US ADHD stimulant shortage highlights growing challenges in adult treatment

Obtaining ADHD treatment presents many challenges for many adults. |Image credit: © Kwangmoozaa – Stock.adobe.com

The continuing shortage of stimulants has exposed critical gaps in the treatment of attention-deficit/hyperactivity disorder (ADHD), particularly in adults, where the number of diagnoses, stigma, and clinical guidance is limited. treatment is complicated by the¹ Patients face increasing barriers to treatment, highlighting the urgent need for improved diagnostics, evidence-based guidelines, and equitable access to medicines.

Recently, well-known brands such as Adderall and Vyvanse may have been removed from the FDA drug shortage database, but it is unclear whether that will continue. On the other hand, many generic drugs for treating ADHD are still in short supply.^{2, 3}

According to an article in It is said that it is connected to JAMA Psychiatry.¹ However, diagnosing ADHD in adults remains complex. Originally recognized as a childhood disorder, ADHD is now recognized as a lifelong disease, affecting an estimated 2.5% to 4% of U.S. adults and costing more than $100 billion annually. I am.

Diagnostic criteria adapted from pediatric guidelines may not adequately capture adult-specific symptoms, such as executive function deficits and emotion regulation challenges. This could lead to potential misdiagnosis or underdiagnosis, the authors explained.

Accessing treatment presents many challenges for many adults. Concerns such as substance abuse, social stigma, and lack of long-term data on treatment outcomes complicate treatment. Another challenge is that health systems, clinicians, and policy makers are grappling with how to balance the benefits of effective treatment with the risks of diversion and stimulant use disorder.

Although stimulants are widely considered to be the most effective treatment for ADHD, non-stimulant and behavioral treatments are often underutilized, the authors argue. The lack of evidence-based treatment guidelines further undermines clinician confidence in prescribing, creating a risk of both over- and undertreatment. Additionally, drug shortages highlight disparities in access to treatment.

In September, the federal Drug Enforcement Administration (DEA) approved increased production of Vyvanse (lisdexamfetamine) and its generic equivalent, raising the total stimulant production quota (APQ) by approximately 24%.⁴ The decision was aimed at addressing the growing demand for treatments for ADHD and bulimia.

However, debate on the issue has not led to confidence that the ongoing meth shortage can be significantly alleviated, with many blaming the problem primarily on production limits imposed by the DEA.

Vyvanse, which became available as a generic in August 2023, is converted in the body to dextroamphetamine, the same active ingredient as Adderall. The DEA also increased the APQ for dextroamphetamine by 18%, but only about 25% of the increased allocation will be allocated for domestic use, resulting in a modest 6.5% increase in lisdexamfetamine supplies to the United States. equivalent. The FDA estimates that demand will increase by 6% from 2023 to 2024, but despite increased demand, production adjustments have not yet closed the supply gap.

The stimulant shortage began with Adderall supply issues in October 2022 and has since affected other ADHD medications, including Vyvanse and Ritalin. While some Adderall manufacturers like Teva Pharmaceuticals have made progress in restoring stocks, the makers of Vyvanse and its generics face deep challenges. DEA restrictions on dextroamphetamine, cited as a key reason for the shortage, limit manufacturers' ability to meet demand even after Vyvanse's patent expires and generic versions become available.

The DEA and FDA acknowledge the challenges, but emphasize their limited authority, saying they cannot mandate drug companies to make additional production or change distribution practices. Critics argue that the DEA's allegedly arbitrary and restrictive annual quotas are the root cause of continued shortages. They argue that adjusting these caps could solve supply problems without the need for additional regulatory intervention.

However, LF-APA's Dr. William Dodson wrote in a blog post on ADDitude that the system utilized by the DEA is designed to combat potential abuse and is therefore inflexible and adaptable to changing patient needs. He said he couldn't do it.⁵ The DEA sets annual production caps for each drug company based on projections made nearly two years in advance.

“I am confident that the FTC will seek public testimony regarding stimulant shortages and pharmaceutical practices. [Federal Trade Commission] Just trying to find a cover [DEA]“DEA is the only government agency that sets production and distribution quotas for all pharmaceutical companies that manufacture controlled medicines,” Dodson wrote. The DEA determines the amount of each drug that can be shipped to pharmacies each month. Therefore, the roots and long prevalence of this problem can be traced back solely to the DEA. No other authority has the power to create or extend it. ”

Critics noted that the DEA's 2022 decision to tighten allocations for ADHD drugs stemmed from concerns about diversion and misuse, despite limited evidence to support these claims. Dodson also points out that most stimulant misuse occurs not among people with ADHD, but among a narrow group of white male college students who rely on these drugs to function in their daily lives. He explained that this is suggested by research.

The shortage worsened when the DEA restricted supplies in response to a surge in adults diagnosed with ADHD. Despite well-documented evidence that ADHD persists into adulthood, the DEA's response appears to ignore this reality, reducing the availability of medications as demand increases.

Initially, the DEA and other agencies, including the FDA and FTC, attributed the shortage to manufacturing and raw material shortages. However, drug companies have consistently said they are producing as much as the DEA allows. Telemedicine clinics, which have been cited as a contributing factor to the pandemic, only fill a fraction of prescriptions, and most have ceased operations. Despite this pivot, shortages remain unresolved and are causing significant disruption for patients who rely on these medicines.

Critics are calling on the DEA to overhaul its flawed quota system and prioritize patient needs over unfounded concerns about abuse. Without swift action, shortages will continue until 2025, prolonging unnecessary suffering for millions of people.

“The idea that drug companies are giving up billions of dollars in profits has always been incredible,” Dodson wrote. “Later, a shortage of raw materials was blamed, but two years later, that explanation has become implausible…It is long past time for the DEA to admit its fault and fix its broken quota system. It has passed.”

References

1. Blanco C, Thurman CBH. Diagnosis and treatment of ADHD in adults: Balancing individual benefits and population risks. JAMA Psychiatry. Published online on October 23, 2024. doi:10.1001/jamapsychiatry.2024.3228

2. FDA drug shortages. F.D.A. Accessed November 25, 2024. https://dps.fda.gov/drugshortages

3. Teva's Adderall has been removed from the FDA's shortage list as ADHD generic drug supply continues to be tight. A fierce pharmaceutical company. May 22, 2024. Accessed November 26, 2024. https://www.fiercepharma.com/manufacturing/tevas-adderall-makes-it-fda-shortage-list-while-generic-adhd-med-supply-squeeze

4. Wolkoff-Waxman M. Vyvanse Shortage Update: DEA OKs Expansion of Production of ADHD Treatment Drug. addition. September 12, 2024. Accessed November 25, 2024. https://www.additudemag.com/vyvanse-shortage-lisdexamfetamine-dimesylate-adhd-medication/

5. Dodson W. The crisis created by the DEA. addition. July 10, 2024. Accessed November 27th https://www.additudemag.com/adderall-shortage-dea-stimulants-adhd-medication/