ADHD medications in shortage due to heavy-handed DEA rules

ADHD medications still in shortage, frustrating patients and doctors

“Everyone’s angry,” said Dr. Leila Javidi, a primary care doctor in Ohio. “Panic is a daily occurrence with my patients.”



U.S. facing ADHD medication shortage as students head back to school

Sept. 9, 2023, 6:53 AM CDT
By Caroline Hopkins

Almost a year into the nationwide shortage of ADHD medications, federal agencies and drugmakers are blaming each other for empty pharmacy shelves.

The Drug Enforcement Administration, which sets limits on the types of amphetamines that pharmaceutical companies can use to make the pills, says companies have more than enough raw ingredients to produce stimulant ADHD medications. Drugmakers contest the claim, saying they’ve run out of ingredients and need the DEA’s permission to acquire more.

Experts doubt the supply of the attention-deficit/hyperactivity disorder medication Adderall or other ADHD drugs will increase any time soon, with shortages potentially lasting through the end of the year.

“Let’s just say I’m very concerned,” said Dr. Max Witznitzer, a pediatric neurologist who treats children with ADHD at University Hospitals Rainbow Babies and Children’s Hospital and Case Western Reserve University. “As the kids restart school, we’re going to see the demand for these prescriptions going up.”

Dr. Leila Javidi, a primary care doctor in Gahanna, Ohio, has been fielding several hundred calls and messages each month from patients who say finding a stocked pharmacy becomes a time-consuming, frustrating quest.

“Everyone’s angry,” said Javidi. “Panic is a daily occurrence with my patients. The whole thing’s a mess.”

Why is there a shortage of ADHD medications?

As of Tuesday, the American Society of Health-System Pharmacists, a group that represents hospital and clinic pharmacists, reported supply problems affecting 141 different doses or formulations of stimulant ADHD medications. The shortage began with Adderall last fall, but has since had a domino effect, with long- and short-acting versions of methylphenidate (Ritalin and Concerta), as well as Focalin, Vyvanse, and numerous generic equivalents of these drugs now in short supply, too.

In late August, the Food and Drug Administration approved several generic versions of Vyvanse for the first time, though it’s too soon to say how that will affect the situation.

Millions of children and adults in the United States are prescribed ADHD medications, which work by increasing dopamine levels in the brain to improve focus. For some, the shortage has been an inconvenience. For many others, not having access to the medications has affected their work, relationships and physical and mental health.

Jessica Urgo, 38, recently drove two hours from her home in Denver to pick up Adderall from a remote pharmacy with only 10 pills left in stock. For Urgo, who says her disorder makes communication difficult, not having the medication has strained her relationship with her husband and frayed her friendships.

Jeremy Didier, 52, a licensed clinician in Kansas City, Kansas, said she recently waited on hold for eight hours to ask whether her local Walgreens had Concerta in stock. Didier and four of her five children take medication for ADHD. Ever since her teenage son was caught driving 20 miles above the speed limit without his medication, she has worried about the shortage’s safety risks.

“Lives could be at stake when people don’t have access to the medications they need to stay focused,” she said.

In early August, the DEA and the FDA released a joint letter in which they recognized the shortage of prescription stimulants, including Adderall, “has been understandably frustrating for patients and their families.” The letter pointed to record-high prescription rates for stimulants and pandemic-era rules allowing doctors to prescribe the medications over telehealth as factors in the current situation.

The federal agencies then argued that, in the face of this sharp rise in demand, ADHD drug manufacturers haven’t been making as many of the pills as they could be.

According to the DEA and FDA’s letter, the DEA conducted an internal analysis revealing companies used only 70% of their allotted ingredient quota in 2022, which they say could have translated into 1 billion more doses. The numbers are trending similarly for 2023, according to the two agencies.

They requested any leftover amphetamine to be returned to the DEA so it could redistribute it, although the agency can’t legally require the companies to hand it back.

A DEA spokesperson confirmed to NBC News that, at the end of 2022, ADHD drug manufacturers had at least 34,980 kilograms (approximately 77,000 pounds) left of amphetamine. The DEA set its amphetamine quota at 42,400 kilograms (an estimated 93,280 pounds), according to the spokesperson, who also said an estimated 38,000 kilograms (roughly 83,600 pounds) of amphetamine would be needed to meet the demand for ADHD drugs. The DEA’s amphetamine quota was first reported by Bloomberg.

Of 16 ADHD drug manufacturers NBC News contacted, none said they had extra amphetamine to make more ADHD drugs. However, companies aren’t required to share this information.

