FDA Seeks Comment on Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids

PUBLISHED: Jun 15, 2017
Source: Food and Drug Administration
Relevant to: Medical Office/Clinic, Long Term Care, Ambulatory Care, Hospice, Behavioral Health, Hospital, Home Health

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).

Background:

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.

Revisions:

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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