APhA Comments to FDA on Draft Opioid REMS CE Blueprint

On December 7, APhA commented to FDA on its draft document entitled ‘‘Blueprint for Prescriber Education for the Long-Acting/Extended-Release Opioid Class-Wide REMS’’ (Blueprint). The draft Blueprint contains core messages for continuing education (CE) providers to develop educational materials to train prescribers of long-acting and extended-release opioids required REMS for these products. The Blueprint is important because it serves as an important model for the impact of REMS programs on pharmacy.

In the comments, APhA supported the utilization of CE for REMS educational materials and made the following requests of FDA:

  • Frame the REMS CE Blueprint model on intra-professional education so accredited provider organizations can utilize a REMS CE Blueprint for their target audience(s);
  • Consider ways in which a REMS CE Blueprint and CE program could include reference to a REMS being part of an overall integrated and coordinated effort to improve patient safety that builds on such things as utilization of electronic health records and improved coordination of care; and
  • Consider appropriate evaluation of the effectiveness and benefit of a REMS education program offered through CE.

FDA will post the final Blueprint on its website when completed.

December 14, 2011