The U.S. Drug Enforcement Administration is putting tighter controls on the nation’s most widely prescribed narcotic painkiller in a move to stem an epidemic of addiction, overdose and death.
The agency said it would publish a rule Friday to place hydrocodone combination products, such as Vicodin and Norco, in the same category as other frequently abused medications, including OxyContin and fentanyl.
Once the rule takes effect in 45 days, all hydrocodone products will be considered Schedule II drugs — pharmaceuticals with accepted medical uses but also the highest potential for harm and abuse. Patients will see new restrictions on prescriptions and refills, and pharmacies will have to follow stricter procedures for handling and storage of the drugs.
Hydrocodone products are among the most commonly prescribed drugs in the U.S. Americans consume 99% of the hydrocodone produced worldwide, according to the International Narcotics Control Board.
But these drugs and other narcotic painkillers cause or contribute to more than 16,000 deaths annually, a death toll greater than for heroin and cocaine combined. As a result of a surge in prescription overdoses, drug fatalities have surpassed deaths from motor vehicle crashes, long the leading cause of accidental death in this country, according to the U.S. Centers for Disease Control and Prevention.
A Los Angeles Times analysis of 3,733 prescription-drug-related fatalities in Southern California from 2006 through 2011 found that hydrocodone was involved in 945 of the deaths, more than any other prescription medication.
Doctors have prescribed painkillers containing hydrocodone and acetaminophen with few restrictions since the combination drugs were introduced four decades ago. Because of the perception that products like Vicodin are less risky than other narcotic painkillers, they are widely prescribed by general practitioners and dentists.
But drug enforcement officials have long complained that hydrocodone is widely abused.
“Almost 7 million Americans abuse controlled-substance prescription medications, including opioid painkillers,” DEA Administrator Michele Leonhart said Thursday. “Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”
For years, the U.S. Food and Drug Administration resisted tighter rules on hydrocodone products out of concern that they would make it more difficult for patients with legitimate pain to obtain the medication. The DEA asked the agency to reconsider its position in light of the drug’s widespread availability on the black market.
In early 2013, the American Academy of Pain Medicine sent an FDA advisory panel a letter saying that although it had some concern that tighter rules could curtail legitimate prescribing, it did not oppose moving hydrocodone to Schedule II.
Days later, the advisory panel voted 19 to 10 in favor of greater restrictions, setting the rescheduling process in motion.
In seeking to stem the increase in fatal drug overdoses, authorities have focused on how addicts and drug dealers obtain prescription narcotics illegally, such as by stealing from pharmacies or relatives’ medicine cabinets. The Times investigation, however, found that many fatal overdoses were caused by drugs prescribed for the deceased by a doctor.
In nearly half of the prescription drug fatalities in four Southern California counties, medications prescribed by physicians caused or contributed to the death, according to The Times analysis of coroners’ records.
In response to the investigation, Gov. Jerry Brown signed two bills aimed at cracking down on reckless prescribing. And Proposition 46, a ballot initiative that will go before California voters in November, would require doctors to check the state’s prescription drug monitoring program, known as CURES, before prescribing powerful drugs such as Vicodin.