Telehealth made access to ADHD drugs easier for many. But a shortage has put the spotlight on virtual prescribing and supply chain issues.
An explosion of telemedicine during the coronavirus pandemic has contributed to a surge in Adderall prescriptions, helping to set the stage for a shortage that has dragged on for months. Patients and even hospitals are struggling to obtain the medication, while regulators are moving to clamp down on telehealth prescriptions for drugs prone to abuse.
Prescriptions for Adderall, a stimulant that is approved to treat ADHD, rose more than 30 percent over the last five years and accelerated during the pandemic, according to data reviewed by The Washington Post.
The Drug Enforcement Administration is proposing a requirement that patients be evaluated in person before receiving a class of tightly regulated drugs, including Adderall, citing their potential for abuse. The proposal had drawn more than 1,750 comments as of Monday, including many from patients and providers who say that it could jeopardize the expanded access to life-changing medications afforded by telehealth.
“It may raise barriers again for some people, especially people in underserved communities, because it’s not always easy to get to locations where there are providers,” said Adelaide Robb, the chief of psychiatry and behavioral sciences at Children’s National Hospital in Washington. “We have people from West Virginia coming to our hospital for treatment,” she said of ADHD patients.
Robb said she had hoped the shortage would resolve at the start of the year, but it’s gotten worse. “Even our hospital pharmacy, which buys bottles of Adderall for inpatients and outpatient prescriptions, they can’t get Adderall,” Robb said. “It’s a real crisis.”
Drugmakers can’t keep up with Adderall demand
Adderall is one of the best-known drugs for treating ADHD, a neurodevelopmental disorder believed to affect 6 million U.S. children that can cause inattention and impulsivity. The medication has also gained popularity in recent years with adults who recognize their ADHD symptoms later in life. It is sometimes abused for its stimulating effects.
In the past, people needed to get a prescription in person, but a pandemic-era waiver enabled providers to prescribe the drug after online consultations.
Nearly 40 percent of all prescriptions for stimulants, including Adderall, were based on telehealth visits last year, up from less than 2 percent before the pandemic, according to analytics firm Trilliant Health. The rise in Adderall prescriptions was driven by adults between 22 and 44 years old, for whom they increased 58 percent between 2018 and 2022, according to Trilliant’s analysis of insurance claims nationally. There were more adults receiving an Adderall prescription than those who had an ADHD diagnosis, the firm found.
“The emergence of telehealth and direct-to-consumer models really has changed the way we treat ADHD,” said Sanjula Jain, Trilliant’s chief research officer. The discrepancy between prescriptions and visits could be partly explained by self-pay clients, whose visits aren’t captured in the data, but she said it raises a question about the rigor of ADHD assessments. “The threshold for getting a prescription maybe has changed,” she said.
In a statement to The Post, the Food and Drug Administration said the Adderall shortage started with manufacturing delays but is now driven by a rise in consumer demand.
“Manufacturers are working to meet the demand, and the FDA is helping with anything we can do to increase supply,” the agency said.
Telehealth spurred virtual prescribing
Telehealth exploded in popularity when the pandemic set in, offering a lifeline to care when many health-care providers stopped seeing patients in person. After a federal emergency declaration, the DEA in March 2020 waived the requirement for in-person evaluations to prescribe controlled substances — regulated because of their potential for abuse. An industry soon sprung up around virtual prescribing, with online providers and pharmacies dispensing everything from benzodiazepines to ketamine.
With the emergency declaration set to expire on May 11, the DEA published a proposed rule that would formally allow prescribing controlled substances by telehealth but imposes new conditions on it. For Adderall and other drugs considered by the DEA to have high abuse potential, an in-person evaluation is required before any prescription.
Even as doctor offices reopened, many have gravitated to telehealth for its convenience and other perceived advantages, and hundreds of patients and health-care providers are pressing the DEA to take a more flexible approach.
Virtual, at-home meetings have also provided new ways of reaching patients who are reluctant to open up, said Lisa Durette, a child psychiatrist and assistant professor at the University of Nevada at Las Vegas. “‘Show me your baseball trophies, show me things you’re proud of,’” she said by way of example. “It’s a way we have of engaging with kids we’ve never had before.”
Federal authorities have started to crack down on telehealth providers they say have improperly handled controlled substances. The DEA alleged in December that Truepill, a retail pharmacy, had wrongfully dispensed thousands of stimulants for ADHD, connecting it to telehealth start-up Cerebral, which the Wall Street Journal has reported is under investigation by the Justice Department. Some pharmacy chains, including CVS and Walmart, stopped filling Adderall prescriptions from Cerebral and another telehealth start-up, Done.
