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HACKENSACK, N.J. — Federal authorities have tightened rules for the most commonly prescribed painkiller in the United States, the latest in a series of policy changes aimed at stopping the nation’s growing epidemic of painkiller abuse and overdose deaths.

Products containing hydrocodone, an opioid found in drugs like Vicodin, will now be restricted as Schedule II controlled substances like oxycodone, a reflection of the drugs’ high potential for abuse, according to a rule released Thursday by the Drug Enforcement Administration.

The rule, which takes effect in 45 days, prohibits automatic refills of products containing hydrocodone and reduces the number of pills allowed per prescription to a three-month supply written in 30-day increments. Patients will have to visit their doctors every three months to get a new prescription.

Nearly 137 million prescriptions for hydrocodone products were dispensed in the U.S. in 2013, according to the DEA. There are several hundred brand-name and generic products containing hydrocodone, often combinations of the drug and an over-the-counter painkiller, or in the form of cough suppressants, such as Tussigon and Hycodan.

Opioid painkillers account for nearly 17,000 American deaths each year, according to federal authorities.

The DEA has sought restrictions on hydrocodone for years but faced opposition from the Food and Drug Administration, which cited concerns that such a measure would make it harder for people in pain to obtain relief.

Such concerns are widespread among pain management advocates and medical groups across the U.S.

“I don’t think this is an unfair constraint,” said Joseph Feldman, chairman of emergency medicine at Hackensack University Medical Center. “Prescription drug abuse has become a huge problem in this country, and providers should pay more attention.”

The new rules do not change the criteria for prescribing hydrocodone, only the regularity with which doctors must meet with patients and write new prescriptions. Still, some say that this change may heighten understanding about the risks.

“I think it will raise the awareness to the issue, and make people more thoughtful,” Feldman said.

“I think everyone is being too liberal with pain medication prescriptions,” Feldman said. “Yes, pain needs to be treated, but there is no reason for patients with simple problems to have 90 days or 120 days, with three refills of narcotics. They should be reassessed and re-evaluated.”

The DEA rule noted that data “strongly” indicated that prescription opioid drug abuse — particularly of hydrocodone products — can lead to heroin abuse. Heroin’s recent resurgence in the U.S. has been tied to the widespread abuse of prescription painkillers.

Some have argued that restricting painkillers like hydrocodone could push addicts toward cheap, illicit alternatives such as heroin. In an interview with The Record last year, Carl Kotowski, special agent in charge of the DEA’s New Jersey division, attributed some of the “increase in demand” for heroin in the state to an effective crackdown and “due diligence” on prescription drug trafficking.

The DEA said the change should not “hinder legitimate access to the medicine.”

The DEA’s rule is the result of a policy change that was years in the making.

Last October, after years of resistance, the FDA recommended tighter controls on hydrocodone-containing products.

That same month, the FDA approved Zohydro, a powerful extended-release hydrocodone product; Zohydro was placed in the restrictive Schedule II category.

In one of the more curious sections of Thursday’s report, the DEA countered public concerns that restricting access to painkillers could adversely affect the residents of nursing homes and long-term care facilities; the authorities said such facilities can be prime sites for drug diversion and medication theft because large amounts of controlled substances are in the care of staff that often includes people with property crime convictions.


©2014 The Record (Hackensack, N.J.)

Visit The Record (Hackensack, N.J.) at www.NorthJersey.com

Distributed by MCT Information Services


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