The federal government will tighten restrictions on narcotic painkillers made with hydrocodone in order to curb the widespread abuse of prescription opioids.
Under new rules published Friday by the Drug Enforcement Administration (DEA), patients seeking painkillers such as Vicodin, the most widely prescribed drug in the United States, will only be allowed one 90-day prescription and would have to see a doctor to get a refill. Doctors won’t be allowed to call in the prescriptions on the phone, and in some states, nurses or physician assistants won’t be able to prescribe the drugs. Pharmacies will be required to keep the drugs in special vaulted areas.
The new restrictions, which go into effect in 45 days, will re-classify hydrocodone combination drugs like Vicodin and Lortab in the same category as codeine and oxycodone, which are considered Schedule II drugs because of their high potential for abuse.
“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 release. “Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”
Overdose deaths from prescription painkillers have more than tripled in the last 20 years, according to the CDC, killing 15,000 people in 2009, more than cocaine and heroin combined. At the same time, the sale of opioids has also increased by 300 percent since 1999.
The move represents a major policy shift from the Food and Drug Administration, which until 2013 rejected multiple bids from the DEA and anti-addiction groups to reclassify hydrocodone combination drugs as Schedule II under the Controlled Substances Act. Highly addictive narcotics such as cocaine, methamphetamine and methadone are also designated Schedule II drugs.
Until now, Vicodin and other hydrocodone combination drugs — which are made with a limited amount of hydrocodone or are combined with non-addictive drugs like acetaminophen — were Schedule III. That meant they were considered to have a “moderate to low potential for physical and psychological dependence,” and patients could be prescribed a six-month supply without going back to the doctor. Hydrocodone itself is considered Schedule II.
Some medical groups have expressed concern that tighter regulations could overburden pharmacies or make it more difficult for people with pain problems to obtain prescriptions.
But supporters say the restrictions are the most important step in curtailing addiction. “Regardless of the painkiller that they’re using, if you speak with them, nine times out of 10, they’ll tell you that their addiction began with use of Vicodin, either medical or recreational,” said Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, in reference to people who are addicted to prescription painkillers.
A 1999 doctor petition to the DEA to reclassify hydrocodone combination drugs led the agency in 2004 to ask the Department of Health and Human Services (HHS) for a scientific and medical evaluation of their scheduling recommendations for the drugs. In 2008, HHS recommended that they remain Schedule III. The following year, DEA asked HHS to reevaluate that data and provide another recommendation. With the passing of the 2012 Food and Drug Administration Safety and Innovation Act, the FDA gathered a panel of experts to discuss tighter regulations of drugs containing hydrocodone, and in 2013 it reversed its position, citing concerns about “abuse and misuse.”
“This is probably the single most important change that could happen on a federal level to bring this public health crisis under control,” Kolodny said. “It will take time to see the impact, but this will turn out to be a turning point in this epidemic.”