All hydrocodone products currently sold in the US are combined with another drug such as paracetamol (acetaminophen), aspirin, or an NSAID (non-steroidal anti-inflammatory). However a recent Notice of Proposed Rulemaking by the DEA aims to move these products (HCPs) from Schedule III to Schedule II, and is supported by the US Assistant Secretary for Health.
A statement from the DEA said its research “shows HCPs have a high potential for abuse and abuse may lead to severe psychological or physical dependence.”
“‘Monitoring the Future’ surveys of 8th, 10th, and 12th graders from 2002-2011 found that twice as many high school seniors used Vicodin, an HCP, non-medically as used OxyContin, a Schedule II substance, which is more tightly controlled,” said the Administration.
Production quotas
Placing a drug under Schedule II rather than III means doctors must write out the prescription and cannot call it in to pharmacists over the phone. Refills are also prohibited without the doctor seeing the patient again.
Drugs under Schedule II classification are furthermore subject by US law to manufacturing quotas “to prevent the aggregate of individual quotas from exceeding the amount determined necessary each year by the Attorney General.”
Volumes are fixed on October 1 each year by the Attorney General who considers national demand, each manufacturer’s inventory levels, the availability of raw materials and even emergencies such as strikes and fires. Drug makers who have already exceeded production before rules are implemented have the excess subtracted from the following year’s quota.
According to the law, volumes are calculated in terms of general quantities and not “in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance.”
400 liver deaths
Under the Controlled Substances Act of 1970, US law enforcement divides drugs into five classifications. Schedule I substances are completely banned and considered to have no therapeutic merit. Drugs are placed under Schedule II if they have medical uses but “a high potential for abuse,” such as amphetamines, oxycodone, morphine, and pure hydrocodone.
Schedule III, which currently comprises combined hydrocodone products, is for less addictive medicines. For now this group includes the hydrocodone/paracetamol combination drugs Lortab (UCB), Norco (Watson) and Vicodin (AbbVie), as well as hydrocodone/ibuprofen tablets such as Vicoprofen (AbbVie).
One reason makers combine other painkillers with hydrocodone is for a deterrent effect because of the toxicity of exceeding the recommended dose of, for instance, paracetamol. However in the US more than 400 people die yearly from liver poisoning caused by acetaminophen (paracetamol).
Controversially, the FDA will this month release the US’s first hydrocodone-only drug, Zohydro. Addiction campaigners have petitioned against the launch, saying the Schedule II drug is open to abuse. Other extended-release, hydrocodone-only pills are rumoured to be in the pipeline for Purdue, Cephalon and Egalet.
Almost 5m Americans over 12 years old abuse pain drugs, outstripping sedative and stimulant misuse, according to a 2012 survey. US pharmacy chain CVS is under federal investigation this week after it emerged hydrocodone pills – 37,000 according to the LA Times – had been diverted from four of its California stores.
The Notice of Proposed Rulemaking (NPRM) will be open for public comment until April 27, after which time the DEA will publish a Final Rule.