Mycophenolate Therapy and Associated Fetal Risk: Improving Healthcare Providers’ Competence in Pregnancy Planning and Contraception Counseling

Jointly provided by Postgraduate Healthcare Education, LLC (PHE) and Postgraduate Institute for Medicine (PIM).

This activity is supported by an independent educational grant from Belcher Pharmaceuticals, LLC/BPI Labs , LLC (A wholly owned subsidiary of Belcher Pharmaceuticals, LLC).

Update as of February 2024

There are now 2 systems for healthcare professionals and patients to access educational resources about mycophenolate and report a pregnancy, including the Mycophenolate Shared System REMS and the Parallel System (PS) Mycophenolate SS REMS.


Steven Gabardi, PharmD, BCPS, FAST, FCCP
Abdominal Organ Transplantation Clinical Specialist
Division of Transplant Surgery
Brigham & Women’s Hospital
Boston, MA

Assistant Professor of Medicine
Department of Medicine
Harvard Medical School
Boston, MA

Monica P. Crespo-Bosque, MD
Assistant Professor of Medicine, Rheumatology
Boston University Chobanian & Avedisian School of Medicine
Boston, MA


Dr. Gabardi has disclosed that he has received grant/research support from Shionogi Pharmaceuticals; and consultant/advisory board fees from Merck and Takeda in the past 24 months.

Dr. Crespo-Bosque has disclosed that she has served as a clinical trial principal investigator for Biogen.

The clinical reviewer, Lisa Holle, PharmD, BCOP, FHOPA, has disclosed that she has no relevant affiliations or financial relationships with a commercial interest to disclose.

Susanne E. Batesko,  MSHF, BSN, RN,  Robin Soboti, RPh, and Susan R. Grady, MSN, RN as well as the planners, managers, and other individuals, not previously disclosed, who are in a position to control the content of Postgraduate Healthcare Education (PHE) continuing education (CE) activities hereby state that they have no relevant conflicts of interest and no financial relationships or relationships to products or devices during the past 12 months to disclose in relation to this activity. PHE is committed to providing participants with a quality learning experience and to improve clinical outcomes without promoting the financial interests of a proprietary business.

The PIM planners and others have nothing to disclose.

Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy.  PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.

All relevant financial relationships have been mitigated.


acpePostgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
UAN: 0430-9999-23-096-H01-P
Credits: 1.0 hour (0.1 ceu)

Type of Activity: Application
Media: Internet

Fee Information: There is no fee. This is a free continuing education activity.
Estimated time to complete activity: 60-minutes

Joint Accreditation Statement

Joint AccreditationIn support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and Postgraduate Healthcare Education.  Postgraduate Institute for Medicine 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.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 1.0 contact hours. Designated for 0.75 contact hours of pharmacotherapy credit for Advanced Practice Registered Nurses.

Physician Continuing Medical Education

The Postgraduate Institute for Medicine designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.


October 31, 2023


October 31, 2025


This activity is intended for all physicians who prescribe mycophenolic acid products and all nurses and pharmacists who do or may encounter patients being prescribed or on a mycophenolic acid product. (Mycophenolate REMS Program)


Participants must 1) read the learning objectives and faculty disclosures; 2) view the educational activity; and 3) complete the posttest and evaluation form directly after the activity within a maximum of 60 days of participating in the activity. To answer the questions, click on your selected choice for each answer then proceed to the next question. Once completed, click on the Grade Exam button at the bottom of the page. Your posttest will automatically be graded. If you successfully complete the posttest (score of 70% or higher), your statement of participation will be made available immediately. Click on the View Statement of Participation link and print the statement for your records. If you receive a score lower than 70%, you will receive a message notifying you that you did not pass the posttest. You will have 2 opportunities to pass the posttest. To receive Credit, you must provide your date of birth and NABP number. All Credit information will be uploaded into CPE monitor within 30 days.


The goal of this educational activity is to provide physicians, nurses, and pharmacists with education covering the Mycophenolate REMS program requirements, including increased risks of miscarriage and birth defects associated with MPA use during pregnancy, the need to counsel women of reproductive potential on the importance of pregnancy prevention and planning when taking MPA, and the need to report pregnancies to the Mycophenolate Pregnancy Registry.


Upon completion of this program, participants should be better able to:

  • Describe the types of congenital malformations associated with the use of mycophenolic acid (MPA) during pregnancy.
  • Summarize the relationship between MPA use and risk of miscarriage in 1st and 2nd trimesters of pregnancy.
  • Develop effective patient counselling strategies in accordance with the Mycophenolate REMS program
  • Summarize the fetal risks associated with mycophenolic acid (MPA) use during pregnancy
  • Counsel patients effectively in accordance with the Mycophenolate REMS program
  • Utilize innovative methods to improve and validate consistent patient understanding of MPA fetal risk and pregnancy prevention and planning


Please ensure the computer system you plan to use meets the following minimum requirements:

  • Operating System: Windows 98 or higher & Macintosh 2.2 or higher
  • Internet Browser (Mac & Windows): Internet Explorer 6.0 or higher, Google Chrome, Safari 5.0.6 or higher, Firefox 3.0.3 or higher, & Opera 5 or higher
  • Broadband Internet connection: Cable, High-speed DSL & any other medium that is internet accessible
  • Peripherals: Computer speakers or headphones
  • Monitor Screen Resolution: 320 x 480 or higher
  • Media Viewing Requirements: Adobe Reader, Microsoft PowerPoint, Flash Player & HTML5

Disclosure of Unlabeled Use and Disclaimer

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of Postgraduate Healthcare Education, LLC, Postgraduate Institute for Medicine (PIM), or Belcher Pharmaceuticals, LLC/BPI Labs , LLC (A wholly owned subsidiary of Belcher Pharmaceuticals, LLC). Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients' conditions, and possible contraindications on dangers in use, (review of any applicable manufacturer's product information) and comparison with recommendations of other authorities.

The author, sponsor, and publisher of this continuing education activity have made all reasonable efforts to ensure that all information contained herein is accurate in accordance with the latest available scientific knowledge at the time of acceptance for publication. However, because information regarding drugs (their administration, dosages, contraindications, adverse reactions, interactions, special warnings, precautions, etc.) is subject to constant change, the reader is advised to check the manufacturer's package insert for information concerning recommended dosages and potential problems and cautions prior to dispensing or administering the drug. Special precautions should be taken when a drug is new, or highly toxic, or is unfamiliar to the dispenser or administrant. This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the U.S. Food and Drug Administration (FDA). Neither the publisher nor sponsor promotes the use of any agent outside of approved labeling. Statements made in this activity have not been evaluated by the FDA.