Case Study: Evaluating REMS CE - A Standards-Based Approach

April 9, 1:30 PM

Kate Regnier, The Accreditation Council for Continuing Medical Education
Linda Kitlinski, REMS Program Companies
Emma Trucks, Boston University School of Medicine

Death from overdose of prescription medications is the second most common cause of accidental death in the U.S. As a response to this public health crisis related to the misuse and abuse of long -acting and extended -release opioid medications, the US Food and Drug Administration (FDA) issued a Risk Evaluation and Mitigation Strategy (REMS) for these medications known as ER/LA Opioid Analgesics REMS (see FDA Blueprint issued July 9, 2012). An important component of the ER/LA REMS is that manufacturers of these products will fund accredited continuing education for prescribers of these products on the risks of these medications and how to mitigate these risks. Manufacturers of these medications are providing educational grants to fund independent accredited REMS-compliant continuing education.

The generation and collection of specific data and information descriptive of the REMS accredited continuing education initiatives has been identified by the FDA as requisite component of the regular reports that the product manufacturers must submit to the FDA.

Early in the REMS development process the continuing accreditation accreditors proposed that this data system be built around a modified MedBiquitous Medical Education Metrics specification (MEMS) so that data from the different accreditation systems could be compiled into one data set for analysis and reporting.

This case study involving one continuing education accreditor and one accredited provider will review how the manufacturers’ needs for data may be met through a novel collaborative process involving the MedBiquitous Medical Education Metrics specification.

Objectives:

By the end of this session, learners will be able to:

  • Describe the impetus for the development of the MEMS standard for use in the REMS CE initiative.
  • Describe the planned flow of CE data to support ER/LA Opioid Analgesics REMS.
  • Describe what steps would be required by one accreditor to implement the MEMS specification and collect REMS data
  • Describe the steps that would be required by CE providers to implement the MEMS specification and collect REMS data
  • Describe how the MEMS specification could be used by manufacturers to collect and report REMS data.