The FDA Risk Evaluation and Mitigation Strategy (REMS) for opioids leverages accredited CE to address the opioid crisis. Here are resources for providers that choose to design education to fulfill the REMS goals.
CME as a Strategic Asset
Since 2009, the ACCME has supported the role of accredited CME 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 CME 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.
- 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 education is controlled, designed, and delivered by accrediting continuing healthcare education providers.
PARS and REMS Data Collection
As a service to the CME 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 Opioid REMS continuing education that has been offered by providers accredited in the ACCME system.
For More Information
- FAQ About REMS
- Risk Evaluation and Mitigation Strategy (REMS) for Opioid Analgesics: This FDA information page includes links to the REMS blueprint, news release, and other resources.
- Opioid Analgesics REMS: This REMS Program Companies (RPC) website includes information for CE providers.
- MEMS 2.0 Summary: This MedBiquitous Webpage features links to resources, including the MEMS Implementation Guidelines for the REMS CE Data Exchange.
- REMS Technical Resources: This page provides resources on submitting de-identified learner data for Opioid Analgesic REMS via tab-delimited batch template, 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.