REMS 101: Navigating FDA Safety Programs in Pharmacy Practice
ACPE Activity Number:0204-0000-26-156-H05-P Release Date: 9/30/2026 Expiration Date: 9/30/2029 Activity Type: Knowledge-based CE Credits: 1 contact hour Activity Fee: Member – Free / Non-Member – Not Available
This activity is a recording of a live webinar, if you claimed credit for the live activity, you should not claim credit for this activity.
Activity Overview
Risk Evaluation and Mitigation Strategies (REMS) programs are an important component of medication safety and pharmacy practice. This educational activity will provide pharmacists with a foundational understanding of REMS programs, including their purpose, regulatory background, evolution, and key program components such as Medication Guides, Communication Plans, Elements to Assure Safe Use (ETASU), and Implementation Systems. Participants will review the roles and responsibilities of pharmacists, pharmacy technicians, prescribers, patients, manufacturers, and healthcare systems in supporting REMS compliance and safe medication use, while also exploring operational considerations such as certification requirements, patient enrollment, monitoring and laboratory testing, restricted distribution, workflow integration, and documentation. Common REMS medications and real-world program examples will be discussed, along with emerging trends, FDA modernization efforts, and strategies for staying current with REMS updates and newly approved programs.
The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education with Commendation.
This activity was planned to meet the educational needs of pharmacists seeking to enhance their understanding of Risk Evaluation and Mitigation Strategies (REMS), including regulatory requirements, operational processes, and best practices for supporting safe medication use and program compliance.
After completing this activity, the learner should be able to:
Describe the purpose, regulatory background, and core components of FDA Risk Evaluation and Mitigation Strategies (REMS) programs.
Identify the roles and responsibilities of pharmacists, pharmacy technicians, prescribers, patients, manufacturers, and healthcare systems in supporting REMS compliance and safe medication use.
Summarize REMS program requirements and operational considerations, including certification, enrollment, monitoring, and restricted distribution requirements.
LisaCristofaro, BSPharm, BCACP MarketAccess Manager, Specialty Pharmacy University of Rochester Medicine Pittsford, NY
Lisa Kumor, PharmD, BCACP Assistant Director, Accreditation and Residency, Specialty Pharmacy Services University of Illinois Chicago Hospital and Health Sciences System Chicago, IL
JennaReynolds, Pharm.D., R.Ph, BCPS Pharmacy Manager - Quality and Compliance Mayo Clinic Arizona Phoenix, AZ
In accordance with our accreditor’s Standards of Integrity and Independence in Accredited Continuing Education, ASHP requires that all individuals in control of content disclose all financial relationships with ineligible companies. An individual has a relevant financial relationship if they have had a financial relationship with an ineligible company in any dollar amount in the past 24 months and the educational content that the individual controls is related to the business lines or products of the ineligible company.
An ineligible company is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The presence or absence of relevant financial relationships will be disclosed to the activity audience.
No one in control of the content of this activity has a relevant financial relationship (RFR) with an ineligible company.
Per ACPE requirements, CPE credit must be claimed within 60 days of being earned. Once you have processed and claimed your CE credit, we encourage you to check your NABP eProfile account to verify your credits were transferred successfully before the ACPE 60-day deadline. It is an electronic direct-report process so your credits should appear in your account within a few minutes. After the 60 day deadline, ASHP will no longer be able to report your credit(s) for this activity.
