November 22, 2013
For the ER/LA Opioid Analgesics REMS, the FDA writes that: “Training will be considered ‘REMS-compliant training’ under this REMS if:
- it, for training provided by CE providers is offered by an accredited provider to licensed prescribers,
- it includes all elements of the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics (“FDA Blueprint”),
- it includes a post-course knowledge assessment of all of the sections of the FDA Blueprint, and
- it is subject to independent audit to confirm that conditions of the REMS training have been met.