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Editorial | ONLINE FIRST

What Does Off-label Prescribing Really Mean?

Patrick G. O’Malley, MD, MPH
Arch Intern Med. 2012;172(10):759-760. doi:10.1001/archinternmed.2012.789.
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The issue of off-label prescribing is a loaded subject. When one scratches the surface, one realizes the myriad limitations of such a construct related to the process of labeling, the monitoring of appropriate prescribing, the inadequacy of evidence to match the complexities of care, and the missed opportunities of leveraging our information systems to better optimize medication use for the care of patients.

Technically, off-label prescribing means the prescribing of medications or devices for indications or population subgroups that regulatory agencies have not officially approved. It is legal in many countries (including the United States) based on the premise that regulatory agencies do not have the authority to control the practice of medicine. But what does it really mean? There are many examples of efficacious medical therapies for conditions for which there has been no official indication approval. Aspirin therapy for acute coronary syndromes is a classic example: regulatory approval for its use did not occur until well after the evidence clearly demonstrated its benefit. The process of drug approval for specific indications is an onerous one, requiring substantial resources and financial risk to seek labeling indications. Even if there are available studies that demonstrate efficacy, the burden of indication application is on the pharmaceutical company. Unless there is reasonable probability for profit margins associated with such investment, the pharmaceutical industry is not likely to seek regulatory approval. Therefore, there is an obvious limitation of the process of labeling that inhibits not only the potential access to efficacious treatments but also the validity of labeling itself. A better process would allow an easier updating of indication labeling that is concordant and commensurate with the strength of the evidence.

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