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National study finds off-label prescribing common, often not backed by data

A study of office-based physicians in the United States suggests that about one-fifth of medications are prescribed to treat conditions for which they are not approved by the U.S. Food and Drug Administration (FDA), and that nearly three-fourths of those uses lack strong scientific support, according to an article in the May 8 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

The FDA evaluates new drugs entering the market but does not dictate physicians' prescribing practices, according to background information in the article. Therefore, physicians can legally prescribe approved medications for any diagnosis, even if that particular diagnosis is not cited on the drug's label or application for FDA approval. Such off-label prescribing allows physicians the freedom to innovate in clinical practice, but also raises questions regarding patient safety and health care costs, since off-label uses do not receive the same level of scientific scrutiny as approved uses.

David C. Radley, M.P.H., Dartmouth Medical School, Hanover, N.H., and colleagues examined data from a national survey of office-based physicians. In each quarter of 2001, about 3,500 randomly selected physicians reported on all patient interactions during two consecutive workdays. Information about diagnoses and prescriptions was entered into an index, from which the researchers retrieved information about the 100 most commonly prescribed drugs and 60 additional drugs randomly selected from among other common medications. They compared each prescription to the indications listed on the drug's package insert and categorized them as approved or off-label. Off-label prescriptions were further evaluated and classified as having strong scientific support if evidence from drug trials or clinical settings suggested the medication was effective for the condition it was prescribed to treat, or as having limited to no scientific support if such evidence did not exist.
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Contact: Rosanne Spector
650-725-5374
JAMA and Archives Journals
8-May-2006


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