REMS programs are authorized by the Federal Food Drug and Cosmetics Act. This allows the FDA to mandate certain steps by drug manufacturers for new or ongoing FDA approval of a medication to ensure the benefits of a drug outweigh the potential risks

The first such program was established for Transmucosal Immediate Release Fentanyl (TIRF) products. Enrollment and abbreviated training is required prior to prescribing, dispensing, or distributing any of the covered TIRF products. You may access the TIRF REMS program by clicking here. Noteworthy is these products are only approved for the treatment of cancer-related breakthrough pain in those patients who are opioid-tolerant.

ER / LA opioid products as a class are covered under a separate REMS program. All extended release, sustained release, and prolonged release opioids are covered under this REMS. Methadone is also covered considering its long and unpredictable terminal half-life. Required components of the ER / LA opioid REMS includes an approved medication guide and communication plan outlining the risks of the product, development and provision of prescriber and other healthcare professional training meeting a specific educational blueprint, and use of patient counseling document.

Immediate release (IR) opioids will soon have their own REMS program although details are not clear what requirements this particular REMS will contain. A draft letter to IR opioid manufacturers directs them to use the existing infrastructure of the ER / LA opioid REMS program to develop a shared IR opioid REMS program.