FDA extends the scope of opioid REMS to include IR and education

By Maggie Lynch

- Last updated on GMT

(Image: Getty/EtiAmmos)
(Image: Getty/EtiAmmos)

Related tags Fda Regulation regulatory Opioid Opioid epidemic Risk strategy

The FDA has approved an updated opioid analgesics risk evaluation and mitigation strategy, including measures that apply to immediate-release opioids.

Immediate-release (IR) opioid medications account for about 90% of the opioid pain medications prescribed for outpatient use. The new expansion of the risk evaluation and mitigation strategy​ (REMS) includes IR medications for the first time. 

Kristofer Baumgartner, a spokesperson from the US Food and Drug Administration (FDA), told us, “The FDA has determined that a REMS is necessary for all opioid analgesics intended for outpatient use to ensure that the benefits of these drugs continue to outweigh the risks.”

The goal of the REMS program is to educate prescribers and other healthcare providers. It requires that the education covers broader information, including alternatives to opioids for pain management.

“As part of the US Department of Health and Human Services' Five-Point Strategy to Combat the Opioid Crisis, the FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing unnecessary and/or inappropriate exposure to opioids and preventing new addiction,”​ said Baumgartner.

Since 2012, manufacturers of extended-release (ER) or long-acting (LA) opioid analgesics have been provided unrestricted grants for companies to provide accredited continuing education courses regarding opioid safety as outlined by the FDA. Now, these grants and requirements will be applied to IR manufacturers.

The education provided through the REMS program is based on the opioid analgesic “FDA Blueprint” which provides guidelines on educating those who are providing treatment and monitoring of patients prescribed opioids or analgesics.

REMS also involves informing patients about their roles and responsibilities, including the risks of opioids and how to use the medications, as outlined in the Medications Guides and Patient Counseling Guide​, Baumgartner told us.

In terms of timelines, he explained, “It’s expected that continuing education under the modified REMS will be available to health care providers by March 2019.”


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