REMS-Compliant CE for ER/LA Opioid Analgesics
Health care professionals who prescribe ER/LA opioid analgesics have a responsibility to help ensure the safe and effective use of ER/LA opioid analgesics. REMS-compliant training programs will focus on the safe prescribing of ER/LA opioid analgesics.
REMS-compliant training will: (a) be delivered by accredited CE providers; (b) cover all elements of the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics ("FDA Blueprint"); (c) include a knowledge assessment; and (d) be subject to independent audit of content and compliance with applicable accrediting standards.
The FDA has developed core messages to be communicated to prescribers in the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics ("FDA Blueprint"), which will be used by Continuing Education (CE) providers to develop the REMS-compliant training programs.
These core messages include:
Understand how to assess patients for treatment with ER/LA opioid analgesics.
Be familiar with how to initiate therapy, modify dose, and discontinue use of ER/LA opioid analgesics.
Be knowledgeable about how to manage ongoing therapy with ER/LA opioid analgesics.
Know how to counsel patients and caregivers about the safe use of ER/LA opioid analgesics, including proper storage and disposal.
Be familiar with general and product-specific drug information concerning ER/LA opioid analgesics.
The first prescriber REMS-compliant training programs are anticipated to be available by March 1, 2013.