August 21, 2014

DEA change means no refills on much-abused painkillers | Charleston Gazette

Frequently abused painkillers like Vicodin and Lortab will soon be harder to come by, after the federal Drug Enforcement Agency moved Thursday to tighten restrictions on such drugs.

The DEA released a rule that will reclassify medications containing the painkiller hydrocodone in combination with other ingredients as Schedule II drugs, not Schedule III drugs. Schedule II is the strictest classification for drugs that have an accepted medical use. Schedule II drugs are defined as having high potential for abuse and abuse can lead to severe psychological or physical dependence.

The strongest prescription drugs, such as OxyContin and methadone, are already Schedule II drugs. Drugs that contain hydrocodone as their only active ingredient have been listed as Schedule II drugs since the Controlled Substances Act was passed more than 40 years ago.

The change officially will go into effect in 45 days. It means that prescriptions cannot be refilled and that they must be written by a doctor, rather than called in to a pharmacy. Doctors can still call in prescriptions for emergencies, but only for a seven-day supply of the drug.

In West Virginia, this will be the second tightening of hydrocodone regulations in the past few months.

Last spring, the Legislature unanimously passed a bill that limited hydrocodone prescriptions to no more than a 30-day supply and no more than two refills. The bill took effect in June.

Dave Gerkin, an inspector with the West Virginia Board of Pharmacy, said people were very upset when the state restrictions went into effect.

“They just had a fit when this new law came out,” Gerkin said. “They come in the pharmacies and beef about it . . . confusion and consternation, I guess. There’s just so many people that use this, and then there’s so many people that misuse it.”

Sen. Joe Manchin has, for much of his time in the Senate, pushed hard for the stricter classification for hydrocodone. He has proposed legislation and lobbied the Food and Drug Administration to recommend the change as a way of fighting what often is referred to as an epidemic of prescription painkiller abuse. The FDA recommended the change last October.

“For far too long, I have seen firsthand the devastating effects that these drugs have had on our communities,” Manchin, D-W.Va., said Thursday in a prepared statement. “Although there is much more that must be done to curb prescription drug abuse, I am confident that rescheduling hydrocodone will undoubtedly begin saving hundreds of thousands of lives immediately.”

West Virginia Attorney General Patrick Morrisey sent the DEA a letter in March, supporting the stricter regulations.

The DEA said it received more than 500 comments as it considered the change, with 52 percent being supportive and 41 percent opposing the reclassification.

In 2008, West Virginia had the nation’s second-highest rate of deaths from drug overdoses, according to a study by the federal Centers for Disease Control and Prevention.

A more recent study, from the Trust for America’s Health, a nonprofit group, found that West Virginia had the highest overdose rate in the country and that the death rate rose by more than 600 percent from 1999 to 2010.

The CDC study found that, in 2008, there were 14,800 deaths from prescription painkillers across the country, more than 470,000 emergency room visits because of prescription painkillers, nearly 2 million people abused or were dependent on the drugs and more than 12 million people were using painkillers for a nonmedical purpose.

By:  David Gutman