Mind the gap: What is causing the ongoing ADHD drug shortage?

Since late 2022, medications for Attention Deficit/Hyperactivity Disorder, or ADHD, have been in a shortage in the United States and the UK. What began as a paucity of long acting medications, specifically Adderall in the US and Methylphenidate prolonged-release capsules in the UK, has snowballed into an ongoing shortage of nearly every ADHD medication as patients scramble to access prescriptions they can fill.

It’s only one of many drug shortages currently affecting patients – as of writing, the FDA is tracking more than 300 – many of which involve life-saving and life-sustaining medications. But the ADHD medication shortage is notable for its persistence, its unique affect on patients, and the ambiguity around causes and potential solutions.

The impact of missing medications

ADHD affects as many as 10% of children in the United States and about 2.5% of adults, both in the US and globally. That number could be higher as adults, particularly women, often go undiagnosed.

In those patients, medication allows them to focus and perform in work and school and to avoid accidents that can be caused by distraction or lack of executive function. If not life-sustaining, it’s at least quality of life sustaining.

“The consequences of not being on your medication are very much like the consequences of not being able to get glasses for a couple of months,” Dr David Goodman, an assistant professor in the Department of Psychiatry and Behavioural Sciences at Johns Hopkins School of Medicine, told Deep Dive. “Imagine that you have blurred vision and you wear glasses, and then somebody steps on your glasses and you can’t get your glasses for two months. How well are you going to function? You’ll muddle through, but you’re clearly not going to function.”

In adults, this can mean everything from strain on relationships to a loss of work productivity to lack of focus at a critical moment leading to a car crash.

“I’ve had a patient who lost their job because they weren’t on their medication,” Goodman said. “They had a fairly high demanding job. [Their employer] couldn’t tolerate the error rate, and they weren’t very understanding about what was going on.”

For children, still the largest population of ADHD patients, lack of medication can lead to disruptions in school and an increased burden on parents and teachers.

“It requires a lot of time on the part of parents to oversee them, make sure they’re sitting down and doing their homework. It requires more attention by the parents in the morning to help get them organised and out to school, out to the bus, out to the car,” Goodman says. “It’s generally exhausting for the parents who are involved with the child who previously was medicated and they were enjoying the relationship. And now they’re left with this unmedicated child who has a lot of needs and demands on the parents’ time.”

As the shortage stretches into its second year, it could have a meaningful effect on kids’ grades, test scores, and futures.

The challenges of filling prescriptions

Furthermore, there are several aspects of ADHD that make shortage conditions particularly challenging.

ADHD medications are powerful stimulants, which means they are heavily regulated. In the United States they can only be prescribed in a 30-day supply and they require prior authorisation for those supplies to be refilled. There are two types of medication options: short release, such as Ritalin, which provide a brief burst of focus for just a few hours; and extended release drugs like Adderall or Lisdexamfetamine (Vyvanse), which can last between eight to 12 hours depending on how quickly the patients body processes the medication. These longer-lasting options tend to be favoured by prescribing physicians and patients.

Strategies for maintaining access to medication include calling multiple pharmacies in the hopes of finding one with the medication in stock, or calling one’s doctor to ask for a different drug, dosage, or formulation – each of which requires a new prior authorisation.
Ironically, that process requires exactly the mental capacity that many patients rely on their medication for.

So why are treatments in short supply for a condition that’s so common? Well, no one knows for certain, or those who do aren’t telling.

“I think one of the most frustrating parts is all of the secrecy that happens with the pharma companies,” Erin Fox, a PharmD and professor at University of Utah who also works with the American Society of Health System Pharmacists as an expert on shortages, told Deep Dive. “The drug companies are actually not required to publicly give a reason for why they’re having a shortage.”

They do have to report reasons to the FDA, but the FDA’s explanations have been limited—they blamed intermittent manufacturing delays at Teva, but that seems insufficient to explain a shortage that’s well into its second year.

In fact, there are a number of plausible hypotheses for the shortage, and the likelihood is that it’s some combination of them.

Manufacturing delays and quotas

When the shortage first began, authorities pinned it on “ongoing intermittent manufacturing delays” at a Teva plant, possibly related to labour shortages caused by the COVID-19 pandemic.

But that explanation doesn’t seem sufficient to explain a shortage of this duration, Fox says.

