(From The New York Times)
Patients and caregivers have struggled for two years to find stimulant medications like Adderall, Vyvanse and Concerta to treat attention deficit hyperactivity disorder. Some spend hours each month going from pharmacy to pharmacy to find a drug, while others are forced to switch to a different brand or formulation, or go without medication for weeks.
This week the Drug Enforcement Administration announced a potential solution: It is raising the amount of lisdexamfetamine (Vyvanse) that can be produced by U.S. manufacturers this year by nearly 24 percent to meet demand in the United States and abroad.
Vyvanse is an amphetamine that has been approved for use in children and adults with A.D.H.D. and has become commonly prescribed after the generic version was introduced last year. According to the D.E.A., the latest data shows that demand for the drug has been rising globally. But right now every manufacturer of generic Vyvanse listed on the Food and Drug Administration website is experiencing a shortage.
Many health care providers who specialize in treating patients with A.D.H.D. said that the D.E.A.’s decision was a positive development but that it was unclear just how much of an effect it might have on the shortage.
“Obviously it’s not going to solve the problem completely,” said Ami Norris-Brilliant, clinical director of the Division of A.D.H.D., Learning Disorders, and Related Disorders at the Icahn School of Medicine at Mount Sinai in New York City. “But I think anything that helps increase drug availability is a good thing.”
It is not the first time that the D.E.A. has increased production quotas for A.D.H.D. drugs. Last year it announced a new 2023 limit for methylphenidate, which is used to make drugs like Ritalin and Concerta, raising the allotted amount by 27 percent for 2023. The drug remains in shortage, however, in the extended release formulation.
The F.D.A. first declared a nationwide shortage of Adderall in the fall of 2022. It didn’t take long before other stimulant medications used to treat A.D.H.D., like Vyvanse, also became difficult to find.
The shortage is “hugely problematic” for children and their families, Dr. Norris-Brilliant said. She recalled a 7-year-old girl at her clinic who did not have access to Vyvanse for three weeks this summer, leading her mother to hire a caregiver who watched her child at camp each day and made sure she didn’t do anything “impulsively dangerous.”
Adults with A.D.H.D. have also suffered. Dr. David W. Goodman, an assistant professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine, said that one of his patients, who works at a hospital, could not obtain Vyvanse for nearly a month. It affected her job performance to the extent that her supervisor and co-workers took notice.
The fact that the D.E.A. is now setting higher production limits for lisdexamfetamine is “a hopeful sign,” Dr. Goodman said.
The agency made its decision after reviewing a letter from the F.D.A. that used market data to make the case that the D.E.A.’s ceiling on lisdexamfetamine production needed to be revised.
Because the stimulants used to treat A.D.H.D. are considered controlled substances with high potential for abuse, the D.E.A. sets limits on how much of each drug can be produced by each manufacturer. Even if a pharmaceutical company has the ability to produce additional doses of a drug, it cannot do so unless the D.E.A. raises those limits.
Drug manufacturers can request a quota increase from the D.E.A., but they do not always receive it. On the flip side, manufacturers do not always produce the full quota allotted by the D.E.A. In 2022, for example, manufacturers of amphetamine medications produced about 1 billion fewer doses than they were permitted to make, according to government records.
Of the 10 manufacturers reporting shortages of lisdexamfetamine, two of the companies — Hikma Pharmaceuticals and Rhodes Pharmaceuticals — told The Times that they would increase production upon receiving additional individual quota from the D.E.A. The other eight manufacturers did not respond to a request for comment.
Given that only a portion of the additional production quota for lisdexamfetamine is allotted to the U.S. market, it probably “isn’t going to make much of a dent in the supply,” said Dr. David Grunwald, a child and adolescent psychiatrist in Berkeley, Calif. Even so, he said, the increase sounded like a move in the right direction.
“I hope they are planning for similar production increases for other stimulants,” Dr. Grunwald added.
For many people, the medications are crucial for everyday functioning. They are not simply a tool to improve focus or get better grades, said Dr. Justine Larson, a child and adolescent psychiatrist who works at Sheppard Pratt, a behavioral health organization that runs special education schools in Maryland. Shortages “can really derail kids’ progress.”
Children at Sheppard Pratt who have skipped doses of Vyvanse have in some cases unexpectedly run out of a school building, sending the staff scrambling, she added.
And while some caregivers have been able to navigate the shortage, it’s a lot to juggle. Many families are “stressed and on the edge,” Dr. Larson said. “It’s really, really disruptive.”
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