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What's behind the ADHD drug shortage

(ADHD Center/Flickr)
(ADHD Center/Flickr)

Many Americans with ADHD are scrambling for their prescription medication due to a months-long shortage.

What’s behind the demand? And, what’s behind the fact that the rate of adult ADHD diagnosis is growing four times faster than diagnoses among kids?

Today, On Point: Understanding the ADHD drug shortage.

Guests

Dr. Anthony Rostain, chair of Psychiatry and Behavioral Health at Cooper University Health Care. Professor emeritus of psychiatry and pediatrics at the University of Pennsylvania.

Transcript

Part I

CHRISTINE LaRUE: Every month I go through so many steps to get my kids the Concerta that they need.

MEGHNA CHAKRABARTI: Christine LaRue of Charleston, South Carolina estimates she spends up to eight hours every month tracking down prescription medication to treat her children’s ADHD.

LaRUE: Call all of the pharmacies, navigate their phone trees. Talk to somebody in the pharmacy staff about whether the prescription was actually in stock. Calling multiple pharmacies and asking all of those questions. And then when you find it in stock, you have to call the doctor’s office and have them send the e-scribe and hope and pray that they actually get it there before somebody else fills their prescription at that pharmacy where you did find availability.

Like Christine, many Americans have been hit hard by a shortage of these prescription drugs. Here’s Christopher Bell:

CHRISTOPHER BELL: It’s been crazy. I’ve been on an off ADHD medication prescribed my entire life, practically.Being told by a doctor, “You’re just gonna have to wait it out. There’s not another option.” It’s pretty insane.

CHAKRABARTI: In October 2022, the U.S. Food and Drug Administration announced there was a limited supply of Adderall, one of the most popular drugs prescribed for people with ADHD. The drugmaker, Teva, cited manufacturing delays.

But more than eight months later, Adderall still isn’t easy to get —and neither are its generic forms. Other stimulants like Ritalin, Concerta, and Vyvanse are also experiencing shortages. Kenneth Powell, Jr., a pharmacist in St. Louis, Missouri says the limited supply has also left many pharmacists scrambling.

KENNETH POWELL, JR.: We’ve had to kind of help our patients augment their medication schedule a little bit to best meet their needs in what is a difficult situation going on. Whether that means changing their doses to two 15 milligram capsules versus the one 30 milligram capsule, taking three 10 milligram capsules versus one 30 milligrams.

CHAKRABARTI: This is On Point. I’m Meghna Chakrabarti. The pandemic, and its attendant supply chain collapses, brought about shortages in sectors across the board. And pharma production was no exception. However, in the case of the drugs used to treat ADHD – the shortages are ongoing … and they have multiple causes beyond a temporary bottleneck in raw materials.

Government regulation is putting something of a ceiling on ADHD drug manufacturing. But there’s also skyrocketing demand among adults with ADHD. And 16 years ago – back in July 2007 – Americans momentarily touched a milestone. That month, the number of ADHD medication prescriptions for adults surpassed the number of prescriptions written for children. And in 2019, researchers found that the rate of adult ADHD diagnosis was four times higher than the rate children were being diagnosed.

Today, we’re going to try to make sense of what’s driving those numbers.

Dr. Anthony Rostain is chair of Psychiatry and Behavioral Health at Cooper University Healthcare, and professor emeritus of psychiatry and pediatrics at the University of Pennsylvania. Dr. Rostain, welcome to On Point.

ANTHONY ROSTAIN: Thank you so much.

CHAKRABARTI: I wonder if we could first start with some definitions, right? Because when we talk about drugs and whether they’re Schedule 1 or Schedule 2, it’s a little hard to understand what exactly we’re talking about. So most ADHD medications contain what? A compound or some drug that puts them under Schedule 2 for federal regulation.

Can you explain a little bit about what that is?

ROSTAIN: Sure. In 1970, the controlled Substances Act established a series of levels of dangerousness and concern about medications and listed Schedule 2 as ones that needed to be carefully monitored. And a host of restrictions placed upon the prescribing of these medications.

CHAKRABARTI: Okay, so the difference then, as I’m seeing here between Schedule 1 drugs, which are, they’re drugs that the government sees as having no current medical use.

