
- Vol 39, Issue 10
The Online, At-Home Ketamine Experience: A Clinician’s Dilemma
At-home ketamine treatment initiated by an online provider presents many legal, clinical, and ethical challenges...
PSYCHIATRY & SOCIETY
Case Vignette 1
“Mr Brad,” a 46-year-old, employed man, is seen in our clinic for medication management of chronic unipolar depression, generalized anxiety, and
Mr Brad underwent a virtual assessment with a multistate licensed online health care provider (HCP) who was physically located in another geographic area. According to the patient, he shared his medical history, medications, and current symptoms. He was not asked to sign a release, and we were not contacted by the HCP. This presented a clinical dilemma as to our role, responsibility, and liability if we continued to treat the patient with these medicines while he was receiving at-home ketamine though another provider.
Prescribing Ketamine
There has been a recent proliferation of online health care businesses that offer at-home ketamine through virtual visits to patients suffering from a variety of mental health conditions.
Ketamine can be rapid acting and studies have shown effectiveness in treatment-resistant depression (TRD), suicidal ideation, and other psychiatric conditions.3,4 The therapeutic effects are often attributed to its antagonistic effects on the NMDA receptor, 1 of 4 subtypes of inotropic glutamate receptors located throughout the central nervous system.5
Ketamine is a dissociative drug with
Simultaneously, there has been an uptick in utilization of online telehealth providers, particularly in mental health. This has been accelerated with technology advances, increased investor interest in this business model, and COVID-19 limiting in-office health care. These businesses claim to make mental health care more convenient, affordable, and accessible by offering care in locations with few mental health care providers.
Access to ketamine as a treatment option can be challenging to interested patients. Many HCPs are reluctant to suggest or use ketamine since it is not approved for psychiatric conditions. Psychiatrists more accepting of ketamine as a treatment option may not have the staff, space, training, or equipment to administer the medication in their offices. Nonpsychiatric health care practitioners including anesthesiologists, mid-level anesthetists, and other HCPs may be skilled at ketamine administration but not in managing patients with
Esketamine has some similar pharmacokinetic and pharmacodynamic properties to ketamine since it is an isomer of the medication and is FDA approved for TRD and major depression with
Recently, several telehealth companies have emerged offering virtual assessments and at-home ketamine delivery, including but not limited to Mindbloom, My Ketamine Home, and Smith Family MD.7-9 These companies specifically market to those looking for ketamine treatment. While promoting at-home ketamine for treatment of psychiatric disorders, many of these companies are led by medical directors without mental health training. Mindbloom, one of the largest such virtual, at-home services, does have psychiatric physicians on its leadership team, including 2 chairmen and vice chairmen of psychiatric hospital departments and a former chief medical officer of the US Department of Health and Human Services.7
In 2008, the Ryan Haight Online Pharmacy Consumer Protection Act was passed after a 17-year-old boy died of an opiate
Case Vignette 2
“Mr Ryan” is a 65-year-old man who agreed to be interviewed regarding his experience with at-home oral ketamine prescribed through an online provider. Mr Ryan has suffered from dysthymia and mild anxiety without much relief from medication or counseling. He has used psychedelics including LSD,
He paid an upfront fee for a package, which included an initial online meeting, follow-up, and exit assessment with a nurse practitioner (NP), 2 sessions with a ketamine “guide,” 6 doses of oral ketamine, and a kit that included a blood pressure cuff, eye mask, educational resources, journal, pen, and audio program to listen to during dosing.
The initial assessment was conducted virtually over 30 minutes in which he was asked about his symptoms, drug experiences, height, weight, medical history, and expectation of treatment. He had to show his blood pressure reading from his cuff. He was not asked to share his health care providers’ names, to sign releases for his HCPs, or to provide any blood work.
He was then sent 450 mg of oral dissolvable ketamine to his home. On the day of dosing, he had a virtual session with his guide during which he was told what to expect during dosing and how to take the medication, given therapeutic readings, and instructed to set an intention for the experience. He had to show his blood pressure readings and have someone else in the home with him before dosing. The guide was not online during the entire session but was available if needed. Mr Ryan was instructed to check in 1 hour after dosing.
Mr Ryan experienced a moderately high level of dissociation with no significant adverse effects. He found it to be pleasant and therapeutic. He had a follow-up visit with the prescribing nurse practitioner a few days later and was then sent all 5 remaining treatments at 750 mg per dose. He met virtually with the guide for the second session. During the last 4 sessions, he was not required to show any more blood pressure readings or to meet with the guide or the NP. He had unlimited access to the guide via texting if he desired.
After his sixth treatment, Mr Ryan had a virtual exit visit with the NP and was offered another 6 doses without a guide for a lower fee. He could pay extra for the guide as well as for an audio program for depression, anxiety, or self-esteem. Although his experience was positive overall, he did have some concerns about the level of monitoring. He would prefer an in-person, more closely supervised experience if it was affordable and available in a warm, therapeutic setting rather than a sterile, medical office environment.
The Risks of At-Home Ketamine
At-home ketamine treatment initiated by an online provider presents many legal, clinical, and ethical challenges to HCPs and potential risks to patients. Some legal questions are whether online prescribing of ketamine, a Schedule III medication, meets criteria for the looser rules of prescribing a CS without an in-person examination, particularly if ketamine is being used for a mind-expanding, emotionally cathartic purpose. The current law states that the prescription must be for a legitimate medical purpose by a practitioner in their usual course of their professional role.12 Whether this meets that definition could be an area of debate. Additionally, by continuing their psychiatric medications and other treatment while they are receiving at-home ketamine, is a clinician giving consent to this treatment? Is a clinician liable if there are complications or drug interactions with a medication they are prescribing during at-home ketamine administration?
