March 12, 2024 – Nearly 18 months after the FDA first identified a nationwide shortage of Adderall, the drug mostly used to treat attention-deficit/hyperactivity disorder, there may be now a widespread shortage of other stimulant medications – and there isn't any sign of them ending in sight . How did this crisis come about and what measures are there to handle it?
The FDA first reported the shortage of Adderall and Adderall IR in October 2022. The list now includes Focalin, Ritalin and Vyvanse, amongst others.
Adding to the continued crisis, the FDA announced in early February that Azurity Pharmaceuticals was voluntarily withdrawing a batch of its Zenzedi (dextroamphetamine sulfate) 30 mg tablets as a result of contamination with the antihistamine.
For the roughly 10 million adults and 6 million children within the United States who struggle with it ADHDWhether a prescription is stuffed with the precise medication ordered by a health care provider often is determined by geographic location, insurance forms and pharmacy supply chains. This is especially difficult for individuals who live in rural or underserved areas and have limited access to nearby pharmacies.
“Not a day goes by that I don’t hear from a number of sadly suffering patients about this shortage,” he said Aditya Pawar, MDChild and adolescent psychiatrist on the Kennedy Krieger Institute and assistant professor of psychiatry and behavioral sciences on the Johns Hopkins School of Medicine in Baltimore.
The ADHD medication The shortage is now in its second 12 months, and each doctors and advocates say there isn't any obvious end in sight.
How did we get here?
Manufacturers and federal regulators blame rising demand and one another for the shortage, while clinicians say insurers, drug distributors and middlemen also play a task in keeping drugs out of patients' hands.
In August 2023, the Drug Enforcement Administration, which sets quotas for the production of controlled substances, and the FDA made a call publicly accused manufacturers for the shortages and claimed they weren't using up their allotments.
At the time, the DEA said manufacturers were producing and selling only 70% of their quota, nearly a billion doses lower than what they were allowed to provide and ship this 12 months.
Authorities also found that a record variety of stimulant prescriptions were prescribed from 2012 to 2021. Driven partly by telemedicine, demand increased in the course of the pandemic. One Recent study reported a 14% increase in ADHD stimulant prescriptions between 2020 and 2022.
Insurers also play a task within the shortage, said Dr. David Goodman, assistant professor of psychiatry and behavioral sciences also at Johns Hopkins University.
Tiered therapy — requiring patients to try one, two or three medications before being approved to take a costlier or newer drug — contributes to the issue, Goodman said. The demand for such drugs is high and the availability is low. Additionally, some insurers only offer coverage to pharmacies inside their network, no matter whether other providers outside of those networks are in a position to fill prescriptions.
“If insurance dictates where you get your pills and that pharmacy doesn't have the pills or the chain pharmacy near you doesn't have those pills, you're out of luck,” Goodman said.
Patients as detectives
To fill prescriptions, patients must “become detectives,” said Laurie Kulikosky, CEO of Children and Adults with Attention-Deficit/Hyperactivity Disorder. “It’s a huge stressor.”
Keeping track of which ADHD medications can be found, backordered, or discontinued requires frequent checking FDA drug shortages website.
Some makers of generic versions of ADHD drugs are only fulfilling orders for existing contracts, while others say recent products won't be available until April or September on the earliest. Everyone blames the dearth of energetic ingredients for the delay.
Teva, which makes each the brand and generic Adderall, reported on the FDA's website that its manufacturing and distribution are at record levels but demand continues to rise.
The brand-name product Concerta is offered, but some makers of generic methylphenidate reported that supplies is not going to be available until July.
Lisdexamfetamine dimesylate is either not available in just about all dosages, is just available in limited quantities or is reordered after a protracted time period. However, the branded product Vyvanse is offered.
Industry and government are responding
In November 2023 opinionThe DEA reported that 17 of 18 drugmakers contacted by the agency planned to completely utilize their DEA quota and increase production this 12 months. The agency said it has made it easier for producers to request changes to allocations and often updating quotas is one possibility.
When asked whether manufacturers had not met their quotas for 2023, a DEA spokesman declined to comment.
An FDA spokesman said it could help manufacturers demand larger quotas and increase production, noting that the DEA increased the quota for methylphenidate (brand names Ritalin and Concerta) in 2023 on the FDA's request.
“The FDA is in regular contact with the manufacturers of ADHD stimulating medications and the DEA, and we will continue to monitor supply,” the spokesperson said.
With many medications — not only those for ADHD — in brief supply, the U.S. Department of Health and Human Services and the Federal Trade Commission launched an investigation of sorts in February to hunt comment on how middlemen and others influence the costs and provide of generic drugs.
“When your doctor prescribes you an important medication and you learn that the medication is no longer in stock, your heart sinks,” HHS Secretary Xavier Becerra said in an announcement. “This devastating reality applies to too many Americans who need generic medications for ADHD, cancer and other diseases.”
On the comments pagewhich is open until April 15, most of the greater than 4,000 complaints filed thus far have come from individuals with ADHD.
Pawar said doctors can't know what's occurring between the FDA, the DEA and the manufacturers, adding, “They need to sit together and figure something out.”
Even members of Congress had difficulty getting answers. In October, Rep. Abigail Spanberger (D-Virginia) and a dozen colleagues wrote to the FDA and DEA asking for details about how authorities were responding to the stimulant shortage. The DEA still hasn't responded.
Workarounds the one option?
In the past, doctors prescribed the optimal medication for every patient based on clinical aspects. Now, certainly one of the major aspects in deciding drug selection is the drug that has “the highest likelihood of benefit and the lowest likelihood of administrative need or burden,” Goodman said.
With so many medications in brief supply, doctors have found ways to fill prescriptions, but they often can't.
If a patient needs a 60 mg day by day dose of a medicine and the pharmacy doesn't have 60 mg tablets, Goodman said they might write a prescription for a 30 mg tablet to be taken twice day by day. However, insurers often only cover 30 tablets per thirty days, which might negate this strategy.
Pawar said he sometimes prescribes Journay PM as an alternative of Concerta since it is usually available. But insurers could deny coverage for Journay PM since it is a more moderen drug, he said. When prescribing ADHD medication, he also provides his patients with an inventory of possible substitutes so that they can check with the pharmacist to see if any are in stock.
With no end to the shortage in sight, doctors often should prescribe multiple medications until their patients find one which is offered. Additionally, patients must make many calls and visit multiple pharmacies until they find one which can fill their prescription.
Meanwhile, the impact of the ADHD medication shortage continues to spread. Prolonged periods without treatment can result in worsening work performance or job loss, broken relationships and even financial hardship, Goodman said.
“If you go a month without pills and don't perform, your work slows down and you lose your job as a result, that's not your fault – that's the fact that you can't get your treatment,” he noted. “The shortage is no longer a nuisance.”