ROSTAIN: That’s correct. Schedule 1 cannot be. Correct. Yes, those are off limits for us to prescribe.

CHAKRABARTI: Totally off limits, high potential for abuse and or addiction.

Schedule 2 has some medically acceptable uses, but still considered by the government as potentially risky. Now, schedule two has things like Oxycodone in it. It’s got fentanyl in it. And what is the compound or the drugs in common ADHD medication that lands in the Schedule 2 category?

ROSTAIN: The two categories of medication are the methylphenidate products and the amphetamine products. And those have various brand names. Everybody refers, in the past to the Methylphenidate products as Ritalin. But that’s, Ritalin was a brand name. So we refer to them all as methylphenidate based.

And then there’s amphetamine-based compounds, which Adderall is the most widely prescribed, but there are several other versions as well.

CHAKRABARTI: Okay, so I think some people might be surprised to hear us say that ADHD medications fall under the same regulatory regime as Oxy or Fentanyl. So I’m going to tease folks with that for just a second and come back to it in a moment. But Dr. Rostain, I had mentioned at the beginning that the pharma companies that make these medications were saying that there were manufacturing delays or supply chain issues that were pandemic related. What’s your best understanding of, yeah, go ahead.

ROSTAIN: First of all, let me just point out that it is extremely disturbing to those of us who prescribe these medications to have medications for ADHD and other disorders that are treated by stimulants to be classified along with those other compounds. For the longest time we believe that these are safe medications to prescribe and unfortunately even though for 50 years they’ve been listed as drugs of abuse and by the way, that means it carries a lot of stigma.

Lots of people don’t want to take these medications because they’re afraid of them, but we know that they work quite well. In fact, they work extremely well, and they’re monitored. They don’t create all these problems that people are afraid of. So we’ve been stigmatizing people who take these medications and we’ve been making it difficult for prescribers because these are listed alongside these other much more concerning medications.

In terms of the shortages, there’ve been shortages way before the pandemic. Shortages in medications across the country have been noted for decades that they occurred with fair degree of regularity and with respect to ADHD medications, we’ve seen these shortages prior to the pandemic.

But this particular one that began last October is worse than any of them. And we’re not in the middle of the pandemic anymore, so there’s a lot of finger-pointing going on right now. A lot of different causes being explored. But I think the manufacturers are being a little bit facile when they say it’s all got to do with supply chains or labor shortages.

And there’s a back and forth going on that’s fascinating between the DEA. That regulates these, how many pounds or tons I should say of amphetamine or methylphenidate are allowed to be produced each year and the manufacturers who produce them. And if you read in the federal register, you’ll see that DEA says, “Hey, we don’t see that there’s, our quotas, our quotas every year are not even being seen as too strict from the standpoint of the pharmaceutical industry.” Meanwhile —

CHAKRABARTI: Can I just jump in here? One second to interrupt and forgive me because you said something that’s really important and I just want to tease it out a little bit.

DEA has basically sets quotas for the amount of these compounds that can be used in the production of medications. Is that right?

ROSTAIN: That’s correct.

CHAKRABARTI: Okay. And then, and you’re saying that even though pharmaceutical companies might be saying hey those DEA restrictions are making it difficult for us to meet demand, that’s not necessarily the case. That in truth, they’re not really saying that it’s too strict.

ROSTAIN: In fact, they, the federal Register recently published a discussion that DEA had with various constituents, and it listed, repeatedly said that when queried, the major manufacturers did not find a problem with the annual production quotas that are currently in existence. So that really jars with the reality of these shortages.

So why, if the pharmaceutical companies say, “Hey we don’t need an expansion of the production quotas, then what’s wrong?  Why aren’t we seeing such problems with distribution?” And you heard the people speaking earlier, how much time people spend going from pharmacy to pharmacy and you have to dig a little bit deeper and say, “Okay, there may be some reduction in production or not an increase in production as we would imagine there should be with greater demand. So why is the supply being limited?” And secondly, what about the distribution? What’s going on with the pharmacies? How are they deciding which pharmacies in which regions get the medication or which don’t?

