Stepping Up Counseling for Patients of Childbearing Potential Taking Mycophenolate

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

Statement of Need

The Mycophenolate Risk Evaluation and Mitigation Strategy (MREMS) was initiated in 2012, yet more than a decade later prenatal exposure to mycophenolate, an immunosuppressive agent with significant teratogenicity, continues to occur at unacceptably high rates. While the MREMS provides direction and resources to educate both health care providers and patients about the increased risks of first trimester pregnancy loss and congenital malformations, the clinical implementation of the program needs improvement.

In this first installment of a two-part interactive CMEO BriefCase demonstration, expert clinicians in transplantation, immunosuppression, and patient care react to video case vignettes that include counseling on contraception. The faculty provides perspectives on interactions done well and offers advice on how they can be improved to ensure successful pregnancy prevention during mycophenolate administration.

Learning Objectives

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

  • Implement the Mycophenolate REMS program in clinical practice
  • Counsel patients of reproductive potential on pregnancy prevention during mycophenolate treatment, including acceptable combinations of contraception

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) 0.5

CME Outfitters, LLC, designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Pharmacists (ACPE) 0.5

This application-based activity is approved for 0.50 contact hours (0.05 CEUs) of continuing pharmacy credit (JA0007185-0000-24-087-H01-P).

Nurses (ANCC) 0.5

This activity is designated for 0.50 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) 0.5

This activity was planned by and for the healthcare team, and learners will receive 0.50 Interprofessional Continuing Education Credit for learning and change.

Physician Assistants (AAPA): 0.5

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 0.50 AAPA Category 1 CME credits. Approval is valid until 10/09/2025. PAs should only claim credit commensurate with the extent of their participation.

ABIM MOC 0.5

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.50 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

It is the policy of CME Outfitters, LLC, to ensure independence, balance, objectivity, and scientific rigor and integrity in all of their CME/CE activities. Faculty must disclose to the participants any relationships with commercial companies whose products or devices may be mentioned in faculty presentations, or with the commercial supporter of this CME/CE activity. CME Outfitters, LLC, has evaluated, identified, and attempted to resolve any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. Relevant financial relationships exist between the following individuals and commercial interests:

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. provided an educational grant to and in support of the Transplant Pregnancy Registry International

 

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)

*All identified conflicts of interest have been mitigated.

Unlabeled Use Disclosure
Faculty of this CME/CE activity may include discussions of products or devices that are not currently labeled for use by the FDA. The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off-label or investigational uses (any uses not approved by the FDA) of products or devices. CME Outfitters, LLC, the faculty, planners, and reviewers do not endorse the use of any product outside of the FDA labeled indications. Medical professionals should not utilize the procedures, products, or diagnosis techniques discussed during this activity without evaluation of their patient for contraindications or dangers of use.

Questions about this activity?

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

BC-127-100924-62

Stepping Up Counseling for Patients of Childbearing Potential Taking Mycophenolate
Event Date: 10/09/2024