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Painkillers Likey to be Limited by FDA (NYT: 25th Jan 13)

Josephine

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An advisory panel of experts to the Food and Drug Administration voted on Friday to toughen the restrictions on painkillers like Vicodin that contain hydrocodone, the most widely prescribed drugs in the country.

The recommendation, which the drug agency is likely to follow, would limit access to the drugs by making them harder to prescribe, a major policy change that advocates said could help ease the growing problem of addiction to painkillers, which exploded in the late 1990s and continues to strike hard in communities from Appalachia and the Midwest to New England.

But at 19 to 10, the vote was far from unanimous, with some opponents expressing skepticism that the change would do much to combat abuse. 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, they pointed out in testimony at a public hearing. They also said the change could create unfair obstacles for patients in chronic pain.

The change would have sweeping consequences for doctors, pharmacists and patients. Refills without a new prescription would be forbidden, as would faxed prescriptions and those called in by phone. Only written prescriptions from a doctor would be allowed. Distributors would be required to store the drugs in special vaults.

But at the panel’s two-day hearing at F.D.A. headquarters in Silver Spring, Md., many spoke against the change, including advocates for nursing home patients, who said frail residents with chronic pain would have to make the trip to a doctor’s office. The change would also ban nurse practitioners and physician assistants from prescribing the drugs, making it harder for people in underserved rural areas.

Dr Nathaniel Katz, assistant professor of anesthesia at Tufts University School of Medicine in Boston said "the importance of Friday’s vote was more symbolic, a message to doctors that they will need to think twice before prescribing hydrocodone, and to patients that the days of “unbridled access” are coming to an end. It will help shape thinking,” he said. Dr Katz, whose clinical research company, Analgesic Solutions, is trying to develop other treatments for pain. He cautioned that patients who need the medications for pain should not suffer inappropriate barriers to access because of the change, a concern that the dissenters shared.

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