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Medication Shortage
Nearly a year after the U.S. Food and Drug Administration announced a nationwide Adderall shortage, many Minnesotans with Attention-Deficit/Hyperactivity Disorder still struggle to refill their prescriptions. The low supply, coupled with a rapid increase in diagnoses since 2020—particularly among women—have made it increasingly challenging for people with ADHD to receive the treatment they need. This is especially true for the 3.5 million U.S. children prescribed stimulant medications to treat ADHD, and the roughly 16 percent of college students with ADHD, who have returned to classrooms this fall without their critical prescriptions.
“The brain is complicated,” says Dr. Brent Nelson, an adult interventional psychiatrist at PrairieCare in Edina. “100 billion neurons, 100 trillion connections—there are a lot of things going on there. And to suddenly change [the medication] formulation on someone when they’re in the midst of a pretty stressful time of their life, such as college—to change it up on them because of some external forces—is really pretty unreasonable.”
What's Causing the ADHD Medication Shortage?
ADHD is generally treated with stimulant medications, which (literally) stimulate neurons in the brain, provoking the release of dopamine—a neurotransmitter that impacts motivation, executive function, learning, attention, and pleasure.
Adderall, Concerta, Ritalin, and Vyvanse are all Schedule II controlled substances—a classification that indicates a prescription’s high abuse potential and includes drugs such as morphine, opium, codeine, and hydrocodone. The U.S. Drug Enforcement Administration limits the amount of raw ingredients that companies can use to manufacture highly controlled prescriptions with the Schedule II classification.
This year, the DEA didn’t increase manufacturing quotas for stimulant medications despite an increase in demand. That's because last year, national manufacturers fell short of the initial quota by almost a billion doses of stimulant medications, according to a joint letter from representatives of the FDA and DEA. They’re on track to do the same in 2023.
“If any individual manufacturer does not wish to increase production, we have asked that manufacturer to relinquish their remaining 2023 quota allotment,” the letter from the FDA and DEA reads. “This would allow DEA to redistribute that allotment to manufacturers that will increase production.”
Teva Pharmaceutical Industries, Ltd., the largest producer of branded and generic Adderall, created a domino effect beginning last fall when they experienced delays in manufacturing. This domino effect was made worse when, in January, Concerta manufacturer Janssen axed its generic brand through its subsidiary Patriot Pharmaceuticals. And while name-brand Adderall is no longer in shortage, its generic counterpart—which is more affordable for many patients—continues to experience shortages.
“When prominent manufacturers can’t keep up, then there is a cascade effect through the other manufacturers who aren’t initially equipped with the material or mechanical resources for manufacturing more product to make up the difference,” says Dr. Matt Hammer, community clinics pharmacy manager at Hennepin Healthcare. “Oftentimes manufacturers would have to choose between producing one drug or another.”
Switching Brands
Many patients have recently reported their stimulant medications aren’t working or are less effective than before the shortage began. While it can be tough to pinpoint the exact reason why, doctors say it may be a sign that it’s time to switch dosages or brands.
Some patients have opted to swap medications—from name-brand to generic, or from one medication to another. Others find that swapping their prescriptions doesn't help with managing symptoms. “Once a patient is stable on a formulation, they generally stay on it,” says Dr. Mike Waldt, system director of pharmacy services at North Memorial Health. “If there is a generic version, that would be an easy substitute for most patients. However, some patients report better results on a specific product, and switching for them would be difficult.”
Subtle differences in the name-brand versus off-brand formulations mean the medications work differently for every patient. Some find that an off-brand variation is entirely ineffective compared to the brand-name counterpart. “We’ve had a lot of cases where folks have made a switch, and then switched back,” Dr. Nelson says. “And when they switch back, the medicine didn’t work as well as it did prior to the original switch. It’s really disruptive.”
Switching to an off-brand medication, or a different formulation altogether, can also lead to other shortages, as demand increases for an alternate to the prescription already experiencing shortages.
Some patients build up a natural resistance to the medication and are encouraged to take “medication vacations,” or avoid taking their meds on the weekends and during breaks. But this method of medication management isn’t recommended for everyone. Patients may be forced to ration their medications or potentially run out and do without.
“Withdrawal can happen quickly with these drugs,” Dr. Waldt says. “Patients could experience any combination of significant side effects, including anxiety, depression, mood swings, and cravings for Adderall or other drugs, among additional side effects. The degree of the symptoms would likely be impacted by the dose the person was taking and how long they had been using it.”
