A ‘perfect storm’ led to an ADHD medication shortage. Here’s why
After nine months of difficulty finding and filling prescriptions for Adderall, ADHD patients are now facing shortages of other medications, leaving millions who rely on the drugs with uncertainty, frustration and bureaucratic hassles.
In addition to Adderall, variations of methylphenidate, commonly known under brand names Ritalin or Concerta, are affected. According to a watchlist from the American Society of Health-System Pharmacists, some extended-release doses of methylphenidate have been in short supply since May.
While Adderall has been consistently hard to get, these other ADHD drugs that patients have turned to as alternatives have only been “intermittently available” themselves, said Dr. Michael Ganio, ASHP’s senior director of pharmacy practice and quality. For many people, the latest inconsistency in supply is nearly as vexing as the original shortage.
“These are really frustrating shortages because you can only get a 30-day supply at a time,” Ganio said. “Patients need a new prescription every 30 days. You can’t get a 90-day supply. You can’t even pay cash for a longer supply if you want to.”
More than 6 million children have been diagnosed with attention-deficit/hyperactivity disorder, according to 2016 data from the Centers for Disease Control and Prevention, and 60 percent were being treated with medication. About 4.4 percent of adults in the U.S. have been diagnosed with ADHD, with about 4.1 percent of them being treated with medication. That’s millions who use medication to help them concentrate or manage their schoolwork, employment and relationships.
Exact figures for how many people have ADHD is the subject of debate. Since 2015, more adults have been receiving pharmaceutical treatment for the disorder, according to Shire PLC, the former maker of popular medication Vyvanse. That year, the company’s analysis found that 53 percent of the 63 million prescriptions written for ADHD medications were for adults.
But while increasing demand is one reason for the shortage, it is not the only cause.
What fueled the ADHD medication shortage?
Manufacturers are required to notify the FDA of a shortage, but not the cause of the interruption. As with any drug shortages in the country, the reasons can vary, from manufacturing problems to more patients using the medication.
The Adderall shortage last year created a “perfect storm” of contributing factors that threw entrenched supply-and-demand patterns out of whack, multiple doctors who treat ADHD told the PBS NewsHour.
During the COVID-19 pandemic, patients turned to telehealth to get ADHD medications, and Adderall prescriptions jumped.
Compared with previous years, which saw small increases in the number of people receiving prescriptions for the stimulants, the percentage of girls and women aged 15 to 44 and men aged 25 to 44 who received prescriptions increased by more than 10 percent from 2020 to 2021, according to the CDC.
The agency noted several caveats, including that people who are prescribed stimulants may use them to treat a condition other than ADHD. Adderall, for example, is also used to treat narcolepsy.
The rise in prescriptions likely is not only due to changes in policies that loosened in-person visit requirements; the pandemic also led more people to seek treatment for mental health challenges, including ADHD.
“I certainly have heard people say that they had more access to care — could get it online — and [had] time for it during the pandemic. They weren’t commuting as much,” said Dr. Craig Surman, an associate professor of psychiatry at Harvard Medical School.
During those months, Surman said, he heard “diverging stories” from patients about their need to treat ADHD. With more people working from home, some realized they needed the structure of the office to keep their ADHD in check, while others found that their homes were less distracting than their offices had been.
“There is an interplay between structure, accountability and ADHD impact,” Surman said. “But it could go either way – better or worse, depending on the particular person and the kind of accountability they had.”
With greater health care accessibility, the change in demand – and manufacturers not being able to keep up with that demand – led to some shortages.
Dr. Meghan Schott, who treats children with ADHD in Washington, D.C., said the Adderall shortage resulted in doctors prescribing alternatives.
“A lot of our kids in our outpatient work are waiting days, weeks to get it to come in, even on the other variants, because [pharmacies are] not stocking it appropriately or because no one’s really prescribing Adderall anymore,” Schott said. “It’s been a hot mess.”
Then another layer: Patients, unable to find their medication in stock, started seeking out ADHD drugs at multiple stores, calling individual locations to inquire about stock. Even if they were able to find their medication, these prescriptions are not transferable between pharmacies and need to be re-issued by doctors.
To those challenging dynamics, add the nuances and limitations of insurance coverage: Brand name prescriptions are not always covered if generics are out of supply, Ganio noted.
“It’s a monthly challenge for the pharmacists and the pharmacy technicians because they’re constantly fielding phone calls and looking for a product,” Ganio said. And that searching by patients also adds to the ongoing supply confusion.
“When people are hunting pharmacy to pharmacy to pharmacy, there’s shifting demand that used to be more static,” Surman said.
What could be done to resolve the shortages?
Satisfying demand and solving shortages of ADHD medications is not as simple as making more medication.
ADHD medications are tightly controlled by regulations because they contain ingredients that are Schedule II controlled substances that, according to the Department of Justice, “have a high potential for abuse which may lead to severe psychological or physical dependence.” Adderall, for example, contains amphetamine, a controlled substance regulated under federal law.
While pharmacists, manufacturers, FDA and the Drug Enforcement Administration do work to anticipate shortages, getting it right ahead of time is not easy. Makers of these drugs must first get approval for a quota from the DEA on a quarterly basis, Ganio said. Pharmacists must request stock from wholesalers who may not completely fill orders.
Some members of Congress have taken note of the Adderall shortage and have called for action by the DEA and FDA. In December and February, Rep. Abigail Spanberger, D-Va., sent letters to the federal agencies asking them for their plans to alleviate shortages. In June, Sen. Ron Wyden, D-Ore., said his constituents, particularly those in rural areas, were facing shortages and that the DEA and FDA had said manufacturers had not requested any increase in production – something manufacturers have denied. Wyden said more transparency was needed and called on federal agencies to make more medication available.
“I believe the DEA and FDA have the responsibility to reach out to the manufacturers of these essential medications that are now difficult to access. These manufacturers need clear guidance on how to navigate this very complicated bureaucratic process,” Wyden said.
In the meantime, it’s “a time-consuming process to get any sort of production quarter increase,” Ganio said. “So the manufacturers cannot just turn on a switch and make more.”
And yet, for patients, the personal stakes are high. Allowing ADHD to go untreated can have long-term, serious effects, including death.
“I would consider ADHD [medication] life-sustaining, on average, across the population of people with ADHD, because you see higher morbidity, mortality and earlier mortality,” Surman said. “People die earlier on average and [have] higher rates of accidents.”
In the adult world, medication “will stop you from getting in car accidents.”
For children, untreated ADHD can manifest as hyperactivity and result in behavioral challenges in the classroom and school discipline, such as suspensions or expulsion, as well as academic underperformance that can affect the rest of their lives.
Medication “actually allows them to function throughout the day and allows them to not get in trouble,” Schott said.
“We don’t think of it as things that you need. But for kids that are struggling with ADHD, it is something they need,” she added.