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:
FDA will post the final Blueprint on its website when completed.
December 14, 2011