Overview of Risk Evaluation and Mitigation Strategies (REMS) for Health Care Providers
June 10, 2022 - December 31, 2023
This webinar will provide an overview of REMS and discuss how the REMS safety requirements impact prescribers, dispensers and patients. Participants should gain an understanding of the REMS authorities, how REMS are implemented, and the entities that provide oversite and support. REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication. While all medications have labeling that informs health care stakeholders about medication risks, only a few medications require a REMS.
- Title 21-FOOD AND DRUGS 21 USC335-1 Risk evaluation and mitigation strategies. https://uscode.house.gov/view.xhtml?req=%28title:21%20section:355-1%20edition:prelim%29%20OR%20%28granuleid:USC-prelim-title21-section355-1%29&f=treesort&edition=prelim&num=0&jumpTo=true. Accessed April 25, 2021.
- FDA Website: Approved Risk Evaluation and Mitigation Strategies (REMS). https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm. Accessed April 25, 2021.
- FDA Website: REMS Resources. https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems. Accessed April 25, 2021.
- Describe when the FDA can require a REMS.
- List the different elements of Risk Evaluation Mitigation Strategies.
- Identify REMS resources available to healthcare professionals.
- Discuss the possible enforcement actions by the FDA.
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH), and physician assistants.
Physicians, physician assistants, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians, physician assistants, and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Faculty
- Kalra, Dipti, R. Ph, MS, Team Leader, FDA - nothing to disclose
- Lacivita, Cynthia, PharmD, Director, Division of Risk Management, FDA - nothing to disclose
Planning Committee
- Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
- Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
- De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
- Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
- Nguyen-Chu, Thanh, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
- Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
CE Consultation and Accreditation Team
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
All relevant financial relationships have been mitigated.
Registration is complimentary; therefore refunds are not applicable.
Must attend 100% of the activity.
Initial Release Date
October 4, 2021
Revised Date
June 10, 2022
Expiration Date
December 31, 2023