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The Critical Role of Pharmacists in Mycophenolate Pharmacovigilance: Addressing the Associated REMS Program
Understanding and Mitigating the Risk of Mycophenolic Acid in Pregnancy: What Pharmacists Need to Know (Part 1)
An Interactive Monograph
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).
Steven Gabardi, PharmD, BCPS, FAST, FCCP
Clinical Specialist in Abdominal Organ Transplantation
Department of Transplant Surgery
Brigham and Women’s Hospital
Assistant Professor of Medicine
Department of Medicine
Harvard Medical School
Cher Enderby, PharmD, BCPS, BCNSP
Coordinator, Education and Staff Development
Mayo Clinic, Department of Pharmacy
Assistant Professor of Pharmacy/PGY1 Residency Program Director
Mayo Clinic College of Medicine
Dr. Gabardi has disclosed that he has received consulting fees from Merck & Co., and research support from Amgen.
Dr. Enderby has no relevant affiliations or financial relationships with a commercial interest to disclose.
The clinical reviewer, Lisa Holle, PharmD, BCOP has disclosed that she has received research support from the International Society of Oncology Pharmacy Practitioners (ISOPP); and, honorarium for CE programs from AXIS Medical Education, Hematology/Oncology Pharmacy Association, HMP CME, Pharmacy Times Continuing Education, and Postgraduate Healthcare Education, Inc., Academy of Managed Care Pharmacists; and, The Rx Consultant.
The medical writer, Thomas Cook, RPh, PhD has no relevant affiliations or financial relationships with a commercial interest to disclose.
Susanne Batesko, RN, BSN, Robin Soboti, RPh, and Susan R. Grady, MSN, RN, as well as the planners, managers, and other individuals, not previously disclosed, who are in a position to control the content of Postgraduate Healthcare Education (PHE) continuing education (CE) activities hereby state that they have no relevant conflicts of interest and no financial relationships or relationships to products or devices during the past 12 months to disclose in relation to this activity. PHE is committed to providing participants with a quality learning experience and to improve clinical outcomes without promoting the financial interests of a proprietary business.
Postgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Credits: 2.0 hour (0.2 ceu)
Type of Activity: Application
Fee Information: There is no fee for this educational activity
Estimated time to complete activity: 120 minutes
December 10, 2021
December 10, 2022
This accredited activity has been designed for pharmacist.
HOW TO OBTAIN CREDIT
During the period December 10, 2021 to December 10, 2022, participants must 1) read the learning objectives and faculty disclosures; 2) view the educational activity; and 3) complete the posttest and evaluation form directly after the activity within a maximum of 60 days of participating in the activity. To answer the questions, click on your selected choice for each answer then proceed to the next question. Once completed, click on the Grade Exam button at the bottom of the page. Your posttest will automatically be graded. If you successfully complete the posttest (score of 70% or higher), your statement of participation will be made available immediately. Click on the View Statement of Participation link and print the statement for your records. If you receive a score lower than 70%, you will receive a message notifying you that you did not pass the posttest. You will have 2 opportunities to pass the posttest. To receive Credit, you must provide your date of birth and NABP number. All Credit information will be uploaded into CPE monitor within 30 days.
The goal of this 2-part educational series is to provide pharmacists with education covering the Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) program requirements, including increased risks of miscarriage and birth defects associated with mycophenolic acid (MPA) use during pregnancy, the need to counsel women of reproductive potential on the importance of pregnancy prevention and planning when taking MPA, and the need to report pregnancies to the Mycophenolate Pregnancy Registry.
Upon completion of this program, participants should be better able to:
- Describe the increased risks of miscarriage and birth defects associated with mycophenolic acid (MPA) use during pregnancy
- Identify alternative immunosuppressive agents for patients who are seeking to become or are pregnant
- Explain the process for reporting pregnancies to the Mycophenolate Pregnancy Registry
- Discuss the MPA REMS as it relates to patient education and elements to ensure safe use
REQUIRED COMPUTER HARDWARE/SOFTWARE
Please ensure the computer system you plan to use meets the following minimum requirements:
- Operating System: Windows 98 or higher & Macintosh 2.2 or higher
- Internet Browser (Mac & Windows): Internet Explorer 6.0 or higher, Google Chrome, Safari 5.0.6 or higher, Firefox 3.0.3 or higher, & Opera 5 or higher
- Broadband Internet connection: Cable, High-speed DSL & any other medium that is internet accessible
- Peripherals: Computer speakers or headphones
- Monitor Screen Resolution: 320 x 480 or higher
- Media Viewing Requirements: Adobe Reader, Microsoft PowerPoint, Flash Player & HTML5
Disclosure of Unlabeled Use and Disclaimer
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of Postgraduate Healthcare Education, LLC or the Mycophenolate REMS Group/U.S. Food and Drug Administration (FDA). Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients' conditions, and possible contraindications on dangers in use, (review of any applicable manufacturer's product information) and comparison with recommendations of other authorities.
The author, sponsor, and publisher of this continuing education activity have made all reasonable efforts to ensure that all information contained herein is accurate in accordance with the latest available scientific knowledge at the time of acceptance for publication. However, because information regarding drugs (their administration, dosages, contraindications, adverse reactions, interactions, special warnings, precautions, etc.) is subject to constant change, the reader is advised to check the manufacturer's package insert for information concerning recommended dosages and potential problems and cautions prior to dispensing or administering the drug. Special precautions should be taken when a drug is new, or highly toxic, or is unfamiliar to the dispenser or administrant. This educational activity may contain discussion of published and/or investigational uses of agents that are not approved by the U.S. Food and Drug Administration (FDA). Neither the publisher nor sponsor promotes the use of any agent outside of approved labeling. Statements made in this activity have not been evaluated by the FDA.