“Cerebral’s clinicians exercise their independent professional judgment in diagnosing and treating their patients,” a spokesperson for the company said, adding that it had stopped prescribing Adderall to new patients last May in anticipation of the federal waiver ending.
Done said in a statement that it understands concerns about misusing Adderall but opposes limiting access. “We believe telehealth is a powerful tool that can help reach and serve more people, breaking down geographical and logistical barriers,” the company said.
Truepill has said it stopped filling Adderall prescriptions by telehealth and indicated it had done nothing wrong. The company did not respond to requests for comment.
Patients can’t fill their prescriptions
At his pharmacy outside Seattle, Richard Molitor learned that the customers trying to fill Adderall prescriptions from telehealth providers had been turned away from other pharmacies. Despite what he called “serious and time-consuming detective work,” he could not verify from the available information that the prescriptions came from a licensed provider, as legally required, and he declined to fill them.
Molitor said he felt badly for the patients. They spend money for a telehealth subscription, he said, “thinking they’re going to get something out of it.”
The continued shortage has perplexed providers and added stress for families, with the source of the shortage remaining elusive. No one, it seems, has a full picture that captures where the breakdown occurs within the complex web stretching from the companies that manufacture Adderall to the pharmacies that dispense it. But data showing the volume of Adderall prescriptions offers clues.
Prescriptions for a range of drugs to treat ADHD rose 19 percent, on average, between 2018 and 2022, according to a Post review of data from IQVIA, a health-care technology firm. Adderall and its generic versions, however, increased by 35 percent over that time, with the sharpest rise coming during the past two years.
The soaring prescriptions for Adderall, compounded by shortages in the supply chain, created a tight market that became increasingly vulnerable to disruption, said Timothy Wilens, an ADHD expert and chief of child and adolescent psychiatry at Massachusetts General Hospital.
Many pharmacies have monthly limits on how much of a controlled substance they can order from their wholesale supplier, according to industry experts. When patients start shopping around to find a pharmacy that has their medication in stock, it doesn’t take long for some stores to start selling out, creating these “local bottlenecks,” Wilens said.
“All you need is five or 10 families to do that and you’ve used up the supply in that Walgreens,” Wilens said.
Wilens said the FDA expects the shortage to start to resolve itself in April — but experts are hesitant to provide a timeline because the shortage has already gone on for months longer than initially expected.
Lenard Adler, the director of the adult ADHD program at NYU Langone Health, said the shortage has been a hardship for his patients.
“I had one patient who had to go to 14 pharmacies before they finally found their prescription,” Adler said.
A problem in the Adderall supply chain
The FDA announced an Adderall shortage in October 2022. One large producer, Teva, had reported manufacturing delays. The DEA limits manufacturers to a quota of the active ingredient for controlled substances, but the agency says companies haven’t hit their limits in the past three years.
“We are aware that the pharmaceutical industry is claiming that there is a quota shortage for the active ingredients in ADHD drugs,” the DEA said in a statement. “Based on DEA’s information — which is provided by drug manufacturers — this is not true.”
Justin Schroeder, global vice president at PCI Pharma Services, a contract manufacturer and distributor, said in February that manufacturers are still dealing with labor shortages and delays on raw materials from suppliers.
“We’re in a very highly regulated industry,” Schroeder said. “If my supplier A wasn’t able to supply me my raw material in a timely manner, I can’t just call up supplier B and say, ‘Hey, I’m switching the order to you guys.’”
In two letters sent in December and February, Rep. Abigail Spanberger (D-Va.) wrote to the DEA and the FDA urging them to coordinate a response to the shortage. Spanberger told The Post last week that she wrote to both agencies so Congress could better understand the problems underlying the shortage. Spanberger said she and Rep. Eric Swalwell (D-Calif.) ended up speaking with Anne Milgram, the DEA administrator, on March 6 to discuss the issue.
Spanberger would not disclose details of the conversation other than to say it was a “very productive phone call.”
In the meantime, some patients are resorting to switching their medications to work around the shortage. Maria Coppola, a lawyer who lives on Capitol Hill, said she’s been have trouble filling the prescription for her 16-year-old son Oliver since last spring — leaving her to call different pharmacies around the city.
“You get desperate, you get crazy,” Coppola said. “I’m spending hours and hours every time it’s time for a refill.”
Coppola said she’s had to switch prescriptions and dosages for Oliver, who’s been taking medication for his ADHD for nine years. The most recent time Coppola got a refill for Oliver was the first time in months that she was able to find the prescription at her regular pharmacy without hitting any snags or delays.
“That was like hitting the jackpot,” Coppola said.
Fenit Nirappil contributed to this report.
Read the full article here