FDA Expands REMS Requirements for Opioids

In September, the Food and Drug Administration (FDA) broadened its Risk Evaluation and Mitigation Strategy (REMS) program for opioids to include immediate-release opioid painkillers, in addition to extended-release and long-acting products. The opioid REMS now covers 347 painkillers, including the medications most commonly prescribed in outpatient settings.

iStock/Moussa81

In addition to expanding the painkiller list, the updated opioid REMS requires that the training be made available to all health care professionals who are involved in the management of patients with pain, and not only to those who prescribe the medication.

A REMS is a drug safety program that the FDA can require for certain medications that have known safety concerns. The exact strategy varies with each drug, but often includes components such as requiring prescribers to have special certifications or requiring patients to be monitored regularly to support the safe use of that medication.

The primary component of the opioid REMS is a requirement that all manufacturers of approved opioid analgesics provide unrestricted grants to accredited continuing education providers for the development of continuing medical education (CME) related to safe opioid prescribing.

There is currently no mandatory federal requirement that prescribers or other health care personnel take these CME modules. However, the agency noted that its Opioid Policy Steering Committee is continuing to assess the landscape of opioid prescribing to see if there are circumstances when the FDA should require some form of mandatory education.

The updated REMS will require that opioid-related CME materials now be made accessible to nurses, pharmacists, and others who are involved in the management of patients in pain. Given the larger audience, the FDA has also broadened the range of information that needs to be included in an opioid REMS. This includes more information on both acute and long-term pain management, including adding sections on pharmacological and non-pharmacological alternatives to opioid analgesics.

“Providers have a critical role to play in making sure these products are appropriately prescribed to patients,” said FDA Commissioner Scott Gottlieb, M.D., in the agency’s press release. “Our new effort is aimed at arming providers with 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. Appropriate prescribing practices and education are important steps that we’re prioritizing to help address the human and financial toll of this crisis.”

The agency also stated that it will require opioid analgesic manufacturers to include information about the availability of REMS-compliant education on the labels of all drugs intended for outpatient settings. The educational information will be listed in the “Boxed Warning” and “Warnings and Precautions” sections of the labels.

The revised CME training materials for opioid painkillers are expected to be available to health care providers in the Spring of 2019. ■