FDA Seeks Comment on Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids
The US Food and Drug Administration (FDA) is seeking comments on draft revisions to the “FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics” (Blueprint). The Blueprint is part of the FDA-approved risk evaluation and mitigation strategy (REMS) for extended release (ER) and long-acting (LA) opioid analgesic medications (ER/LA Opioid Analgesics REMS).
On July 12, 2012, FDA approved an ER/LA Opioid Analgesics REMS, the goal of which was reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of ER/LA opioid analgesics while maintaining patient access to pain medications.
The ER/LA Opioid Analgesics REMS requires that training in the form of accredited continuing education be made available to health care providers who prescribe ER/LA opioid analgesics. The accredited continuing education must include all elements of the FDA Blueprint, which includes a basic outline and the core messages related to ER/LA opioid analgesics.
The FDA is now considering modifications to the existing Blueprint in light of recommendations from a May 2016 Advisory Committee meeting. The draft revisions would broaden the Blueprint to include:
- Information on pain management, including the principles of acute and chronic pain management
- Non-pharmacologic treatments for pain
- Pharmacologic treatments for pain (both non-opioid analgesic and opioid analgesic).
Follow the link below for additional information, including comment submission instructions. Comments will be accepted through July 10, 2017.
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