From U Utah: Off-label prescribing of medications for pain

http://www.ncbi.nlm.nih.gov/pubmed/22764854

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

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

Ruble J.

Source

James H. Ruble, PharmD, JD, is Assistant Professor (Clinical) of Pharmacotherapy, University of Utah College of Pharmacy , Salt Lake City, Utah , USA .

Abstract

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.