Hydrocodone bitartrate and acetaminophen pills, also known as Vicodin. The FDA recommended new restrictions on prescription medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.

Toby Talbot, Associated Press

Rules crack down on access to painkiller

  • Article by: Sabrina Tavernise
  • New York Times
  • August 21, 2014 - 8:24 PM


– The federal government tightened the prescribing rules for 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, the most widely prescribed painkiller in the United States and which includes drugs like Vicodin, is one of the most far-reaching efforts to stop the growing epidemic of prescription drug abuse, which takes the lives of more than 20,000 Americans every year according to federal data.

The rule places hydrocodone in a tougher, more restrictive category, and the changes it requires are sweeping. Doctors will no longer be able to call in prescriptions by phone, and patients will not be allowed to get refills on the same prescription but will have to return to a health care professional to get a new one. The drug will have to be kept in special vaults in pharmacies. The Drug Enforcement Administration 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.”

Abuse of painkillers now claims the lives of more Americans than heroin and cocaine combined, 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 deaths have outpaced those from traffic wrecks.

Sen. Joe Manchin III, D-W.Va., whose state is among those hardest hit by the epidemic of pain pill abuse, applauded the change. He called the shift “a tremendous step forward in fighting the prescription drug abuse epidemic,” one that he said would “undoubtedly help prevent these drugs from getting into the wrong hands and devastating families and communities.”

Still, the change is sure to draw strong criticism from some pain management experts, who argue that the rule creates unfair obstacles for patients with chronic pain, making it harder, for example, on 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 highly abused painkiller and the main ingredient in OxyContin, has been in the more restrictive category since it first 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 the changes could bring would probably be offset by an increase in heroin use.

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