The Food and Drug Administration on Wednesday confirmed a nationwide shortage of the attention-deficit/hyperactivity disorder medication Adderall, more than two months after some pharmacies reported difficulties filling prescriptions.
The shortage affects the immediate-release form of Adderall, a stimulant that helps manage ADHD symptoms.
The FDA said in a statement that it was in “frequent communication with all manufacturers of amphetamine mixed salts, and one of those companies, Teva, is experiencing ongoing intermittent manufacturing delays.”
Teva Pharmaceuticals is the country’s largest manufacturer of Adderall. It first reported delays in filling orders in August, attributing them to a labor shortage on its packaging line that it said had since been resolved.
Spokesperson Kelley Dougherty said Thursday that Teva expects “inventory recovery in the coming months.”
“Teva has active supply of both branded Adderall and its generic version and continues to produce and refill the channel regularly at levels above historical demand. It is possible that some people may encounter a backorder (intermittently) based on timing and demand, but these are only temporary,” she said in a statement.
Dougherty added that Teva expects “intermittent delays through end of year.”
The supply from the other Adderall manufacturers isn’t enough to meet the need, the FDA said.
The FDA suggested that “patients should work with their health care professionals to determine their best treatment option,” which may include alternatives like the drug’s extended-release formulation.
The shortage has been “a mess” for people who take ADHD stimulants, said Dr. Gabrielle Shapiro, a psychiatrist and a professor at the Icahn School of Medicine at Mount Sinai in New York.
Shapiro, who sees patients of all ages, said the challenge is particularly acute for children who have been off their medication as the new school year has started.
“Parents are panicked. Their children are being sent home from school or told they cannot come back if they are not on their meds,” said Shapiro, who is also a member of the American Psychiatric Association’s council on children, adolescents and their families. “I have high school students that are trying to take their SATs and do their applications for college, and they can’t focus. They can’t get them done.”
“I have high school students that are trying to take their SATs and do their applications for college, and they can’t focus. They can’t get them done.”
Psychiatrist Dr. Gabrielle Shapiro
Adderall is a controlled substance regulated by the federal Drug Enforcement Administration. Dougherty said Teva is “working closely with our manufacturing facility and the DEA to see what additional volume we may be able to support in the future.”
Emily Hoffman, 34, of Seattle, said she has ping-ponged between pharmacies trying to find one with Adderall in stock. Recently, she said, she had to go a week without her medication.
“The fact that it’s controlled means you can’t ask for the prescription early,” she said. “I have to call when I’m down to my last pill or two.”
At Parker’s Pharmacy in Baton Rouge, Louisiana, sales director Tylan Jones said that he has been able to fill Adderall prescriptions for current patients but that there have been delays. He has had to turn away patients from other pharmacies because there isn’t enough supply for both current and new customers, and pharmacies are subject to limits on how much of a controlled substance they can distribute.
“We don’t want to neglect our patients that we’re currently filling here, so, unfortunately, we have to send some patients on their way,” Jones said.
“Patients sometimes get very frustrated, aggravated, sometimes even aggressive,” he said. “But I would say usually it’s just patients are disappointed and anxious.”
While Adderall has been in short supply before — the FDA reported a shortage from September 2019 through this May — Jones said this shortage has been unusually difficult.
“It is something we’ve seen before, but not to the severity, this bad, before,” he said.
The shortage has hit pharmacies differently
Some pharmacies have been having trouble filling Adderall prescriptions since the summer. A survey by the National Community Pharmacists Association conducted from July 25 through Aug. 5 found that roughly 64% of about 360 independent pharmacies that responded were having difficulty obtaining Adderall.
Large pharmacy chains CVS and Walgreens told NBC News in late August that they weren’t experiencing widespread problems, although many people who had unsuccessfully tried to fill their prescriptions at those pharmacies voiced frustration on social media at the time.
CVS said Thursday it was “aware of intermittent shortages of generic amphetamine medication in the supply chain.”
As for the patients who say the shortages have stretched as far back as August, CVS Health spokesperson Matt Blanchette said only, “We are working with our patients to meet their needs.”
Walgreens didn’t answer questions about its current Adderall supply other than to reiterate that the FDA had confirmed a nationwide shortage.
“Questions about supply and availability need to be directed to manufacturers,” it said.
A crucial tool in managing ADHD
ADHD is a neurodevelopmental condition marked by inattentiveness, impulsivity and/or hyperactivity that is severe enough to interfere with school, work and other aspects of life.
The Centers for Disease Control and Prevention estimates, based on data from 2016 to 2019, that about 10% of children are diagnosed with it, with boys more likely to receive diagnoses.
Adderall and other stimulant drugs are commonly used to manage ADHD, and demand is higher than ever: Adderall prescriptions dispensed in the U.S. spiked to 41.4 million last year, up by 10.4% from 2020, according to IQVIA, an analytics provider for the life sciences industry. Experts say more awareness about ADHD has contributed to the increase, although there is also concern that stimulants have been overprescribed, because the drug can be abused if it’s taken improperly or without a prescription.
In May, Walmart and CVS announced they would stop filling prescriptions for controlled substances from telehealth startups such as Cerebral and Done Health, which prescribe stimulants and gained footing during the pandemic.
For those who need it, Shapiro said, going without ADHD medication can be disastrous.
“They’ll feel badly about themselves,” she said. “You have a kid that was doing well in school, doing their homework, and all of a sudden they’re bouncing off the wall.”
Source: | This article originally belongs to Nbcnews.com
