Collateral Damage from a Shortage of ADHD Drugs

Collateral Damage from a Shortage of ADHD Drugs

That spring, Riana Shaw Robinson learned that her 11-year-old son, Madison, had run out of class chasing a squirrel through her Berkeley, California schoolyard.

Not her usual sixth grader behavior. But that day, Madison had not taken her Adderall — a drug that, she says, helps her brain slow down, “from 100 miles per hour — like a car — to 70 miles per hour.”

Robinson said Adderall worked better for his son than other drugs they used to treat his attention deficit hyperactivity disorder. With Adderall, he is calmer and better able to focus.

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“He really got a taste of what relief feels like,” Robinson said.

But for almost a year now, the medicine — Madison uses the generic version — has been hard to find. He had to miss doses, sometimes by up to two weeks, because the nearest pharmacy was out of stock.

Her family is rationing her pills this summer so Madison, who is only 12 years old, will be taking them throughout the school year.

“We try to manage with a few caffeinated drinks during the day and football in the afternoon,” says Robinson, a strategy he says has helped his son regulate his emotions.

In July, the Food and Drug Administration noted more shortages of the ADHD drug, adding a generic version of Concerta and two types of Vyvanse capsules to the list. And in August, the FDA and the Drug Enforcement Administration took the rare step of issuing a joint public letter acknowledging the shortfall and asking manufacturers to ramp up production.

A representative for Takeda Pharmaceuticals, which makes Vyvanse, said in an email that “a production delay, which we are actively working on,” had created a temporary disruption in the supply of certain Vyvanse capsules, adding that “we expect this to continue through September 2023.”

Parents and caregivers across the country spend hours each month hunting pharmacies stocked with ADHD medication and getting their doctors to transfer or rewrite prescriptions, a process many have likened to having a second job. Others pay hundreds of dollars out of pocket for brand-name drugs that are sometimes more readily available but, unlike generics, are not covered by their insurance. Some children end up taking similar but less effective medications or go without medication for months because their families don’t have the extra time or money.

ADHD, which is often characterized by inattention, disorganization, hyperactivity, and impulsivity, is one of the most common childhood neurodevelopmental disorders. Due to a drug shortage, children across the country with the condition are falling behind in their schoolwork during the spring, and their relationships are often strained as they struggle to regulate their emotions, according to interviews with many doctors and parents. Meanwhile, they all wonder: Why is this happening, and when will it end?

‘He Can’t Catch Up’

One of the cruelest aspects of the ADHD medication shortage, some parents say, has been the damage to their children’s self-esteem.

Kari Debbink, who lives in Bowie, Maryland, said her daughter, who was about to enter her senior year of high school, would lose motivation to do her schoolwork when her ADHD medication, Concerta, was not available in either brand name or generic versions. His grades, which were usually B’s, plummeted — and so did his confidence.

“Once he falls behind, he can’t catch up,” says Debbink. “At the end of the year, we were just trying to prevent him from failing the class.”

Drew Tolliver, 12, who lives in DeKalb, Illinois, usually uses the generic version of the Concerta, but since February, his family has had trouble finding one.

On taking medication regularly, Drew says, “I feel like I know myself.”

“I feel like a better me,” she adds, “like how ‘myself’ should be.”

Her mother, Amy Tolliver, recently found the cure — but she has to pick it up 40 minutes from the gas company where she works 10-hour shifts, six days a week.

In the spring, Drew refused to go to class when he wasn’t taking his medication, said Michelle Tolliver, Amy’s wife and Drew’s second parent. He and Amy Tolliver sometimes relented and allowed him to stay at home.

“I hate to see him feel like a failure,” said Michelle Tolliver.

‘I Was Detained For 50 Minutes’

Because ADHD medications are considered controlled substances, patients are required to get a new prescription for every 30-day supply.

“I waited 50 minutes waiting to speak to a pharmacist,” Dr. David Grunwald, a child and adolescent psychiatrist in Berkeley, California, said of the recent calls to track down ADHD medication for a child whose mother has a chronic illness. and can’t spend hours on the phone.

In practice, he says, long wait times with large pharmacy chains are becoming commonplace.

“It feels like a game where you don’t know which stimulant will be in short supply each week or month,” he says. “It’s very frustrating.”

Dr. Kali Cyrus, a psychiatrist in private practice in Washington, DC, has to call pharmacies so often that she plans to hire someone to help her check availability. Currently, she tries to call all day, including in the morning, when she’s making breakfast or walking her dog.

In her sessions with patients, she says, she sometimes has to decide “how to combine different strengths or formulations to get my patient’s normal dose — or as close as possible,” or switch to another, more readily available stimulant.

