The US Food and Drug Administration (FDA) unveiled a new strategy today that will be added to its broader efforts in addressing the current opioid crisis. The agency has approved the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS).

REMS for the first time requires that all healthcare providers involved in pain management be able to receive voluntary training, and it should not be limited to prescribers. REMS training, therefore, must be made available to nurses and pharmacists.

"As part of our comprehensive work in this area, we are taking new steps to rationalize prescribing and reduce overall exposure to these drugs as a way to cut the rate of new addiction," commented FDA Commissioner Scott Gottlieb, MD, in a statement. "Many people who become addicted to opioids will have their first exposure in the medical setting."

He explained that the agency's new effort is aimed at giving providers the most current and comprehensive information on the appropriate management of pain.

"This includes ensuring that prescriptions are written for only appropriate purposes and durations of use," Gottlieb said. "The action also adds new labeling for all opioids to raise awareness about available educational materials on prescribing these powerful medications."

The new REMS now includes a requirement that education for healthcare professionals encompass much broader information about appropriate pain management, including alternative options to opioids.

The FDA is also approving new product labeling that includes information about the healthcare provider education that will be available through REMS.

Expanded Coverage

Also for the first time, the REMS will now apply to immediate-release (IR) opioid analgesics that are intended for use in an outpatient setting as well as to extended-release and long-acting (ER/LA) agents.

Since 2012, companies that manufacture ER/LA opioid analgesics have had to make training available to prescribers of those products. To meet this requirement, pharmaceutical manufacturers have been providing unrestricted grants to accredited continuing education providers to develop continuing education courses based on content outlined by the FDA.

In addition, as part of the FDA approval of the new REMS, these educational requirements will now also apply to IR opioid analgesic products intended for outpatient use. These agents constitute about 90% of all opioids used in the outpatient setting.

"Appropriate prescribing practices and education are important steps that we're prioritizing to help address the human and financial toll of this crisis," Gottlieb explained.

"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. At the same time, we are also taking new steps to advance the development of evidence-based, indication-specific guidelines to help further guide appropriate prescribing of opioids," Gottlieb explained.

Expanded Labeling

The number of opioid products covered by the REMS has now been expanded from 62 products to 347 intended for outpatient use. The REMS program will continue to include Medication Guides for patients and caregivers, new Patient Counseling Guides to assist providers with discussions concerning pain management, and plans for assessing the program's effectiveness.

New safety labeling for all agents intended be prescribed for outpatient use has also received FDA approval. The FDA will now require product labels to include information about the availability of education through the REMS for prescribers and other providers, as well as information about REMS-compliant education in the Boxed Warning and Warnings and Precautions sections.

The FDA "strongly encourages providers to complete a REMS-compliant education program; counsel patients and caregivers on the safe use, risks, and appropriate storage and disposal of these products; emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist; and to consider other tools to improve patient, household and community safety."

Training provided through the REMS is not mandatory, however, and completing training is not a precondition to be able to prescribe opioids. That said, the FDA's Opioid Policy Steering Committee is continuing to evaluate whether there may be circumstances when the FDA should require some type of mandatory education for healthcare providers and how the agency would pursue this goal.

With that in mind, the FDA has recently contracted with the National Academies of Sciences, Engineering, and Medicine to assist in developing a framework to help medical professional societies develop evidence-based guidelines on appropriate opioid analgesic prescribing to treat acute pain.

"Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines," Gottlieb said.