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Hydrocodone bitartrate and acetaminophen pills, also known as Vicodin, are arranged for a photo at a pharmacy in Montpelier, Vt. / Toby Talbot, AP

Tough new restrictions on the powerful, highly addictive hydrocodone combination painkillers, such as Vicodin, will take effect in mid-October as the federal government elevates the opioid drug to Schedule II under the Controlled Substances Act.

The notice, to be published Friday in the Federal Register, announces that the change takes effect in 45 days.

The move from Schedule III to Schedule II follows years of requests from the Drug Enforcement Administration, which argued that the drug was overprescribed, creating drug addictions and too often diverted to the black market. The move required approval from the Food and Drug Administration, the Department of Health and Human Services and a years long hearings and comments process.

The Controlled Substances Act places drugs into five categories. Drugs in Schedule I, such as LSD and heroin, are determined by the Food and Drug Administration to have no medical use and are illegal. Drugs in Schedule II have an accepted medical use, but also have high potential for abuse.

Hydrocodone, by itself, has been listed in Schedule II along with oxycodone, another powerful pain medicine in such pills as OxyContin, since 1971, when the Controlled Substances Act took effect. The new rule adds drugs that contain both hydrocodone and other substances such as ibuprofen or acetaminophen.

For the millions of patients who rely on drugs such as Vicodin or Lortab for relief from severe pain, the new rules will sharply reduce how many pills a doctor can prescribe for them at one time. Doctors, who under schedule III could prescribe a six-month supply as a 30-day prescription with up to five refills, will now be limited to a three-month supply under schedule II. The rule also mandates that doctors must write the prescriptions in 30-day increments that can only be filled sequentially. Pain patients using the drugs will have visit their doctors every three months for a new prescription.

The change also adds a new layer of regulations manufacturers and pharmacies, which must keep the drugs under tighter security and keep more extensive records.

Opiate painkillers are among the most abused prescription medicines in the U.S., DEA Administrator Michele Leonhart said in a statement. Adding non-narcotic drugs, such as aspirin, to narcotic painkillers doesn't make them less addictive, Leonhart said. Monitoring the Future's survey of high school seniors found that twice as many of the students abused Vicodin than abused the more tightly controlled narcotic painkiller OxyContin.

"Today's action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available," Leonhart said.

The DEA first attempted to get Vicodin rescheduled in 2004, but the FDA rejected that request in 2008, arguing that the hydrocodone combination drugs had less abuse potential than other drugs in schedule II, such as oxycodone. The FDA changed its position in 2013 as reports of abuse and overdoses grew . The Department of Health and Human Services approved the change in December.



Copyright 2014USA TODAY

Read the original story: Narcotic pain pills to face tougher regulations

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