All Opioids Now Subject to REMS, FDA Says

Alicia Ault

September 29, 2017

The US Food and Drug Administration (FDA) has made good on its promise to require that immediate-release (IR) opioids be subject to the same set of prescribing rules as extended-release formulations of the drugs.

In July, FDA Commissioner Scott Gottlieb, MD, put the public and manufacturers on notice that the agency would soon be putting all opioids on a level playing field. On September 28, Dr Gottlieb said the agency had now taken action and that 277 IR opioids would be subject to Risk Evaluation and Mitigation Strategy (REMS) requirements.

"This week, we issued letters notifying 74 manufacturers of IR opioid analgesics intended for use in the outpatient setting that their drugs will now be subject to a more stringent set of requirements under a Risk Evaluation and Mitigation Strategy," said the FDA Commissioner in a blog post. "The REMS requires that training be made available to health care providers who prescribe IR opioids, including training on safe prescribing practices and consideration of nonopioid alternatives," said Dr Gottlieb.

The FDA has asked manufacturers to extend the training offer to pharmacists, nurses, and any providers involved in pain management.

To offer the training, manufacturers have provided unrestricted grants to accredited continuing education providers for courses that have content that has been "outlined" by the FDA, said Dr Gottlieb. That "blueprint" of training content is being updated to cover principles on acute and chronic pain management; nonpharmacologic, opioid, and nonopioid pharmacologic pain therapies; information about the safe use of opioids; and basic information about addiction medicine and opioid use disorders.

The FDA said it is also seeking public comment on whether such training should be mandatory for prescribers.

Interested parties have until December 29 to submit comments to the agency.

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