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.
The ACCME appreciates that the FDA recognizes the value of accredited education and chose to leverage the CE system to carry out this important public health initiative. This Web page provides updates and resources for accredited CME providers that choose to design education to fulfill the REMS goals.
PARS and REMS Data Collection
As a service to the CME community and to the FDA, the ACCME has modified the Program and Activity Reporting System (PARS) to enable accredited providers to submit information specific to the REMS CME activities they provide.
- The ACCME has prepared a report 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
- Ask ACCME about PARS and REMS Data Collection
Information for Providers Doing RPC-Funded REMS CME Activities
- Resource: The ACCME has prepared a fact sheet including information for providers doing REMS activities that are funded by the REMS Program Companies/Campbell Alliance, Ltd (RPC). This resource describes the ACCME’s understanding of the shared responsibilities of the RPC, ACCME, and accredited providers.
Educational Tools and Resources
- Accredited Continuing Medical Education and the FDA's Risk Evaluation and Mitigation Strategies: A Fact Sheet for Accredited CME Providers
- Ask ACCME About REMS
- Additional Resources: Presentations, commentaries, interviews, and news announcements
For More Information
- 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 Web site includes information for CE providers.
- MEMS 2.0 Summary: This MedBiquitous Web page features links to resources, including the MEMS Implementation Guidelines for the REMS CE Data Exchange.