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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 III to schedule II in response to requests from both the U.S. 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 will publish 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 non-narcotics 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," according to the final rule.
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 due 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. The AMA’s House of Delegates had also voted in 2013 to oppose rescheduling.
The American College of Emergency Physicians also urged against rescheduling, telling the DEA in April that it would not likely solve the abuse and diversion problems, but would lead to a greater administrative hassle for physicians.
The DEA said it received 573 comments after it proposed rescheduling, with 52% in favor, 41% opposed, and 7% taking no position. The agency received the most comments from the general public (44%; 250 comments) and pharmacists and pharmacy students (21%; 122 comments), physicians (13%; 73 comments), patients (6%; 35 comments), and midlevel practitioners (5%; 31 comments). Just over half of the physician comments supported, or supported with qualification, rescheduling.
Most of the commenters who were opposed to rescheduling were pharmacists, pharmacy students, and patients. Those opposed were concerned about how it would affect prescribing practices and patient access to medicine, and how it might impact long-term care facilities. Commenters also said that it would not prevent abuse or diversion.
The DEA said that although moving to schedule II does, for instance, prohibit refills, it would not necessarily block physicians from writing prescriptions for supplies of longer than 30 days, or from writing multiple prescriptions at once. State laws might have limits, however, and those will take precedence over the DEA rule.
The DEA rescheduling follows an FDA advisory committee recommendation in Jan. 2013 to do so, and the FDA’s backing of the proposal in Oct. 2013. HHS followed with its own recommendation to the DEA.
In comments on the proposed rule, manufacturers and pharmacies asked for more time to implement the rescheduling, but the DEA said no, citing high rates of abuse, overdose, and deaths relating to hydrocodone combination products.
The rescheduling goes into effect on Oct. 13, 45 days from the date of the rule’s publication in the Federal Register.
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