Now More Than Ever: Implementing the Mycophenolate Risk Evaluation and Mitigation Strategy in Clinical Practice


Almut G. Winterstein, RPh, PhD
Distinguished Professor, Pharmaceutical Outcomes and Policy
Director, Center for Drug Evaluation and Safety
University of Florida
Gainesville, FL
Almut G. Winterstein, RPh, PhD

Almut Winterstein is Distinguished Professor and the Dr. Robert and Barbara Crisafi Chair for Medication Safety in the Department of Pharmaceutical Outcomes and Policy, Affiliate Distinguished Professor in Epidemiology, and the founding Director of the Center for Drug Evaluation and Safety at the University of Florida. Since 2019, she also serves as director of the Consortium for Medical Marijuana Clinical Outcomes Research, a state-funded consortium of 9 universities in Florida. Dr. Winterstein’s research interests center on the post-marketing evaluation of medications in pediatrics and pregnancy, infectious disease and psychiatry and the evaluation of policy surrounding medication use using real-world data. As expert in drug safety, she has chaired the Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee from 2012-2018. Recognizing her contributions in pharmacoepidemiology, Dr. Winterstein was inducted as a fellow of the International Society of Pharmacoepidemiology in 2013 and served as president of the society from 2019-2020. In 2022, she was inducted in the Academy of Science, Engineering and Medicine in Florida. She received her pharmacy degree from Friedrich Wilhelm University in Bonn, Germany, and her PhD in Pharmacoepidemiology from Humboldt University in Berlin. Pertinent to this program, Dr. Winterstein has evaluated the safety of mycophenolate on pregnancy loss and the effectiveness of the REMS program on prenatal exposure.

Miae Kim, PharmD, MS, BCPS
Clinical Pharmacy Specialist
Center for Advanced Heart Disease
Brigham and Women's Hospital
Boston, MA
Miae Kim, PharmD, MS, BCPS

Miae Kim, PharmD, MS, BCPS, received a master’s degree in Clinical Pharmacy from Seoul National University in South Korea, then moved to the U.S. where she graduated Summa Cum Laude with high distinction from the University of Minnesota with a PharmD. She completed her PGY-1 pharmacy practice training at Beth Israel Deaconess Medical Center, and did a PGY-2 training in solid organ transplant at Brigham and Women?s Hospital in Boston. Dr. Kim joined the Center for Advanced Heart Disease at Brigham and Women’s Hospital as a heart transplant/MCS pharmacy specialist in 2013, working in both the inpatient and outpatient settings. She attained board certification as a Pharmacotherapy Specialist in 2013. Dr. Kim’s current interests include cardiac transplant complications, antibody-mediated rejection, and cardiac allograft vasculopathy, and she has published in multiple peer-reviewed journals and textbooks and presented at local, national, and international transplant conferences.

Statement of Need

Mycophenolate is a commonly used immunosuppressant to prevent organ rejection in transplant recipients. It is also used as an immunosuppressant in other disciplines, such as rheumatology. While mycophenolate has been available for decades – it remains the focus of an ongoing FDA Risk Evaluation and Mitigation Strategy (REMS) program due to the high probability for fetal teratogenicity during pregnancy. Congenital malformations in children born to mothers taking mycophenolate have included hearing loss, cleft palate, heart defect, and various other malformations of the face, head, kidneys, limbs, and esophagus.

Currently, the importance of pregnancy planning and/or prevention is even more critical than in previous years. As of August 2023, twenty-two states ban abortion or restrict the procedure earlier in pregnancy than the standard set by Roe v. Wade for the past 50 years, which was overturned by the Supreme Court in 2022. Thus, as the title of this education initiative states — adherence to the mycophenolate REMS (MREMS) program is of paramount importance — now more than ever.

Please join an expert multidisciplinary faculty in a compelling live and on-demand webcast on how to effectively implement MREMS in clinical practice. As a bonus feature, you’ll also be able to participate in an engaging MREMS “Clinical Clues” Escape Room activity to further reinforce the importance of pregnancy planning and/or prevention when using mycophenolate in women of childbearing potential.

Learning Objectives

  • Identify the pregnancy and fetal risks related to mycophenolate use.
  • Counsel patients of reproductive potential on pregnancy prevention and/or planning during mycophenolate treatment.
  • Monitor and report relevant pregnancies 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 practitioners (PCPs), nurse practitioners (NPs), physician associates (PAs), nurses, and pharmacists

Credit Information

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Interprofessional (IPCE) 1.0

This activity was planned by and for the healthcare team, and learners will receive 1.0 Interprofessional Continuing Education (IPCE) Credit for learning and change.

Physicians (ACCME) 1.0

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Nurses (ANCC) 1.0

This activity is designated for 1.0 contact hour.

Note for California Nurses

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Pharmacists (ACPE) 1.0

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PAs (AAPA) 1.0

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Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1.0 medical knowledge MOC point in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. 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

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Royal College MOC

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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.

Dr. Winterstein reports the following financial relationships:

Consultant: Bayer; Genentech, Inc.; Ipsen Biopharmaceuticals, Inc.; and Merck & Co., Inc.

Dr. Kim reports no financial relationships to disclose.

Disclosures were obtained from the following peer reviewer and CME Outfitters, LLC, staff, with no disclosures to report:

  • Michael Franks, APRN, AGACNP-BC, FNP-BC (peer reviewer)
  • Thomas Heinrich, MD (planning committee)
  • Mary Gleason, PhD (planning committee)
  • Warren Beckman (planning committee)
  • Susan H. Yarbrough, CHCP (planning committee)
  • Sandra Caballero, PharmD (planning committee)
  • Sharon Tordoff (planning committee)

Faculty of this 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.

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Now More Than Ever: Implementing the Mycophenolate Risk Evaluation and Mitigation Strategy in Clinical Practice
Event Date: 11/08/2023 at 6:30 pm ET