FDA REMS

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the US Food and Drug Administration (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. The FDA REMS for opioids leverages accredited CE to address the opioid crisis. The FDA REMS for Mycophenolates leverages accredited CE to mitigate the risk associated with the use of mycophenolate during pregnancy. Here are resources for providers that choose to design education to fulfill the REMS goals.

CE as a Strategic Asset

Since 2009, the ACCME has supported the role of accredited CE as a strategic asset to US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS), provided the proper controls are in place to ensure independence.

The first REMS to incorporate accredited CE was the Extended-Release and Long-Acting (ER/LA) Opioid Analgesics REMS, approved by the FDA in July 2012. In 2018, the FDA launched the Opioid Analgesic REMS which expanded the program to include Immediate-Release (IR) opioids. In 2021, the FDA launched the Mycophenolate REMS.

• The centerpiece of the Opioid Analgesics REMS is a prescriber education program about the risks of opioid medications as well as safe prescribing and safe use practices.
• The goal of the Mycophenolate REMS is to mitigate the risk of embryofetal toxicity associated with the use of mycophenolate during pregnancy by educating healthcare providers.
• The education is controlled, designed, and delivered by accrediting continuing healthcare education providers.

PARS and REMS Data Collection

As a service to the CE community and to the FDA, the ACCME modified the Program and Activity Reporting System (PARS) to enable accredited providers to submit information about REMS-compliant activities.

The ACCME prepares reports containing explanations and examples of the types of data that has been collected in PARS about REMS continuing education that has been offered by providers accredited in the ACCME system.

CME Passport

This search tool helps clinicians find Opioid Analgesics and Mycophenolate REMS-Compliant accredited CE activities. 

For More Information

• Risk Evaluation and Mitigation Strategy (REMS) for Opioid Analgesics: This FDA information page includes links to the OA REMS blueprint, news release, and other resources.
• Risk Evaluation and Mitigation Strategy (REMS) for Mycophenolate: This FDA information page provides information and resources on the Mycophenolate REMS.
• MEMS 2.0 Summary: This MedBiquitous Webpage features links to resources, including the MEMS Implementation Guidelines for the REMS CE Data Exchange.

Key Resources

• REMS Technical Resources: This page provides resources on submitting de-identified learner data for Opioid Analgesic REMS via XML batch template and web services.
• PARS Activity Registration for OA REMS: This tutorial provides step-by-step instructions on how to register activities for Opioid Analgesic REMS. 
• Entering Opioid Analgesic REMS Learners in PARS: This tutorial provides step-by-step instructions on how to enter learners in PARS for Opioid Analgesic REMS.