Today’s issue of WorkCompRecap features the FDA’s recent announcement of their approval of a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting opioids. The REMS is part of a federal initiative to address the prescription drug abuse, misuse, and overdose epidemic and introduces new safety measures designed to reduce risks and improve the safe use of opioids.
Under the new plan, companies will be required to make education programs available to prescribers based on an FDA Blueprint, make available FDA-approved patient education materials on safe use, and perform periodic assessments of the implementation of the REMS and the success of the program. However, there is no mandatory requirement that prescribers take the training and no precondition to prescribing ER/LA opioids to patients.
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