Despite widespread abuse of the narcotic hydrocodone and its ties to murders and robberies, federal regulators for 12 years have put off deciding whether to tighten controls over the addictive painkiller.
As The Associated Press reports, the Drug Enforcement Administration and Food and Drug Administration claim to still be actively studying whether medications with hydrocodone, which include Vicodin, should be reclassified as more-restricted Schedule II medications. That would require the drugs to be locked up in pharmacies, and prescribed only one bottle at a time. Patients also would need to provide an original prescription slip every time they buy the medication.
Currently, hydrocodone remains classified as a Schedule III drug. That means they can be refilled up to six times without a visit to a doctor, and physicians can renew prescriptions by phone or fax.
An investigation by the AP found that the review of the drug’s classification has bounced up and back between the two federal agencies since 1999 — and that officials say the analysis still is in the preliminary stage.
But Robert DuPont, president of the Institute for Behavior and Health, a Rockville, Md.,-based think tank, countered, “They aren’t doing a darn thing.”
“There’s no study that takes 12 years,” he said. “When you think how many people have died of hydrocodone overdoses, it’s inexcusable.”
The lack of action spurred 58 members of Congress in March to file a bill providing for the DEA and FDA rule-making process to be bypassed so that tougher controls on hydrocodone can be adopted.
From 2000 to 2009, emergency room visits due to non-medical hydrocodone use increased more than fourfold – from 19,221 to 86,258. In Florida, the drug killed 910 people and contributed to the deaths of 1,803 others from 2003 to 2007. In addition, drug cocktails containing the narcotic caused the death of actors Heath Ledger, Brittany Murphy and Corey Haim.
Hydrocodone seizures by police have skyrocketed from 13,659 in 2001 to 44,815 in 2010.
The proposal in Congress, however, has raised concerns among patients suffering from pain. Patricia O’Donnell, president of a support group for people with neurological diseases in Allentown, Pa., said many people depend on hydrocodone to maintain normal lives, and doctors, pharmacies and hospitals already are wary of treating such patients.”All of these doctors are so afraid that the FDA is going to come after them that they won’t prescribe these Schedule II drugs,” she said. “I know people are abusing hydrocodone, but if you reschedule it they’ll just find other things to abuse.”
Four decades ago, hydrocodone was given its Schedule III classification and primarily used as a cough suppressant. That was before scientists understood its potency, said Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, an advocacy group that wants tighter controls. “They made a terrible mistake,” he said.
The violent crime associated with the drug was underscored in June, when a man gunned down four people in a Long Island, N.Y., pharmacy and walked out with 11,000 hydrocodone pills.
Abbott Laboratories, which makes Vicodin, and Watson Pharmaceuticals, which makes Norco, another drug containing hydrocodone, said neither of the agencies has asked the company for information.
Charles Mayr, a spokesman for Parsippany, N.J.-based Watson, called the Long Island slayings “a terrible situation,” but said he wasn’t sure that reclassifying the drug would solve the crime problem and also protect patients. “We want to make sure these drugs get to patients who need them,” he said.
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