FDA Sets Stricter Requirements for Immediate-Release Opioids to Prevent Misuse & Abuse

“Many people who are currently addicted to opioids became medically addicted,” says U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD. Dr. Gottlieb also says that approximately 90% of all opioids prescribed are for immediate-release (IR) formulations, which account for approximately 160 million yearly prescriptions.¹ Because of this, the FDA is expanding its Risk Evaluation and Mitigation Strategy (REMS) program to include manufacturers of IR opioids.

Since 2012, 64 extended-release (ER)/long-acting (LA) opioid products have been subject to the FDA’s REMS program. Manufacturers of these ER/LA opioids must provide training on safe prescribing practices, the consideration of non-opioid pain medications or other subjects to prescribers. To meet this requirement, ER/LA opioid analgesic manufacturers have been providing unrestricted grants to accredited continuing medical education providers to develop courses based on content outlined by the FDA, which the agency calls the blueprint.

The FDA recently sent letters to 74 manufacturers of IR opioids intended for use in the outpatient setting, notifying them that IR opioids will be subject to REMS following a public comment period. Along with the makers of ER/LA opioids, IR opioid manufacturers will soon be required to provide training and fund the development of education courses for doctors, nurses, pharmacists and other healthcare professionals involved in managing pain patients (e.g., those who prescribe, treat and monitor pain patients).

Dr. Gottlieb says the FDA believes all healthcare professionals involved in patient pain management must be educated about the safe use of opioids to ensure these products are actually indicated for patients and used under appropriate clinical care. The healthcare provider education component of the new IR-opioid REMS is mandatory. Documentation of program completion and knowledge assessment of the education are also mandatory. Providing continuing medical education credits for the REMS education is voluntary. The goal is to reduce overall opioid exposure by ensuring prescribers are properly informed about appropriate prescribing recommendations, understand how to identify the risk of abuse by individual patients and know how to get addicted patients into treatment.

Extending REMS to IR-opioid manufacturers will significantly increase the total number of covered opioids. After the requirement goes into effect, 277 more opioids will be subject to REMS. Implementation may take about a year to complete.

Other Actions in the Fight to Deter Opioid Abuse
The FDA is seeking public input relevant to its newly established Opioid Policy Steering Committee as it considers how its authority can or should be used to address the nation’s opioid abuse crisis. Comments must be submitted by Dec. 28, 2017.

The agency will also soon issue final guidance for manufacturers on the development of generic versions of abuse-deterrent opioid formulations.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Gottlieb S. FDA takes important steps to stem the tide of opioid misuse and abuse. FDA Voice. 2017 Sep 28.