Off-Label Use in Orthopaedic Surgery

Benjamin C. Taylor, MD; Jacob J. Triplet, DO; Taleed El-Sabawi, MS, JD

Disclosures

J Am Acad Orthop Surg. 2019;27(17):e767-e774. 

In This Article

Abstract and Introduction

Abstract

Surgeons frequently use orthopedic devices in an off-label manner. It is the responsibility of the surgeon to be familiar with the product and to use it based on scientific and clinical rationale. However, such practices are poorly publicized, and there remains paucity in the current literature surrounding the off-label use of orthopedic devices. Furthermore, the off-label use of devices is fraught with difficulty, including limitations in investigational studies and insurance reimbursement or coverage of use. Surgeons should be aware of the common off-label use in orthopedics. This review provides an overview of the off-label use in orthopedics and the obstacles associated with it; this review also offers clinical examples of its implementation.

Introduction

In the United States, formal approval of medications and medical devices is overseen by the US FDA.[1] Any use of medications or medical devices in an unapproved age group, with differing dosage or route of administration, or in a manner different than specifically sanctioned by the FDA is defined as off-label use (Table 1). Off-label use is legal as long as it is in accordance with the medical standard of care—care that is reflective of the type of care that a reasonable physician would provide under similar circumstances.[2] Practically, this care translates to the use of the device in a way that serves patient needs in an equivalent or better manner than other currently available options.[1] Unlike other nonsurgical specialties, orthopaedic surgeons need to be familiar with off-label use guidelines of both medications and surgical implants. In this review, we discuss the FDA approval process, define off-label use, review common orthopedic practices, and clarify legal and regulatory compliance with its use.

Comments

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