Medications cannot be marketed in the United States without an FDA determination that they are safe and effective for their intended use. To obtain such certification, pharmaceutical companies submit their products to rigorous scrutiny (eg, in vitro studies, animal studies, human clinical trials) and present the subsequent data to the FDA, which determines whether the medication in question is safe and effective for a specific purpose. FDA approval comes with specific labeling requirements for the product, including the approved indications for use, the appropriate dosing, and the specific populations for its use. Once a medication has been approved for a specific use, physicians and other prescribers are permitted to prescribe the medication for conditions not covered by the approved use.
Several recent studies have demonstrated that off-label prescribing is very common among physicians, particularly among psychiatrists. Legal scholars have estimated that approximately 40% to 60% of prescriptions are for off-label use.1 In one important study, researchers examined office-based prescribing patterns for 160 commonly prescribed medications and determined that approximately 21% were for off-label use. In this study, off-label use was most common for cardiac medications (46%), anticonvulsant medications (46%), and asthma medications (42%). The investigators also found that most off-label use (73%) had limited or no scientific support.
The greatest disparity in the percentage of scientifically supported versus unsupported off-label use occurred with psychiatric medications. In 96%, the off-label use was determined to have little or no sound scientific evidence for the condition for which the drug was prescribed.2
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