Does the ACCME information about the ER/LA Opioid Analgesics REMS apply to all REMS?

Published Date: 
October 25, 2012

No. The ACCME Q&A and other materials about the FDA Extended-Release and Long-Acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) apply only to that specific REMS.

For the ER/LA Opioid Analgesics REMS, the FDA developed and issued a blueprint for prescriber education that contains the core educational messages. The ACCME materials explain that it is acceptable for accredited CME providers to base their activities on the FDA blueprint for the ER/LA Opioid Analgesics REMS because it was developed and issued independent of the control of any ACCME-defined commercial interest. There is no special use standard or safe harbor for CME that addresses the ER/LA Opioid Analgesics REMS. Accredited providers must comply with the accreditation requirements when developing and presenting all CME activities.

Resources:

FDA Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids: This FDA information page includes links to the ER/LA Opioid Analgesics REMS blueprint, Q&A, news release, and other resources.

 

Was this useful?