FDA Requires REMS for Immediate-Release Opioids
In an attempt to curb the growing opioid epidemic, the U.S. Food and Drug Administration (FDA) has ordered that drug manufacturers provide and pay for training for clinicians who prescribe immediate-release (IR) opioids. Similar regulations are already in place for extended-release (ER) opioids.
About the Opioid REMS Program
According to Medscape, the FDA has mandated that all IR opioids will now be subject to the same Risk Evaluation and Mitigation Strategy (REMS) program as ER formulations.
A REMS is a strategy to manage a known or potential serious risk associated with a drug or biological product with the goal of ensuring that the benefits of the drug or biological product outweigh its risks.
Currently, the REMS program for ER opiods requires that drug makers provide training for clinicians prescribing their ER opioid products and such trainings are paid for in full by the drug maker. Drug makers will not be required to do the same for immediate-release formulations.
When announcing the new mandate, FDA Commissioner Scott Gottlieb, MD, stated that “America is simply awash in immediate-release opioid products.” Gottlieb also cited data indicating that 90% of all opioid prescriptions in the U.S. are for IR formulations – this amounts to about 200 million IR opioid prescriptions ever year.
FDA Considers Further Regulations
In addition to the new REMS requirements for IR opioids, the FDA is also considering making the training mandatory.
While opioid REMS do require manufacturers to provide and pay for training, participation the training remains voluntary for clinicians.
Should the trainings be made mandatory, it could affect health care providers beyond clinician and include nurses and pharmacists involved in pain management.
Several physician organizations have openly opposed mandatory education.