When Off-Label Ketamine Meets Direct-to-Consumer Telehealth: Liability Risks and Ethical Responsibilities.

Abstract

Aided by COVID-19-era regulatory flexibilities, direct-to-consumer telemedicine has expanded access to mental health care. Ketamine prescribed off-label for psychiatric conditions is increasingly marketed online and delivered at home through telehealth platforms. Taking a wrongful death lawsuit against a telehealth ketamine provider as a point of departure, the authors examine how combining off-label prescribing with on-demand delivery can strain clinical safeguards. Given the limited oversight of many telehealth platforms and the drugs they prescribe, responsibility and liability for patient safety rest heavily on clinicians. When off-label prescribing is combined with on-demand telehealth, the structures that sustain responsible care require support, including the capacity to sustain robust clinical relationships, monitoring, and accountability.

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