Stephen Murray spent six months taking his daughter to appointments to try and reach a diagnosis for attention difficulties that were making her fall behind in school. In June, she was finally diagnosed with attention deficit hyperactivity disorder (ADHD) and prescribed Concerta (methylphenidate) to treat it. But nearby pharmacies are out of her medication and she has gone three months without taking a single pill.
"The problem is that she really can't function in school," Murray, who is a health researcher in Massachusetts, told Salon in a phone interview. "We're really anxious about the school year starting and not being able to get her something that we are confident is going to help a lot."
Nationwide, 97% of pharmacists have reported experiencing the on-going amphetamine drug shortage as it stretches into its 10th month. Although the U.S. Food and Drug Administration (FDA) recently approved generic Vyvanse (lisdexamfetamine) to treat ADHD, which is expected to ease the shortage, some still worry that demand will put even more pressure on supply chains as schools start.
In the meantime, patients are going without their amphetamine medications like Adderall, used to treat not just ADHD but also narcolepsy and binge eating disorder. As providers turn to alternative treatments, other drugs like Ritalin or Concerta, are becoming harder to find, too.
Some have been forced to go "cold-turkey" off of their medication and are suffering withdrawals, said Dr. Ryan Marino, an emergency medicine physician at Case Western Reserve University School of Medicine. Untreated ADHD and narcolepsy have been linked to higher rates of car accidents, as well as substance use. When untreated, these conditions can also impact a person's school or work performance and relationships.
"Not only have people been cut off of their medications, which can be uncomfortable and miserable in itself," Marino told Salon in a phone interview. "Now there are these secondhand shortages, so even people who weren't taking Adderall are having a difficult time getting their other medications."
On Aug. 1, the FDA and the Drug Enforcement Agency (DEA) issued a joint letter addressing the drug shortage, blaming one manufacturing delay last fall and high prescription rates. Stimulant prescriptions were already rising before COVID-19, but they increased even more during the pandemic when regulators allowed for prescribing via telehealth.
"We want to make sure those who need stimulant medications have access," the FDA and DEA statement reads. "However, it is also an appropriate time to take a closer look at how we can best ensure these drugs are being prescribed thoughtfully and responsibly."
Because amphetamines are a Schedule II controlled substance, they have more hoops to jump through to get on the market. For medications like Adderall, the DEA is in charge of setting "quotas" for how much supply is produced. According to the letter, manufacturers only sold 70% of this quota for amphetamine products in 2022 and a similar trend is happening in 2023.
While supply or manufacturing delays could have been to blame for not meeting this quota, some are critical of the DEA's role in determining how much of certain medications go on the market in the first place, and question why the agency doesn't just raise its quota to meet demand in light of manufacturing issues.
"The DEA is not a medical organization — they are law enforcement and prosecutors," Marino said. "It's a little strange that they are setting these quotas, and making determinations of what prescriptions are legitimate or not, without having any sort of medical facilities to do so."
On the other hand, concerns have been raised that overprescribing is behind the surge in demand. The FDA cited "widespread misuse" of amphetamine medications in its letter, and some research has suggested as many as 1 in 4 students reported misusing ADHD drugs in the past year.
Additionally, additudes around ADHD are changing. Increased visibility and awareness — as well as less stigma — about the condition in recent years may be driving the uptick in diagnoses, particularly in adults whose symptoms were missed in childhood. The FDA called for more research into ADHD in adults, which has historically been underdiagnosed. As an "invisible" condition, it is treated differently than other neurological conditions and has been trivialized, Marino said. Although it was discovered at the turn of the 20th century, it wasn't included in the American Psychiatric Association's first "Diagnostic and Statistical Manual of Mental Disorders (DSM)" until 1968.
Regardless, just because more patients are diagnosed with ADHD doesn't mean they'll be prescribed mixed-salt amphetamine products like Adderall, and it can be difficult to calculate how much supply is necessary for an increasing demand, said Michael Ganio, the Director of Pharmacy Practice and Quality at the American Society of Health-System Pharmacists (ASHP). Expansions that allow for telehealth prescribing are set to expire in November, which also complicates manufacturing estimates.
"From the manufacturing perspective, cases are going up, but as far as understanding how much to increase production and how much to request from the DEA for quotas, it's not clear," Ganio told Salon in a phone interview. "It's a moving target trying to find exactly how much to produce without overproducing and leaving products on shelves. … I think that's why this has persisted so long."
In 2022, the DEA launched an investigation into telehealth startups like Cerebral that were advertising medications on TikTok and Meta for general symptoms that didn't always meet the criteria for an official ADHD diagnosis. Since then, some major pharmacy chains stopped filling orders prescribed through the platform and Cerebral is currently not offering prescriptions, according to its website. Yet the shortage continues, suggesting that if the company was contributing to the problem, there is something more at play.
According to the ASHP, over 300 prescription drugs are currently in shortage, including cancer treatments and Ozempic, which was originally prescribed as a diabetes drug but has since become a popular weight loss drug. Drug shortages have become so widespread that one-third of hospitals reported rationing, delaying or cancelling treatments because of them, according to an ASHP survey.
Close to a dozen of those shortages are caused by increased demand like Adderall appears to be, whereas it's far more common for shortages to be caused by supply disruptions, Ganio said.
Although there may be supply chain or manufacturing issues at play, the DEA could also expand the number of companies they allow to make Adderall or allow other companies that are already making it to increase their quota, Marino said.
"The DEA has the power to solve all of this with a snap of their fingers, honestly," he said.
As these agencies work to resolve the trilogy of issues related to manufacturing, demand, and supply quotas, patients will continue to go without their medications. Kelli Coviello, a principal's assistant at an elementary school in Massachusetts, also struggled to find Concerta for her 13-year-old son, Jack.
Jack has long COVID and has been doing remote schooling for the past year as he slowly recovers. On top of organizing cardiology, physical therapy and neurology appointments to treat his long COVID, Coviello's husband had to call 10 pharmacies in their area to try and find his medication. He didn't have any luck, and eventually, they had to switch medications, even though Jack was doing well on Concerta.
"He has at times had to go without for a day or two but I think because he wasn't in school it wasn't that big of a deal," she said. "Dealing with that going back, that could be a challenge for him."
Ganio said controlled substances can't be transferred from pharmacy to pharmacy, so patients must physically drive their prescription for these substances from store to store, or have their provider resend an electronic record of the prescription to each new pharmacy they try.
"It becomes this kind of Whac-a-Mole game either over the phone or driving from pharmacy to pharmacy to try to find a prescription," Ganio said. "It's really most difficult on the patients, but you can imagine being a prescriber and having to manage this."
Without her medication, Murray's daughter fell behind in school last year. Tension arose with teachers and at home when she struggled to complete her schoolwork. This week, she started seventh grade, but Murray is worried she'll withdraw and become distant and depressed like she did last year when her condition went untreated.
"To see her suffering, knowing something so simple can be done is a grueling feeling as a parent," Murray said. "I want her to feel better and I want her to feel like she can succeed. I am pretty confident this medication is going to do that for her, and here we are just twiddling our thumbs."
