FDA moving to limit opioid overuse
Hydrocodone moves to Schedule II
In response to growing concerns about overuse of opioids, the U.S. Food and Drug Administration has recommended reclassifying hydrocodone products as Schedule II drugs — those with a high potential for abuse.
That means that prescriptions for drugs such as Vicodin or Lortab would be limited to 90 days, and patients would need to see their physician for a new prescription. The change must be approved by the U.S. Department of Health and Human Services and the U.S. Drug Enforcement Agency. The drugs are currently Schedule III.
"[T]he FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States," Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research, said in a statement.
"While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse," she said.
Opioid abuse is a growing concern in workers' compensation. The hydrocodone-acetaminophen combination is the third-most commonly prescribed drug in workers' compensation, according to the National Council on Compensation Insurance, based in Boca Raton, FL. The top 1% of workers' compensation claimants consume 40% of all narcotics, NCCI found. (For more information on opioid overuse, see HEH, September 2013, p. 101.)
The change will have ramifications for injured workers who suffer from ongoing pain, says Kathryn Mueller, MD, MPH, FACOEM, an occupational medicine physician at the University of Colorado in Denver and a contributor to the American College of Occupational and Environmental Medicine (ACOEM) guideline on chronic pain management.
"Whenever these types of decisions are made, we should think carefully about all the consequences," says Mueller, who is president-elect of ACOEM.
Reevaluate patients after a week
Limiting prescription duration to 90 days will provide better control over the drug and help prevent overuse or abuse, she said. But physicians are often reluctant to prescribe Schedule II drugs, and that may leave some people with unresolved pain, she says. Schedule II drugs involve additional documentation and reporting requirements.
For example, some people can't metabolize codeine, which makes codeine-containing prescriptions ineffective for them. "We're going to have a failure in some patients," says Mueller. "If that's the main choice, then those patients might not get any pain relief or very little."
Patients should be reevaluated after a week on pain medications to ensure that they are getting adequate relief, she says.
Interestingly, even as the FDA moved to restrict use of hydrocodone products, the agency approved Zohydro ER, an extended-release capsule form of hydrocodone bitartrate.
The FDA is requiring the maker, Zogenix, to conduct post-marketing studies "to assess the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long term use beyond 12 weeks."
Zohydro ER provides another option for patients who need pain relief, the FDA said. "Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with [extended-release, long-acting] opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Zohydro ER is not approved for as-needed pain relief," the FDA said.