The U. S. Drug Enforcement Administration issued a final rule in the Federal Register today to move certain narcotic pain medications, including some commonly prescribed for back pain and other work-related injuries, into a more strictly regulated drug category. The action is part of government efforts to reduce widespread opioid addiction and abuse.
Effective Oct. 6, 2014, the rule moves hydrocodone combination products (HCPs) from Schedule III to the more-restrictive Schedule II category of drugs. HCPs are the most frequently prescribed drugs in the United States. Production of HCPs increased from 15,359 kilograms in 1998 to 63,338 kilograms in 2012 in response to higher volumes of prescriptions for painkillers.
According to the National Council on Compensation Insurance, narcotics account for 25 percent of workers’ compensation drug costs. More than 45 percent of costs are for drugs with Oxycodone HCL as an active ingredient.
Schedule III medications can be refilled up to five times and prescriptions can cover a 180-day period. Under Schedule II, a new prescription is required after 90 days; refills are not allowed. Prescription and dispensing rules are contained in 21 CFR part 1306 and subpart C of 21 CFR part 1311.
“Almost 7 million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” said DEA Administrator Michele Leonhart. “Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”