Nearly 18 months after the US Food and Drug Administration (FDA) first acknowledged a national shortage of Adderall, the most common drug used to treat attention-deficit/hyperactivity disorder (ADHD), there is now a widespread scarcity of other stimulant medications — with no end in sight. How did this crisis develop and what measures are underway to address it?
The first shortage of immediate release formulations of amphetamine mixed salts (Adderall, Adderall IR) was reported by the FDA in October 2022. Now, the list includes Focalin, Ritalin, and Vyvanse, among others.
Adding to the ongoing crisis, the FDA announced in early February that Azurity Pharmaceuticals was voluntarily withdrawing one lot of its Zenzedi (dextroamphetamine sulfate) 30 mg tablets because of contamination with the antihistamine, carbinoxamine.
For the roughly 10 million adults and 6 million children in the United States grappling with ADHD, getting a prescription filled with the exact medication ordered by a physician is dictated by geographic location, insurance formularies, and pharmacy supply chains. It's particularly challenging for those who live in rural or underserved areas with limited access to nearby pharmacies.
"Not a day goes by when I don't hear from a number of unfortunately struggling patients about this shortage," Aditya Pawar, MD, a child and adolescent psychiatrist with the Kennedy Krieger Institute and an assistant professor of psychiatry and behavioral sciences at Johns Hopkins School of Medicine, Baltimore, Maryland, told Medscape Medical News.
The ADHD drug shortage is now well into its second year, and clinicians and advocates alike say there is no apparent end in sight.
How Did We Get Here?
Manufacturers and federal agencies blame the shortage on rising demand and each other, while clinicians say that insurers, drug distributors, and middlemen are also playing a role in keeping medications out of patients' hands.
In August 2023, the Drug Enforcement Administration (DEA), which sets quotas for the production of controlled substances, and the FDA publicly blamed manufacturers for the shortages, claiming they were not using up their allocations.
At the time, the DEA said manufacturers made and sold only 70% of their quota, nearly 1 billion doses short of what they were allowed to produce and ship that year.
The agencies also noted a record-high number of prescriptions for stimulants from 2012 to 2021. Driven in part by telehealth, the demand intensified during the pandemic. One recent study reported a 14% increase in ADHD stimulant prescriptions between 2020 and 2022.
Insurers also play a role in the shortage, David Goodman, MD, an assistant professor of psychiatry and behavioral sciences also at Johns Hopkins University, told Medscape Medical News.
Stepped therapy — in which patients must try one, two, or three medications before they are authorized to receive a more expensive or newer drug — contributes to the problem, Goodman said. Demand for such medications is high and supply low. In addition, some insurers only provide coverage for in-network pharmacies, regardless of the ability of other providers outside such networks to fill prescriptions.
"If the insurance dictates where you get your pills, and that pharmacy doesn't have the pills or that pharmacy chain in your area doesn't have those pills, you're out of luck," Goodman said.
Patients as Detectives
To get prescriptions filled, patients must "turn into detectives," Laurie Kulikosky, CEO of Children and Adults with Attention-Deficit/Hyperactivity Disorder, told Medscape Medical News. "It's a huge stressor."
Tracking which ADHD medications are available, on back order, or discontinued requires frequent checking of the FDA's drug shortages website.
Some manufacturers of generic versions of mixed amphetamine salts are only fulfilling orders for existing contracts, while others say new product won't be available until at least April or as late as September. All blame the delay on the shortage of active ingredients.
Teva, which makes both the brand and generic of Adderall, reported on the FDA's site that its manufacturing and distribution is at record-high levels, but demand continues to rise.
The branded Concerta is available, but some makers of generic methylphenidate reported supplies won't be available until July.
Lisdexamfetamine dimesylate in almost all dosages is either unavailable, available in restricted quantities, or on extended back order. However, the branded product Vyvanse is available.
Industry, Government Respond
In a November 2023 statement, the DEA reported that 17 of 18 drug manufacturers the agency contacted planned to use their full DEA quota and increase production for that year. The agency said it had made it easier for manufacturers to request changes in allocations and that periodically updating quotas was a possibility.
Medscape Medical News asked the DEA whether any manufacturers had not met their 2023 quotas, but an agency spokesperson said it would not comment.
An FDA spokesperson said it could help manufacturers ask for bigger quotas and to increase production, noting that in 2023, the DEA increased the quota for methylphenidate following an FDA request.
"The FDA is in frequent communication with the manufacturers of ADHD stimulant medications and the DEA, and we will continue to monitor supply," the spokesperson said.
For 2024, the FDA told the DEA that it predicted a 3.1% increase in use of amphetamine, methylphenidate (including dexmethylphenidate), and lisdexamfetamine. The DEA took that into account when it issued its final quotas for 2024. Whether those amounts will be enough remains to be seen.
With many drugs — not just those for ADHD — in short supply, in February, the US Department of Health and Human Services (HHS) and the Federal Trade Commission opened an inquiry of sorts, seeking comments on how middlemen and others were influencing pricing and supply of generic drugs.
"When you're prescribed an important medication by your doctor and you learn the drug is out of stock, your heart sinks," HHS Secretary Xavier Becerra said in a statement. "This devastating reality is the case for too many Americans who need generic drugs for ADHD, cancer, and other conditions."
On the comments site, which is open until April 15, many of the 4000-plus complaints filed to-date are from individuals with ADHD.
Pawar said clinicians can't know what's going on between the FDA, the DEA, and manufacturers, adding that, "they need to sit together and figure something out."
Even Members of Congress have had trouble getting answers. In October, Rep. Abigail Spanberger (D-Virginia) and a dozen colleagues wrote to the FDA and DEA seeking information on how the agencies were responding to stimulant shortages. The DEA has still not replied.
Workarounds the Only Option?
In the past, physicians would prescribe the optimal medication for individual patients based on clinical factors. Now, one of the major factors in determining drug choice is the agent that has "the highest likelihood of benefit and the lowest likelihood of administrative demand or burden," Goodman said.
With so many medications in short supply, clinicians have figured out workarounds to get prescriptions filled, but they don't often pan out.
If a patient needs a 60-mg daily dose of a medication and the pharmacy doesn't have any 60-mg pills, Goodman said he might write a prescription for a 30-mg pill to be taken twice a day. However, insurers often will cover only 30 pills for a month, which can thwart this strategy.
Pawar said he sometimes prescribes Journay PM in lieu of Concerta because it is often available. But insurers may deny coverage of Journay PM because it is a newer medication, he said. When prescribing ADHD medications, he also provides his patients with a list of potential substitutes so they can ask the pharmacist if any are in stock.
With no end to the shortage in sight, clinicians must often prescribe multiple medications until their patients are able to find one that's available. In addition, patients are burdened with making calls and visits to multiple pharmacies until they find one that can fill their prescription.
Meanwhile, the ripple effects to the ADHD drug shortage continue to spread. Extended periods without treatment can lead to declining job performance or job loss, fractured relationships, and even financial distress, Goodman said.
"If you go without your pills for a month and you're not performing, your work declines and you lose your job as a result, that's not on you — that's on the fact that you can't get your treatment," he noted. "The shortage is no longer an inconvenience."
Goodman, Pawar, and Kulikosky reported no relevant financial relationships.
Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in publications including JAMA and Smithsonian.com. You can find her on X: @aliciaault.