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Tracy Hampton, PhD

JAMA. 2007;297:683-684.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Off-label drug use has been around for decades, and it is perfectly legal for physicians to prescribe a medication for a condition not described in the approved labeling if it seems reasonable or appropriate.

Determining the appropriateness of such prescribing can be difficult, however, as physicians are drowning in reports from laboratory studies and clinical trials, potentially dubious promotions from pharmaceutical companies, pressure from patient advocacy groups to provide more therapies for various conditions, and hurdles to reimbursement by insurance providers. Experts suggest that changes in regulations and reimbursement relating to off-label therapies may be needed to help physicians give each patient the best care possible in today's clinical environment.

Physicians must weigh a number of factors, including clinical data, promotions from pharmaceutical companies, and reimbursement hurdles when deciding when to prescribe a medication off-label.

APPROPRIATE PRESCRIBING

According to the US Food and Drug Administration (FDA), when prescribing a . . . [Full Text of this Article]