The Mycophenolate Pregnancy Registry

This activity is part of a series


Steven Gabardi, PharmD, BCPS, FAST, FCCP
Abdominal Organ Transplant Clinical Specialist, Brigham and Women's Hospital
Assistant Professor of Medicine, Harvard Medical School, Boston, MA
Steven Gabardi, PharmD, BCPS, FAST, FCCP

Steven Gabardi, PharmD, BCPS, FAST, FCCP, is a clinical specialist in organ transplant with the Department of Transplant Surgery at Brigham and Women’s Hospital in Boston, MA. He is also an Assistant Professor of Medicine at Harvard Medical School, where he became the first PharmD to receive an academic appointment. Dr. Gabardi earned his PharmD at Butler University?s College of Pharmacy and Health Sciences in Indianapolis, IN in 1999 and subsequently completed his residency in pharmacy practice at Tufts Medical Center in Boston, MA in 2000. After completing his residency, he was hired as a co-funded faculty member at Northeastern University’s Bouvé College of Health Sciences. His clinical practice site was at the Brigham and Women’s Hospital Division of Renal Transplant working in both the inpatient and outpatient settings.

Board-certified as a Pharmacotherapy Specialist and a Fellow of both the American Society of Transplantation and American College of Clinical Pharmacy, Dr. Gabardi has published in a multitude of textbooks and peer-reviewed journals. He has been invited to speak at local, national, and international conferences on many different transplant-related topics. Dr. Gabardi became the first transplant pharmacist to be named an Associate Editor for both the American Journal of Transplantation and Transplantation. He is also an editorial board member for several other peer-reviewed journals.

Lisa A. Coscia, RN, BSN, CCTC, FAST
Senior Registry Research Coordinator, Transplant Pregnancy Registry International, Philadelphia, PA
Lisa A. Coscia, RN, BSN, CCTC, FAST

Lisa Coscia received a bachelor’s degree in nursing science from the University of Michigan and is a registered nurse in Pennsylvania, U.S. She received her Certified Clinical Transplant Coordinator certification in 1996, which remains current. Lisa has over 30 years of experience in the field of transplantation, including as a staff nurse and transplant coordinator, and has been with the Transplant Pregnancy Registry International (TPRI) for 25 years. Lisa is active within the transplant community, and she currently holds the position of Chair of the Women’s Heath Community of Practice at the American Society of Transplantation (AST). She was also a previous board member of the International Transplant Nurses Society (ITNS) from 2014-2016. Lisa has written and co-authored numerous articles about pregnancy and contraception after transplantation. Additionally, she has presented and been a co-author on abstracts which have been presented at national and international meetings on the topic of pregnancy after transplantation.

Statement of Need

Within the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) system, one of the key requirements is that health care providers (HCPs) monitor mycophenolate-treated patients of reproductive potential for pregnancy both prior to initiation of treatment as well as routinely throughout the treatment course. HCPs are also responsible for appropriately responding to any pregnancies that do occur in the setting of mycophenolate treatment. It is imperative that HCPs are thoroughly educated on providing appropriate counsel to these patients as well as the importance of reporting the pregnancy to the Mycophenolate Pregnancy Registry, which was established with the goal of analyzing mycophenolate-exposed pregnancies and their outcomes in an effort to advance understanding of mycophenolate exposure in utero.

In part three of this REMS CME Outfitters Snack series, Lisa Coscia, RN joins host/moderator Dr. Steven Gabardi to provide guidance on appropriate monitoring strategies for pregnancy as well as the importance of reporting any pregnancies that do occur to the Mycophenolate Pregnancy Registry.

Learning Objectives

At the end of this CME/CE activity, participants should be able to monitor patients of reproductive potential for pregnancy to report to 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

Primary care physicians, physician associates (PAs), nurse practitioners (NPs), nurses, pharmacists, and physicians specializing in transplant medicine, OB/GYN, surgery, rheumatology, immunology and cardiology

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) 0.5

This activity was planned by and for the healthcare team, and learners will receive 0.5 Interprofessional Continuing Education (IPCE) Credit for learning and change.

Physicians (ACCME) 0.5

CME Outfitters, LLC, designates this enduring activity for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurses (ANCC) 0.5

This activity is designated for 0.5 contact hours.

Note for California Nurses

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

Pharmacists (ACPE) 0.5

This application-based activity is approved for 0.5 contact hours (0.05 CEUs) of continuing pharmacy credit.
Activity UAN: JA0007185-0000-22-157-H01-P

PAs (AAPA) 0.5

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 0.5 AAPA Category 1 CME credits. Approval is valid until expiration date listed above. PAs should only claim credit commensurate with the extent of their participation.

Family Physicians (AAFP) 0.5

The AAFP has reviewed the activity and deemed it acceptable for up to 0.50 Enduring Materials, Self-Study AAFP Prescribed credits. Term of Approval expires with the expiration date of the credit availability. 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.


Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.5 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.

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 attempted to resolve 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. Gibardi reports no financial relationships to disclose.

Ms. Coscia reports the following financial relationships: Grants: Veloxis Pharmaceuticals, Inc. (Educational grant to her institution)

The following peer reviewer and CME Outfitters staff have no financial relationships:

  • Thomas Heinrich, MD (peer reviewer)
  • Morgan Stockberger, MD (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

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 (75% pass rate required). This website supports all browsers except Internet Explorer for Mac. For complete technical requirements and privacy policy, visit our Privacy & Confidentiality page.

Questions about this activity?

Call us at (877) CME-PROS or (877) 263-7767



The Mycophenolate Pregnancy Registry
Event Date: 10/21/2022