Webcast

Why Are We Still Talking About the Mycophenolate REMS in 2024

Launch Date
10/09/2024 at 06:30 pm EST
Credit Amount
1
Credit Expires
10/09/2024

Faculty

Michelle A. Josephson, MD
Moderator
Professor of Medicine and Surgery 
Director of Education, Transplant Institute 
University of Chicago 
Chicago, IL 
Michael J. Moritz, MD
Principal Investigator Transplant Pregnancy Registry International
Gift of Life Institute
Philadelphia, PA
Lisa A. Coscia, RN, BSN, CCTC, FAST
Senior Nurse Research Coordinator
Transplant Pregnancy Registry International
Gift of Life Institute
Philadelphia, PA
Lisa A. Coscia, RN, BSN, CCTC, FAST

Lisa Coscia received a bachelor’s degree in nursing science from the University of Michigan and is a registered nurse in Pennsylvania, U.S. She received her Certified Clinical Transplant Coordinator certification in 1996, which remains current. Lisa has over 30 years of experience in the field of transplantation, including as a staff nurse and transplant coordinator, and has been with the Transplant Pregnancy Registry International (TPRI) for 25 years. Lisa is active within the transplant community, and she currently holds the position of Chair of the Women’s Heath Community of Practice at the American Society of Transplantation (AST). She was also a previous board member of the International Transplant Nurses Society (ITNS) from 2014-2016. Lisa has written and co-authored numerous articles about pregnancy and contraception after transplantation. Additionally, she has presented and been a co-author on abstracts which have been presented at national and international meetings on the topic of pregnancy after transplantation.

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Statement of Need Learning Objectives Financial Support Target Audience Credit Information Disclosure Declaration

Statement of Need

Despite the associated high probability of fetal risks in pregnant patients, mycophenolate remains one of the most commonly used immunosuppressants for patients receiving a solid organ transplant (SOT). To help combat the risks associated with mycophenolate treatment, the ongoing FDA mycophenolate Risk Evaluation and Mitigation Strategy (MREMS) program was introduced in 2012 with a focus on very specific safe-use behaviors to ensure prevention of prenatal exposures to mycophenolate. Although MREMS was introduced over a decade ago, evidence shows that clinician adoption in practice is suboptimal. Engaging and sustained educational efforts are needed in 2024 to not only raise awareness of the mycophenolate REMS, but also to drive improved implementation of the program in practice.

Please join a panel of expert multidisciplinary faculty in a compelling live and on-demand webcast on how to better evaluate toxicity and pregnancy risks in patients taking mycophenolate, counsel patients of reproductive potential, monitor relevant pregnancies and patient reporting to the Mycophenolate Pregnancy Registry, and implement MREMS in clinical practice.

Learning Objectives

At the conclusion of this activity, learners will be able to better:

  • Evaluate embryofetal toxicity and pregnancy risks associated with the use of mycophenolate
  • Counsel patients of reproductive potential on pregnancy prevention and/or planning during mycophenolate treatment
  • Monitor relevant pregnancies to encourage patient reporting to the Mycophenolate Pregnancy Registry

Financial Support

This activity is supported by an independent educational grant from the Mycophenolate REMS Group. This activity is intended to be fully compliant with the Mycophenolate REMS education requirements issued by the U.S. Food and Drug Administration (FDA).

Target Audience

Transplant medicine specialists, OB/GYNs, surgeons, rheumatologists, dermatologists, immunologists, cardiologists, primary care physicians, nurse practitioners (NPs), physician associates (PAs), nurses, and pharmacists 

Credit Information

Jointly Accredited Provider

In support of improving patient care, CME Outfitters, LLC, 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.

Physicians (ACCME) 1.0

CME Outfitters, LLC, designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Pharmacists (ACPE) 1.0

This application-based activity is approved for 1.00 contact hours (0.1 CEUs) of continuing pharmacy credit (JA0007185-0000-24-085-L01-P).

Nurses (ANCC) 1.0

This activity is designated for 1.00 contact hours.

California Residents: This continuing nursing education activity was approved by the California Board of Registered Nursing. CME Outfitters, LLC’s provider number is CEP15510.

Interprofessional (IPCE) 1.0

This activity was planned by and for the healthcare team, and learners will receive 1.00 Interprofessional Continuing Education Credit for learning and change.

Physician Assistants (AAPA): 1.00

CME Outfitters, LLC, has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1.00 AAPA Category 1 CME credits. Approval is valid until 12/09/2024. PAs should only claim credit commensurate with the extent of their participation.

ABIM MOC 1.0

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1.00 MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

MIPS Improvement Activity

Completion of this accredited CME activity meets the expectations of an Accredited Safety or Quality Improvement Program (IA_PSPA_28) for the Merit-based Incentive Payment Program (MIPS). Clinicians should submit their improvement activities by attestation via the CMS Quality Payment Program website.

Royal College MOC

Through an agreement between the Accreditation Council for Continuing Medical Education and the Royal College of Physicians and Surgeons of Canada, medical practitioners participating in the Royal College MOC Program may record completion of accredited activities registered under the ACCME’s “CME in Support of MOC” program in Section 3 of the Royal College’s MOC Program.

Disclosure Declaration

Dr. Josephson reports the following financial relationships:

Consultant: Alexion Pharmaceuticals, Inc. and Vera Therapeutics

Grants: Apollo Therapeutics

Research Support: Part of BESTOW trial with Eledon Pharmaceuticals, Inc.

Stock Shareholder (directly purchased): Seagen Inc. (formerly Seattle Genetics, Inc.)

Other financial or material support: Served as moderator for an educational webinar last year that was a part of an educational series put together by Fresenius

Dr. Moritz reports the following financial relationships:

Financial Support: Veloxis Pharmaceuticals, Inc. has provided an educational grant to and in support of the Transplant Pregnancy Registry International

Ms. Coscia reports the following financial relationships:

Grants: Educational grant from Veloxis Pharmaceuticals, Inc.

Research Support: Astellas Pharma Inc.

The following individuals have no financial relationships to disclose: 

Rebecca Vargas-Jackson, MD  (Peer Reviewer)
Michael Franks, APRN, AGACNP-BC, FNP-BC (Peer Reviewer)
Evan Luberger (Planning Committee)
Warren Beckman (Planning Committee)
Scott J. Hershman, MD, FACEHP, CHCP (Planning Committee)
Sandra Caballero, PharmD (Planning Committee)
Sharon Tordoff (Planning Committee)

Questions about this activity?

Call us at 877.CME.PROS (877.263.7767).

WC-088-100924-62

Why Are We Still Talking About the Mycophenolate REMS in 2024
Event Date: 10/09/2024 at 06:30 pm EST
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