INFORM: Information Needed for Optimal Regulation of Mycophenolate- A REMS Activity
May 10, 2023
May 10, 2024
This activity is jointly provided by American College of Osteopathic Obstetricians and Gynecologists (ACOOG) and The France Foundation.
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).
The Mycophenolate REMS Group includes the following companies: Accord Healthcare Inc., Akorn Inc., Alkem Laboratories, Ltd., Amneal Pharmaceuticals LLC, AMTA, Apotex Corp, Avet Pharmaceuticals Inc., Biocon Pharma Limited, Concord Biotech Limited, Genentech, Inc., Hikma Pharmaceuticals USA Inc., Hisun Pharmaceuticals USA, Inc., Jubilant Cadista Pharmaceuticals Inc., Lannett Company, Inc., Meitheal Pharmaceuticals, Inc., Mylan Pharmaceuticals Inc., Novartis Pharmaceuticals Corporation, Par Pharmaceuticals, Inc., RK Pharma Inc., Sandoz Inc., Strides Pharma Science Limited, Teva Pharmaceuticals USA, Inc., TWi Pharma USA, VistaPharm, Inc., Wuxi Fortune Pharmaceutical Co., Ltd., and Zydus Pharmaceuticals (USA) Inc.
- 2 Category 1B AOA Credits
- 2 AMA PRA Category Credits™
All other healthcare professionals completing this course will be issued a statement of participation.
The target audience for this initiative includes obstetricians, gynecologists, primary care physicians, physician assistants, nurse practitioners, pharmacists, and care team members involved in the treatment of women across their reproductive lifespan who may have been prescribed mycophenolate products.
Clinicians who work with women of childbearing age who are, or will be, taking mycophenolate must ensure that their patients receive appropriate counseling about the teratogenic effects of mycophenolate and the need for use of contraceptives during the time they are taking the drug. This interactive course is based on the FDA’s Mycophenolate REMS Education Blueprint.
Upon completion of this activity, participants should be better able to:
- The increased risks of first trimester pregnancy loss and congenital malformations associated with mycophenolate
- Importance of educating women of reproductive potential about the increased risk of first trimester pregnancy loss and congenital malformations associated with exposure to mycophenolate during pregnancy
- Importance of prescribers providing or facilitating patient education about pregnancy prevention and planning, including acceptable methods of contraception during mycophenolate treatment
- When treating a pregnant patient or a patient who is considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity
- Importance of reporting to the Mycophenolate Pregnancy Registry any pregnancies that occur during mycophenolate treatment or within 6 weeks following discontinuation of treatment
- Importance of encouraging pregnant patients to participate in the Mycophenolate Pregnancy Registry
Emmie Strassberg, DO
A Maternal-Fetal Medicine physician practicing in Virginia and West Virginia.
Barrett Crowther, PharmD
Team Lead for Ambulatory Care Solid Organ Transplant and Hepatology Pharmacy Services and PGY2 Solid Organ Transplantation Pharmacy Residency Program Director at University of Colorado Health.
Vivek Gupta, MD
A Maternal-Fetal Medicine physician practicing in Virginia and West Virginia.
Physician Accreditation Statement
The American College of Osteopathic Obstetricians and Gynecologists is accredited by the American Osteopathic Association to provide osteopathic continuing medical education for physicians.
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the American College of Osteopathic Obstetricians and Gynecologists and The France Foundation. The American College of Osteopathic Obstetricians and Gynecologists is accredited by the ACCME to provide continuing medical education for physicians.
Physician Credit Designation
The American College of Osteopathic Obstetricians and Gynecologists designates this program for a maximum of 2 AOA Category 1-B credits and will report CME and specialty credits commensurate with the extent of the physician’s participation in this activity.