And again, that leads the public and in particular, patients and prescribers, in this really weird state where we aren’t told where things were going, we don’t know when this shortage will be alleviated. We have no input. There’s no regulation really of the whole problem of the shortage, because the current system is not set up in a way that allows transparency and gives patients and prescribers the chance to realize where and how are these shortages going to be addressed. There’s still no answer.

CHAKRABARTI: Yeah. And what’s quite interesting about this moment is that in the past when we had shortages, in terms of prescription drug medications, it was oftentimes because there was maybe one manufacturer.

So failures with that manufacturer were understandable in terms of leading to shortages at the other end, when people try to go to the pharmacy and get the medications they need. But in this case, there actually are several manufacturers, including generic makers who are all saying the same thing.

We’ve got the Schedule 2 regulation that you talked about with DEA. And it’s such a like crazy thicket between.

ROSTAIN: It really is.

CHAKRABARTI: When pill pills are made and when people can get the prescriptions and there was a new complication added to that thicket that the opioid settlement. Regarding oxycodone actually limits how many pills, all Schedule 2 pills whole can give to pharmacies.

Part II 

CHAKRABARTI: Dr. Anthony Rostain joins us today. He’s chair of Psychiatry and Behavioral Health at Cooper University Healthcare, and he’s with us to help us understand the multiple forces that are behind the shortage that people with ADHD are experiencing when it comes to getting their medications, their prescription drugs that they need.

Now, Dr. Rostain, before the break, we had talked a little bit about the Schedule 2 issue, and we will come back to that in a moment, but then I was just about to ask about the fact that there is a legal settlement that also may have an impact on these ongoing shortages.

Do you want to talk about that for a little bit?

ROSTAIN: For sure. So we all know that the opiate crisis in the United States has had devastating impact on our nation, on individuals throughout the country who became addicted and eventually many of them succumbed to their opiate use disorder.

And the DEA was very much concerned about establishing limits to how many pills would be available as a way to mitigate the chances of the sort of overprescribing that we saw. Now let’s keep in mind no one doubts the necessity for careful prescribing of opiates. Just like no one doubts the need for careful prescribing of stimulant medication. But what’s happened is that immediately the sort of the two medications, opiates and stimulant medications, have become equated in the public’s mind and in the regulator’s minds.

And so there’s a lot of concern right now about stimulant misuse and abuse, which is a problem. No one doubts it, but it’s nowhere near the scale of the problem that we see with opiates and with the way in which opiates were prescribed. So I would call it a kind of a guilt by association phenomenon where people who are prescribing stimulant medications are almost watched even more carefully recently.

We’ve always been carefully monitored, but now there’s an extra scrutiny because of what happened with the opiate crisis. And then I think both manufacturers and other forces in the, for example, pharmacies themselves have now been refusing some of the prescriptions that we write.

Out of the question of why are you giving this patient more than X amount of milligrams per day? And I am regularly asked by pharmacists to justify prescriptions that I’ve been giving to patients for years. Again, under this, somehow what I would call the carryover effect or guilt by association.

Suddenly, stimulant medications become the focus of a great deal of oversight and concern by people really who shouldn’t be getting in the middle of what our relationship between patients and their clinicians.

CHAKRABARTI: Okay. So a little bit more detail here because it’s really interesting.

This is a larger group of people who are in a sense, indirectly being impacted by the opioid crisis, because to be clear, there are several big, main pharmaceutical wholesalers. I’m seeing that they’re AmerisourceBergen Corp., Cardinal Health. And McKesson Corporation, they’ve all tightened monitoring of what they believe are quote-unquote suspicious orders from pharmacies.

Basically, what they’re doing is they’re making, are they limiting the number of medications for ADHD that go to the pharmacies where people would be filling their prescriptions?

ROSTAIN: Again, I don’t know how they’re making decisions. I see the end result, which is that my patients have to literally call around, like you heard in the earlier segment.

And they’ll all say the same thing. “We don’t know when they’re coming in, oh, there’s a shipment coming in on Tuesday.” Literally people are waiting for days to see if the medication they’ve been prescribed is gonna show up in their pharmacy. And I’ll have one other anecdote, which is one of my very kind of enterprising patients actually called the head.

