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Written by Daniel Z. Lieberman, MD
By now, the news of critical medications being in short supply since the start of the pandemic isn’t really, well, new.
It’s been more than a year since the FDA formally announced that pharmaceutical companies cannot produce enough Adderall to meet demand for the common ADHD medication. The FDA even maintains a regularly updated database to track drug shortages.
And earlier this year, the overwhelming celebrity and social media buzz about the weight-loss side effect of the diabetes drug semaglutide, more commonly known as Ozempic, made it difficult for patients with the actual disease to access their medication.
The shortages now seem to be extending to ketamine, an anesthetic drug that has become popular in recent years as a treatment for some mental illnesses, including severe depression and post-traumatic stress disorder. Many psychotherapists and psychiatrists offer ketamine-assisted therapy to patients whose conditions have been resistant to other forms of treatment, especially those dealing with suicidal ideation.
The FDA considers this application of the drug “off-label,” meaning it’s outside the specific parameters that the agency has approved—and just last month, the agency issued a warning about the risks of off-label usage.
According to a VICE News article published shortly after, two of the largest ketamine providers in the U.S. have been “cracking down on supplying the drug to anyone using it for off-label purposes.” And a survey conducted by the American Society of Ketamine Physicians, Psychotherapists, and Practitioners (ASKP3) found that 82% of its responding members said they’d had difficulties obtaining ketamine recently.
For patients whose treatment regimen depends on having access to ketamine in controlled environments, missing doses could have devastating effects. With the random and unforeseeable nature of medication shortages—and with no end in sight—how are providers adapting to help patients? Why do drug shortages happen to begin with, and what are the risks of seeking out treatments with high potential for misuse?
We checked in with Dr. Daniel Lieberman, Clinical Professor of Psychiatry and Behavioral Sciences at George Washington University and SVP of Mental Health at Hims and Hers, to ask all that, and learn how concerned should patients be about being able to find the treatment they need, when they need it most.
Dr. Lieberman: Some of them are hangovers from the supply chain issues from the pandemic. Others are a result of the DEA not providing adequate authorization to pharmaceutical manufacturers to produce enough—we see that with the Adderall shortage.
But it can also be because there is a sudden increase in demand for medications that manufacturers either did not anticipate or simply are not able to keep up with because of the difficulty of manufacturing the drug.
I think it can happen in two ways. One way is that there can be a breakthrough that provides a medication that is a quantum leap forward in terms of efficacy. And that's what we're seeing with Ozempic, Mounjaro, and drugs in that class. In many ways, that's exciting. It's wonderful news.
But in the enthusiasm, people can lose sight of some of the disadvantages and the limitations of these medications. And typically, what we see is a pendulum swing—there's huge excitement, and then people realize, this is reality not fantasy, and there are significant problems. And then it swings back and there's huge disillusionment.
Another way it can happen is that you just get maybe one single charismatic influencer, who says, “This is the best thing ever. I've suffered my whole life. I've tried a million things. Nothing ever worked. This is a miracle.” And then it starts to spread. It starts to spread because other people get excited about it and it also starts to spread because anything that gets lots of views gets copied.
I think that that may be what happened with ketamine—like Ozempic, ketamine can be a wonderful medication for the right patients. But the subtleties get lost in the enthusiasm, and people begin to think that this is a good drug for themselves, even though they have not had a full workup by a qualified healthcare professional to determine if that's correct.
I have referred quite a few patients for ketamine treatment, so it's a medication that I'm very grateful for. And I think it has an important role in treatment. However, it carries substantially higher risks than the other antidepressants, so it really needs to be reserved for people who have not responded to at least four or five trials of other medications. It's a medication that has abuse potential, so it is regulated by the DEA.
It's a medication that has not been as well-studied for depression. We don't know a lot about it. Because it's typically used as an anesthetic, it's approved for the treatment of pain. When it's used as an anesthetic, it's used once and that's it. And when it's used that way, it's incredibly safe.
On the other hand, if it's used on a daily basis, as some addicts do, it can cause terrible, terrible bladder issues, such that people are unable to urinate. And it has other serious, serious risks as well, that I think that most people are unaware of.
They look at its historical safety record when used medically, and it looks fantastic! But they don't realize that for depression, it's being used by some people in a very different way.
