Drs Harding and Halaris review the requirements health care settings must follow in order to procure, prescribe, and dispense intranasal esketamine as treatment resistant depression therapy.
Lisa Harding, MD: Angelos, what kind of training did your pharmacist or the doctor that’s running it in the setting have to undergo? What do you think they needed to understand about being set up to do this? Like you, I’ve done this in a university setting as well as in a private practice. One of the questions I want to help demystify for a psychiatrist is, “Can I do this by myself? Do I need to have an anesthetist with me?” Could you touch on your own comfort level in doing this yourself as a psychiatrist?
Angelos Halaris, MD, PhD, APA, ACNP, CINP: Very much so. I’m very comfortable doing it, not by myself. We need to have 1 clinician, preferably an RN [registered nurse] or APRN [advanced practice registered nurse], who keeps a close eye on the patient for the entire 2 hours, ideally inside the room or in an adjacent room where the nurse or medical assistant can keep an eye on the patients throughout the entire 2-hour observation period. Other than that, if there’s a pharmacy embedded within the institution, the pharmacy needs to become REMS [Risk Evaluation and Mitigation Strategy] certified. That’s not a terrible training, but there are certain requirements mandated by the FDA that need to be met in order to be certified as a pharmacist or as a pharmacy.
In the case of a practice site that doesn’t employ a pharmacist or doesn’t have their own pharmacy, there are certified pharmacies that are available. That works very smoothly in terms of ordering the medication ahead of time with refills like any other medication. These refills obviously need to be updated as necessary. Insurance companies have to go through the process of approving a refill. It’s no different from any other medication.
Lisa Harding, MD: Excellent. Thank you so much for demystifying that.
Angelos Halaris, MD, PhD, APA, ACNP, CINP: It’s not that cumbersome. It sounds scarier than it really is.
Lisa Harding, MD: Tell me a little about how you enroll your patients with the REMS setting. Given the COVID-19 pandemic, we’ve utilized a lot of the REMS enrollment online. We’ve used the email system, in which we send it to the patient and that reduces the number of times that they have to come in the office. What have you been doing with your patients in terms of enrolling them in the REMS? Because the sticking point is that the patient has to be enrolled in the REMS before the first treatment. We really like to talk about that with the referring for providers who refer to us.
Angelos Halaris, MD, PhD, APA, ACNP, CINP: Yes. My approach is to see the patient, ideally in the office or via video telehealth. I want to see the patient, if not on site in the office, then at least in the video. It’s a limited face-to-face contact, but better than just telephone. Then I go through the assessment we discussed earlier. If I deem the patient is a suitable candidate, then we proceed to obtain the registration of the patient. It’s that simple. It has to be submitted to the REMS office before any treatment can be started.
This transcript has been edited for clarity.