Integrating the FDA Mycophenolate Safety Standards to Prevent Adverse Pregnancy Outcomes
Tracking # 20-895296
What you'll learn
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
Course 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 FDA Mycophenolate Safety Standards 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.
Subject areas
This course counts toward the state boards and subject areas below.
Bahamas Medical Council
Medical Practitioner
Specialty Medical Practitioner
Louisiana State Board of Medical Examiners - Physicians & Surgeons
Physician & Surgeon
Physician and Surgeon Compact License
Mississippi State Board of Medical Licensure
Medical Doctor
New Mexico Medical Board
Medical Doctor
South Carolina Board of Medical Examiners
Medical Doctor
State Medical Board of Ohio
Doctor of Medicine
Disclosure statements
EDUCATIONAL OBJECTIVES
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
STEERING COMMITTEE
Monica Crespo-Bosque, MD - CME Course Director; Assistant Professor of Medicine, Boston University School of Medicine, Boston, MA
Nancy Figueiredo, RN - NCPD Course Advisor; Rheumatology Nurse,
Boston Medical Center Rheumatology Clinic, Boston, MA
Amanuel Kehasse, PharmD, PhD - Clinical Pharmacy Specialist -Rheumatology & ILD, Boston Medical Center Health System, Boston, MA
Michael Wu, MD, RhMSUS - Assistant Professor, Baylor College of Medicine, Houston, TX
Boston University School of Medicine (BUSM) and Potomac Center for Medical Education (PCME) adheres to the policies and guidelines, including the Standards for Integrity and Independence in Accredited CE, set forth to providers by the Accreditation Council for Continuing Medical Education (ACCME) and all other relevant professional organizations, stating those activities where continuing education credits are awarded must be balanced, independent, objective, and scientifically rigorous.
All persons in a position to control the content of an accredited continuing education program provided by Boston University School of Medicine and the Potomac Center for Medical Education are required to disclose to BUSM and PCME all financial relationships with any ineligible company within the past 24 months. All financial relationships reported are identified as relevant and mitigated by BUSM and PCME in accordance with the Standards for Integrity and Independence in Accredited CE in advance of delivery of the activity to learners. The content of this activity was vetted by BUSM and PCME to assure objectivity and that the activity is free of commercial bias. All relevant financial relationships have been mitigated by BUSM and PCME.
Disclosures will be made known to the participants prior to the start of the activity.
FDA DISCLOSURE
The contents of some CME/CE activities may contain discussions of non-approved or off-label uses of some agents mentioned. Please consult the prescribing information for full disclosure of approved uses.
If you are not a physician or would like to share this activity with others please visit www.rockpointe.com/mycorems
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