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Evidence and Ethical Off-label Prescribing

Emily A. Largent, BS; Franklin G. Miller, PhD; Steven D. Pearson, MD, MS

Arch Intern Med. 2009;169(19):1745-1747.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Following US Food and Drug Administration (FDA) approval, clinicians may lawfully prescribe a drug or biologic agent for treatment regimens not specified in the approved labeling or package insert. This is known as off-label use. A recent study¹ found that for 160 common drugs in the United States, off-label use accounted for 21% of all prescriptions. Many off-label uses are accepted as standard of care, for example, use of β-blockers for congestive heart failure. Many other off-label uses, however, lack evidence of clinical efficacy.¹ In light of growing concerns about appropriateness and cost, off-label use has been identified as 1 aspect of problematic drug prescribing.^2-3

Currently, there is little guidance to distinguish clearly between off-label uses that are well-supported by evidence and those that are not. In this article, we address that gap at the level . . . [Full Text of this Article]

SIGNALS FOR SCRUTINY

New Drugs

Novel Off-label Use

Drugs With Known Serious Adverse Effects

High-Cost Drugs

EVIDENCE LEVELS TO GUIDE OFF-LABEL PRESCRIBING

PHYSICIAN RESPONSIBILITIES AND ACTIONS
Supported Off-label Use

Suppositional Off-label Use

Investigational Off-label Use

COMMENT

AUTHOR INFORMATION


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Importance of Distinguishing Supported and Unsupported Off-label Drug Use
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