Ketamine clinic popularity has surged in recent years, with a growing number of psychedelic med spas appearing across the United States and globally. However, patients and providers alike have raised regulatory, legal, efficacy, and safety concerns about these clinics.
Ketamine: From Club Drug to Breakthrough Therapy
In the 1970s, ketamine was considered a single-use anesthetic confined to intravenous or intramuscular injection at a surgeon’s office. But it wasn’t long before ketamine emerged beyond the walls of the inpatient setting onto the club scene, where it became a highly popular recreational drug given its dissociative effects. By 1999, this gained the attention of the Drug Enforcement Administration (DEA), which then classified ketamine as a Schedule III controlled substance due to its high risk of dependence, lethal side effects, and potential for abuse.
Despite its controversial history, interest in ketamine for therapeutic applications began to build around 2015 and in recent years there has been a rapid rise of ketamine clinics, enthusiastic to meet this newfound demand. These clinics offer off-label ketamine for a wide range of conditions, including neuropathic pain, anxiety, Lyme disease, and rheumatoid arthritis.2 As ketamine clinics popped up around the country, the Food and Drug Administration (FDA) approved a nasal spray containing esketamine (the S+ enantiomer) in 2019, called Spravato®, which is approved in conjunction with an oral antidepressant for 1) treatment-resistant depression and 2) patients with major depressive disorder (MDD) presenting with acute suicidal ideation or behavior.
Although only meant for these specific indications, the approval of Spravato® helped drive ketamine’s perceived legitimacy for chronic disease management. Shortly after Spravato® was approved, the COVID-19 pandemic took over the world and led to a major shift in medical treatment modality as telehealth became both necessary and increasingly popular. As a result, a deregulated ketamine marketplace flourished online under the cover of telemedicine. This expanding market has raised serious red flags among healthcare providers and government agencies, now playing catch-up to protect public safety.
To understand if today’s ketamine clinics are serving patients’ best interests — or simply taking advantage of a lucrative loophole — we spoke with Lisa M Harding, MD, Board Certified Psychiatrist and Assistant Clinical Professor at Yale School of Medicine, and Griffen Thorne, JD, Partner Attorney at Harris Sliwoski, to learn more.
Do Ketamine Clinics Benefit Patients?
On the surface, ketamine clinics seem to improve access to care for patients in rural areas or places with limited resources. However, Dr Harding is skeptical about the sudden proliferation of ketamine clinics, especially as they don’t take insurance. “Access to care has never meant giving substandard care. The folks operating in a space with no formal rules say they are improving access to seem less nefarious,” she explained. “There is no way that one kind of treatment required by the FDA to be delivered in a medical setting is equal to a similar treatment delivered outside of a medical setting just because there are no written rules. The safety challenges are still there.”
While early ketamine clinics relied on intravenous infusion centers with medical supervision, today’s online clinics allow clients to fill generic prescriptions in the form of lozenges that they then take at home with the help of a designated “sitter” — who isn’t necessarily a medical professional.
“Ketamine is now prescribed online, and in some cases even mailed to patients,” shared Thorne. But this wasn’t always the case. “A federal law, the Ryan Haight Act of 2008, prohibited physicians from prescribing controlled substances without at least 1 in-person evaluation beforehand. But this requirement was suspended during the COVID public health emergency declaration, so now things that weren’t available before are now available online. Some of these laws didn’t immediately change back after the COVID emergency ended,” he said.
Nonetheless, some patients argue that at-home ketamine has been a life-changing treatment and advocate for the continued allowance of telemedicine ketamine treatment. “The DEA is trying to work through a middle ground where telehealth is still available for those who need it,” explained Thorne.
However, many psychiatrists and regulators worry that ketamine treatment outside of a medical setting puts patients at risk. Dr Harding explained,
Ketamine was only studied in the short term. No long-term efficacy study has been done on ketamine. Many papers look at retrospective data or comment on models implemented at academic institutions. For example, most patients in treatment with intravenous ketamine get treated once a month with an infusion and are evaluated with a face-to-face physician visit every 3-6 months once they are stable.
However, she shared that esketamine does have a long-term safety study (the Sustain III trial), which enabled the approval of Spravato®. “Patients are treated once a week or once every two weeks, and the data published at the 4-year mark show no new safety signals. Patients in maintenance are assessed by their care team.”
Dr Harding notes in her published work that esketamine is the only antidepressant of its kind to be researched and FDA-approved for depression symptoms in suicidal patients. It works within hours of administration, offering a significant advantage over other antidepressants that can take weeks.
