Ketamine / Esketamine Infusion Informed Consent

# Ketamine / Esketamine Infusion Informed Consent **Facility / Practice:** ___________ **Prescribing Physician / APRN:** ___________, ___________, NPI ___________ **Patient Name:** ___________ **Date of Birth:** ___________ **Date of Consent:** ___________ **Diagnosis/Indication:** ___________ --- ## 1. Description of Treatment You are being offered treatment with **ketamine** (racemic ketamine administered intravenously, intramuscularly, orally, or intranasally) or **esketamine (Spravato®)** (FDA-approved intranasal formulation) for ___________. **Route of administration for this patient:** ___________ **Proposed dose / protocol:** ___________ **Planned session schedule:** ___________ --- ## 2. Off-Label Use Disclosure **Racemic ketamine** (IV, IM, intranasal, oral) is approved by the FDA as a general anesthetic but is used **off-label** for the treatment of treatment-resistant depression (TRD), major depressive disorder (MDD), bipolar depression, post-traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), chronic pain conditions, and suicidal ideation. The evidence base for these uses is growing but differs in quality across conditions and routes. Your provider has reviewed the available evidence and concluded that this treatment is appropriate for your situation. **Esketamine (Spravato®)** is FDA-approved for treatment-resistant depression and major depressive disorder with acute suicidal ideation or behavior (MDSI) in adults. It is administered under the FDA Risk Evaluation and Mitigation Strategy (REMS) program, which requires in-office administration and monitoring. The Patient understands and accepts that off-label prescribing is a lawful and common medical practice, and that the prescriber is exercising clinical judgment. --- ## 3. Potential Benefits