According to Michael Ganio, senior director of pharmacy practice at the American Society of Health-System Pharmacists, a drug company may not want to disclose it has leftover amphetamine in its quota to avoid pressure to hand it over to other companies. Any amphetamine a company gives up is amphetamine it can’t produce and sell for profit.

“Some individual manufacturers might be sitting on unused quota thinking they’ll increase production,” he said.

Spokespeople from five major ADHD drug manufacturers told NBC News via email that their companies have requested more quota from the DEA.

Teva Pharmaceuticals and Sandoz, two of the larger companies that make ADHD medications, responded that they’d used 100% of the DEA quota allotted to them in 2022 and requested quota increases accordingly.

Sandoz, Granules Pharmaceuticals and Sun Pharma have requested increases in quota, but haven’t heard back from the DEA, according to company spokespeople.

William Newman, an attorney who represents Ascent Pharmaceuticals with his partner Nick Oberheiden, said in an email that the company is still waiting on this year’s quota it requested from the DEA in 2022. Ascent Pharmaceuticals produces generic versions of Adderall, Ritalin, Focalin and Concerta,

“It never got any to begin with and so it completely stopped manufacturing ADHD stimulant medications because of the quota issue,” Newman said.

A spokesperson for the DEA said the agency doesn’t comment on the amount allocated to manufacturers.

 

Continued:

‘This ends when supply matches demand’

Ganio said the mismatch between what the DEA says and what companies say is likely because the agency’s quota tally is industrywide, not specific to companies.

“Big picture, this is what the FDA and DEA are seeing, but it doesn’t give you any insight into what individual manufacturers are seeing,” he said.

Individual companies may be out of quota, while others are keeping quiet about having more on hand. As of 2022, there were 107 U.S. businesses involved in manufacturing ADHD medications, according to the market research company IBISWorld.



Even if the overall quota is sufficient, Ganio said, the DEA needs to do a better job of allocating the quota to the right companies. The agency can’t accomplish this without transparency from companies on their individual supply and manufacturing capacities. Companies are rarely forthcoming about these internal details, he said.

For as long as the DEA and manufacturers continue their quota miscommunication and misalignment, Ganio said the supply likely can’t increase.

“Very simply put, this ends when supply matches demand,” Ganio said.

Cutting off telehealth access

Changes to telehealth prescriptions could be one way to stabilize ADHD medication demand, experts say. That could at least allow the DEA and drug companies to accurately anticipate how much they’ll need in years ahead.

The DEA sets its quotas based on numbers from previous years, Ganio said.

Although doctors have been permitted to continue prescribing stimulant medications over telehealth since the U.S. public health emergency expired in May, the allowance is set to end Nov. 11. At that point, first-time prescriptions for stimulant medications won’t be allowed over telehealth.

The DEA will allow patients who already have prescriptions via telehealth to continue doing so for an additional year. After Nov. 11, 2024, all patients will need in-person visits to continue their ADHD prescriptions, though the DEA says this plan could change.

“We continue to work towards a final set of telemedicine regulations,” a DEA spokesperson wrote in an email.

The drawback to these changes, some argue, is that they risk exacerbating health disparities.

“For people who live in rural areas and people who work long hours and can’t get into doctors’ offices, this is going to pose a problem,” Javidi said.

Case Western’s Witznitzer said he hopes the agencies find ways to regulate telehealth prescriptions while ensuring equitable access.

“We’re hoping the DEA can meet us halfway,” he said. This could mean requiring doctors to provide the same quality of care over virtual connections as they would in their offices and spend just as much time with their patients. In Wiznitzer’s in-person practice, an initial ADHD visit is around 1½ hours, versus 30 minutes for telehealth visits.

Even if telehealth changes do lower demand, Wiznitzer said, he wouldn’t be surprised if the ADHD medication shortage continues well into the fall, and potentially through the end of the year.

Meanwhile, people say they’ve picked up unique coping strategies. For some, that’s meant splitting pills, tweaking doses or compensating with extra caffeine. For Michelle Czarnecki, 35, also in Denver, it’s meant a lot of sugary soda, and choosing her words carefully when telling others what she’s going through.

“I’ve started telling people, ‘Hey, I’m struggling because I can’t get my medication,’” she said. “I’ll leave it at that and let them wonder if it’s my blood pressure medication. It’s easier than telling the truth and dealing with whatever assumptions people make.”

 

Same here with one of my sons. It’s what made me aware of this issue. Government rules can be very heavy-handed and the laws aren’t well thought out.

I’ve had some luck calling small independent pharmacies. Didn’t have to go to Dallas though.