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 is the Extended-Release and Long-Acting (ER/LA) Opioid Analgesics REMS, approved by the FDA in July 2012.
- The centerpiece of the ER/LA 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 ER/LA Opioid REMS continuing education that has been offered by providers accredited in the ACCME system.
For More Information
- FAQ About REMS
- FDA Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids: This FDA information page includes links to the ER/LA Opioid Analgesic REMS blueprint, Q&A, news release, and other resources.
- ER/LA Opioid Analgesics REMS: This REMS Program Companies (RPC) website includes information for CE providers.
- Request for Applications (RFA): This page contains information about the RPC Request for Continuing Education Grant Applications.
- MEMS 2.0 Summary: This MedBiquitous Webpage features links to resources, including the MEMS Implementation Guidelines for the REMS CE Data Exchange.