Magazine article Clinical Psychiatry News

DEA Moves Hydrocodone Products to Schedule II

Magazine article Clinical Psychiatry News

DEA Moves Hydrocodone Products to Schedule II

Article excerpt

The Drug Enforcement Administration is making it harder to prescribe hydrocodone combination products.

The move was expected, as the agency proposed in February to move hydrocodone combinations from schedule 111 to schedule II in response to requests from both the Department of Health & Human Services and the Food and Drug Administration.

Some physician groups have opposed the move, saying that it will lead to more administrative burdens, do nothing to curb abuse and diversion, and potentially decrease access to medications.

The DEA published the final rule on the rescheduling in the Federal Register on Aug. 22. Manufacturers, distributors, and prescribers will have to comply by Oct. 13.

The agency said it is time to rein in opioid prescribing and that rescheduling will help accomplish that goal.

"Almost 7 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 in a statement. "Today's action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available."

Hydrocodone combination products were placed on schedule III by Congress in 1970 when it created the Controlled Substances Act, in part because it was believed that adding acetaminophen or other nonnarcotics might lessen the abuse potential. Hydrocodone itself was placed on schedule II. Now, "the scientific, medical, and epidemiological data are robust and support rescheduling [of hydrocodone combination products] into schedule II," the final rule said.

Data show that the products are widely diverted and abused at rates similar to that of oxycodone products, which are schedule II, said the agency, which added that abuse is associated with severe psychological or physical dependence, and many are being admitted to addiction treatment.

The hydrocodone combinations are also associated with large numbers of deaths, said the agency. More than 16,000 deaths in 2010 were tied to abuse of opioids, including hydrocodone combinations, according to the DEA.

About 137 million prescriptions for hydrocodone combinations were dispensed in 2013, the agency said. The most frequently prescribed combination is hydrocodone/acetaminophen.

In comments to the proposed rule in April, the American Medical Association, along with a group of organizations and companies in the long-term care field, asked the agency to delay the final rule until an exception was made for nursing homes and other long-term care facilities. …

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