Article In Brief
Shortages of generic Adderall for attention deficit hyperactivity disorder and narcolepsy have been putting a strain on patients, parents, and the neurologists who care for them for at least the past eight months.
Max Wiznitzer, MD, FAAN, a professor of pediatric neurology at Case Western Reserve University, treats many children and young adults with attention deficit hyperactivity disorder (ADHD). But in November of 2022, the director of the Rainbow Autism Center at Rainbow Babies and Children's Hospital began to notice a problem with access to some of his patients' medications.
“At first, it was extended-release generic Adderall [mixed salts],” he said. “After that, it evolved into generic immediate-release Adderall. Then everything fell apart: we were being told that they couldn't get certain strengths of generic Concerta, or that the pharmacies had difficulties getting their hands on immediate-release methylphenidate or dexmethylphenidate, which is Focalin.”
“We started getting calls from parents: the pharmacy no longer has ‘fill in the blank medication,’” Dr. Wiznitzer said. “Parents would call our office to say that they couldn't get their prescription at their usual pharmacy and ask to be switched to another. Or they'd be told that they couldn't get the drug in the extended release 30 mg dose, but the pharmacy had the 15 mg dose, so we'd have to modify the prescription and the patient would take two capsules instead of one.”
Dr. Wiznitzer's experience is not unique. In interviews with Neurology Today, pediatric neurologists who manage pediatric or adult patients with ADHD and narcolepsy shared similar stories. The ongoing shortage of generic Adderall (amphetamine mixed salts) in October of 2022 quickly spilled over to other drugs such as various generic and brand-name forms of methylphenidate, including Concerta, Ritalin, and Vyvanse, has been putting a strain on patients, parents, and the neurologists who care for them for at least the past eight months.
As of May 4, the American Society of Health-System Pharmacists in partnership with the University of Utah Drug Information Service reported shortages affecting more than 50 different doses or formulations of generic and brand-name Adderall from a variety of manufacturers, and about 40 versions of methylphenidate.
“Parents would call our office say that they couldn't get their prescription at their usual pharmacy and ask to be switched to another. Or they'd be told that they couldn't get the drug in the extended release 30mg dose, but the pharmacy had the 15mg dose, so we'd have to modify the prescription and the patient would take two capsules instead of one.”—DR. MAX WIZNITZER
“Right now, we have a bunch of high school and college kids going into their exams. When you're in the middle of finals, you don't need this stress,” said Sarah Cheyette, MD, a pediatric neurologist at the Palo Alto Medical Foundation and the author of several books on ADHD.
“Today, I was emailing a patient to see if he could go to a different pharmacy or ask his usual pharmacy if there were other formulations or doses they might have in stock. That's something I find myself doing all the time now. I have an adult patient with ADHD who hasn't turned in his taxes. I know of people who have been fired. It's bad enough for kids, but the consequences of ADHD as an adult can be much higher. Jobs and relationships can depend on managing it well.”
For patients with narcolepsy, the dearth of available medications can lead to excess sleepiness, which can compromise their ability to drive safely and function at work.
“It affects a person's quality of life, school or work performance, and also their families,” said Jeffrey Steinberg, MD, whose neurology practice in Fort Lauderdale, FL, practice includes a significant number of adult ADHD patients, as well as patients with narcolepsy who are treated with Adderall.
“One of my adult patients with ADHD had to leave law school because it became so difficult for her to manage her responsibilities without the right medication. Another patient with narcolepsy was doing very well on Adderall, but when she couldn't obtain her prescription nothing else seemed to work as well, and she lost her job. These are more extreme situations, but many of my other patients just aren't doing as well as they were before. It adds to their frustration and anxiety. Some patients get very upset. It's gotten so bad that one pharmacist told us he needed to hire security because patients were belligerent and physically disruptive in the store.”
A Shortage with Complex Causes
The US Food and Drug Administration (FDA) initially announced the Adderall shortage in October of 2022, confirming clinician reports that had begun to surface over the summer. It is sometimes hard to tease out exactly why shortages occur with specific drugs, said Erin Fox, PharmD, associate chief pharmacy officer of shared services at the University of Utah Health Sciences Center, who testified before a Senate committee on drug shortages in March 2023.
“Manufacturers are not required to publicly provide specific reasons for shortages, and we typically do not identify a reason for at least half of the shortages we track,” she told the committee.
Teva, the primary manufacturer of Adderall, cited increased demand, workforce shortages, and manufacturing disruptions due to packaging constraints as reasons for its supply problems. Other manufacturers also make Adderall, which is approved to treat ADHD and narcolepsy, but Teva is by far the largest supplier of both branded and generic versions.
Diagnoses of ADHD, and demand for medications, have definitely increased over the past several years, related in part to the pandemic, Dr. Wiznitzer said.
“People were stuck at home, and the ADHD symptoms became very apparent to parents or spouses. Parents have told me over and over again about how difficult remote learning was for kids with ADHD. In the absence of a teacher physically in front of them to help make sure they focused, many of these kids just could not.”
A survey conducted in 2021 by ADDitude magazine found that among their readers, 26 percent of adults and children received their formal ADHD diagnosis during the pandemic. Nearly 22 percent of adults and 17 percent of children had started taking ADHD medication for the first time, and many more had modified, added, and switched treatments within the previous year.
