At-Home Ketamine: Why Safety, Ethics, and Medical Oversight Must Come First

At-Home Ketamine: Why Safety, Ethics, and Medical Oversight Must Come First

The 2023 death of a 27-year-old man following at-home ketamine use has reignited critical discussion across the medical community about the safety and ethics of unsupervised ketamine therapy. While details remain the subject of ongoing legal proceedings, this case underscores what many clinicians and researchers have cautioned for years: ketamine is not a medication that should ever be administered without direct medical supervision.

The Changing Landscape of Ketamine Therapy

During the COVID-19 pandemic, emergency waivers to the Ryan Haight Online Pharmacy Consumer Protection Act temporarily lifted the requirement for an in-person medical evaluation before prescribing controlled substances through telemedicine. This change made sense for certain conditions during lockdowns, but it also led to a surge in telehealth ketamine models offering compounded oral or sublingual ketamine for home use. These models often rely on remote questionnaires, brief video visits, and mailed “monitoring kits,” with little to no live medical oversight during administration. The tragic case of Phillip Ward, whose death was attributed to ketamine toxicity in the context of hypertension, highlights the potential risks of this model.

Clinical Realities: Why At-Home Ketamine Is Unsafe

1. Setting and Monitoring Are Critical
Ketamine is a powerful dissociative anesthetic that can increase blood pressure and heart rate while altering consciousness. In a clinical environment, trained professionals continuously monitor vital signs, titrate dose, and respond immediately if complications arise. At home, none of these safeguards exist. A mailed blood-pressure cuff or an app check-in is no substitute for in-person medical monitoring.

2. Route of Administration Matters

IV ketamine is the most studied and controllable route, providing 100 % bioavailability and allowing clinicians to stop or adjust the infusion in real time. Oral or sublingual troches, often used in at-home programs, have variable absorption rates (roughly 20–25 %), delayed onset, and unpredictable potency. That unpredictability can magnify cardiovascular and psychological risks, especially in individuals with hypertension or anxiety.

3. Patient Screening and Safety Protocols
Responsible ketamine therapy begins with comprehensive medical screening, including vital signs, cardiac assessment, medication review, and a mental-health evaluation. Patients with hypertension, tachycardia, or active substance use should be approached with great caution, and in many cases excluded from unsupervised treatment entirely. At Transcend, every patient receives a 12-lead EKG on intake, continuous monitoring throughout the infusion, and immediate access to interventions such as IV labetalol if blood pressure rises.

4. Therapeutic Context
Ketamine can open profound psychological and emotional experiences. Without therapeutic support, those experiences can feel disorienting or unsafe. In-person care, with both medical supervision and a licensed therapist, ensures a therapeutic container for integration, grounding, and safety, something the at-home model cannot replicate.

Key Takeaways from Preliminary Legal Proceedings

Although legal proceedings are still underway, there have been several key points from preliminary proceedings. The full wrongful death complaint, which is a publicly available court filing, can be found here; please note that allegations have not been proven in court during the time of this post: https://acrobat.adobe.com/id/urn:aaid:sc:VA6C2:1dab9322-4ddd-43fd-8952-aa28f484c754

But here are some of the key takeaways; all of the below statements are made according to the complaint:

1. Telehealth Ketamine Model

• According to the complaint, MindBloom allegedly operated a nationwide telehealth program prescribing compounded oral ketamine troches for home use. The medication was compounded and shipped by Enovex Pharmacy.
• The complaint claims this business model bypassed FDA safety controls requiring medical supervision for Schedule III substances like ketamine.

2. Lack of Supervision and Screening

• Phillip Ward’s medical records reportedly showed hypertension, tachycardia, depression, and substance use, which should have warranted caution.
• He missed several required telehealth appointments and safety check-ins, but the complaint alleges that MindBloom continued prescribing despite this.
• A blood-pressure monitor (“Bloombox”) was provided but found unused after his death; no readings were requested by providers.

3. Defective Product and Design Claims

• The compounded oral troches are described as unapproved, untested, and unpredictably absorbed, creating risk of overdose.
• The plaintiff argues that a safer alternative (IV administration in a clinic) was available and should have been the only approved method.

4. Failure to Warn

• The defendants allegedly did not provide adequate warnings about:
  
  • Variability of oral absorption and overdose potential
  • Elevated cardiovascular risks in hypertensive patients
  • Lack of FDA approval and required monitoring

5. Negligence and Gross Negligence Claims

• The complaint asserts a pattern of reckless disregard for patient safety, including continued prescribing after missed visits.
• Supervising physician oversight was allegedly insufficient.
• The complaint includes claims for punitive damages based on willful disregard of risks.

