educational Concepts in Medicine. Postgraduate Institute for Medicine 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.

Physician Continuing Medical Education
The Postgraduate Institute for Medicine designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education
The maximum number of hours awarded for this Continuing Nursing Education activity is 1.0 contact hours. Designated for 0.2 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.

ASCLS P.A.C.E.® Credits
Postgraduate Institute for Medicine is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. This program is approved for up to 1.0 ASCLS P.A.C.E.® contact hours.

Interprofessional Continuing Education
This activity was planned by and for the healthcare team, and learners will receive 0.5 Interprofessional Continuing Education (IPCE) credit for learning and change.


PA Continuing Education
PA's may claim a maximum of 1.0 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 Credit™ from organizations accredited by ACCME or a recognized state medical society

Nurse Practitioner Continuing Education
The American Academy of Nurse Practitioners Certification Program (AANPCP) accepts certificates of participation for educational activities certified for AMA PRA Category 1 Credit™ from organizations accredited by ACCME. Individuals are responsible for checking with the AANPCP for further guidelines.

Method of Participation
During the period of April 5, 2019, through April 5, 2020, participants must:

  • Read the learning objectives and faculty disclosures
  • Study the educational activity
  • Complete the posttest by recording the best answer to each question
  • Complete the evaluation form

A statement of credit will be issued automatically upon successful completion of the post-activity survey with a score of 75% or better and submitting the activity evaluation.

Fee Information
There is no fee for this educational activity.

Disclosure of Conflicts of Interest
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 CME activity:

Name of Faculty or Presenter Reported Financial Relationship
Robert Sidonio Jr, MD Consulting Fees: Biomarin; Bioverativ; Genentech; Gifols; Kedrion; Novo Nordisk, Inc.; Pfizer Inc.; Roche; Shire; Spark and Uniqure

Contracted Research: Bioverativ; Genentech; Grifols; Kedrion and Octapharma
Stefan Tiefenbacher, PhD Consulting Fees: Siemens Healthcare; Shire; Novo Nordisk

Stockholder and officer of Laboratory Corporation of America® Holdings
Christine Guelcher, RN-BC, MS, PPCNP-BC/ HEM/ONC Consulting Fees: Genentech, Inc.; Novo Nordisk, Inc.; Octapharma

The planners and managers 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 CME activity:

Name of Planner or Manager Reported Financial Relationship
Postgraduate Institute for Medicine Clinical Reviewers Have no real or apparent conflicts of interest to report.
Educational Concepts in Medicine Reviewers Have no real or apparent conflicts of interest to report.

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. The planners of this activity do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer
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 patients’ conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Media
Internet

Commercial Support
This activity is supported by an independent educational grant from Bayer Healthcare Pharmaceuticals, Inc.

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