TAMPA — By the time they see Dr. Benito Torres, cancer patients just out of surgery need a strong painkiller. A pain specialist on staff at H. Lee Moffitt Cancer Center, Torres typically prescribes medication like Vicodin or Lortab, which both deliver the powerful drug hydrocodone.
What happens after the pill bottle is empty, but the pain continues? Torres can phone in refill orders to pharmacies. But that would change under a proposal to put new restrictions on painkillers containing hydrocodone.
Facing an unrelenting prescription drug abuse crisis, the U.S. Food and Drug Administration may reclassify hydrocodone into the most restricted category of legal drugs. The move would prohibit refills, meaning patients would have to return to their doctors for a new prescription.
Supporters say the move is long overdue, arguing it will force doctors to think twice before handing out a potentially addictive drug that is the most-prescribed painkilling medication in the nation.
"The net result might be less prescribing or more careful prescribing," said Len Paulozzi, a U.S. Centers for Disease Control and Prevention medical epidemiologist. "If it's prescribed less liberally, then it might be less likely to fall into the hands of people who abuse it."
But critics say there's no strong evidence that reclassifying a drug curbs abuse. Legitimate patients, they say, will bear the burden of further restricting hydrocodone by having to face the expense and trouble of additional trips to the doctor's office.
"To make them get out of their home after they just had surgery and drive over here to see me, that's not the best for care," Torres said of his patients. "Obviously (federal regulators) are trying to protect the population. But I think they're going a little overboard. And it's going to affect people who have limited ability to get to their doctors."
Nursing home advocates say the change could be a particular burden for frail residents. And it could have a chilling effect on doctors, who already are more skittish about prescribing pain medications after the creation of Florida's prescription drug monitoring database, said LuMarie Polivka-West, senior director of policy for the Florida Health Care Association, which represents most of the state's nursing homes and assisted living facilities.
Her concern is that pain among the elderly — especially those with dementia — already is undertreated. "They need to look at this very carefully," she said.
Hydrocodone belongs to a class of drugs called opioids, which also includes oxycodone, morphine and heroin. It is sold in combination form, typically with acetaminophen. When the federal Controlled Substances Act went into effect in 1971, hydrocodone was listed as a Schedule III drug, meaning it comes with fewer restrictions than such Schedule II drugs as Oxycontin and Percocet, both of which contain oxycodone.
At the time, hydrocodone medications were thought to be less addictive, perhaps in part because they contained other substances that limited the maximum safe dosages, according to a 2004 DEA report.
But since the 1990s, hydrocodone-containing drugs have become the most widely prescribed painkiller in the nation. In 2011, nearly 131 million prescriptions for hydrocodone drugs were dispensed to 47 million patients, according to an FDA report. That was up from 100 million prescriptions in 2004.
About 40 percent of the prescriptions for hydrocodone drugs were written by primary care doctors and internal medicine specialists, the report says. Another 10 percent were written by dentists.
Clearwater rheumatologist Adam Rosen said he thinks too many patients whose pain could be addressed with less potent drugs are getting hydrocodone. He said the patients for whom he prescribes hydrocodone drugs have severe arthritis, in many cases in the spine. "They really, truly need it," he said.
Small-scale studies show that patients who have severe pain that lasts only a day or two — such as after some surgeries — get 10- or 30-day supplies of hydrocodone. Often the unused pills sit in their medicine cabinets, where they can end up in the hands of people with no medical need, such as teens, according to the American Academy of Pain Medicine.
"I think rather than reclassify the medicine they should reclassify which doctors can prescribe," Rosen said.
Paulozzi, the CDC epidemiologist, said multiple studies have shown hydrocodone is as addictive as oxycodone and should be regulated as such. A drug's potential for addiction is a key factor in any decision to move it into a stricter category.
He acknowledged that oxycodone is heavily abused though it's already in the most restrictive category. But if it weren't a Schedule II drug, oxycodone abuse "might be worse,'' he said.
Dr. Richard Goldberger, an orthopedic surgeon in Tampa, said hydrocodone drugs work well for his patients with post-operative pain. But even now, he rarely just calls in refills without seeing the patient again.
The U.S. Drug Enforcement Agency cites other factors supporting the reclassification. Since 2009, hydrocodone has been second only to oxycodone in prescription drugs seized at crime scenes.
But the FDA, which turned down an earlier request to reclassify the drug, has said in the past that the abuse potential is not clear cut. A report prepared last October for the FDA advisory panel found a lack of consistent data suggesting hydrocodone-combination drugs carry enough abuse potential to be reclassified.
By some measures, hydrocodone drugs haven't been as risky as those containing oxycodone. In 2009, for instance, the rate of emergency room visits per 1 million prescriptions was more than twice as high for oxycodone drugs as hydrocodone, according to the FDA report.
A report by Florida Department of Law Enforcement last year cited hydrocodone as the cause of death in 307 people in 2011, compared with 1,247 deaths caused by oxycodone. The five deadliest drugs in the state that year were heroin, methadone, oxycodone, the painkiller fentanyl and alprazolam — better known as Xanax, an anti-anxiety drug that is more lightly regulated than hydrocodone.
John Coleman, president of the Prescription Drug Research Center in Virginia, said he expects drugs like Xanax will be next on the list for new restrictions. But with nearly two dozen firms making hydrocodone medications, he said, adding restrictions to its use is not a done deal.
"This is a $2 billion a year market," he said. "Those guys are going to protect the market."
Jodie Tillman can be reached at [email protected] or (813) 226-3374.