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J Pain Palliat Care Pharmacother. 2012 Jun;26(2):146-52. doi: 10.3109/15360288.2012.671243. Epub 2012 Apr 19.

Off-label prescribing of medications for pain: maintaining optimal care at an intersection of law, public policy, and ethics.

Author information

  • Department of Pharmacotherapy, University of Utah College of Pharmacy, Salt Lake City, UT 84112-5820, USA. jim.ruble@hsc.utah.edu


For more than 60 years, regulations limited marketing of medications for off-label uses to very low levels. Some key policy changes in the late 1990s ushered in an era of deregulation of off-label marketing. Policy changes included revised United States federal law as well as modifications of Food and Drug Administration (FDA) regulations. Subsequent investigations documented an explosion in scope off-label prescribing. Attempts to limit off-label advertising by manufacturers were vigorously challenged in the courts. Other modalities are needed to maintain a clinical care environment that places the patients' best interests first. In many circumstances, an off-label medication may be in the patient's best interests; however, where there is a lower level of clinical justification, the informed consent of the patient and shared decision making of the patient is essential to optimize outcome.

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