Manufacturers have reported that they don’t have sufficient raw materials to make more drugs. Because ADHD drugs are schedule 2 drugs, those materials are doled out by the Drug Enforcement Agency (DEA) in the US via a quota system. But there’s a catch – DEA and FDA say the manufacturers aren’t even utilising the quota they have.

“We also hear from companies that they don’t have enough quota, the raw materials, to make the products,” Fox said. “But then we have the DEA who is in charge of the quota, coming out and saying you have plenty, you just haven’t chosen to make enough drug. We had the very unusual situation of FDA and DEA together writing a letter telling these drug companies, ‘Make more drug.’”

NBC news dug into this he said-she said, but the best they could do was speculate that some manufacturers may be sitting on unused quota, something they wouldn’t be required to share.

“There’s a lot of finger-pointing between the pharmaceutical manufacturers, the providers for the basic elements to make the medication, and then the distributors and the insurance companies,” Goodman said. “Everybody’s got fingers pointed at everybody else.”

In the UK, supply chains are partly to blame, with a report in The Guardian suggesting that a number of NHS drug shortages, including the stimulant shortage, can be traced back to the effects of Brexit – both on the importation of drugs and the red tape associated with the UK’s standing up internal approval processes rather than using the European Medicines Agency.

Increased demand

Another explanation, also partially fuelled by COVID-19, is that the industry simply wasn’t ready for an increase in demand for ADHD medications, stemming from an influx of adult ADHD diagnoses.

Goodman said the number of adult ADHD diagnoses has been steadily increasing in recent years, likely owing to a combination of a decrease in stigma among patients, especially millennials and Gen Z, and growing professional consensus among providers about the reality and seriousness of adult ADHD.

The pandemic may have accelerated this trend in a couple of ways. For one thing, pandemic-era telehealth rules made it easier to obtain an ADHD prescription. For another, adults with undiagnosed or untreated ADHD who were able to function without medication in an office environment may have found themselves in need of more assistance in the new, distracting world of work from home.

“If you’re in a structured environment and you’re held accountable to that, the structure allows you to perform at a higher level,” Goodman said. “If you have to sit at home, structure yourself, and be self-disciplined and initiate tasks, it becomes more challenging. For a lot of ADHD individuals, being at home wasn’t a very good way of conducting their work.”

Fox says there’s one problem with the demand explanation.

“I think If there’s any bright spot to the pandemic, it was telehealth and giving people more access, which I think is great,” she said. “I think on the demand side, if demand was truly driving this, then it seems like DEA would increase the quota, but they haven’t.”

Unintended side effects of the opioid settlement

Finally, there’s one more unexpected cause behind the shortage in the US: The legal settlement between the US government and the opioid manufacturers. In addition to manufacturers needing to order quotas of raw materials from the DEA, the settlement requires wholesalers like McKesson and Cardinal to limit the amount of controlled substances, including ADHD medications, they give to pharmacies.

That supply is calculated according to a formula that’s not made public, leaving pharmacies unable to get the drugs they order and not sure why.

“This whole system is really incentivized to not have any extra on the shelves,” Fox said. “Basically, as a pharmacy, you have to prove that you are out or you don’t have enough to fill your prescriptions, but that automatically means that patients are going without getting a prescription. This entire settlement is designed to almost make sure that patients are going without treatments.”

Unlike legislation, a legal settlement, even one involving the government, can’t really be addressed by lobbying and its terms aren’t even publicly available, Fox says.

Solving the shortage

Everyone from government bodies to manufacturers says they are working to solve the shortage, and Fox says there are signs that it’s getting better.

The end of the pandemic telehealth allowances in November could lead to a decrease in demand that helps alleviate the shortage if it hasn’t been solved by then. But it’s unlikely to have a full effect because newly diagnosed or prescribed adults won’t stop taking medications that work for them just because they now have to go into a doctor’s office to get them.

The FDA approved new generics last year, which could also help ease the difficulties. And the DEA announced changes to its quota process late last year that could also help.

Meanwhile, patients are increasingly vocal about the need for a solution.

“I think the public shaming is usually where we sometimes see action,” Fox said. “But I think that’s where we’re at. I think we’re at the public shaming part of this.”

Jonah Comstock is a veteran health tech and digital health reporter. In addition to covering the industry for nearly a decade through articles and podcasts, he is also an oft-seen face at digital health events and on digital health Twitter.

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