Primary Care Research

One of every five medications approved for certain diagnoses are prescribed by office-based physicians for other conditions

Physicians can legally prescribe approved medications for any diagnosis, even when the diagnosis is not specified on the drug's label or in the application for approval from the Food and Drug Administration. Off-label prescribing allows physicians the freedom to innovate but also raises questions about patient safety and costs, since off-label uses do not receive the same level of scientific scrutiny as approved uses.

According to a new study, supported in part by the Agency for Healthcare Research and Quality (HS13405), off-label medication use is common in outpatient care and most of it occurs without scientific support. Using data from the 2001 National Disease and Therapeutic Index, researchers found that 21 percent of 725 million prescriptions written for 500 drugs in 2001 were for off-label use and 73 percent of these lacked strong scientific support for that use. The drugs most likely to be prescribed off-label were cardiac medications (46 percent), anticonvulsants (46 percent), and drugs to treat asthma (42 percent).

Off-label use of medications with little or no scientific support was more common than supported off-label use for all therapeutic classes except diabetes therapies. The greatest disparity between supported and unsupported off-label use was found in psychiatric drugs (4 percent strong support vs. 96 percent limited or no support) and allergy therapies (11 percent strong support vs. 89 percent limited or no support).

See "Off-label prescribing among office-based physicians," by David C. Radley, M.P.H., Stan N. Finkelstein, M.D., and Randall S. Stafford, M.D., Ph.D., in the May 8, 2006, Archives of Internal Medicine 166, pp. 1021-1026.

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