6. Unfair and Deceptive Trade Practices

• The plaintiff alleges deceptive marketing suggesting the treatment was “safe and medically sanctioned.”
• The complaint cites public statements implying a spotless safety record, which it claims were misleading. 

Ethics and the Ryan Haight Act

The Ryan Haight Act was designed to prevent exactly the kind of unsupervised prescribing now emerging in the at-home ketamine space. While pandemic waivers were enacted to maintain access to care, extending them indefinitely for controlled substances like ketamine is not ethically or clinically justifiable. Reinstating the Act’s original safeguards would once again require an in-person medical evaluation before controlled substances are prescribed. This standard protects both patients and practitioners by ensuring that complex medications like ketamine are used responsibly, with full awareness of cardiovascular, psychiatric, and pharmacologic risk.

Our Clinical Approach

We believe that the safest and most effective ketamine therapy occurs under direct medical supervision.
Our model includes:

• Comprehensive medical and psychiatric evaluation before treatment
• Continuous, real-time monitoring of blood pressure, oxygen, and heart rate by registered nurse
• IV titration that allows individualized dosing and rapid adjustment
• On-site medical staff trained to respond to emergent events
• Integrated psychotherapy to support emotional processing and lasting change

These safeguards allow us to treat even medically complex patients with confidence, compassion, and precision.

Moving Forward: Rebuilding Trust Through Safety

Ketamine-assisted psychotherapy has immense potential to relieve suffering and catalyze healing. Yet that potential depends on rigorous safety standards, not convenience. The current telehealth landscape, born from pandemic necessity, has shown both innovation and risk. Now, as emergency policies expire, we have an opportunity to reset the standard of care. Reinstating the Ryan Haight Act’s in-person evaluation requirement, reaffirming ethical prescribing standards, and ensuring that all ketamine treatments occur with real-time medical supervision will help protect patients and preserve the integrity of this promising therapy.

In Summary

• At-home ketamine therapy carries unpredictable medical and psychological risks.
• Continuous monitoring, individualized dosing, and medical oversight are essential for safety.
• Telehealth prescribing of controlled substances should return to pre-pandemic standards except in rare, highly justified cases.
• Ethical practice in psychedelic medicine means prioritizing safety, transparency, and patient care above all else.

Ketamine can be a transformative tool but only when used within a medically supported, ethically grounded framework.

As the field grows, our guiding principle remains simple: accessibility should never come at the cost of safety.

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This article is for informational purposes only and does not constitute any legal or medical advice. All legal claims referenced are allegations, not established facts. All descriptions of the parties’ actions are drawn from publicly filed legal documents.  

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American Psychiatric Association, & American Society of Ketamine Physicians, Psychotherapists and Practitioners (ASKP3). (2021). Consensus guidelines on the use of ketamine in the treatment of mood disorders. Journal of Affective Disorders, 296, 1–12. https://doi.org/10.1016/j.jad.2021.08.048

Food and Drug Administration. (2019). Spravato (esketamine) REMS: Risk Evaluation and Mitigation Strategy. U.S. Department of Health and Human Services. https://www.accessdata.fda.gov

Ryan Haight Online Pharmacy Consumer Protection Act of 2008, 21 U.S.C. § 829(e). (2008).

Transcend Ketamine Clinic. (2022). Considerations and caution regarding at-home ketamine therapy. https://www.transcendketamine.com/blog-posts/considerations-and-caution-regarding-at-home-ketamine-therapy

U.S. Department of Justice, Drug Enforcement Administration. (2023). Temporary extension of COVID-19 telemedicine flexibilities for prescription of controlled substances. Federal Register, 88(63), 19617–19621.

Ward v. MindBloom, Inc., Enovex Pharmacy, LLC, Skwerer, E. S., & Rasul, I. (2025). Complaint for wrongful death, No. 25CV008485-730 (N.C. Super. Ct., Pitt County, Oct. 21, 2025).

Zarate, C. A., Singh, J. B., Carlson, P. J., Brutsche, N. E., Ameli, R., Luckenbaugh, D. A., ... Manji, H. K. (2006). A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Archives of General Psychiatry, 63(8), 856–864. https://doi.org/10.1001/archpsyc.63.8.856

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