Yesterday the FDA announced the approval of a final REMS “governing the use of immediate-release opioid analgesic medications.” And the FDA did it in a big way, approving some 437 supplements for the various immediate-release opioid products. The FDA stated in its new release (here):
This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS now, for the first time, applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting (ER/LA) opioid analgesics, which have been subject to a REMS since 2012.
The revised REMS provides for training of not only physicians, but also nurses and pharmacists. The Agency goes on to say:
In addition to expanding the REMS to include IR opioid analgesic products intended for outpatient use, the agency has approved the new FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint).
While at this time the educational components in the REMS and product labeling are not mandatory, the FDA has not ruled out making it mandatory if the FDA deems treatment and prescribing habits have not improved. The full release can be read at the link provided above. To see a list of supplements approved yesterday click here and look at the September 18th listing.