Abstract

Off-label use: Patient, surgeon & industry

Highlights

  • What does this have to do with Foot & Ankle Surgery: Techniques, Reports & Cases (FASTRAC)? Well, I have witnessed an influx of submissions that involve patients receiving care with “off-label use.” As defined by the United States Food & Drug Administration (US FDA), off-label use is, “. . .prescribing medications for indications, or using a dosage or dosage form, that have not been approved by the US FDA”.1 Interestingly, much of what we do as foot & ankle surgeons involves off-label drug or product use.[2]

  • One benefit for our industry partners is that they can better understand how their products are being employed by foot & ankle surgeons

  • The foot & ankle surgeons reading FASTRAC will be able to determine if the approach taken by the authors warrants the potential medical-legal risks associated with offlabel drug or product use in their own practices

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Summary

Introduction

What does this have to do with Foot & Ankle Surgery: Techniques, Reports & Cases (FASTRAC)? Well, I have witnessed an influx of submissions that involve patients receiving care with “off-label use.” As defined by the United States Food & Drug Administration (US FDA), off-label use is, “. . .prescribing medications for indications, or using a dosage or dosage form, that have not been approved by the US FDA”.1 Interestingly, much of what we do as foot & ankle surgeons involves off-label drug or product use.[2].

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