Another major reason for the shortage: generic and branded forms of both Adderall and methylphenidate are schedule 2 controlled substances, and the Drug Enforcement Agency (DEA) sets annual limits on the active ingredients pharmaceutical companies use to make these drugs. In December of 2022, despite the shortages, the DEA announced that it would not increase its production quotas for the ingredients used in stimulant medications from 2022 levels.
“One of my adult patients with ADHD had to leave law school because it became so difficult for her to manage her responsibilities without the right medication. Another patient with narcolepsy was doing very well on Adderall, but when she couldn't obtain her prescription nothing else seemed to work as well, and she lost her job. These are more extreme situations.”—DR. JEFFREY STEINBERG
Some manufacturers have said that their shortages are at least in part related to access to raw materials. “But the DEA has said that the companies haven't used up all their materials quotas,” said Dr. Fox. “What makes things more confusing is the fact that the DEA doesn't list out the exact amount they give to each company, so some companies could in fact be out of raw materials, while other companies might not be using all their supply. That's a limitation in the way the quota system is handled; it assumes that all the manufacturers are able to produce drugs, and that's not always the case. If someone is having a manufacturing or staffing issue, that company is holding onto quota other companies can't use.”
Dr. Cheyette strongly disagrees with the restrictive stance that the FDA and DEA have taken on ADHD medications. “They have scheduled these medicines as highly addictive, and at the doses that are prescribed, they are not. I have to check 6-year-olds in the CURES (Controlled Substances Utilization Review and Evaluation System) database,” she said.
“I have many patients who take their ADHD medications Monday through Friday only, not on the weekends and not in the summer, because their ADHD primarily affects their ability to function in school. How could they do that if these medications were so highly addictive? The heart of the problem is that the DEA should reclassify these substances, particularly the long-acting ones which have very low risk of addiction.”
That's not likely to happen, said Dr. Fox. “Could some of these drugs be rescheduled if the DEA and FDA worked together on it? Yes. But the drug companies would have to request that, and they're unlikely to want to have to invest the money and other resources in providing the required data that at least some of these drugs have a lower potential for abuse, particularly because most of them are generics.”
Stopgap Solutions
Neurologists who manage patients with ADHD and narcolepsy have been forced to spend an enormous amount of time helping patients and their families find temporary solutions, such as turning a 20mg dose prescription into two 10mg capsules or substituting one drug for another. “The shortage is wearing me down as a health care provider, and my staff who have to field all those messages every day. It's just brutal,” Dr. Cheyette said.
“It's a lot of extra phone calls, especially for our nurses,” Dr. Wiznitzer said. “Sometimes hospital pharmacies have medications in stock when the chain pharmacies do not, so we'll guide patients in that direction. Sometimes we've had to change prescriptions from a generic to a brand-name product, or from Adderall XR to Vyvanse, for example.”
The burden also often falls on adult patients, or the parents of children, to call multiple pharmacies in an effort to find a supply of their medication, or an alternative dose that they must then ask their neurologist to prescribe.
“Asking people who have trouble completing a task to chase down their medications when they haven't been able to take them—that's such an added burden,” Dr. Cheyette said.
And switching medications entirely isn't always an option, or at least not a good one. “This isn't a simple switch,” Dr. Steinberg agrees. “You can't just go from 20 mg of Adderall to 20 mg of Ritalin. A lot of times, the alternative medications just don't work as well. These are people who have been well managed on their medications for years, and it's very sad that we have to start playing with new medicines over the course of months to try to find something else that will work for them.”
Changing from a generic to a branded medication often costs the patient more out of pocket as well. “We tried to ask the insurance plans if they would modify the tier of some of the brand-name products while the shortage is ongoing, at least temporarily, but that has not happened,” Dr. Wiznitzer said.
“If you're on one of the generic drugs, assuming you've met your initial deductible, your copay may be something like $20, while if you're on the branded drug, it might be $100. And because you can only fill a 30-day supply of these medications since they are Schedule 2, that's every month.”
Calling around to multiple pharmacies trying to find one that has the right medication and dosage in stock may not necessarily be the solution, Dr. Fox added. “Shopping around is sometimes necessary, but many pharmacies are prioritizing the patients who have been with them for a while. So if that's the case with your patient, they may want to bear with that pharmacy for a week or two and see if they are able to help them.”
There are some signs that the shortage is easing, Dr. Wiznitzer said. “It's not as bad as it was. I don't get as many calls, but I do still get calls on a regular basis from parents stating that they are having problems accessing their child's medication.”
“I'm hearing anecdotally from providers in our system, ‘Hey, my patients are able to fill their prescriptions now,’” agreed Dr. Fox. “Things do seem to be getting better, but it's hard to quantify.”
“Could some of these drugs be rescheduled if the DEA and FDA worked together on it? Yes. But the drug companies would have to request that, and they're unlikely to want to have to invest the money and other resources in providing the required data that at least some of these drugs have a lower potential for abuse, particularly because most of them are generics.”—DR. ERIN FOX
“Right now, we have a bunch of high school and college kids going into their exams. When you're in the middle of finals, you don't need this stress.”—DR. SARAH CHEYETTE
And it's definitely not over yet. “Some companies are now reporting that they have enough drug in stock, others say they won't have enough until June, or can only supply product to existing customers,” Dr. Wiznitzer said. “The shortage is still ongoing, although I would have expected it to have resolved by this point.”
Dr. Cheyette said she has seen little improvement for her patients so far. “I have uncountable patients dealing with this. I get calls about it every day, multiple times a day. It's a bad situation and I don't know how it will end.”
