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FDA: Immediate-Release Opioids Now Under REMS

September 18, 2018 4:36 PM | Sally Winkelman (Administrator)

Sept. 18, MedPage Today

The FDA said Tuesday that it is broadening its Risk Evaluation and Mitigation Strategy (REMS) for opioids to include immediate-release agents prescribed for outpatients, and will cover all "providers who are involved in the management of patients with pain" -- not just those writing prescriptions.

But although the agency is requiring opioid manufacturers to create new training modules for nonprescribers, and that cover immediate-release products, the training will remain voluntary for professionals.

The broadened REMS will also apply to extended-release and long-acting (ER/LA) opioids for outpatient use, for which the FDA first imposed a REMS in 2012. The agency noted that Tuesday's action raises the number of individual products subject to the opioid REMS from 62 to 347.

"Our aim is to make sure the medical community can take advantage of the available education on pain management and safe use of opioid analgesic products," said FDA Commissioner Scott Gottlieb, MD, in announcing the changes.

"At the same time, we're also taking new steps to advance the development of evidence-based, indication-specific guidelines to help further guide appropriate prescribing of opioids. The goal is that these guidelines will provide evidence-based information on the proper number of opioid doses that should be dispensed for different medical conditions for which these drugs may be indicated. The aim is to reduce overall dispensing as a way to further reduce exposure to these drugs," Gottlieb added. He did not give a timeline for when these more specific guidelines would be released.

The FDA noted that the new training -- components of which were outlined in a "blueprint" document -- must be made available to nurses and pharmacists, for example, in addition to those authorized to prescribe opioids. "The new REMS also requires that the education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain. The agency is also approving new product labeling containing information about the health care provider education available through the new REMS," the agency said.

That labeling about education will now appear as part of the boxed warnings and other sections on "warnings and precautions."

Previously, the opioid REMS ordered manufacturers of ER/LA opioids to develop training materials for prescribers, with the aim of minimizing risks of overuse and abuse. However, the FDA stopped short of requiring prescribers to undergo special training. REMS requirements for many other types of medications do include mandatory training, and the agency said opioids could eventually be added to that list.

"The FDA's Opioid Policy Steering Committee continues to consider whether there are circumstances when the FDA should require some form of mandatory education for health care providers and how the agency would pursue such a goal," according to the Tuesday announcement.

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