FDA Institutes REMS for Immediate-Release Opioids

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Alicia Ault

Seeking to curb prescribing of immediate-release (IR) opioids, the US Food and Drug Administration (FDA) is making it mandatory for drug manufacturers to provide and pay for training for clinicians who prescribe these medications — the same restrictions that are already in place for extended-release (ER) formulations of the drugs.

“America is simply awash in immediate release opioid products,” said FDA Commissioner Scott Gottlieb, MD, in announcing  several new efforts by the agency to address the opioid epidemic. At an FDA meeting on abuse-deterrent formulations, Dr Gottlieb said 90% of all opioid prescriptions in the United States are for IR formulations, amounting to some 200 million prescriptions annually.

The FDA will start notifying manufacturers of the new requirements over the next few weeks. All IR formulations will now be subject to the same Risk Evaluation and Mitigation Strategy (REMS) program as ER opioids, and drug makers will be required to cover the cost of prescriber training.

However, although providing and paying for the training are mandatory for drug makers, taking the training is voluntary for clinicians.

FDA Pondering Mandatory Training

The FDA now requires the training to be extended to other health providers involved in pain management, including nurses and pharmacists. Currently, participation is voluntary, but the FDA is pondering mandatory training.

“Based on the feedback we’ve received from two public meetings over the past year, we’re actively exploring the question of whether, in the future, there should be mandatory provider education, and how we’d operationalize such a condition,” said Dr Gottlieb.

Physician organizations, such as the American Medical Association, have said they oppose mandatory education.

“Mandating CME [continuing medical education] for individual prescribers is not the solution for this public health crisis,” said Wanda Filer, MD, chair of the American Academy of Family Physicians (AAFP) board, in a letter to the FDA. Education “must be designed to address needs and gaps of the learners,” said Dr Filer, adding, “one size fits all education is not optimal.”

The FDA’s new REMS for IR and ER formulations will include modifications to the FDA Blueprint for Prescriber Education for Extended Release and Long-Acting Opioid Analgesics,  such as broadening information on pain management, non-pharmacologic and pharmacologic treatments.

Dr Filer said the AAFP sees the Blueprint as “overly proscriptive.” The agency “should focus less on an individualized clinician approach that ignores team based care, and more on promoting patients as stakeholders in their own care via shared decision making and collaborative physician-patient management plans,” said Dr Filer, adding that “these are currently missing within the Blueprint.”

The advocacy group Physicians for Responsible Opioid Prescribing also registered objections  about the Blueprint, saying it failed to closely follow Centers for Disease Control and Prevention prescribing guidelines on opioids for chronic pain.

As part of its overall opioid strategy, the FDA is also investigating potential changes to how abuse-deterrent formulations are marketed and prescribed.

The agency will be conducting a study to delve into prescriber beliefs and attitudes about the formulations, aiming to see whether perceptions about the products “match the clinical realities,” said Dr Gottlieb.

The agency wants to determine whether nomenclature used to describe and label the abuse-deterrent opioids allows prescribers “to adequately distinguish between the risk of abuse and the risk of addiction,” he said. “We don’t want to improperly convey a perception that a product that’s resistant to manipulation and abuse is somehow also less prone to fueling addiction, when that’s is simply not true,” he said.

“Patients can still become addicted to opioid products with abuse deterrent features,” said Dr Gottlieb.



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