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DEA imposes tighter restrictions on hydrocodone combination products

September 09, 2014

By Kelly Soderlund

PHoto of Dr. Unger
Dr. Unger
The Drug Enforcement Administration is reclassifying hydrocodone combination products and subjecting them to tighter restrictions.

Hydrocodone combination products, which include opioids such as Vicodin, Lorcet, Lortab and Norco, will be reclassified as Schedule II substances, effective Oct. 6. The DEA says the reclassification will protect public health and safety by reducing the potential for abuse, dependence and diversion of the highly addictive substances, while still ensuring that they're available to patients with a legitimate medical need and who have an ongoing consultation with their health care professional.

"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 news release. "(This) action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available."

Hydrocodone combination products are the most frequently prescribed drugs in the United States and more than 137 million prescriptions for hydrocodone combination products were written in 2013, according to the DEA.

The Centers for Disease Control estimates that more than 27,000 people die from opioid-related causes each year.

The Controlled Substances Act places substances with accepted medical uses into one of four schedules. Schedule II contains the substances with the highest potential for harm and abuse. Hydrocodone combination products, which were previously under the less restrictive Schedule III, are drugs that contain both hydrocodone and specified amounts of other substances, such as acetaminophen or aspirin.

"With such a short implementation time before the new rule goes into effect, dentists will have to make sure they are properly credentialed to continue to prescribe these drugs as needed for their patients," said Dr. Joseph Unger, vice chair of the ADA Council on Dental Practice. "In the long run, it could mean higher office overhead."

The ADA Center for Dental Practice created a frequently asked questions on the new regulation, available here.