Now More Than Ever: A Mycophenolate REMS Escape Room Challenge


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

Statement of Need

Mycophenolate is the most common immunosuppressant used for preventing organ rejection in transplant recipients and is frequently employed in other disciplines, such as rheumatology. In response to the discovery of fetal teratogenicity associated with mycophenolate use during pregnancy, the FDA introduced a Risk Evaluation and Mitigation Strategy (REMS) program in 2012. Yet, more than a decade later, an alarmingly high number of pregnancies still occur while on mycophenolate, leading to devastating congenital malformations or first trimester pregnancy losses.

To help bridge this significant practice gap, educational interventions for both clinicians and patients are being offered nationwide, including this unique CME activity for health care providers titled, Now More Than Ever: A Mycophenolate REMS Escape Room Challenge. This interactive, escape room format provides engaging reminders to counsel and follow up with all persons of childbearing potential about the contraindication of mycophenolate in pregnancy. While these challenges are intended to be a fun way to learn and retain information, the subject matter underscores a serious health imperative.

Learning Objectives

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

  • 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

Supported by

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 (PCPs), 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.

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.

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

Pharmacists (ACPE) 1.0

This application-based activity is approved for 1.00 contact hours ( 0.1 CEUs) of continuing pharmacy credit ( JA0007185-0000-23-101-H01-P ).

PAs (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 02/27/25. PAs should only claim credit commensurate with the extent of their participation.

Optometry (COPE) 1.0

This course is COPE approved for 1.00 hours of CE credit. Course #: 90372-PH Activity #: 127974

Psychologists (APA) 1.0

Continuing Education (CE) credits for psychologists are provided through the co-sponsorship of the American Psychological Association (APA) Office of Continuing Education in Psychology (CEP). The APA CEP Office maintains responsibly for the content of the programs.

Dentists (ADA CERP) 1.0

CME Outfitters, LLC is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to the Commission for Continuing Education Provider Recognition at CME Outfitters, LLC designates this activity for 1.00 continuing education credits. Concerns or complaints about a CE provider may be directed to the provider, or to the Commission for Continuing Education Provider Recognition at


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

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.

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 03/01/2024 to 03/01/2025.  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

Dr. Winterstein reports the following financial relationships:

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

The following individuals have no financial relationships to disclose: 

Jeffrey Helfand, DO (Peer Reviewer)
Shirley Michelle Franks, MSN, APRN, FNP-BC (Peer Reviewer)
Thomas W. Heinrich, MD (AAFP Content Reviewer)
Mary Gleason, PhD (Planning Committee)
Warren Beckman (Planning Committee)
Susan H. Yarbrough, CHCP (Planning Committee)
Sandra Caballero, PharmD (Planning Committee)
Sharon Tordoff (Planning Committee)

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 (70% 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).


Now More Than Ever: A Mycophenolate REMS Escape Room Challenge
Event Date: 02/27/2024