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Off-Label Prescribing: A Call for Heightened Professional and Government Oversight

Published online by Cambridge University Press:  01 January 2021

Rebecca Dresser  and
Joel Frader
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Extract

Off-label prescribing is an integral part of contemporary medicine. Many patients benefit when they receive drugs or devices under circumstances not specified on the label approved by the Food and Drug Administration (FDA). An off-label use may provide the best available intervention for a patient, as well as the standard of care for a particular health problem. In oncology, pediatrics, geriatrics, obstetrics, and other practice areas, patient care could not proceed without off-label prescribing. When scientific and medical evidence justify off-label uses, physicians promote patients’ interests by prescribing products off label.

Off-label prescribing can also harm patients, however. The potential for harm is greatest when an offlabel use lacks a solid evidentiary basis. A 2006 study examining prescribing practices for 169 commonly prescribed drugs found high rates of off-label use with little or no scientific support. Researchers examining off-label use in U.S. children’s hospitals concluded, “[W]e still have incomplete knowledge about the safety and efficacy of many medications commonly used to treat children across a range of drug classes and clinical diagnoses.”

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Independent
Information
Journal of Law, Medicine & Ethics , Volume 37 , Issue 3 , Fall 2009 , pp. 476 - 486
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

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