More than a year after the US Food and Drug Administration (FDA) announced a shortage of the ADHD medication Adderall, doctors and patients say they are still struggling to get their hands on medication for the disorder.
Despite repeated promises from drugmakers that the supply crunches would be resolved soon, shortages persist, and frustration is growing, reports NBC News.
Americans are battling to find pharmacies that stock medications for attention-deficit/hyperactivity disorder – not just Adderall, but also others, like Ritalin and Concerta, as well as their generics.
High demand for the drugs, coupled with pharmaceutical companies’ claims that they’re being restricted in how much they can make, has fuelled a nationwide shortage.
In October 2022, the FDA announced a shortage of Adderall, but since then, doctors say other ADHD medications, like Focalin, Ritalin and Vyvanse, have become in short supply.
As of 2022, there were 107 US companies involved in manufacturing ADHD drugs, according to the market research company IBISWorld.
Drugmakers have published estimates of when the medications will be back in stock, but as they struggle with demand, those estimates have been pushed back.
Aurobindo Pharma, which makes a generic version of Adderall, for example, estimated in June that some doses of the drug would be available in December, only for the timeline to be pushed back several months, to September, according to the FDA drug shortage database.
Teva Pharmaceuticals, a major manufacturer of ADHD medications, did resolve many of its Adderall shortages. However, certain doses estimated to be available in October or December have been postponed to February or May.
Dr Lenard Adler, director of the adult ADHD programme at NYU Langone Medical Centre in New York, said about 30% to 40% of the prescriptions he writes for ADHD medications have to be rewritten because pharmacies may not have them in stock.
Prescriptions can’t be transferred between pharmacies, meaning doctors have to issue patients new ones.
“I have several patients who have been off their meds for two to three months,” he said. “When they get off their medications, their symptoms come back and then they forget to make a follow-up appointment, and I have no way of knowing this is happening.”
Who’s to blame for the shortage?
Drugmakers and the Drug Enforcement Administration (DEA), which regulates controlled substances, are blaming each other for the problem, said Erin Fox, senior pharmacy director at the University of Utah Health.
Makers of ADHD drugs say they don’t have enough ingredients to make the medicines and need permission from the DEA to make more. The DEA is insisting that drugmakers have not met their quota for production and could make more of the drugs if they wanted to.
Adderall is a controlled substance regulated by DEA, which sets limits on how much of the active ingredient companies are allowed to produce in a given time frame. Drugmakers must get approval from the DEA before they go over their quotas.
In August, the DEA and FDA issued a joint statement calling on drugmakers that do not wish to increase production to relinquish their allotment so that other companies may produce more of the ADHD medications.
The FDA said it was also taking steps to provide alternative treatment options.
In a bid to boost the availability of the medications, in August the FDA approved several generic versions of Vyvanse.
There doesn’t appear too much else the FDA can do in the near term, experts say.
In a statement, Chanapa Tantibanchachai, a spokesperson for the FDA, said the agency was working with “numerous manufacturers” and others in the supply chain to “understand, mitigate and prevent” shortages.
“The FDA recognises the potential impact that lack of availability of certain products may have on healthcare providers and patients,” she said.
Certain formulations of Adderall are also now more widely available, according to the FDA’s drug shortage database, however, the agency still lists the medication as being in shortage.
Dr Sarah Cheyette, a paediatric neurologist who treats both children and adults with ADHD at the Palo Alto Medical Foundation, said January was a bad month for her patients.
Vyvanse, even with generic versions recently approved, is still hard to come by, she said; so are Ritalin and Focalin.
Patients have to go to multiple pharmacies to find their prescriptions, she said, and many pharmacies tell them they have the drugs on back order.
Dr David Goodman, director of the Adult Attention Deficit Disorder Centre of Maryland, said that for his patients, the shortage is not as “problematic” as it was several months ago, but it’s not alleviated yet.
He said the brand name version of Adderall was more readily available, but not its generic versions.
“You have to consider that ADHD individuals have a low frustration tolerance, which is even lower when they are not on their medication,” said Goodman, also an assistant professor of psychiatry and behavioural Sciences at the Johns Hopkins University School of Medicine.
“Their ability to manage the situation and stick with it grows very thin.”
NBC News article – ‘I’m fed up’: Frustrations grow as ADHD drug shortage continues (Open access)
See more from MedicalBrief archives:
Critical shortage of ADHD medication in US and demand rises
Benefits of long-term use of ADHD medications questioned
Drug shortage fears as supply chain challenges persist