Series Description

FDA's Division of Drug Information in the Center for Drug Evaluation and Research (CDER) sponsors a series of educational webinars targeting the needs of health care professionals and students. The webinars cover a broad range of FDA drug regulation and medication safety topics. These focused webinars support FDA's mission of promoting and protecting public health through interaction and education to strengthen current and future partnerships and relationships with clinicians and researchers.

Lecture Description
This webinar will describe the Risk Evaluation and Mitigation Strategy (REMS) Integration Project, REMS structured product labeling (SPL), and the REMS Public Dashboard. The REMS integration project entails development of an open source, innovative, stakeholder-driven approach to use contemporary data standards and technologies for integration of REMS. The REMS SPL can be used to capture and present REMS information in a format that is easily shared with stakeholders and readily incorporated into health information technology. The REMS Public Dashboard, launched in December 2021, was developed to improve access and transparency of REMS information. The FDA REMS Public Dashboard can be accessed through the REMS@FDA website. These innovative tools and initiatives are intended to support target users such as healthcare providers, patients, researchers, pharmaceutical companies, or regulators.

References

• HL7 CodeX FHIR Accelerator. REMS Integration Use Case. Available at: https://confluence.hl7.org/display/COD/Risk+Evaluation+and+Mitigation+Strategies+%28REMS%29+Integration.
• George A. Neyarapally, Ed Millikan, Claudia Manzo. Implementation and Integration of Risk Evaluation and Mitigation Strategies into the Health Care System. Appl Clin Inform 2023;14:354–355.
• U.S. Food and Drug Administration. (2023). REMS Document Technical Conformance Guide (Version 1.0). Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/rems-document-technical-conformance-guide.
• U.S. Food and Drug Administration. Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/risk-evaluation-and-mitigation-strategy-rems-public-dashboard.
• U.S. Food and Drug Administration. REMS@FDA. https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm.
• Toyserkani, G.A., Lee, J.H. & Zhou, E.H. The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities. Pharm Med 37, 349–353 (2023). https://doi.org/10.1007/s40290-023-00489-5.

Series Objectives

• Explain how to utilize FDA's Drug Information, medication safety resources, and regulatory guidances to improve delivery of patient care and optimize outcomes.
• Describe and inform health care providers of recent labeling, policy and regulatory changes which would impact prescribing and medication management to optimize patient care.

Learning Objectives After completion of this activity, the participant will be able to:

• Describe the approach for the REMS Integration Prototype and Use Case and how it can reduce REMS implementation burden
• Explain the REMS integration pilots and opportunities to contribute to the REMS Integration Use Case
• Review how the REMS SPL files can assist health care professionals in identifying REMS drugs and their corresponding requirements
• Discuss how to use the REMS Public Dashboard and how it can be used

Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH), and physician assistants.

Requirements for Receiving CE Credit

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.

Important Note regarding completion of evaluations and receiving credit
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.

Disclosure

Faculty

• Millikan, Edward, PharmD, R. Ph, Senior Informatics Pharmacist, Office of Medication Error Prevention and Risk Management | Office of Surveillance and Epidemiology - nothing to disclose
• Neyarapally, George, PharmD, JD, MPH, R. Ph, Senior Pharmacist/Regulatory Science Research Policy Lead, OSE/FDA/CDER - nothing to disclose
• Toyserkani, Gita, PharmD, MBA, Associate Director, 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

• Littlefield, Jr, Kenneth P., Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose

Registration Information
Registration is complimentary; therefore refunds are not applicable.