The FDA only approved Spravato® to be administered in a regulated environment. A Risk Evaluation and Mitigation Strategy (REMS) requires patients to stay in an approved facility for monitoring 2 hours after treatment and data is recorded after every treatment. These safeguards don’t apply to the off-label ketamine often provided at ketamine clinics.
Is It Legal to Prescribe Ketamine?
Ketamine can regularly be administered under the supervision of a licensed doctor in a medical setting, but ketamine prescriptions for at-home use aren’t legal in every state.8 Thorne advised, “Physicians who want to administer ketamine need a DEA registration like any other Schedule III controlled substance.”
Because of the many state, federal, and healthcare regulations that exist, Thorne recommends having a robust compliance plan before operating a ketamine clinic. He said the rules change regularly, and what works in some states won’t pass in others. For example, certain states like New York and California have a rule called the Corporate Practice of Medicine (CPOM). This means that businesses like ketamine clinics generally must be owned by a licensed physician. However, CPOM laws vary greatly from state to state, so the requirements in one state may be completely inapplicable to its neighbor. Furthermore, states that don’t require CPOM may have different licensing requirements that need to be followed.
“With ketamine, you deal with healthcare regulations, which are very complicated. And it’s all regulated under state law.” He discussed how this differs from cannabis, which is a Schedule 1 controlled substance. Any time a state legalizes cannabis for recreational use, it still cannot legally be prescribed because it is a Schedule I controlled substance. Doctors can recommend cannabis to patients who can purchase it themselves from a dispensary. But ketamine, which requires a prescription and is subject to greater penalties, is much more heavily regulated in its prescription and administration.
Thorne also noted that just because someone is a doctor and has the legal authority to prescribe ketamine, it doesn’t necessarily mean they’re the best person for the job. “There are all kinds of licensed folks who try to get in on the action, which can lead to some concern, like if you’re dealing with ketamine therapy and you’re actually a podiatrist. Typically, anesthesiologists are involved, especially with infusions. Getting the right people is one of the main issues, especially if you want the drug to be given in a safe, effective, and appropriate way,” said Thorne.
The Future of Ketamine and Other Drugs
Thorne admits that some providers push the limits when it comes to prescribing off-label ketamine. He predicts that more regulation is likely as a result. He also suspects that certain psychedelic drugs are likely to get approved in the next few years, and the DEA will make more rules on how clinics can operate.
“There’s a big interest in all the psychedelics, and there’s a strong chance of approval by 2026, if not sooner, for MDMA and maybe even psilocybin drugs,” Thorne explained. “Oregon has some state allowances for psilocybin, which are soon to come for Colorado. But there isn’t a retail market where you can buy and take it home. It’s all in an office or ‘service center,’ and someone licensed needs to watch you through the course of the drug. If a physician is to participate in that process, it’s not clear to say whether the state boards will approve it.”
Thorne goes on to describe how cost can be a barrier.
It would be a challenge to have insurance cover it. In some ways, these state-level programs are designed to fail because it’s a long time for a licensed facility to be there monitoring. It’s not a sustainable market because only a select group of people can afford it. If it’s going to be so expensive, people will need it to be insured at the federal level, which won’t happen with things like MDMA and psilocybin until the FDA approves them, at the very least. Even with ketamine, which has been used clinically for years, most physicians still only take cash.
According to Dr Harding, the need for more mental health therapies is apparent, but she’s not convinced that ketamine or psychedelics are the answer. “To date, there is no cure for depression,” she shared. “Data tells us that if a patient has more than three bouts of depression, they will be in care for the majority of their life and will always be at risk. Treatment is always individualized, and there must always be informed consent. Patients must understand the risks, benefits, alternatives, and risks of no treatment at all.”
Dr Harding agreed that patients need more options to care for their mental health, but only when supported by solid evidence. “I think there should be further trials to support mood disorders. We don’t have good treatments for [post-traumatic stress disorder] or bipolar depression. But we need clinical trials to support us,” she said.
For now, Dr Harding encourages providers and patients to use caution when it comes to ketamine. “For providers, there is a lot of continuing education through the American Psychiatric Association to understand specific state laws… For patients, talk to your current treating providers. They are connected in communities and can connect you with care. Not every treatment is right for you. If an expert tells you that they don’t think it will help, they are probably right,” she advised.
Note: This article originally appeared on Psychiatry Advisor
Comments