The Food and Drug Administration is recommending new restrictions on prescription medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the US.
In a major policy shift, the agency said in an online notice Thursday that hydrocodone-containing drugs should be subject to the same restrictions as other narcotic drugs like oxycodone and morphine.
Technically, the change involves the reclassification of hydrocodone-containing painkillers as Schedule II medications from their current classification as Schedule III drugs. The scheduling system, which is overseen by the Drug Enforcement Administration, classifies drugs based on their medical use and their potential for abuse and addiction.
Schedule II drugs are those drugs with the highest potential for abuse that can be legally prescribed. They include painkillers like oxycodone — the active ingredient in OxyContin — methadone and fentanyl, as well as Adderall and Ritalin, which are prescribed for attention deficit hyperactivity disorder.
This means patients would have to have a written prescription from a doctor — instead of a prescription submitted orally over the phone — to access the drugs. And refills would be prohibited; patients would have to check in with the doctor to get another prescription.
In an online statement posted Thursday, the FDA said it “has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States.”
Approximately 80% of the world’s pain pills are consumed in the United States, according to 2011 congressional testimony from the American Society of Interventional Pain Physicians. Since 1999, sales of prescription painkillers in the United States have quadrupled. So have the number of fatal poisonings from prescription painkillers. One person dies every 19 minutes from a prescription drug overdose in the United States. Almost twice as many people abuse prescription drugs as the number of people abusing cocaine, heroin, hallucinogens and inhalants combined, the DEA says.
In a telephone interview with the New York Times, Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, said that F.D.A. officials were aware that changing the prescribing rules would affect patients. She said, however, that the impact on public health caused by the abuse of the drugs as well as their medical use had reached a tipping point.
“These are very difficult trade-offs that our society has to make,” she said. “The reason we approve these drugs is for people in pain. But we can’t ignore the epidemic on the other side.”
The law is expected to go into effect in 2014.
If you or someone you love is struggling with prescription drug addiction, please call 1-800-951-6135.