PARS Modifications Support REMS Data Collection and Auditing Process
As a service to the CME community and to the FDA, the ACCME has agreed to contribute to fulfilling the data collection and auditing requirements for the Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids. We have released new resources in order to support accredited providers that choose to design education to fulfill the REMS goals.
Data Collection: The ACCME has modified the Program and Activity Reporting System (PARS) to enable accredited providers to submit information about REMS CME activities and has a process for generating reports containing data about those activities. PARS can now accept the data mandated by the FDA, including how many REMS CME activity participants prescribed ER/LA opioids within the last year, and a breakdown of these individuals by profession. Accredited CME providers may also submit information on the number of participants that were registered with the DEA to prescribe Schedule 2 and 3 drugs, as well as participants by practice type (primary care, pain specialist, non-pain specialist). Accredited providers can indicate whether their activities are REMS-compliant or REMS-related, and if they are REMS-related, which section(s) of the FDA Blueprint the educational instruction addressed. The ACCME believes that these modifications will offer accredited CME providers within the ACCME system a streamlined, efficient, and effective process for submitting data about REMS-compliant activities.
Auditing: The FDA has mandated that there be an independent audit of REMS-compliant accredited CE activities to confirm that the education has met the FDA requirements. The FDA has agreed that accrediting bodies can serve as the independent auditors. The ACCME has agreed to conduct independent audits of at least 10 percent of RPC/Campbell Alliance, Ltd-funded, REMS-compliant activities. Each audit will include a review of whether the content of the activity complied with the requirements outlined in the FDA Blueprint, as well as with the ACCME’s Standards for Commercial SupportSM: Standards to Ensure Independence in CME Activities.
Resources: Please visit the following resources for more information.
- CME In Support of REMS: This dedicated Web page provides updates, resources, and Q&A for accredited CME providers that choose to design education to fulfill the REMS goals.
- Accredited Continuing Medical Education and the FDA's Risk Evaluation and Mitigation Strategies: A Fact Sheet for Accredited CME Providers: This fact sheet for accredited providers explains the role of accredited continuing education, the ACCME, and accredited providers in fulfilling the goals of the FDA ER/LA Opioid Analgesics REMS. We have updated the fact sheet and it now includes 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.