ER/LA Opioid REMS
In April 2011, the FDA announced the elements of a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of extended-release and long-acting (ER/LA) opioid analgesics outweigh the risks. The ER/LA opioid REMS supports national efforts to address the prescription drug abuse epidemic, while ensuring patients have access to appropriate treatment options to manage their pain.
As part of the REMS, all ER/LA opioid analgesic companies must provide:
• Education for prescribers of these medications, which will be provided through accredited continuing education (CE) activities supported by independent educational grants from ER/LA opioid analgesic companies.
• Information that prescribers can use when counseling patients about the risks and benefits of ER/LA opioid analgesic use.
The FDA developed core messages to be communicated to prescribers in the Blueprint for Prescriber Education (FDA Blueprint). The approved FDA Blueprint for ER/LA Opioid Analgesic REMS is posted on the FDA website for CE providers to develop the actual CE activity.
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Release date: December 6, 2013
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