RELEASE DATE:
July 30, 2007

EXPIRATION DATE:
July 31, 2008

Effective and Safe Managment of Anemia Banner
ADDRESSING THE FDA BLACK BOX WARNINGS TO IMPROVE PATIENT OUTCOMES


Erythropoiesis-Stimulating Agents and Anemia Management: Safety Considerations

Addressing the FDA black box warnings to improve patient outcomes

Designated for 1.0 AMA PRA Category 1 CreditTM

This CME activity is a web-based audio slide set based on an April 20, 2007 Satellite Symposium to the 21st Annual Critical Care Medicine 2007 Comprehensive Update and Board Review Course in McLean, Virginia. An addendum to the live event is also included on issues raised at the 5/10/2007 ODAC meeting.

Presented by:
Jeffery Carson, MD
Chief, Division of General Internal Medicine
University of Medicine and Dentistry of New Jersey
Robert Wood Johnson Medical School
New Brunswick, New Jersey

Scientific Reviewers:
Henry Masur, MD*
Bethesda, Maryland

Joseph E. Parrillo, MD
Professor of Medicine
Robert Wood Johnson Medical School
University of Medicine and Dentistry of New Jersey

Chief, Department of Medicine
Edward D. Viner MD Chair, Department of Medicine
Director, Cooper Heart Institute
Cooper University Hospital
Camden, New Jersey

* The views expressed by the participants do not necessarily represent the opinions of the NIH, DHHS, or the federal government.

Needs Assessment


Anemia is a common condition that may increase the risk for a number of adverse events, including perioperative myocardial ischemia and cardiac morbidity. Anemia occurs secondary to various clinical conditions, including infections, chronic kidney disease/renal failure, and treatment with chemotherapy and certain drugs (eg, zidovudine-treated HIV patients). Anemia also occurs perioperatively and in the critical care setting. Erythropoietin (EPO) is an endogenous regulator of red blood cell production. EPO levels are normally regulated by tissue hypoxia, but EPO production is often compromised in patients with certain diseases or who have been treated with chemotherapy. Erythropoiesis-stimulating agents (ESAs) including darbepoetin alfa and epoetin alfa were developed with the goal of alleviating the need for red blood cell transfusions and associated complications.

ESAs have been demonstrated to stimulate red blood cell production and correct anemia in various clinical situations. Clinical trials have shown that, compared with untreated subjects, ESA-treated patients have increased serum EPO concentrations, increased reticulocyte counts, and increased hemoglobin and hematocrit values; and require fewer red blood cell transfusions than those who do not receive such treatment. However, in randomized prospective trials the use of ESAs in patients with target hemoglobin levels >12 g/dL is associated with increased risk for arterial and venous thromboembolic events, including myocardial infarction, stroke, congestive heart failure, and hemodialysis graft occlusion. These safety concerns prompted the FDA to require a black box warning on the prescribing information for ESAs.

Significant educational gaps have therefore arisen surrounding the management of anemia. This timely activity is designed to address optimal management of the anemic patient with ESAs. Topics for discussion include review of the clinical experience with ESAs, safe/effective management of anemia with ESAs in various clinical situations, and dose modifications to achieve target hemoglobin levels.

Learning Objectives


After taking part in this session, participants should be able to:

  • Define the mechanisms of anemia

  • Identify patients at risk for anemia

  • Provide details on the efficacy and safety of red blood cell transfusion and erythropoiesis-stimulating agents from randomized trials

  • List safe and effective strategies for maintaining adequate oxygen-carrying capacity with erythropoiesis-stimulating agents


Target Audience


This activity has been developed for hematologists, nephrologists, and oncologists.

Accreditation


The Center for Bio-Medical Communication, Inc. (CBC) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

This CME activity was planned and produced in accordance with the ACCME Essentials.

CME Credit


CBC designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit. Physicians should only claim credit commensurate with the extent of their participation in the activity.


Faculty Disclosure Information


Disclosure is requested when faculty members are confirmed. This educational activity may include discussion of an unlabeled use or an investigative use not yet approved for a commercial product. Therefore, it is incumbent on individuals participating in this activity to be aware of these factors in interpreting its contents and evaluating its recommendations. Every effort has been made to encourage faculty to disclose any commercial relationships or personal benefits that may be associated with their participation in this activity. The following indicates the faculty and the nature of their commercial relationships and off-label or investigative use discussion.

Dr. Carson has received grant research support from the National Institutes of Health and Ortho Biotech.

As part of CBC's mechanism for resolving potential conflicts of interest, the contents of this activity have undergone peer review by an independent CME reviewer.

Acknowledgement


The sponsor of this program gratefully acknowledges the unrestricted educational grant received from Ortho Biotech in support of this activity.


How To Obtain Credit


This CME activity is a web-based audio slide set of a recorded scientific presentation. Viewers are expected to view the entire presentation before attempting to take the test and completing the activity evaluation.

Please follow these steps to receive CME credit for viewing and listening to the audio slide set:

  • Review the complete audio slide set activity

  • Click on the link to the CME Posttest/Evaluation to download the DOC

  • Print the Posttest/Evaluation and Answer Sheet

  • Fill out all required personal information on the Posttest/Evaluation and Answer Sheet

  • Please write legibly as this information will be submitted to the ACCME

  • Answer the Posttest/Evaluation questions on the accompanying answer sheet

  • Mail or fax the answer sheet to CBC using the below information

  • Participants who achieve a score of 70% or better AND respond to the evaluation questions will receive a CME certificate with 6 weeks




For questions on the CME activity, please contact:

Donni Hawthorne
Program Coordinator
Center for Bio-Medical Communication, Inc.
433 Hackensack Ave, 9th Floor
Hackensack, NJ 07601
Phone:  201-342-5300
Fax: 201-978-2775
E-mail: dhawthorne@cbcbiomed.com

This activity is supported by an unrestricted educational grant from Ortho Biotech

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