title: Off-label prescribing of medications for pain: maintaining optimal care at an intersection of law, public policy, and ethics.
abstract: 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.
authors: Department of Pharmacotherapy, University of Utah College of Pharmacy, Salt Lake City, UT 84112-5820, USA. jim.ruble@hsc.utah.edu
authors: James
authors: J
authors: Ruble
mesh_terms: D003657:Decision Making; D004348:Drug Labeling; D006291:Health Policy; D006801:Humans; D007258:Informed Consent; D056687:Off-Label Use / Q000941:ethics / Q000331:legislation & jurisprudence*; D010146:Pain / Q000188:drug therapy*; D010358:Patient Participation; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration