The U.S. Drug Enforcement Administration (DEA) is going ahead with tough new controls on painkillers containing hydrocodone, which has been tied to a surge in dangerous addictions across the United States.
The new restrictions would cover prescription narcotic drugs such as Vicodin, Lortab and their generic equivalents, putting them in the same regulatory class as painkillers such as Oxycontin, Percocet and codeine. Patients will now only have access to a three-month supply of the drug and will have to see a doctor to get any refills.
The new rules, posted online by the DEA on Thursday, come more than 18 months after a U.S. Food and Drug Administration advisory panel met to discuss the fate of painkillers containing hydrocodone. That 2013 meeting followed the DEA's request for an FDA panel review on the issue. The painkillers were previously classified as Schedule III drugs, but the DEA wanted them placed under the more restrictive Schedule II designation.
"Almost seven million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents," DEA Administrator Michele Leonhart said Thursday in a news release. "Today's action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available."
One expert applauded the move toward stricter oversight.
"Moving hydrocodone-combination products into DEA Schedule II for controlled substances will have several important effects," said addiction psychiatrist Dr. Eric Collins, physician-in-chief at Silver Hill Hospital in New Canaan, Conn. "It will relatively rapidly reduce the now very easy availability of hydrocodone -- this will help mitigate the rapid growth we've seen in the last 20 years in addiction to opioid [narcotic] pain relievers and heroin."
Collins also believes the move will "reduce both the number of new initiates to opioid use and the number of accidental and intentional overdose deaths. This change is both most welcome and long overdue."
Janina Kean, president and CEO of High Watch Recovery Center in Kent, Conn., said she thinks the DEA's new regulations "will have more of an impact on the adult population or individuals inappropriately prescribed very strong narcotics for mild operative procedures, than it will for the nation's adolescents, a population where 96 percent of substance abuse starts."
The new regulations, Kean added, should reduce the availability of "prescription drugs developed for excruciating pain from being used to treat much less severe ailments like dental procedures or minor surgery."
But she foresees potential problems with the stricter regulations. "With access to drugs like Vicodin and Percocet limited by the regulations and harder to obtain, we may end up seeing a trend of [teens] skipping the pills and going straight to heroin," she said.
The regulation of prescription painkillers has been a contentious issue.
Supporters of a move to a more restrictive Schedule II status pointed to tragic deaths and suicides that have been the result of misuse of these prescription drugs.
But, opponents of the tougher classification fear that tightening access to the drugs would mean that people who really need them to ease pain would not be able to get them.
Few people dispute the fact that too many of these opioid drugs are too widely available, even though the pharmaceutical industry has recently developed "abuse-resistant" formulations to help fight misuse.
Overall, some 22 million Americans have misused prescription painkillers of one kind or another since 2002, according to a report released by the U.S. Substance Abuse and Mental Health Services Administration. The agency noted that prescription painkillers now rank only behind marijuana as a drug of abuse in the United States.