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

Faculty

Almut G. Winterstein, RPh, PhD, FISPE
(Moderator)
Distinguished Professor, Department of Pharmaceutical Outcomes and Policy
Director, Center for Drug Evaluation and Safety
University of Florida, College of Pharmacy
Gainesville, FL
Almut G. Winterstein, RPh, PhD, FISPE
(Moderator)

Almut Winterstein, RPh, PhD, FISPE is a Distinguished Professor and the Dr. Robert and Barbara Crisafi Chair for Medication Safety in the Department of Pharmaceutical Outcomes and Policy, and the founding Director of the Center for Drug Evaluation and Safety (CoDES) at the University of Florida, College of Pharmacy in Gainesville, Florida. Dr. Winterstein is also an Affiliate Distinguished Professor in the Department of Epidemiology in the College of Public Health and Health Professions at the University of Florida in Gainesville, Florida. Since 2019, Dr. Winterstein has served as Director of the Consortium for Medical Marijuana Clinical Outcomes Research, a State of Florida-funded multi-university consortium . 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 an 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, Germany. 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.

Dahima Cintron, MD, MSc
Medicine-Pediatrics Fellow, Division of Rheumatology and Immunology
Duke University School of Medicine
Durham, NC
Dahima Cintron, MD, MSc

Dahima Cintron, MD, MS is a dual internist and pediatrician, who is currently pursuing combined adult and pediatric Rheumatology fellowship training in the Department of Medicine at Duke University School of Medicine in Durham, North Carolina. Originally from Puerto Rico, Dr. Cintron completed her undergraduate degree at Universidad de Puerto Rico, her medical degree at the University of Puerto Rico School of Medicine, and her residency training in the combined Internal Medicine-Pediatrics program at the University of Puerto Rico School of Medicine in San Juan, Puerto Rico. During this time, she also completed a Master’s Degree in Clinical and Translational Sciences from the Mayo Clinic in Rochester, Minnesota. Her medical career so far has included numerous academic presentations and peer-reviewed publications addressing women’s health, patient-important outcomes, and transition to adult care. Her academic training and research experience have provided her with an excellent background in clinical research, with focus on reproductive health, socioeconomic impacts of health, and patient-important outcomes. She is currently pursuing research on improving reproductive health conversations with women on mycophenolate, as well as developing her clinical interest in Hispanic health within rheumatology.

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 practioners (PCPs), nurse practitioners (NPs), physician associates (PAs), nurses, dentists, optometrists, psychologists, 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.

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.

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.

Nurses (ANCC) 1.0

This activity is designated for 1.00 contact hours.

Pharmacists (ACPE) 1.0

This application-based activity is approved for 1.00 contact hours ( 0.1 CEUs) of continuing pharmacy credit ( JA0007185-0000-23-103-H01-P ).

PAs (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 11/08/2024. 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 medical knowledge MOC points 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

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

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Family Physicians (AAFP) 1.0

The AAFP has reviewed this activity and deemed it acceptable for up to 1.00 Enduring Material AAFP Prescribed credits. Term of approval is from 11/08/2023 to 11/08/2024. Physicians should claim only the credit commensurate with the extent of their participation in the activity. AAFP Prescribed credit is accepted by the American Medical Association as equivalent to AMA PRA Category 1 Credit™ toward the AMA Physician’s Recognition Award. When applying for the AMA PRA, Prescribed credit earned must be reported as Prescribed, not as Category 1.

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. Cintron reports no financial relationships to disclose.

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:

  • Rebecca Vargas-Jackson, MD (peer reviewer)
  • Joshua Caballero, PharmD (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.

Obtaining Credit

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WCV-076-110823-62

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