FDA recommends stricter painkiller rules

Hydrocodone bitartrate and acetaminophen pills, also known as Hydrocodone bitartrate and acetaminophen pills, also known as Vicodin, are arranged for a photo at a pharmacy. (Feb. 19, 2013) Photo Credit: AP

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The U.S. Food and Drug Administration Thursday recommended strict new rules governing how doctors prescribe hydrocodone-based pain pills, which have been abused by millions of Americans.

The FDA's new policy, expected to be approved later this year, changes the classification of painkillers containing hydrocodone to Schedule II from Schedule III drugs, making them harder to obtain. The drugs include Vicodin, which statistics show has been among the most widely abused painkillers on Long Island and across the country.

"This long overdue action on the part of FDA will provide a national standard and stop folks from traveling to neighboring states that haven't been as progressive" as New York, said Dr. Jeffrey Reynolds, executive director of the Long Island Council on Alcoholism and Drug Dependence. "To be frank, had the FDA acted on this sooner, Vicodin would not have become the drug du jour and perhaps addiction levels would be lower."

Hydrocodone-based pain pills are among the most commonly prescribed prescription drugs in the United States, with roughly 131 million prescriptions being written for an estimated 47 million Americans in 2011 alone, government data shows. The drugs are prescribed for a range of maladies, from tooth extractions to arthritis.

The reclassification is expected to be approved by the U.S. Department of Health and Human Services and formally adopted by the Drug Enforcement Administration. The change could take effect next year.

The FDA reclassification would require patients to take prescriptions for hydrocodone-based pain pills to a pharmacy, where now they can have doctors call in a prescription. The new rules also allow for fewer refills before a patient must return to a doctor's office for a new prescription.

Current FDA rules allow patients to refill hydrocodone-based pain pills five times during any six-month period before they have to return to a doctor's office for a new prescription.

"Each day that passes means rising abuse, and even death, at the hands of hydrocodone-based drugs," said Sen. Charles Schumer (D-N.Y.), a proponent of the reclassification. "The FDA has made the wise choice in heeding my call and will tighten up control of one of the most highly-prescribed -- and abused -- drugs on the New York market."

Some pain-pill users say the new rules would create more obstacles for patients who legitimately need them. "This is another roadblock that makes it harder for people in pain, people who are not addicts, to get the drugs they need in order not to suffer," said Jeffrey Sperling, 64, a retired construction worker from Hauppauge who said he takes Vicodin for leg pain. "We pay the price for the people who abuse these drugs."

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