Clara Pitts has always strived for perfection.
The 17-year-old Utah native has been named a 2023 National Merit Scholarship finalist. And she heads to Brigham Young University as a freshman this fall.
But despite all of her achievements, Clara has one thing weighing on her mind: What if she fails?
Clara was diagnosed with attention-deficit/hyperactivity disorder (ADHD) in 10th grade, during the summer of 2020, after months of digital schooling had started to take its toll.
“For the first time, I started struggling with getting my homework done [and] having a set schedule that I had to do myself,” Clara said. “It was because of online school.”
So along with her mother, Rebekah, she made the decision to try medication.
“I didn’t realize just how much my ADHD was inhibiting me from acting the same way as all of my friends until I had that experience of leveling the playing field,” Clara said.
By December 2020, Clara was prescribed 10 milligrams of Adderall, a formulation of amphetamine mixed salts, to be taken twice a day. Immediately, she noticed a difference.
“It seemed like the logical course of action, like something that shouldn’t have been happening in my brain was being fixed,” Clara said. “Naturally, my brain goes really, really fast, and I don’t even notice it because it’s what I’ve grown up with, and it’s the only mind I’ve ever experienced. But once I started having a different experience mentally, I felt a lot calmer.”
For the two years that followed, Clara was finally able to lead what she called a normal life, managing school, extracurricular activities and social life – all with the help of Adderall.
But in October 2022, Clara’s sense of calm was stripped away when the US Food and Drug Administration announced a shortage of Adderall and its generic counterparts.
“I hadn’t heard anything about a shortage,” she said. “I didn’t really take it seriously at first until later that week – maybe three or four days later – when I started to hear news about the shortage, and it really started to sink in.”
CNN first spoke with Clara and her mother, Rebekah, about a month after the FDA’s announcement. At the time, Clara had eight Adderall pills left in her prescription bottle – enough to last her four days.
“Initially, I was just very surprised when I tried to refill the prescription and they would not [refill it],” Rebekah says. “Very quickly, I went from surprised to afraid.”
On October 24, Rebekah texted Clara the bad news. The shortage had finally affected them, and their pharmacy could not refill Clara’s medication due to the shortage.
“They wouldn’t put you on a waiting list,” Rebekah texted her daughter. “I’m just sitting here crying because I can’t get you these meds.”
Rebekah says she called eight local pharmacies, and each one turned up empty.
“I felt really emotional about it in that first week or two … like I had failed my child, even though it wasn’t my fault,” Rebekah said. “I felt scared for what that would mean for her as a senior.”
The FDA announced a shortage of Adderall on October 12. The agency noted that it was in communication with all manufacturers of amphetamine mixed salts and that one of those companies, Teva, was “experiencing ongoing intermittent manufacturing delays.” Although other manufacturers continued to produce the drug, the agency said, “there is not sufficient supply to continue to meet U.S. market demand through those producers.”
Jim McKinney, a spokesperson for the agency, told CNN that the manufacturing delay has been resolved and that the shortage is now “demand-driven.”
Data from the analytics and research company IQVIA shows that the demand for Adderall has risen nearly 27% in recent years, with prescriptions jumping from 35.5 million in 2019 to 45 million last year.
On its website, the FDA lists eight manufacturers that have reported Adderall shortages to the agency. The website lists the shortage reason for some versions of the drug, such as “demand increase” or “shortage of active ingredient,” but for other versions, it just says “other” or lists no reason at all.
Each year, the Drug Enforcement Administration tracks and sets a limit on production of amphetamine, one of the key ingredients in Adderall. It says that for the past three years, manufacturers didn’t expend all of the ingredients that were available for their use.
“DEA is committed to ensuring that all Americans can readily access needed medications,” an agency spokesperson told CNN in a statement. “We are aware that the pharmaceutical industry is claiming that there is a quota shortage for the active ingredients in ADHD drugs. Based on DEA’s information – which is provided by drug manufacturers – this is not true.”
CNN reached out to the eight manufacturers that reported shortages to the FDA.
Teva Pharmaceuticals, Epic Pharma and Rhodes Pharmaceuticals did not respond. Alvogen, SpecGX and Sunrise Pharmaceutical declined to comment.
Sandoz said it had enough product to meet current customer orders. Lannett also said it had enough to meet current customer orders but added that it did not have enough to fulfill increased demand.
McKinney, the FDA spokesperson, said supply is increasing.
“The FDA recognizes the potential impact that reduced availability of certain products may have on health care providers and patients and is working closely with numerous manufacturers and others in the supply chain to understand, mitigate and prevent or reduce the impact of intermittent or reduced availability of certain products,” he said.
McKinney clarified that although the FDA is working with manufacturers, the agency does not make drugs and “cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug.”
Dr. Yoram Unguru, a pediatric hematologist and oncologist with joint faculty appointments at the Herman & Walter Samuelson Children’s Hospital at Sinai and the Johns Hopkins Berman Institute of Bioethics, studies drug shortages.
He says a lack of transparency about details – how big the shortage is and how much drug each company is making – is hindering solutions.
“Pharmaceutical manufacturers are not required to disclose the reason for disrupted supply. Knowing the exact reason for a given shortage is always challenging,” Unguru said. “It’s really difficult to be able to anticipate and let alone come up with meaningful solutions if you don’t know what the problem is.”
Clara ultimately went without Adderall for two and half months as she coped with the stresses of senior year. She began taking a different ADHD medication, Vyvanse, in mid-January.
Rebekah says she hopes Adderall will be an option for Clara again one day, adding that she doesn’t have the emotional stamina to keep searching for the medication.
“I would like her to have medication as an option and for it to be reliable, because college will probably be the hardest journey for her with ADHD.”
Clara says that life without Adderall is like trying to see the world vividly while wearing smudged glasses.
“You go around with dirty glasses. You get used to it, and you don’t realize that they’re dirty. But when you clean them off, having that extra bit of clarity makes a world of difference.”
#Adderall #users #struggle #ongoing #shortage #reason #resolution #remain #uncertain #CNN