FDA Expands REMS To Include Immediate-Release Opioids

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On September 18, 2018, the US Food and Drug Administration announced that it has broadened its Risk Evaluation and Mitigation Strategy (REMS) requirement for opioids to include immediate-release agents prescribed for outpatients, as well as extended-release products previously covered by REMS.  This change will cover all providers who are involved in the management of patients with pain, including those not writing prescriptions.  This is the first time opioid training is to be made available to non-prescribers, and while the FDA is requiring opioid manufacturers to create new training modules for non-prescribers to address immediate-release products, the training will remain voluntary for care givers.

The initial REMS requirements for extended-release opioids went into effect in 2012, and this expansion of the requirement increases the number of products subject to the opioid REMS from 62 to 347.

Additional information about various opioid medications, including codeine, hydrocodone and morphine can be found in the Top 300 Pharmacy Drug Cards.  If you or your institution subscribes to AccessPharmacy, use or create your MyAccess Profile to sign-in to the Top 300 Pharmacy Drug Cards.  If your institution does not provide access, ask your medical librarian about subscribing.


For More Information

Reporting from MedPage, click here.

Press release from the FDA, click here

Go to the profile of Lee C. Vermeulen

Lee C. Vermeulen

Professor of Medicine and Pharmacy, University of Kentucky

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