Stephen Murray spent six months taking his daughter to appointments to try to arrive at a diagnosis of attention difficulties that were keeping her behind in school. In June, she was finally diagnosed with attention deficit hyperactivity disorder (ADHD) and was prescribed Concerta (methylphenidate) to treat it. But the nearby pharmacies are out of her medication and she has not taken a single pill for three months.
“The problem is, she really can’t function in school,” Murray, who is a health researcher in Massachusetts, told Salon in a telephone interview. “We are very excited about the start of the school year and not being able to give her something that we are sure will help a lot.”
Nationwide, 97% of pharmacists reported experiencing a continuing amphetamine shortage as it extends into its 10th month. While the U.S. Food and Drug Administration (FDA) recently approved generic Vyvanse (lisdexamfetamine) to treat ADHD, which should alleviate shortages, some still fear that demand will put even more pressure on supply chains as schools start.
Meanwhile, patients go without amphetamine medications like Adderall, used to treat not only ADHD but also narcolepsy and binge eating disorder. As providers turn to alternative treatments, other medications such as Ritalin or Concerta are getting harder to find too.
“Now there’s a shortage of second-hand products, so even people who weren’t taking Adderall are having a hard time getting other drugs.”
Some have been forced off medication and are experiencing withdrawals, said Dr. Ryan Marino, an emergency medicine physician at Case Western Reserve University School of Medicine. untreated ADHD and narcolepsy have been associated with higher rates of car accidentslike this substance use. When left untreated, these conditions can also affect a person’s health. academic or professional performance and relationships.
“Not only have people been cut off their medications, which can be uncomfortable and miserable in and of itself,” Marino told Salon in a telephone interview. “Now there’s a shortage of second-hand products, so even people who weren’t taking Adderall are having a hard time getting other drugs.”
On August 1, the FDA and the Drug Enforcement Agency (DEA) issued a joint agreement Letter address drug shortages by blaming a manufacturing delay last fall and high prescription rates. Stimulant prescriptions were already on the rise before COVID-19, but increased even more during the pandemic when regulators allowed prescribing via telehealth.
“We want to ensure that 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 best to ensure these medicines are prescribed thoughtfully and responsibly.”
As amphetamines are a Schedule II controlled substance, they have more obstacles to reach the market. For drugs like Adderall, the DEA is responsible for setting “quotas” for the amount of supply produced. According to the letter, manufacturers sold just 70% of this quota for amphetamine products in 2022 and a similar trend is playing out in 2023.
While supply or manufacturing delays may have been to blame for this quota not being met, some are critical of the DEA’s role in determining how much of certain drugs go to market in the first place, and question why the agency doesn’t just increases its quota to meet demand in light of manufacturing issues.
“The DEA is not a medical organization; she is responsible for law enforcement and prosecutors,” Marino said. “It’s a little strange that they are setting these quotas and determining what prescriptions are legitimate and what are not, without having any kind of medical facility to do so.”
“It’s a little strange that they are setting these quotas and determining which prescriptions are legitimate and which are not.”
On the other hand, concerns have been created this over-prescription is behind the increase in demand. The FDA cited the “widespread misuse” of amphetamine medications in its letter, and some to look for suggested that 1 in 4 students reported ADHD drug misuse in the past year.
Also, additions around ADHD are changing. Increased visibility and awareness, as well as reduced stigma about the disease in recent years, may be driving the rise in diagnoses, especially in adults whose symptoms were not detected in childhood. The FDA called for more research on ADHD in adults, which has historically been underdiagnosed. Because it is an “invisible” condition, it is treated differently than other neurological conditions and has become commonplace, Marino said. although it was uncovered at the turn of the 20th century, was not included in the first “Diagnostic and Statistical Manual of Mental Disorders (DSM)” of the American Psychiatric Association 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 needed for a growing demand, said Michael Ganio, the Director of Practice and Quality Pharmacist of the American Society of Health System Pharmacists (ASHP). The expansions that allow telehealth prescriptions are due to expire in November, which also complicates production estimates.
“From a production perspective, cases are increasing, 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 telephone interview. “It’s a moving target trying to figure out exactly how much to produce without over-producing and leaving products on the shelves. I think that’s why it’s persisted for so long.”
“It’s a moving target trying to figure out exactly how much to produce without over-producing and leaving products on the shelves. I think that’s why it’s persisted for so long.”
In 2022, the DEA released a investigation in telehealth startups like Cerebral, which advertised medications on TikTok and Meta for general symptoms that didn’t always meet the criteria for an official ADHD diagnosis. Since then, some large drugstore chains stopped answering requests prescribed through the platform and Cerebral currently does not offer prescriptions, in accordance with its website. However, the shortage remains, suggesting that if the company was contributing to the problem, there is something else at play.
According to ASHPover 300 prescription drugs are currently out of stock, including cancer treatments It is Ozempicowhich was originally prescribed as a medication for diabetes but it has since become a popular weight loss drug. Drug shortages have become so widespread that a third of hospitals report rationing, delaying or canceling treatments because of it, according to an ASHP study. survey.
Nearly a dozen of these shortages are caused by increased demand, as Adderall appears to be, although it’s much more common for shortages to be caused by disruptions in supply, Ganio said.
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While there may be supply chain or production issues at play, the DEA could also expand the number of companies it allows to manufacture Adderall or allow other companies that are already manufacturing it to increase their share, Marino said.
“The DEA has the power to resolve all of this with a snap of its fingers, honestly,” he said.
“The DEA has the power to solve all of this with a snap of its fingers.”
As these agencies work to resolve the trilogy of issues related to production, demand and supply quotas, patients will continue to run out of their drugs. Kelli Coviello, an assistant principal at an elementary school in Massachusetts, also struggled to find the Concerta for her 13-year-old son, Jack.
Jack has had COVID for a long time and has been studying distance learning for the past year as he slowly recovers. In addition to arranging cardiology, physical therapy and neurology appointments to treat her long COVID, Coviello’s husband had to call 10 area pharmacies to try to find her medication. He was unlucky and eventually they had to switch medications, although Jack was fine on the Concerta.
“He would sometimes miss a day or two, but I guess since he wasn’t in school it wasn’t a big deal,” she said. “Dealing with that can be a challenge for him.”
Ganio said that controlled substances cannot be transferred from pharmacy to pharmacy, so patients must physically carry a 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 a kind of Whac-a-Mole game, whether it’s over the phone or driving from pharmacy to pharmacy trying to find a prescription,” Ganio said. “It’s really hard on patients, but you can imagine being a prescriber and having to manage that.”
Without medication, Murray’s daughter fell behind in school last year. Tension arose among teachers and at home as she struggled to complete schoolwork. This week, she started seventh grade, but Murray is worried she might pull away and become distant and depressed like she did last year when her condition went untreated.
“Watching her suffer, knowing that something so simple can be done is an exhausting feeling for parents,” Murray said. “I want her to feel better and to feel like she can succeed. I’m pretty confident this medication will do that for her, and here we’re just twiddling our thumbs.”
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