@article{ref1,
title="Off-label prescribing of medications for pain: maintaining optimal care at an intersection of law, public policy, and ethics",
journal="Journal of pain and palliative care pharmacotherapy",
year="2012",
author="Ruble, James",
volume="26",
number="2",
pages="146-152",
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.<p /> <p>Language: en</p>",
language="en",
issn="1536-0288",
doi="10.3109/15360288.2012.671243",
url="http://dx.doi.org/10.3109/15360288.2012.671243"
}