Makers of immediate-release products will have to provide prescriber training
However, there is no mandate on physicians to take it
FDA commissioner: "America is simply awash in immediate-release opioid products"
To help curb the nation’s opioid overdose epidemic, US Food and Drug Administration Commissioner Scott Gottlieb announced, the agency will expand its requirements for prescription opioid manufacturers to provide prescriber training to clinicians, including nurses and pharmacists as well as physicians.
Until this point, the FDA required manufacturers of only extended-release, or long-acting, painkillers to provide this type of education. However, this requirement is being extended to include manufacturers of immediate-release, or short-acting, opioids.
The FDA’s blueprint for training will also be updated, Gottlieb said, to include not only how to assess and manage patients for treatment with opioids but also information on non-opioid therapies for pain.
Although manufacturers must provide the education, there is no mandate on physicians to take the training.
According to the FDA, about 90% of all opioid prescriptions in the United States are written for short-acting formulations, which are mostly combinations of acetaminophen and opioids such as morphine, oxycodone or hydrocodone.
“America is simply awash in immediate-release opioid products,” Gottlieb said. “Many people who become addicted to opioids will eventually move on to seek higher-dose formulations of these drugs or illicit street drugs, which are increasingly the low-cost alternatives.”