As far as he could go up on the customer service side of a pharmacy chain to speak to him directly about his difficulties because his prescription was a little bit higher than other people’s, and he was able to get an assurance and then actually was able to get more regular access to his medication, but he had to call all the way up the corporate chain of that pharmacy company, of the pharmacy.

So I would say there’s a lot going on behind the scenes that we’re not privy to. But it is the case as you said, that they are apportioning the shipments very closely, very carefully. And there’s also apportion attempts to reduce costs on the side of pharmacy plans, so it doesn’t hurt them at all to say limit whatever there is because they’re worried. As you pointed out earlier, that the demand for these medications has gone up. How do we regulate supply? That’s really something that’s mysterious to those of us that are really seeing this as a public health problem, but apparently, it’s being turned into something of an economic issue.

CHAKRABARTI: So there’s some interesting detail from Reuters in reporting they’ve done about this. In reading some letters that AmerisourceBergen wrote to one pharmacy and interviews with pharmacists, they found that in certain cases, wholesalers imposed the bans because pharmacies had filled prescriptions written by medical practitioners who prescribed what they say were controlled substances.

That included prescriptions for stimulants and sedatives to the same patient. So they’re making some decisions there, essentially for the patient, in between what the doctor says and the pills that they can get.

And then Reuters also said that they interviewed several pharmacists in at least five different states, and those pharmacies were told they were going to be cut off from the distribution of all controlled substances. They were going to be cut off by the wholesalers because of their filling of prescriptions written by doctors. So I completely agree with you. There’s a very murky middle here that deserves some understanding.

ROSTAIN: That’s a very important, that’s a very important point that the pharmacists at the front line themselves are feeling squeezed by the wholesalers.

And again, if you want my honest opinion, there needs to be some sort of national commission, some sort of effort, maybe by Congress, to look into what’s going on here. Because the patients are being harmed and I think public health needs are not being addressed when these sorts of policies are being written behind the scenes.

And once again, it may be well motivated, may be well motivated by a wish not to repeat what happened with the opiate pandemic, as we saw. But I really think they’re going overboard. And the other thing that’s occurring is that they’re getting it and they’re meddling into medical practice.

We do have patients that take stimulants along with other medications, most adults, for example, with attention deficit hyperactivity disorder, actually suffer from other conditions like depression, like anxiety. Many of them have trauma. We might be, in fact, combining medications for patients who are complex, and I think that’s really dangerous for anybody to be telling practitioners what’s best for their patients.

CHAKRABARTI: But just to be clear Dr. Rostain, again, this is all coming because of, as you mentioned upfront, the terrible cost of the opioid epidemic, and now we have things like fentanyl, which are killing people. When taken especially illicitly, and the government still sees the compounds used in medications to treat ADHD as essentially an equivalent risk for abuse as things like fentanyl. Are you saying that’s wrong?

ROSTAIN: That’s a false equivalency, No. 1. No. 2, if you go way back to the 1970s and the Control Substances Act, it was actually developed under the Nixon administration with a very explicit agenda aimed at making illegal substances that were becoming widely used by both young people in the anti-war movement and the Black power movement.

Then they really used it as a weapon to try to stifle, if you will, the dissent in those days. Now, it’s not to say that substances shouldn’t be controlled, but you have to remember that before 1971, amphetamines and methylphenidate products were prescribed widely for these conditions we’re describing.

There was not the level of scrutiny and almost a sort of a sense of criminalization. And patients now when they go to the pharmacy are routinely looked at as though they are misusing, abusing, or are faking their disorder. And there’s a whole area of, a whole incredible, a blowback effect on patients themselves who feel stigmatized. They feel ashamed. They feel afraid. And the other interesting problem is that whereas pediatricians, and family physicians, and child psychiatrists and neurologists will prescribe stimulants routinely for children.

When it comes to adults, adult patients with ADHD are finding it very hard to find providers in primary care to prescribe these medications. ‘Because they’re basically told if you have ADHD, I don’t feel comfortable prescribing it. Go see a psychiatrist. So there’s a sort of a whole mental health crisis in terms of access to providers for adults with ADHD. Because yes, they need, maybe it’s fine to come to a psychiatrist for a diagnosis and for making sure that they’ve started on the right treatment.

