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DEA Tightens Rules for Hydrocodone Combo Pills

Change will affect how arthritis patients are able to access the popular pain reliever.

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The government is tightening controls on pain medications that contain hydrocodone, the most frequently prescribed opioid in the country. The U.S. Drug Enforcement Administration (DEA) is moving hydrocodone combination products – such as Vicodin, Lorcet and Lortab – from Schedule III to the more restrictive Schedule II category of controlled substances in recognition of their highly addictive nature. People with arthritis are often prescribed these medicationsto relieve joint pain.

“This will actually affect patient access to the medication,” explains Donald Miller, PharmD, chair of the Pharmacy Practice Department at North Dakota State University in Fargo. “Schedule II is the strongest level of control on a legal prescription drug.”

Once the change goes into effect, on October 6, patients will be limited to a single 90-day supply. No refills will be allowed, so a new prescription will be needed each time the medication runs out. Written prescriptions will also be required by pharmacies, although in emergencies, oral or faxed prescriptions may be accepted. In some states, non-physicians – such as nurse practitioners and physician assistants – may not be able to prescribe them. Pharmacies will also be subject to increased controls and recordkeeping on the drugs.

The DEA notes that hydrocodone, which is taken orally for moderate to severe pain, “is associated with more drug abuse and diversion than any other licit or illicit opioid.”

The Controlled Substances Act has five schedules (or categories) for potentially dangerous medications associated with a high risk of addiction and abuse. Schedule I medications (such as heroine and LSD) are illegal in the U.S., and each subsequent schedule represents a step down in terms of the risk of harm, abuse and misuse.

Hydrocodone, as a single-ingredient product, has always been a schedule II drug; this change from schedule III to schedule II includes so-called combination products that contain ibuprofen or acetaminophen in addition to hydrocodone. They are available as both brand name and generic products.

The DEA says the change had been evaluated and debated for more than a decade; the change was initially requested in 1999. A U.S. Food and Drug Administration (FDA) advisory committee voted 19 to 10 in favor of the change in 2013.

In a press release, DEA Administrator Michele Leonhart explained the reason behind this decision: “Almost 7 million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents.”

Although most patients with arthritis may use these types of drugs responsibly, Miller says this change is a good chance for people to recognize that the regular, long-term use of a product with both hydrocodone and a second analgesic is not generally recommended.

“It is better to individualize the dose of each drug – to use hydrocodone and any other analgesic in separate pills, individualized to the patient – because one may be taking excessive and unneeded medication otherwise,” says Miller, who specializes in rheumatology and serves on the FDA Arthritis Advisory Committee.

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