In an effort to educate clinicians and patients on the potential side effects of using Mycophenolate’s during pregnancy, Rockpointe and their partner organizations Boston University School of Medicine and Potomac Center for Medical Education have developed a online booklet and patient handouts in multiple languages to meet the needs of an diverse patient population.
Used in formulations to prevent rejection of transplanted organs and in various autoimmune diseases, mycophenolic acid (MPA) has become a front-line anti-rejection and 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. Despite the FDA issuing a Mycophenolate Shared System Risk Evaluation and Mitigation Strategy (MREMS) in 2012, pregnancies still occur too frequently in patients being treated with MPA products, leading to preventable adverse pregnancy outcomes. To counter this trend and to help clinicians meet the goals of the MREMS, Rockpointe and joint providers the Boston University School of Medicine (BUSM) and the Potomac Center for Medical Education have developed a free CME/CNE/CPE activity booklet and patient handout that will be available until Dec. 27, 2022.
The FDA approved mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium in 1995 and 2004, respectively, as immunosuppressants used in anti-rejection therapies. Since it was issued in 2012, the MREMS has struggled to meet its goals of educating clinicians and patients on the pregnancy risks associated with the use of MPA. To that end, Integrating the FDA Mycophenolate Safety Standards to Prevent Adverse Pregnancy Outcomes will provide health care practitioners 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.
A downloadable patient handout will help physicians inform female patients of reproductive potential who are prescribed MPA about pregnancy risks and the importance of appropriate planning and birth control. In addition to English, the printable patient handout is available in Spanish, French, Chinese, and Vietnamese.
This activity is intended for U.S. clinicians who write prescriptions for mycophenolate products in the treatment of patients and pharmacists involved in the care of patients taking mycophenolate products. At its conclusion, 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.
This program is CME, CNE, and CPE certified and qualifies the participant for 1 hour of credit. To receive credit, participants must review all activity information, including the learning objectives, disclosure statements, and content, and complete the post-test (achieving a passing grade of 70%) and program evaluation. Certificates can be printed immediately. There is no fee for this activity, which is supported by an independent educational grant from the Mycophenolate REMS Group and is jointly provided by Boston University School of Medicine, PCME, and Rockpointe. Full accreditation information will be provided to participants prior to starting the course.
Through effective accredited continuing education, Rockpointe, a leader in educational programming with more than 26 years of experience, strives to improve and advance the quality of patient care. Its educational programs have been at the forefront of new issues in healthcare, including implementing MIPS, combatting the nation’s opioid and COVID-19 crises, recognizing issues with vaping, and utilizing technical advances in care. Sign up for Rockpointe’s CME course catalog and view a list of current educational opportunities, including on-demand webcourse offerings and live webinars, at www.rockpointe.com.
As part of its commitment to quality, Rockpointe works to inform the continuing-education community of significant quality-improvement issues through news and analysis on Policy & Medicine, which offers a daily look at legal, regulatory, and compliance issues affecting the pharmaceutical and device industry. Rockpointe also publishes Policy & Medicine Compliance Update, a monthly publication that provides a concise update on compliance issues facing the life science industry and goes in-depth into important cases, laws, and regulations in straightforward articles. At Rockpointe, education equals quality.
To register for Integrating the FDA Mycophenolate Safety Standards to Prevent Adverse Pregnancy Outcomes, click here.