More than a year after the Food and Drug Administration announced a nationwide shortage of Adderall, doctors and patients say they are still struggling to get their hands on ADHD medications. Despite repeated promises from drugmakers that the supply crunches would be resolved soon, shortages persist and frustration is growing.
Wendy Steele, 48, of Baltimore, says that for the past year, she’s had a hard time finding pharmacies that stock ADHD medications prescribed for both herself and her 9-year-old son, Colton.
Steele takes a generic version of Adderall. Colton is on a generic version of Concerta, which has the same active ingredient as Ritalin. At times, both have had to skip, delay or go without their medications for several weeks. Steele said she believes the shortage is now affecting Colton’s school work.
“I’m fed up with it,” Steele said. “It’s annoying for me, but it is a really critical medication for my son. And that’s what makes me sad. His education is suffering.”
More than 6 million children in the U.S. have been diagnosed with ADHD, one of the most common neurodevelopmental disorders, according to the Centers for Disease Control and Prevention. Millions of adults have it as well, although some may not know it. People with ADHD can seem restless, may have trouble concentrating and may act impulsive. Adderall and other ADHD medications help people with the disorder concentrate and focus, while reducing impulsive behavior.
High demand for the drugs, coupled with drugmakers’ claim that they’re being restricted in how much they can make, has fueled a nationwide shortage, experts say.
In October 2022, the FDA announced a shortage of Adderall.
Since then, doctors say other ADHD medications, such as Focalin, Ritalin and Vyvanse, have become in short supply.
As of 2022, there were 107 U.S. companies involved in manufacturing ADHD drugs, according to the market research company IBISWorld.
Drugmakers have published estimates of when the medications will be back in stock, but as they struggle with demand, those estimates have been pushed back.
Aurobindo Pharma, which makes a generic version of Adderall, for example, estimated in June that some doses of the drug would be available in December, only for the timeline to be pushed back several months, to September, according to the FDA drug shortage database. Teva Pharmaceuticals, a major manufacturer of ADHD medications, did resolve many of its Adderall shortages. However, certain doses estimated to be available in October or December have been pushed back to February or May, according to the database.
Dr. Lenard Adler, director of the adult ADHD program at NYU Langone Medical Center in New York, said about 30% to 40% of the prescriptions he writes for ADHD medications have to be rewritten because pharmacies may not have them in stock. Prescriptions can’t be transferred between pharmacies, meaning doctors have to issue patients new ones.
“I have several patients who have been off their meds for two to three months,” he said. “When they get off their medications, their symptoms come back and then they forget to make a follow-up appointment, and I have no way of knowing this is happening.”
The shortage has created a huge “burden” for people with the disorder, he added.
“It has been quite difficult,” he said. “It’s sometimes hard to find an alternative medicine. It may require switching preparations or switching doses.” However, the alternative may not be a generic, he added, meaning it will likely cost the patient more money.
Who’s to blame for the shortage?
Drugmakers and the Drug Enforcement Administration, which regulates controlled substances, are pointing fingers at one another for the problem, said Erin Fox, senior pharmacy director at the University of Utah Health.
Makers of ADHD drugs say they don’t have enough ingredients to make the drugs and need permission from the DEA to make more. The DEA is insisting that drugmakers have not met their quota for production and could make more of the drugs if they wanted. Adderall is a controlled substance regulated by DEA, which sets limits on how much of the active ingredient drugmakers are allowed to produce in a given time frame. Drugmakers must get approval from the DEA before they go over their quotas.
In August, the DEA and FDA issued a joint statement calling on drugmakers that do not wish to increase production to relinquish their allotment so that other drugmakers may produce more of the ADHD medications. The FDA said it was also taking steps to provide alternative treatment options.
In a bid to boost the availability of the medications, in August the FDA approved several generic versions of Vyvanse.
NBC News reached out to five of the major ADHD drug manufacturers for updates on their supplies. They didn’t respond. In addition, the DEA did not immediately respond to requests for comment.
There doesn’t appear too much else the FDA can do in the near term, experts say. NBC News has reached out to the FDA for comment.
Certain formulations of Adderall are also now more widely available, according to the FDA’s drug shortage database, however, the agency still lists the drug as being in shortage.
Dr. Sarah Cheyette, a pediatric neurologist who treats both children and adults with ADHD at the Palo Alto Medical Foundation, said January was a bad month for her patients.
Vyvanse, even with generic versions recently approved, is still hard to come by, she said; so is Ritalin and Focalin.
Patients have to go to multiple pharmacies to find their prescriptions, she said, and many pharmacies tell them they have the drugs on back order.
Dr. David Goodman, director of the Adult Attention Deficit Disorder Center of Maryland, said that for his patients, the shortage is not as “problematic” as it was several months ago, but it’s not alleviated yet.
He said he has noticed that the brand name version of Adderall is more readily available, but not its generic versions.
The reason for that, he said, could be because many insurance companies exclusively cover generic versions, prompting patients to quickly get these versions as soon as they hit the market, leading to increased demand and short supply. Some insurance companies, he said, have recently started paying for the brand-name drug if patients are unable to get their hands on the generic versions.
Still, many patients are “frustrated,” he said, adding that some have to wait two to four weeks before they’re able to get their prescription filled, up from a typical wait time of three to four days.
“You have to consider that ADHD individuals have a low frustration tolerance, which is even lower when they are not on their medication,” said Goodman, also an assistant professor of psychiatry and behavioral Sciences at the Johns Hopkins University School of Medicine. “Their ability to manage the situation and stick with it grows very thin.”
Steele, of Baltimore, said that in recent months, she began calling pharmacies about a week before her son’s prescription runs out to make sure they have it in stock. Because ADHD medications are controlled substances, patients can get a prescription filled for only 30 days at a time.
It’s been an “awful” experience, she said, saying it still sometimes takes weeks to get a prescription filled.
“When is this going to end?”
Source: | This article originally belongs to Nbcnews.com