Issues of safety evoke clinical questions as to who should be prescribing concomitant psychiatric medicines during ketamine use. There may be medical and/or psychiatric changes related to ketamine dosing that could require alterations in the medication regimen. Although most side effects of ketamine are mild and transient, there are potentially serious safety concerns including elevations in blood pressure, anxiety, severe dissociation,
Although there are no specific guidelines for off-label ketamine administration, there are standards of care that often include a dosing range based on weight, a medical screening that typically includes baseline blood work, and, in many cases, drug screens and an EKG, along with coordination of care with the patient’s HCPs. Most clinicians dosing ketamine will follow blood pressure, pulse, and, in some cases, pulse oximetry and cardiac monitoring by a trained health care professional during each treatment. Esketamine shares many of the same risks as racemic ketamine and was approved with the restriction that it could only be administered under a Risk Evaluation and Mitigation Strategy (REMS) program.15 REMS is for certain medications with serious safety concerns to help ensure the benefits outweigh the risks. There is required registration and training for the patients, HCPs, and pharmacists. There is a 2-hour minimum observation by a medical professional and blood pressure monitoring in office with a prescriber onsite.
With the self-administration and availability of multiple dosing with at-home ketamine, there is an opportunity for intentional or unintentional overadherence and overdosing. There is a risk with combining at-home ketamine with alcohol or drugs of abuse including opiates, amphetamines, or benzodiazepines, or with legitimately prescribed medications that could have serious and life-threatening interactions.
This also raises questions as to whether oral ketamine is even efficacious in the treatment of any psychiatric condition. Ketamine been most studied with intravenous administration starting at doses of 0.5 mg/kg. There are only 2 randomized control studies looking at antidepressant efficacy of oral ketamine in which much lower doses were used than those given by many online prescribers.16 Most other studies are small case reports and series.17 Oral ketamine has low and varied bioavailability (
Concluding Thoughts
We made the decision to notify Mr Brad that we did not agree with his decision to undergo at-home ketamine. Our concern was whether this was an appropriate treatment for him and what we perceived was inadequate at-home monitoring. Furthermore, we were not comfortable with the concomitant use of benzodiazepines and high-dose stimulants. We suggested that if he was going to continue this treatment against our recommendation, he taper off both of those medications. We informed him that we felt it was unsafe for us to continue managing his psychiatric medications while he was self-administering ketamine at home.
This case illustrates an important issue that clinicians will likely soon confront (if they are not encountering it already). Although at-home ketamine is a reality for now, it is conceivable that similar issues may arise with other off-label or unproven therapies, including the much-hyped psychedelic medicines, becoming available to our patients. Access to these therapies, even when illegal, is becoming easier, and government agencies, medical regulatory bodies, and clinicians need to be prepared to manage these situations as they arise.
Dr Banov is a psychiatrist at PsychAtlanta/PsychAtlanta Research Center and on the faculty in the Department of Psychiatry at the Medical College of Georgia. Dr Banov reports disclosures as a speaker for AbbVie, Supernus, Janssen, Intracellular Therapies, and Teva. Ms Landrum is an MD candidate at the Louisiana State University Health Sciences Center.
Acknowledgment: Thanks to Marla Fleming, APRN, for her assistance in this article.
References
1. Wilkinson ST, Toprak M, Turner MS, et al.
2. Sanacora G, Frye MA, McDonald W, et al; American Psychiatric Association (APA) Council of Research Task Force on Novel Biomarkers and Treatments.
3. Berman RM, Cappiello A, Anand A, et al.
4. Murrough JW, Iosifescu DV, Chang LC, et al.
5. Maeng S, Zarate CA, Du J, et al.
6. Thielking M. Ketamine gives hope to patients with severe depression. But some clinics stray from the science and hype its benefits. STAT. September 24, 2018. Accessed August 16, 2022.
7. Ketamine: science-backed, safe, and effective. Mindbloom. Accessed August 16, 2022.
8. How it works. My Ketamine Home. Accessed August 16, 2022.
9. Treatment protocol. Smith Ketamine Services. Accessed August 16, 2022.
10.
11. DEA information on telemedicine. Substance Abuse and Mental Health Services Administration. 2020. Accessed August 16, 2022.
12. State telehealth policies for online prescribing. Center for Connected Health Policy. 2022. Accessed August 16, 2022.
13. Jercich K. More than 70 orgs urge DEA: revise telehealth controlled-substance rules. Healthcare IT News. March 7, 2022. Accessed August 16, 2022.
14. aan het Rot M, Collins KA, Murrough JW, et al.
15. A long-term, safety and efficacy study of intranasal esketamine in treatment-resistant depression (SUSTAIN-2). ClinicalTrials.gov. Updated May 6, 2020. Accessed August 16, 2022.
16. Rosenblat JD, Carvalho AF, Li M, et al.
17. Al Shirawi MI, Kennedy SH, Ho KT, et al.
18. Schoevers RA, Chaves TV, Balukova SM, et al.
19. Chen LY, Chen CK, Chen CH, et al.
Articles in this issue
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Tackling Treatment Issues in Adult ADHDalmost 3 years ago
Important Lessons for Psychiatry and Beyondalmost 3 years ago
Mental Health’s Most Toxic Mythalmost 3 years ago
Exploring DTx for Clinical Carealmost 3 years ago
COVID-19 and Mental Health: Global Consequences and CAM Approachesalmost 3 years ago
Exploring Integrative Medicine and Nutrition for PTSDalmost 3 years ago
Neurobiological Mechanisms of Mind-Body Medicinealmost 3 years ago
Herbal Medicine: What Psychiatrists Need to Knowabout 3 years ago
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