The American College of Osteopathic Obstetricians and Gynecologists designates this enduring activity for a maximum of 2 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
ACOG Cognate Credit(s)
The American College of Osteopathic Obstetricians and Gynecologists designates this activity for Category 1 College Cognate Credits. Maximum Cognates are equal to the number of maximum AMA PRA Category 1 Credits™. A reciprocity agreement with the AMA exists that allows AMA PRA Category 1 Credits™ to be equivalent to ACOG Cognate Credits.
NPs, PAs & CNMs
The American Academy of Nurse Practitioners Certification Board (AANPCB) recognizes activities approved for Category 1-A credit through the American Osteopathic Association and Category 1 AMA PRA Category 1 Credits™ as providing advanced practice CE content hours for applicants seeking renewal through continuing education credit.
The National Commission on Certification of Physician Assistants (NCCPA) recognizes activities approved for Category 1-A credit through the American Osteopathic Association and AMA PRA Category 1 Credits™ as Regular Category 1 CME for national certification maintenance.
The Certificate Maintenance Program of the American Midwifery Certification Board accepts AMA PRA Category 1 Credits™ to satisfy its contact hours requirement.
All NPs, PAs, CNMs and other health professionals participating in this activity will receive a certificate of completion commensurate with the extent of their participation in the activity. ACOOG strongly recommends all non-physician health professionals check with their certification/licensing organizations to confirm credit reciprocity.
Disclosures of Conflicts of Interest
ACOOG requires each planner and presenter to identify all conflicts of interest, and mitigates risk of bias using a series of strategies for relevant conflicts. Unless otherwise noted below, the ACOOG, ACOOG staff and planners for this activity have no relevant financial relationships to disclose.
- Emmie Strassberg, DO
- Dr. Strassberg has no relationships with an ineligble company to disclose.
- Barrett Crowther, PharmD
- Dr. Crowther disclosed that in the past 24 months he was an advisory board participant for Veloxis Pharmaceuticals. This relationship ended in 2021. This relationship has been mitigated.
- Vivek Gupta, MD
- Dr. Gupta has no relationships with an ineligble company to disclose.
Instructions for Participation and Credit
There are no fees for participating and receiving CME credit for this enduring activity. To receive CME credit participants must:
- Read the CME/CE information and faculty disclosures.
- Participate in the online activity.
- Submit the evaluation form.
Certificates will be emailed to the participant.
Course Viewing Requirements
Internet Explorer 8.0+ for Windows 2003, Vista, XP, Windows 7, Windows 8.1 and above
Google Chrome 28.0+ for Windows, Mac OS, or Linux
Mozilla Firefox 23.0+ for Windows, Mac OS, or Linux
Safari 6.0+ for Mac OSX 10.7 and above
Supported Phones & Tablets:
Android 4.0.3 and above
iPhone/iPad with iOS 6.1 or above
Disclosure of Unlabeled Use
ACOOG requires that faculty participating in any CME activity disclose to the audience when discussing any unlabeled or investigational use of any commercial product or device not yet approved for use in the United States.
This activity is designed for educational purposes. Participants have a responsibility to utilize this information to enhance their professional development to improve patient outcomes. Conclusions drawn by the participants should be derived from careful consideration of all available scientific information. The participant should use his/her clinical judgment, knowledge, experience, and diagnostic decision-making before applying any information, whether provided here or by others, for any professional use.
Any registrant finding evidence that the continuing medical education program presented is inappropriate with regard to facilities, materials, content, or observes any unacceptable promotion by a commercial interest in the same room as the educational activity, whether by company representative or presenter, may submit a grievance in writing to ACOOG, PO Box 17598, Fort Worth, TX 76102. Unresolved issues regarding this activity will require a formal written complaint to the AOA Division of CME, 142 East Ontario Street, Chicago, IL 60611.
This activity complies with ACOOG’s privacy policies.
Data collected as part of this activity may be analyzed as part of educational research to study the effectiveness of educational interventions on health care, population health, health care providers and others, or to identify additional needs and gaps for future interventions.
For CME questions please contact: [email protected].