The Drug Enforcement Administration said it would reclassify hydrocodone combination drugs such as Vicodin and put them in the category reserved for medical substances with the highest potential for harm. The "rescheduling" means people will be able to receive the drugs for only up to 90 days without obtaining a new prescription.
The opioid pills are taken by millions of Americans, including after dental surgery, for back problems and broken bones. Currently the pills can be refilled up to five times and prescriptions can cover a 180-day period. The new classification will take effect in 45 days, the DEA said.
"Today's action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available," said DEA Administrator Michele Leonhart.
The change means that, in most instances, patients will have to present to a pharmacy a prescription from a health-care provider and no longer can rely on a phoned or faxed-in one.
The move had been resisted by drug makers, wholesalers, drugstores and patients with pain. They said there were other ways to reduce painkiller abuse and were concerned that people suffering acute pain could be harmed by barriers to treatment.
Seriously ill patients will now have to visit their doctors more often than necessary to receive the drugs, said Mark Fleury, a policy analyst at the American Cancer Society Cancer Action Network, a lobbying group that opposed the change. The move also will limit the ability of nurse practitioners and physician assistants to prescribe the drugs in some states, he said.
Most people who abuse prescription drugs illicitly obtain them from friends or relatives with legitimate prescriptions, said David Belian, a spokesman for Actavis PLC, a maker of generic hydrocodone-based medications. He added in an interview that the change "will place a significant burden on patients, the vast majority of whom use them in a legitimate manner."
The new restrictions also will place additional burdens on pharmacies, which will have to store the drugs in secure locations, said John Norton, a spokesman for National Community Pharmacists Association.
Antiaddiction advocates said the decision would prompt health providers to be more vigilant about how they store the drugs and offer them to patients.
"If you're treating someone with a condition so painful they require treatment with a highly addictive drug, that's someone who should be monitored closely," said Andrew Kolodny, chief medical officer for the nonprofit addiction treatment organization Phoenix House, who campaigned for the change for five years.
The Centers for Disease Control and Prevention has said that more than 16,500 people died after overdosing on opioid-based painkillers in 2010. No other class of drugs, legal or illegal, is responsible for as many deaths, its figures show.
Hydrocodone combination drugs are largely sold as generics. Major makers include Teva Pharmaceutical Industries Ltd. and Mallinckrodt PLC. A few are known by brand names, including Vicodin, made by AbbVie Inc.
Mallinckrodt said it backed the DEA's decision as part of a "comprehensive approach" to reduce opioid abuse. "We do not believe the rescheduling of these hydrocodone combination products is likely to have a significant impact on our business," said Lynn Phillips, a Mallinckrodt spokeswoman.
Some 127.86 million prescriptions for them were dispensed in the U.S. in 2013, down 6% from 2012, according to data provider IMS Health Holdings Inc. Sales reached $1.05 billion in 2013, up 21% from 2012, IMS estimated.
The DEA in 2009 asked the Department of Health and Human Services to weigh in on the merits of rescheduling. The Food and Drug Administration, a unit of HHS, said nine months ago that the drugs should be reclassified.
Hydrocodone combination pills had been in the less-restricted category since 1970, when Congress passed the Controlled Substances Act that set the categories used by the federal government. Pure hydrocodone drugs had always been in the highest category for medical substances, the DEA said.
Linden Barber, a former DEA attorney who now heads DEA compliance operations with the law firm Quarles & Brady LLP in Indianapolis, said he didn't believe the action would have a significant impact, given abuse of drugs such as OxyContin that already had tougher classifications.
He also warned that it was possible that doctors would lose any incentive to prescribe lower-strength hydrocodone combination products once they entered the same category as higher-strength products.
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