Citation

Ruble J. J. Pain Palliat. Care Pharmacother. 2012; 26(2): 146-152.

Affiliation

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

Copyright

(Copyright © 2012, Informa - Taylor and Francis Group)

DOI

10.3109/15360288.2012.671243

PMID

22764854

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.

Language: en