Return to CME/CE Activities

Comparative Effectiveness of In-Hospital Off-Label Use of Recombinant Factor VIIa vs. Usual Care

• CME Information
• Faculty Biographies & Disclosures
• References
• Course Presentations
• CME Posttest

CME Information

Course Overview Educational Objectives Target Audience Method of Participation

Accreditation Statement Term of Approval Peer Review Program Director

Disclaimer Disclosure Acknowledgement of Support

Course Overview

Recombinant activated coagulation factor VII (rFVIIa) is a form of human factor VII produced by recombinant technology that was initially intended for use in hemophilia patients who developed antibody inhibitors that compromised the use of standard factor replacement.¹ FDA-approved indications for rFVIIa in hemophilia A and B and related disorders made up only 10% of all reported rFVIIa use from 2000–2008 in the Premiere Database.²

Off-label use of rFVIIa originates in the capacity of rFVIIa to “bypass” multiple defects in the coagulation pathway. The first non-hemophilia-related use of rFVIIa was for thrombocytopenia in 1996.³ Since that time, off-label use of rFVIIa has expanded rapidly in clinical situations where there is need to control bleeding. In 2008, an estimated 97% of in-hospital dosing was for off-label indications. Although there has been widespread use of this expensive medication, there is limited comparative information on the benefits or risks associated with its off-label use.²

This CME activity covers the data from the systematic review and meta-analysis of existing research that was conducted by the Stanford–UCSF Evidence-based Practice Center to evaluate the level of evidence currently available to support the effectiveness and safety of using recombinant activated coagulation factor VII (rFVIIa) for clinical indications beyond those approved by the Food and Drug Administration (FDA).² The study involves three components: analyses of a) the research available on the spectrum of rFVIIa off-label use, b) the effectiveness of rFVIIa for five selected indications, and c) the potential harms for the five indications.

References

1. Macik BG, Hohneker J, Roberts HR, Griffin AM. Use of recombinant activated factor VII for treatment of a retropharyngeal hemorrhage in a hemophilic patient with a high titer inhibitor. Am J Hematol 1989;32:232-234.
2. Yank V, Tuohy CV, Logan AC, et al. Comparative Effectiveness of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care, Comparative Effectiveness Review No. 21 (Prepared by Stanford-UCSF Evidence-based Practice Center under Contract No. 290-02-0017). Rockville, MD: Agency for Healthcare Research and Quality; May 2010. AHRQ Pub. No. 10-EHC030-EF.
3. Kristensen J, Killander A, Hippe E, et al. Clinical experience with recombinant factor VIIa in patients with thrombocytopenia. Haemostasis. 1996;26(Suppl 1):159-164.

Educational Objectives

At the conclusion of this activity, the participant should be able to:

• Characterize the trends and patterns of rFVIIa use for in-hospital off-label indications.
• Determine if the benefits outweigh the harms for the use of rFVIIa vs. usual care for intracranial hemorrhage, trauma, liver transplantation, cardiac surgery, or prostatectomy.
• Identify the immediate research needs for studies of in-hospital, off-label uses of rFVIIa including intracranial hemorrhage, trauma, liver transplantation, cardiac surgery, or prostatectomy based on real-world patterns of use and analysis of benefits and harms.

Target Audience

This CME activity is designed to meet the educational needs of physicians of varying specialties who treat patients with intracranial hemorrhage or trauma or whose patients have undergone, liver transplantation, cardiac surgery, or prostatectomy.

Method of Participation

This activity is in PowerPoint file format and is accompanied by talking points and references linked to PubMed abstracts.

To receive a maximum of 1.0 AMA PRA Category 1 Credit(s)™ you should:

• View the presentations in this enduring material.
• Complete the posttest (you must answer 8 out of 10 questions correctly).
• Complete and submit the CME registration and evaluation forms.

The estimated time to complete this activity, including review of the materials, is 1.0 hour(s).

Hardware/software requirements: Activities should be run with recent versions of common browsers, including Internet Explorer, Firefox, and Google Chrome.

If you have questions about the participation process, please e-mail the Office of Continuing Medical Education, cme@bcm.edu or phone 713.798.8237.

Accreditation/Credit Designation

Baylor College of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Baylor College of Medicine designates this enduring material activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.    

Term of Approval

October 2010 through October 2013. Original release date: October 2010

Peer Review

In August 2010, this continuing medical education activity was reviewed by Mark M. Udden, M.D., a professor of medicine in the Section of Hematology–Oncology in the Department of Medicine at Baylor College of Medicine in Houston, Texas.

Disclosures: Nothing to disclose.

Program Director

Martha P. Mims, M.D., Ph.D. 
Associate Professor of Medicine 
Section of Hematology–Oncology
Department of Medicine
Baylor College of Medicine
Houston, Texas

Disclosures: Nothing to disclose.

Disclaimer

This CME activity is designed for use by healthcare professionals for educational purposes only. Information and opinion offered by the contributors represent their viewpoints. Conclusions drawn by the participant should be derived from careful consideration of all available scientific information. Prescription information and use of medical devices should be undertaken only after confirmation of information by consulting the FDA-approved uses and information.

Baylor College of Medicine makes every effort to have accurate information presented, no warranty, expressed or implied, is offered. The participant should use his/her clinical judgment, knowledge, experience, and diagnostic decision-making before applying any information, whether provided here or by others, for any professional use.

Links are provided to other Internet sites solely for the convenience of users. Once you link to another site, you are subject to the site's terms and conditions of use including copyright and licensing restrictions.

Disclosure

The Office of Continuing Medical Education (OCME) makes every effort to develop CME activities that are scientifically based, accurate, current, and objectively presented. In accordance with the Accreditation Council for Continuing Medical Education Standards for Commercial Support ^SM, Baylor College of Medicine (BCM) has implemented a mechanism requiring everyone in a position to control the content of an educational activity (e.g., directors, planning committee members, contributors, peer reviewers) to disclose any relevant financial relationships with commercial interests (drug/device companies) and manage/resolve any conflicts of interest prior to the activity. Individuals must disclose to participants the existence or non-existence of financial relationships: l) at the time of the activity or within 12 months prior; and 2) of their spouses/partners.

Baylor College of Medicine does not view the existence of interests or relationships with commercial entities as implying bias or decreasing the value of a presentation. It is up to the participants to determine whether the interests or relationships influence the presenter with regard to exposition or conclusions.

If at any time during this activity you feel that there has been commercial or promotional bias, please inform us by using the commercial bias comments box in the evaluation form. Please answer the questions about balance in the CME activity evaluation candidly.

The following individual(s) has/have reported no financial or other relationships with commercial entities whose products/services may relate to the educational content of this activity:

Margaret P. Mims, M.D., Ph.D., Activity Director: nothing to disclose.
Veronica A. Yank, M.D., Contributor: nothing to disclose.
Mark M. Udden, M.D., Peer Reviewer: nothing to disclose.

Some drugs/devices identified during this activity may have United States Food and Drug Administration (FDA) clearance for specific purposes only or for use in restricted research settings. The FDA has stated that it is the responsibility of the individual physician to determine the FDA status of each drug or device that he/she wishes to use in clinical practice and to use the products in compliance with the applicable law.

Baylor College of Medicine requires that all contributors disclose an unlabeled use or investigational use (not yet approved for any purpose) of pharmaceutical and medical device products, and provide adequate scientific and clinical justification for such use. Physicians are urged to fully review all the available data on products or procedures before using them to treat patients.

Acknowledgement of Support

This activity is supported by a contract, HHSA290200810015C, from the Agency for Healthcare Research and Quality.

Return to Top of Page