In late summer, the FDA approved several first generic versions of Vyvanse (which has been in short supply since earlier this summer), approved for adults and children ages six and up. The FDA also approved two generic versions of Concerta. These off-brand variations likely wont reach consumers until late this year or early next year, reports indicate.
Supply issues aren’t exclusive to stimulant medications. The American Society of Health-System Pharmacists recently reported that drug shortages in the U.S. hit a 10-year high during the first quarter of 2023. In April, there were 301 drugs in shortage—an increase of 47 drugs in the first quarter of 2023 alone, and 100 more than five years ago.
“[The shortages have] really wrestled our control away and put it in the hands of someone that’s not necessarily aligned with the patient’s interest,” Dr. Nelson says. “Changing the conversation back to being between the patient and the provider, and getting their autonomy, their independence, their well-being back in their own hands, I think is the key piece.”
Increase in demand
Sue Abderholden, executive director of NAMI Minnesota, also points to the uptick in diagnoses since the start of the pandemic. “Prescriptions for this type of medication increased during the pandemic, [when] there was more awareness by parents of ADHD in their children when they were homeschooled,” Abderholden says.
The CDC released a study this March showing how prescriptions for stimulants used to treat ADHD surged during COVID-19 times—but that increase happened especially among adults. Interestingly, the number of ADHD diagnoses among women aged 23–29 and 30–49 almost doubled from 2020 to 2022, according to researchers.
Some have criticized therapy providers, alleging they have over-diagnosed ADHD after the CDC made it easier for people with ADHD to receive care via telehealth appointments during the COVID-19 pandemic. One study verified the uptick in prescriptions during the pandemic, with researchers pointing to an increased need for more specific diagnostic criteria for adult ADHD. Others say ADHD is a vastly under-diagnosed disorder, so this uptick actually represents a more accurate proportion of the population.
Some symptoms of ADHD—such as inattentiveness, brain fog, and forgetfulness—can also be hallmarks of other mental health conditions, like post-traumatic stress disorder, anxiety, and a new—yet pressing—chronic health issue: long COVID. Some early case reports show that the use of mixed amphetamine salts (AKA Adderall) can help with symptoms of inattention associated with long COVID.
Even if someone without ADHD—or long COVID—takes stimulant medications, they’d experience similar benefits of the drug, making it difficult to suss out who suffers from ADHD and who may be suffering from a temporary inability to focus or another mental health condition. “This is why it can be a popular diverted drug, because it can help people focus,” Dr. Waldt says.
But, Dr. Mark Holtan, a pharmacist at Hennepin Healthcare, notes that people who take these medications without ADHD may experience adverse reactions, including anxiety, agitation, headaches, and jitteriness.
Coping with Collateral Damage
The immediate impact of the ADHD medication shortage is simple: People are struggling to pay attention.
While this sounds harmless; it’s anything but. Attention is necessary for routine activities such as driving, working, and cooking dinner. People with ADHD are more likely to get into vehicle crashes, half of people with ADHD can’t hold down a job, and ADHD may cause unhealthy food consumption.
The classification of stimulant medications as a Schedule II controlled substance can make it difficult for patients to transfer a prescription from a pharmacy experiencing shortages to a pharmacy not experiencing shortages. Worse yet, “They may not be legally transferred from one pharmacy to another,” Dr. Hammer says.
This places pharmacies in a precarious predicament. “Pharmacies are trying to allocate the drug fairly,” Dr. Waldt says.
“Even if you are able to refill a prescription, it can take more than a pill to address the symptoms [of ADHD],” Abderholden says. “This includes therapy, getting a good night’s sleep, creating structure, learning relaxation techniques, moving, or exercising.”
Dr. Nelson concurs. Getting extra sleep, managing other mental health conditions, and eating well, likely won’t entirely address the symptoms of ADHD, but it can help patients, nonetheless.
“So saying, OK, I’m going to do smaller groups of work,” Dr. Nelson says. “I’m going to work for 10 minutes at a time instead of an hour at a time, you know, really giving their brain a break in between groups of tasks so that the day is more approachable, and it doesn’t overwhelm their brain, just trying to stay focused for too long.”
“It’s frustrating that we do lean on those other mechanisms—coping skills, accommodation strategies,” Dr. Nelson adds. “Those skills are best developed when we’re not in crisis, [when] we’re not in a shortage.”
Experts say it’s also important to communicate with your health care provider, who can help determine the best course of action—whether that’s switching prescriptions, changing dosages, or finding pharmacies that have supplies—that meets each patient’s individual needs.
