Intransal Esketamine and REMS


Two psychiatrists discuss the importance of intranasal esketamine having a Risk Evaluation and Mitigation Strategy (REMS) and how that impacts treatment for treatment resistant depression.

Lisa Harding, MD: I have a question about you being a certified REMS [Risk Evaluation and Mitigation Strategy] treatment center. What was involved in becoming a REMS treatment center?

Angelos Halaris, MD, PhD, APA, ACNP, CINP: It’s not as awesome or as scary as it may sound. First, you need to have a physician who’s REMS certified. That’s a process that requires training and exposure. In my case, because I was involved early on during phase 3 clinical trials, I pretty much automatically became certified and have maintained my certification. I take it with me when I go to bed every night, so to speak. That has allowed me to help establish REMS-certified treatment centers, both at a university medical center and in a private practice setting.

The process is fairly simple. It takes an application. The company Janssen [Pharmaceuticals] is very helpful in assisting prospective sites, whether a medical center or a private practice setting, achieve REMS certification. Certain conditions needed to be met: the equipment—there’s no equipment other than a suitable chair for the patient to rest comfortably; monitoring vital signs; and installing a safe, because the medication needs to be under double lock with limited access with a code for the REMS-certified provider, which applies to the physician as well as a nurse usually, or an APN [advanced practice nurse].

Lisa Harding, MD: I’m curious to ask you what your conversation is about misuse and abuse. I have patients who have treatment-resistant depression who are a couple of years out from substance abuse. I don’t preclude those patients in my private practice, but it’s a very different conversation in terms of the other treatments. “Are you in AE? Are you in NE? Are you going to groups? What does that look like? For me, it’s an extension of the conversation that I already have with patients whom I prescribe any schedule 3 substance to. What about you?

Angelos Halaris, MD, PhD, APA, ACNP, CINP: There are lots of issues. We need more time. Let me go back to the contraindications. Blood pressure is a major issue, and I want to be on record reinforcing the need for stable blood pressure. Sometimes patients come in on blood medication. I’ve had 1 patient who was on 3 blood pressure medications and upon initial evaluation, her blood pressure was all over the place. I can reinforce and stress efficiently they need to have adequate stable control of hypertension if hypertension is an issue. And allow 2 weeks after adjustment of medications to make sure that blood pressure remains stable, because blood pressure elevation does happen almost invariably. Generally, if blood pressure is stable, we’re looking at 20 to 30 mmHg in systolic blood pressure. That’s relatively short-lived. We start seeing it at about 20 minutes postadministration, and by 60 to 90 minutes, it’s almost close to baseline. That’s 1 issue that’s very important.

Lisa Harding, MD: We have similar data as well. My anecdotal experience in our office is we usually find between 60 and 90 minutes is when things start to “normalize.”

This transcript has been edited for clarity.

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