Preventing the Preventable: Improving Mycophenolate Practices in Patients of Childbearing Potential

Statement of Need

Mycophenolate-containing medications are potent immunosuppressants used to prevent organ transplant rejection and to treat (off label) some autoimmune disorders. Despite the well-documented fetal risks associated with mycophenolate, as outlined in the U.S. Food and Drug Administration’s (FDA’s) Mycophenolate Risk Evaluation and Mitigation Strategy (MREMS), there has not been a significant reduction in pregnancies among patients receiving ongoing treatment with mycophenolate. Continued education for clinicians is vital to reinforce effective techniques for patient counseling, pregnancy testing, and effective contraception that prevents pregnancy during mycophenolate exposure.

In this CME Outfitters BriefCase, expert faculty will utilize real-world case studies to explore gaps in clinician and patient adherence to the MREMS, including discussions and/or demonstrations of counseling, pregnancy testing, acceptable contraception methods, and monitoring of confirmed pregnancies via the Mycophenolate Pregnancy Registry to support ongoing pharmacovigilance.

Learning Objectives

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

Identify the teratogenic risks associated with mycophenolate use during pregnancy
Counsel patients of childbearing potential before and during mycophenolate administration on appropriate pregnancy testing and acceptable contraception methods
Monitor confirmed pregnancies for the Mycophenolate Pregnancy Registry to support ongoing pharmacovigilance

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 specialists, OB/GYNs, rheumatologists, immunologists, primary care providers (PCPs), physician associates (PAs), nurse practitioners (NPs), 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 enduring material 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 (JA0007185-0000-25-108-H01-P).

Nurses (ANCC) 1.0

This activity is designated for 1.00 contact hours.

California Residents: Provider approved by the California Board of Registered Nursing, Provider # CEP 15510, for 1.00 Contact Hours.

Note to Nurse Practitioners: The content of this CNE activity pertains to Pharmacology.

Physician Assistants (AAPA): 1.0

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 10/30/2026. 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 and patient safety MOC credit 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 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 CE activity. CME Outfitters, LLC, has evaluated, identified, and mitigated any potential conflicts of interest through a rigorous content validation procedure, use of evidence-based data/research, and a multidisciplinary peer review process. The following information is for participant information only. It is not assumed that these relationships will have a negative impact on the presentations.

Dr. Shah reports the following financial relationships:

Advisory Board: Outset Medical, Inc.

Consultant: Miller Medical Communications, LLC

Grants: National Institutes of Health (NIH)

Dr. Mylod reports the following financial relationships:

Advisory Board: Bristol Myers Squibb Company and Boehringer Ingelheim

Speakers Bureau: AbbVie Inc.; Aurinia Pharmaceuticals Inc.; Boehringer Ingelheim; and Janssen Pharmaceuticals, Inc.

The following individuals have no financial relationships to disclose:

Jeffrey Helfand, DO (Peer Reviewer)
Albert Eubanks, Jr., RN (Peer Reviewer)
Nichole Lainhart (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.

Obtaining Credit

Post-tests, credit request forms, and activity evaluations must be completed online (requires free account activation), and participants can print their certificate or statement of credit immediately (0% pass rate required). This website supports all browsers except Internet Explorer for Mac.

Questions about this activity?

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

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