WASHINGTON — The federal government tightened restrictions on prescribing the most common form of painkiller in the country Thursday, the final step in a policy shift that has been years in the making.
The stricter rule for hydrocodone, which is the most widely prescribed painkiller in the United States and which is an ingredient in medications such as Vicodin, Lortab and their generic equivalents, is one of the most far-reaching efforts to stop the growing epidemic of prescription-drug abuse.
More than 20,000 Americans die every year because of prescription-drug abuse, according to federal data.
The rule places hydrocodone in a tougher, more restrictive category, and the changes it requires are substantial. Doctors will no longer be able to phone in prescriptions, and patients will be limited to one 90-day supply of medication and will have to see a health-care professional to get a refill. In many states, only doctors will be able to prescribe the medications, not nurses or physician assistants.
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The drug will have to be kept in special vaults in pharmacies. The Drug Enforcement Administration (DEA) published the rule Thursday; it will take effect in 45 days.
“This is substantial,” said Dr. Nathaniel Katz, assistant professor of anesthesia at Tufts University School of Medicine in Boston. “It’s a sign of a shift toward more cautious opioid prescribing.”
He added: “This will be an inconvenience to some, but policy is a machete, not a scalpel, and you have to figure out where to use it. I think people will be more helped than harmed.”
The move comes more than a decade after the DEA first recommended reclassifying hydrocodone due to its risks for abuse and addiction. For years, physician groups and the Food and Drug Administration (FDA) opposed the change, saying it would burden health-care providers and patients while driving up costs. Last year, the FDA changed its position, citing the national epidemic of overdoses and deaths tied to the drug.
Abuse of painkillers kills more Americans than heroin and cocaine combined, according to federal data, and the number of Americans who die from prescription-drug overdoses has more than tripled since the late 1990s. Prescription drugs account for the majority of all U.S. drug-overdose deaths. In all, drug-induced deaths have outstripped those from traffic accidents.
Sen. Joe Manchin III, D-W.Va., whose state is among those hardest hit by the epidemic of painkiller abuse, applauded the change. He called the shift “a tremendous step forward in fighting the prescription drug-abuse epidemic.”
The change is sure to draw strong criticism from some pain-management experts, who argue that the rule creates unfair obstacles for patients in chronic pain, making it harder, for example, for those who cannot easily make a trip to the doctor.
Other experts point out that the change will not necessarily lead to less abuse. For example, oxycodone, another abused painkiller and the main ingredient in OxyContin, has been in the more restrictive category since it came on the market. Oxycodone and methadone account for far more overdose deaths than hydrocodone.
Dr. John Mendelson, a professor of medicine at the University of California, San Francisco, and an addiction specialist, said he expected the change would lead to an increase in prescriptions of other drugs such as oxycodone, and a rise in the use of heroin, which has been increasing as towns and cities crack down on prescription-drug abuse. He said he believed the small decrease in addiction to prescription drugs that the changes could bring would probably be offset by an increase in heroin use.
Material from The Associated Press is included in this report.