Switching medications can lead to less effective treatment, doctors say, because certain stimulants work better for some people than others. Even switching from a brand-name drug to a generic version can be problematic. Generic versions of Concerta, for example, may not release their medication over time in the same way as the original.

Due to a shortage, Paige and Leo, who live in Northern California, are now giving their 7-year-old son Andy the drug Metadate, which they say only lasts six hours. (The family asks to be referred to by their middle name to protect their privacy.)

This meant that Andy then needed an extra dose in the afternoon, which was given during his after school program. Sometimes staff forget, says Paige.

When that happened, “we would get calls like, ‘Your kid is out of control,’” says Leo.

Demand for Stimulants Soars

For children with ADHD who have problems functioning in everyday life, stimulant drugs such as amphetamine (Adderall) and methylphenidate (including Ritalin and Concerta) have long been considered the gold standard of treatment by psychiatrists and pediatricians.

“It’s one of our most effective treatments in psychiatry—period,” says Dr. Alecia Vogel-Hammen, assistant professor of psychiatry at the University of Washington School of Medicine. “They have changed lives.”

In recent years, this drug has been in great demand. The use of prescription stimulants to treat ADHD more than doubled from 2006 to 2016. And between the 2020 and 2021 pandemic years, the percentage of people who have a prescription for stimulants increased by more than 10% among some adults and adolescents, according to an analysis from the Centers for Control and Disease Prevention.

The increasing number – and the ease with which they can be evaluated via telehealth – has raised concerns that some people are being misdiagnosed and that stimulants for ADHD are over-prescribed or abused by people who do not have ADHD but are using the drug to be more productive at school. or at work. But this is not the case at all. Studies have found that girls, people of color and those who identify as LGBTQ are often underdiagnosed and treated for ADHD.

Doctors say the demand for ADHD drugs is also increasing due to increased awareness of the condition in both children and adults.

Why Do Shortages Happen?

Disruption to ADHD drugs reflects shortages of hundreds of other types of drugs, including generic forms of chemotherapy, which are falling victim to faltering pharmaceutical supply chains.

Typically, drug shortages are tied to a single manufacturing facility, says Michael Ganio, drug shortage expert at the American Society of Health-System Pharmacists.

But in this case, according to the FDA’s online drug database, the ADHD drug shortage now involves multiple manufacturers — mostly those who make generic drugs — and has been going on since last fall. On the FDA website, the reasons each manufacturer offers are sometimes vague such as “regulatory delays” or “other”. Others say “lack of active ingredients” or “demand is increasing.”

Some manufacturers have given specific time frames for when the problem can be resolved, such as “mid-August”. But it’s unclear when that will translate to replenished pharmacy shelves.

Because controlled substances have a high potential for abuse, the DEA limits the amount of these drugs that can be produced. But by 2022, amphetamine drug manufacturers produced about 1 billion fewer doses than allowed, according to government records. They also don’t fully meet their quota in 2020 or 2021.

When asked more specifically which companies did not meet their quota or whether any companies had requested an additional quota, a DEA official replied that the details of each company’s quota were considered confidential.

“The fact that there is no information is much more frustrating,” said Ganio.

Emails to drug manufacturers currently described as having a shortage of ADHD medication provide some clarity as to when the problem may be resolved. A representative for Teva Pharmaceuticals, which manufactures Adderall, said it was continuing to see “unprecedented demand” that could cause “intermittent delays” but planned to manufacture the full number of doses it was authorized to make. Granules Pharmaceuticals, which makes the generic equivalents of Adderall XR and Adderall IR, said it had asked to increase the DEA quota.

Another factor potentially driving the scarcity: a $21 billion settlement brokered between three pharmaceutical distributors and most states that is imposing new requirements on pharmaceutical companies to help stem the flow of controlled substances such as prescription painkillers. This has resulted in tens of thousands of canceled drug orders, including those for ADHD drugs.

“There is a higher level of oversight on all controlled substance orders by pharmacies,” said Ilisa Bernstein, senior vice president at the American Pharmacists Association. “It creates a perfect storm.”

Suzana, who lives in Tennessee and asks to be referred to by her first name to protect her family’s privacy, described the lack of it as a “nightmare”.

This year, he says, his 16-year-old son’s long-release generic Focalin has become hard to find. And because they couldn’t get it consistently, the fourth quarter went like a roller coaster.

“One week, he’ll get 100 in class, and the next week, a few zeros,” he said.

Over the summer, Suzana said, she stopped her medication so they could save her pills for the school year, which starts Monday. That meant he would have extra time to find his medication refills.

“This morning, I actually counted the pills to see how many pills I had left,” he said.

Now that her son has a driver’s license, she plans to limit driving, but she worries: “If he doesn’t take the dose and he drives, will he be okay?”

c.2023 New York Times Company

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