The Ketamine & Esketamine Care Teams, and Necessary Monitoring

After the US Food and Drug Administration (FDA) approved esketamine (Spravato) for treatment-resistant depression and depressive symptoms in adults with major depressive disorder with acute suicidal ideation in 2019, discussion shifted from the potential of ketamine-based drugs and anesthetics in psychiatric, to how exactly it needs to be used.

As one expert explained to HCPLive, much of the care precedent is now set for esketamine; what’s needed next is greater monitoring.

In the second segment of an interview during the American Psychiatric Association (APA) 2022 Annual Meeting in New Orleans this week, Roger S. McIntyre, MD, professor of psychiatry and pharmacology at the University of Toronto, discussed the ideal esketamine or ketamine delivery care team. From his experience, a series of care providers across sub-disciplines are qualified: nurse practitioners, nurses, anesthetists, psychiatrists, and even primary care.

“The key thing is, there needs to be multidisciplinary expertise in the administration of what is, in fact, an anesthetic now repurposed as an antidepressant, as well as the competencies around assessing and treating depression,” McIntyre said.

The 2 agents—one regulated by the FDA, the other used in limited investigative capacity—differ in standards of procedure, but include similar needs for careful monitoring.

“I think there has to be, on premise, expertise in mental health,” McIntyre said. S”econdly, the esketamine treatment requires a risk evaluation mitigation strategy (REMS), so the premise and the staff have to adhere to the FDA requirement. With ketamine, we also require an observation period. It doesn’t have a REMS, it’s not FDA approved—but we also recommend a similar observation that requires infrastructure and a staff to do that.”

Going forward, McIntyre sees a variety of psychiatric care opportunities with the drug class: potential use in treating bipolar depression, as well as prominent depressive comorbidities including alcohol or substance use disorders or even post-traumatic stress disorder (PTSD). He’s also interested in research surrounding treating pediatric mood disorders.

But in the current real-world application of ketamine and esketamine, clinicians like McIntyre are lacking much-needed databases and repositories, to refer to acute and long-term patient outcomes, as well as safety considerations including potential risk of drug abuse development in treated patients.

“We clearly need a database, because unlike most treatments, ketamine and esketamine are really being delivered at least so far at specialized clinics,” McIntyre said. “And even though there’s many of these clinics opening up, they’re not really brought together to network.”

“It’s not about being alarmist, it’s about being prepared,” he added.

Lastly, McIntyre highlighted the impact these anesthetics have had during an evolutionary period of psychiatric care, discussing how their adopted use in regulated practice may provide blueprints for psychedelics or psychoactive drugs like MDMA. He stressed similar regulation and careful approach when considering the utility of these investigative drugs, though.

“If these drugs are truly capable of helping people, then they’re capable of hurting people,” McIntyre said. “And I think that we need to make sure these studies are done by people who’ve got core competencies and the experience in doing these, and there needs to be a fidelity to good clinical trial methodology to doing these.”

Nonetheless, the options to treating severe depression are expanding—and few of the newest agents are similar to the old guard.

“There’s a paradigm shift of sorts—maybe a paradigm affirmation—wherein maybe people can take treatments episodically,” McIntyre said. “For example, treatments like zuranalone are under development for the episodic treatment of depression—take it when you need it, not once a day.”