Risk Evaluation and Mitigation Strategy (REMS)
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks.
The FDA has required a REMS for extended-release and long-acting (ER/LA) opioid analgesics.
Under the conditions specified in this REMS, prescribers of ER/LA opioid analgesics are strongly encouraged to do all of the following:
Train (Educate Yourself) – Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) for your discipline
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