The Food and Drug Administration will be requiring stronger language on the labeling of extended-release and long-acting forms of opioids to “ensure their safe and appropriate use,” according to a
statement published on the FDA’s website on Tuesday.
The correct dosage and use of opioids such as morphine, oxycodone and fentanyl have been under scrutiny for a while, and even led to a
Sentinel Event Alert issued in August 2012 by The Joint Commission. (For more information on last year’s “Safer use of opioids in hospitals” alert, see your Sept. 10, 2012, edition of
Inside the Joint Commission.)
Because the extended-release and long-acting forms of opioids may contain higher doses of the drugs, the FDA wants to encourage providers to explore “other, less potentially addictive, treatment options … first.”
According to an article about the new labeling in the
Washington Post, a national survey in 2009 “found that about 2 million Americans were hooked on or abusing prescription pain relievers, numbers that eclipsed those for both cocaine or heroin.”
Right now, labels for opioid drugs indicate the extended-use drugs “are for ‘the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time’,” according to the FDA statement.
The new labeling will say that the drugs are "indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate."