DEA to tighten control of a type of pain pill

Jeanmarie Perrone, at the Hospital of the University of Pennsylvania, was pleased to hear Thursday's news about the new opioid restrictions.
Jeanmarie Perrone, at the Hospital of the University of Pennsylvania, was pleased to hear Thursday's news about the new opioid restrictions. (MICHAEL BRYANT / Staff Photographer)
Posted: August 23, 2014

One type of opioid painkiller - among the most commonly prescribed, abused, and misused medications in America - will soon be more difficult to obtain.

The Drug Enforcement Administration will publish new rules in the federal register Friday reclassifying hydrocodone combination drugs from Schedule III to the more-restrictive Schedule II. The rules kick in 45 days later.

Opioid painkillers are highly addictive. People young and old have intentionally or accidentally misused them so frequently in recent years that overdose deaths now exceed those from cocaine and heroin, according to the Centers for Disease Control and Prevention.

The DEA, citing IMS Health figures, said nearly 130 million prescriptions for hydrocodone products were written in 2013 in the United States, far more than anywhere else in the world.

Until this change, prescriptions for brand-name hydrocodone-based drugs such as Vicodin and Lortab, plus hundreds of generic versions, could be renewed up to five times without seeing a health-care professional. Under the new rules, a 90-day supply will be the limit without another visit. Some states also prohibit physician assistants or nurses from writing these prescriptions.

Hydrocodone alone had been a Schedule II drug since 1970, when Congress passed the Controlled Substances Act. But the law said that when hydrocodone was combined with substances such as acetaminophen or ibuprofen or aspirin, it would be a less-restrictive Schedule III drug. That made it easier to prescribe and obtain - and abuse.

"This move - which closed the Vicodin loophole - will help bring the opioid addiction epidemic under control because it will lead to fewer pain patients and recreational users becoming addicted," said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing.

Kolodny was among the doctors critical of the Food and Drug Administration for being slow to move toward restricting hydrocodone combination drugs, and for approving last November a hydrocodone-only Schedule II drug called Zohydro.

The Generic Pharmaceutical Association, which represents many hydrocodone manufacturers, declined comment Thursday, but urged the DEA in April to avoid restricting legitimate use and give time for smooth adjustments to the supply chain.

Jeanmarie Perrone was pleased by Thursday's news. She is tired of seeing the blue faces of overdose patients arrive in the emergency room at the Hospital of the University of Pennsylvania. A professor and director of medical toxicology, Perrone was among the FDA advisory committee members who voted for this change in January 2013.

She has long worried that, besides the intentional and acute abuse in search of a high, many middle-aged patients slowly but steadily get addicted to the point that their hearts simply stop pumping enough blood and they die in their sleep.

"I believe this move will help to educate prescribers and patients that these hydrocodone products do carry risk of addiction consistent with the additional safety measures needed with Schedule II substances such as oxycodone," Perrone said. "Hopefully, this will remind practitioners that these drugs should be prescribed with appropriate caution."



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