Getting Certified to Administer Esketamine for Treatment-Resistant Depression


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Requirements that healthcare clinics must satisfy to become a certified treatment center permitted to administer intranasal esketamine to patients with treatment-resistant depression.

Steven Levine, MD: It sounds like all of you have a pretty thorough process for getting patients ready for treatment and do a wonderful job with it. I’m looking to any of you 3 if I need a doctor. You’re highlighting that there are some special logistical considerations in prescribing this therapy. Among them is actually procuring and prescribing intranasal esketamine. Patricia, would you like to start talking about the requirements health care settings have to satisfy in order to do so?

Patricia Ares-Romero, MD, FASAM: Yes. It varies between the setting. For instance, my outpatient clinic is part of a hospital setting, so we have an in-house pharmacy. For us, it’s a little easier, unless the patient’s insurance requires a specialty pharmacy. Otherwise, here’s what we do. When a patient is cleared, we go through the insurance. We make sure the patient understands their co-pay if they have a commercial insurer, because we want to make sure they are aware of what it’s going to cost. We’re telling them, “It’s a 3-month commitment, and every time you come in, this might be your co-pay.” We want to make sure we have that right up front. When we bring in a patient, one of our technicians walks with the patient to the pharmacy, which is right next door, and they sign for the medication. The patient never receives it. The technician brings it back to the treatment room so that we can provide the treatment. That’s one of the things. Other colleagues of mine have it shipped directly to their office from the specialty pharmacy.

Lisa Harding, MD: That’s what I do.

Patricia Ares-Romero, MD, FASAM: For us, it’s much easier. In regard to logistics, I often get asked, “Where do you put the patients? How much space do you need for it?” Between providers, everybody decides on something different. I had real estate in my clinic, so I was able to use individual rooms. Some of my colleagues will do the treatment in a room, but they don’t have enough rooms, so they’ll put 2 people in another room to rest. There are different models that can be used, but everyone would be able to do it in a private setting.

Lisa Harding, MD: I do this from a specialty pharmacy, like you mentioned, Patricia. Everybody starts on 56 mg. I’ve designed my clinics where every Monday and Thursday I do it, simply because of specialty pharmacies. I was originally treating on a Tuesday, but they need the lead time to deliver the drug. The crux is in doing your homework and finding the nearest specialty pharmacy that can deliver the drug to your office. After you have that, we have—per DEA [Drug Enforcement Administration] guidelines—a storage room, which is a drug room behind 2 locked doors. If the safe is less than 700 pounds, it has to bolted down. We have all those things in place.

Then we have a timeout process, by which the patient is given their card stating that it was delivered here and they’re given a card stating their co-pay. We have a timeout process between myself and Miami. We do patient name, date of birth, and everybody starts on 56 mg. Then I visit with the patient to determine the next dose, because we have to preorder it to have it delivered to the clinic for the next dose. That’s how we do it here.

Steven Levine, MD: Terrific. Of course, to have it delivered to your office, you must be a certified Spravato treatment center. We mentioned that a bit earlier when we were talking about the REMS [Risk Evaluation and Mitigation Strategy] program. One of the requirements is to become a certified Spravato treatment center. Patricia, would you like to talk a little about what’s required to have that designation?

Patricia Ares-Romero, MD, FASAM: There’s paperwork to be completed. I was probably one of the first ones, so we needed to fill it out. Now, you can do it online on a portal. It’s things like who the provider is going to be, the DEA, your NPI [National Provider Identifier] number, and the actual location, a room number where you’re going to be administering the treatment. It’s a seamless process. You upload it, they verify everything, and then you’re able to be REMS-certified. The important thing is to make sure you certify the patient prior to treatment. That was one of the hiccups at the beginning. I was really excited to get a patient I knew started, and I brought him to the clinic and we did the treatment. I was told, “You were supposed to certify them first.” That was one of my hiccups. I wasn’t sure of the logistics. We now do it when they come in for the consultation. We get their consent and certify it then, and that gives us time to make sure we have medication. Then they come in for the next visit. It’s a really easy process.

Lisa Harding, MD: Absolutely. There are guidelines for health care settings. You must be able to have visibility of the patient. You have to be able to monitor things like SpO2 [oxygen saturation] and their blood pressure at certain intervals. From the REMS form, all of us know we have to have a prior reading, one at 40 minutes after the dose is given, and one before the patient is discharged. Those things are what the REMS is ensuring the provider attests to having. I used to be an emergency department physician before I became a wonderful psychiatrist. One of the requirements is that at least 1 provider at the site of an outpatient setting is ACLS [advanced cardiac life support]-certified as a recommendation. In that same package insert, as well as from the FDA, there are guidelines for you to read through as a prescriber when you’re thinking about implementing this.

Angelos Halaris, MD, PhD, APA, ACNP, CINP: There’s one more thing that must be said. Because esketamine is a controlled substance, the sites that are going to be using and administering it must keep it in a locked safe. That’s commercially available; it’s not that expensive to buy, and it can be accessed either by a code or 2 locks. There are 2 individuals who each have a different key or their own code to open the safe and retrieve the vial and the applicator that’s going to be used for that patient at that particular time before locking it back up again.

Steven Levine, MD: These are all important logistical considerations when thinking about administering esketamine.

Transcript Edited for Clarity

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