But then when I and my colleagues try to send these patients back to their own primary care providers, many of those providers will refuse. They will say, no, I don’t prescribe stimulants. And it’s because they are afraid of both the harm that those stimulants might cause and that they will be viewed as, they’ll be taken advantage of by patients who are somehow gaining the system.

So it’s a very thorny situation in terms of access to care. And I feel really we are just not equipped. We do not have the resources from the provider side, from people who are willing to take this on. We can’t refer these patients back to their primary care practitioners.

And so we end up having to work overtime in the adult psychiatric world.

CHAKRABARTI: Yeah, there may be some gaming of the system because of that gap that you’re talking about regarding the inadequate number of providers. So I promise you I’ll come back to that in a second here.

But just to recap, it seems as if we’re resting our analysis of the shortage for patients of ADHD medications on a stool with three legs. One of them may actually be some input supply chain issues. That the pharmaceutical companies themselves have been making.

The second one that we’ve talked about in detail is not only the Schedule 2 classification, but then also the wholesalers curbing the number of pills that pharmacies can actually put out, because of the aftermath of the opioid epidemic. You just mentioned the third one, which is essentially the increase in demand, especially amongst adults.

So that’s what I want to talk about for the rest of the hour. And first, let’s listen to some folks who describe what they need. And here’s some voices that can maybe get us talking about what’s behind the increase in ADHD diagnosis, particularly in adults.

BREZINA: I was diagnosed with ADHD when I was 51 years old. Adderall is like walking into a quiet room.

JANE: I have an adult child who doesn’t have ADHD but has narcolepsy, and we have been dealing painfully with the Adderall shortage.

RAPPMUND: My son was diagnosed with ADHD several years ago. And at least how it manifests for him, we’re able to manage quite well with other forms of support, like cognitive behavioral therapy support from his school through the counselor and his teachers.

MICHELLE: I have been using fish oil and DMAE to greatly reduce, I mean, to a small amount, my ADHD medication.

CHAKRABARTI: Those were On Point listeners Berwin Brezina in Washington, North Carolina; Jane in Salt Lake City, Utah; Denise Rappmund in Santa Fe, New Mexico; and Michelle in Little Rock, Arkansas.

So, Dr. Rostain, at the top of the show, I read a fact, a research finding that showed that even prior to the pandemic, the rate of ADHD adult diagnosis was four times the rate that children were being diagnosed. Does that match with what you’ve seen in your practice in terms of who’s coming in, seeking help?

ROSTAIN: Yes. Yes. Let’s start off with some facts that are behind what you just stated.

No. 1, when we began, there were finally some epidemiologic studies that looked at the rates of ADHD in the general population of adults. And it wasn’t until the 21st century when that was even asked of epidemiologic surveys looking at mental disorders. And lo and behold, over 4% of adults in the United States met criteria for ADHD.

Only about 11% of them at the time were getting any treatment for it. When you look at comparable statistics for children, roughly 7% to 8% of children or maybe a little more and depending where met criteria for ADHD. And over 30% to 40% of those children were getting treated.

And in fact, now, at the time as we speak, it isn’t clear, roughly half of kids are in some way or other getting a treatment, not necessarily with medication, but whereas the numbers of adults have always, it seemed to us, No. 1, under-recognized and No. 2, undertreated. So what you’re probably seeing in this rise in the adult diagnosis is the growing recognition of the disorder in adults.

The growing capacity of clinicians to identify and treat it and the lowering of stigma towards the treatments for adult, ADHD, and I’m proud to say that one of the organizations that I am a member of and was once the president of, the American Professional Society of ADHD and Related Disorders has made a major effort over the last decade to help clinicians identify ADHD in adults and be able to begin a course of treatment, using the proper kinds of assessment tools.

By the way, treatment is not just medication. I’ve always, for the decades that I’ve worked in this field, whenever I go to talk about ADHD, all I talk about, because that’s what people want to talk about, it’s stimulants and why are we giving stimulants, but truly a full menu of treatment includes cognitive therapy, workplace or school accommodations, changes in your environment.

So this has to be embedded in a broader discussion about A) how do we help those adults? And how do we not just restrict the discussion to meds. But definitely medications can help.

This article was originally published on WBUR.org.

Copyright 2023 NPR. To see more, visit https://www.npr.org.

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