ISSN Druckformat: 2151-805X
ISSN Online: 2151-8068
Ethical Considerations Regarding Disclosure of Off-Label Drug and Device Use as a Component of Informed Consent in a Resident Training Program
ABSTRAKT
Since the twentieth century, informed consent has been considered an ethical obligation and legal requirement. Relatively few studies have evaluated the quality of informed consent in practice settings, and where such studies have been undertaken, large gaps have been identified. The present study considers the issue of condition-specific Food and Drug Administration (FDA) approval status for drugs and devices employed in the practice of orthopedics and its relationship to informed consent. Twenty-six orthopedic surgery attending surgeons and twenty-six orthopedic surgery resident surgeons were surveyed about their use of gabapentin, Lidoderm patches, and the Endobutton CL BTB (ECLFD, Smith and Nephew, Memphis, Tennessee) and if they disclosed the anticipated off-label use to their patients. In addition, orthopedists and those in training were queried regarding their disclosure of allograft utilization. We conclude knowledge deficits regarding the FDA-approved indications for drugs and devices contribute to nondisclosure of off-label use. There is also a discrepancy regarding disclosure of allograft material among those in practice compared to those in training. Furthermore, some physicians may deem off-label disclosure unnecessary if its particular usage has been well studied in the literature.