There's all kinds of wonderful information out there on psychiatry and psychological health. And I think it's wonderful that there is an increasing interest in it, and that people are taking the time to learn more about it. But they've got to remember that doctors spend many, many, many years of their life learning about the intricacies of the human body and the human mind. And it's not possible to communicate this expertise with a TikTok video. If it were, we wouldn't have to go to medical school.
So it's good to come to a doctor's office prepared with information. It's good to come to a doctor's office prepared with preferences for what kind of treatment you would like, but take advantage of the doctor's expertise. It can be very, very valuable.
To give one example, I had a patient who was suffering from insomnia. I prescribed her a sleeping pill, and it worked wonderfully for making her fall asleep. But she was groggy the next morning. So as a physician, I knew that she needed a medication that had a shorter duration of action.
Now, she had seen a commercial on television for a drug that has a longer duration of action. But the commercial said, “Fall asleep easily and wake up refreshed.” And she said, “That's what I need! I need to wake up refreshed. I want this medication.” And it took me a long time to explain to her why that was not right. She continued to be dubious, even after she left. But we had established a relationship, she trusted me, she took the medication that I prescribed, and it did exactly what she wanted.
The point is that sometimes it's hard to interpret the information you get from the sources, and you really need a doctor to sort them out. And to really decide what's best for you as an individual.
The good thing about telehealth is really that it increases access to experts.
Seeking mental healthcare can be a lot of work, and there are a lot of barriers to picking up the phone and making an appointment to see somebody in person. Aside from the inconvenience, and often the increased expense, if only associated with driving and parking, the stigma associated with mental illness can make it hard to say, “Hi, I’m feeling weak. And I need somebody to help me. I can’t do it on my own.” That's very, very hard. It's very important, but it's very hard.
On the other hand, if you're able to go online or download an app and access an expert who can give you personalized care that's much more convenient, and is less embarrassing, that's going to open up the door to a lot of people who wouldn't otherwise get help.
There's really no perfect solution. When possible, we will try to prescribe a medication that is similar to the one that's unavailable. And with ADHD, we saw a transition from Adderall to a drug called Vyvanse. And that worked initially, but then so many people switched over that there were shortages of Vyvanse.
Another thing we can do is give patients a paper prescription that they can carry to different pharmacies if their usual location doesn’t have their medication in stock, as opposed to an electronic prescription sent directly to only one pharmacy.
Ketamine is trickier, because ketamine is not typically prescribed by ordinary psychiatrists. Usually, it's administered intravenously in a special ketamine clinic, or being given through telehealth, which is a greater concern for this drug. So I'm afraid in many cases, patients are just going without, which is the worst possible outcome in some ways.
It’s another reason to carefully ask yourself, Is this the best medication for me? Is this popular, trendy medication going to be best for me? Or is it possible that a medication that is easily available would be better or just as good?
I think that when the ketamine pendulum swings, it's going to swing hard. I think there's gonna be lawsuits from people who got addicted to this medication and suffered serious, potentially long-term side effects. And you don't want to jump on the bandwagon without a doctor's guidance when the enthusiasm is at its absolute peak and people are ignoring all of the negative things.
And here’s something really critical: SSRIs may not be trendy and sexy, but because they've been around for a long time, we have an enormous amount of experience with them. We know that they're not perfect. They don't work all the time the way we want them to. We know they have side effects.
But we also know that they are enormously safe over the long term, that millions of people have taken these drugs for decades. So if you take a deep breath for a moment and say, hey, what do I really want to put in my body? It's usually the tried and true one.
And again, let me repeat, I do refer people to ketamine treatment! But only after I've exhausted the better studied, safer options. And the practitioners that I refer to administer it in a way that I am very familiar with, and is consistent with the research science behind it.
Typically, they will give six treatments to start, and then they will start spreading them out. And it’s given intravenously.
Now that's different from other providers who, in my opinion, are not relying upon the science. They're often giving it orally because they can do that without a big, expensive clinic, and they’re sometimes giving it every single day for months and months and months. That terrifies me. And I think that people are going to run into problems with addiction, bladder problems, and other issues as well.
The other thing is that when ketamine is used properly, patients are observed for two hours following the treatment because this is an anesthetic agent. And they don't allow people to drive home after this—they either have to be picked up or use a ride-share service.
With telehealth or orally prescribed ketamine, there’s way less supervision of patients. And unfortunately, not everybody has good judgment. Some people are not going to wait two hours after the effects wear off before they drive, and they're still gonna be under the influence of this anesthetic agent. That’s very, very dangerous.