Integrating the FDA Mycophenolate Safety Standards to Prevent Adverse Pregnancy Outcomes

Target Audience
This activity is intended for clinicians within the United States who write prescriptions for mycophenolate products in the treatment of patients and pharmacists involved in the care of patients taking mycophenolate products.

Program Overview
Mycophenolic acid (MPA) products, including mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium, were approved by the FDA in 1995 and 2004, respectively, as immunosuppressants used in preventing rejection of transplanted organs. MPA has become a front-line anti-rejection therapy in combination with calcineurin-inhibitors and corticosteroids. However, use of MPA during pregnancy is associated with increased risk of pregnancy loss, congenital malformations, and low birth weight. The FDA approved the Mycophenolate Shared System Risk Evaluation and Mitigation Strategy (MREMS) in 2012, but despite the information provided to clinicians and patients on the pregnancy risks associated with the use of MPA, pregnancies are still occurring too frequently in patients being treated with MPAs leading to preventable adverse pregnancy outcomes.

Integrating the Mycophenolate Risk Evaluation and Mitigation Strategy (MREMS) into Practice to Prevent Adverse Pregnancy Outcomes will provide HCPs who prescribe MPAs with information on MPA-associated pregnancy risks, the need for counseling female patients of reproductive potential on birth control and planning, and the need for reporting pregnancies to the Mycophenolate Pregnancy Registry. It will also provide information to female patients of reproductive potential who are prescribed MPA about the pregnancy risks and the importance of appropriate planning and birth control.

Learning Objectives
The proposed initative is designed to address the Accreditation Council for Graduate Medical Education, the Interprofessional Collaborative Practice, and the National Academy of Medicine competencies, including delivering patient-centered, team-based care and practicing evidence-based medicine as well as competencies for pharmacists including foundational knowledge and essentials for practice and care, developed by the American Association Colleges of Pharmacy's Centers for the Advance of Pharmacy Education (CAPE) Educational Outcomes.

At the conclusion of this education, participants should be able to:

Recognize the pregnancy and fetal risks associated with mycophenolate use in female patients of reproductive potential
Provide or facilitate counseling and education to female patients of reproductive potential on the need for pregnancy prevention and planning during mycophenolate treatment
Report pregnancies that occur during mycophenolate treatment to the Mycophenolate Pregnancy Registry