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Stimulant Shortage the Result of a “Perfect Storm”
Millions of people living with attention deficit/hyperactivity disorder (ADHD) in the United States face a challenging situation that may only worsen over the next couple of months: a shortage of prescription stimulants, including Adderall and its generic formulation, as well as an extended-release generic formulation.
Six out of 9 of the major manufacturers of these drugs, including Teva Pharmaceuticals, have reported that increased demand is placing additional pressure on their already strained production capabilities.
While news of a shortage first started circulating in September of this year—with concerns about the spike in ADHD diagnoses as early as May—the US Food and Drug Administration (FDA) officially announced a shortage of amphetamine/dextroamphetamine to treat ADHD on October 12. “Until supply is restored, there are alternative therapies” that patients can discuss with their doctors in the meantime, the FDA noted in a news release.
The question that quickly follows what to do in the face of the shortage, though, is why the deficit is happening in the first place.
“The shortage of stimulants is [the] consequence of a ‘perfect storm,’” said Vladimir Maletic, MD, MS, clinical professor of psychiatry and behavioral science at the University of South Carolina School of Medicine, and Psych Congress Network ADHD Section Editor.
Rise in Diagnoses and Prescription Strength
“The COVID-19 pandemic was associated with a sharp rise in newly diagnosed ADHD in child, adolescent, and adult patients,” Dr Maletic explained via email correspondence with Psych Congress Network. “Moreover, many patients were requiring increased dosages during and after the COVID-19 pandemic to function appropriately under a novel set of circumstances.”
In 2020, there were 37 million active Adderall prescriptions. In 2021, that number shot up to 41 million, with many anticipating that demand will continue to rise as many patients grapple with increased anxiety brought on by the pandemic.
Further, the stress of geopolitical circumstances as well as an emphasis on staying at home exacerbated symptoms for many already diagnosed with ADHD, and brought out new symptoms for others. Prescriptions for amphetamine/dextroamphetamine in patients aged 22 to 44 increased by 15.1% from 2020 to 2021, according to Trilliant Health.
Supply Chain Woes and Government Regulation
“Issues with supply and manufacturing [have] further aggravated this problem,” Dr Maletic continued. “Additionally, [the] government controls production quotas for manufacturers of stimulant medications.”
According to the FDA, Teva Pharmaceuticals, the largest manufacturer of Adderall and generic amphetamine/dextroamphetamine is “experiencing ongoing intermittent manufacturing delays.” The company told Bloomberg in August that delays could be attributed to “packaging capacity constraints.” MedPageToday this week reported that delays were “the downstream effect of a past labor shortage on the packaging line which has since been resolved.”
Manufacturing issues have been compounded by the Drug Enforcement Administration’s (DEA) quota system, designed to control supply and distribution of schedule I and schedule II substances; amphetamine/dextroamphetamine falls into the latter category. While the DEA can adjust quotas for manufacturers, one executive at another drug company that works closely with Teva indicated that after the company reached their production limit in July, they had requested and received a small additional quota allowance.
“In an ideal scenario,” Dr Maletic observed, “there would be a quota adjustment to reflect changes in clinical needs. Sometimes these projections are inaccurate.”
Telehealth to Blame?
A number of clinicians have raised concern that the rise in telehealth combined with the DEA relaxing of prescribing restrictions in spring 2022 for controlled substances have created an unregulated environment in diagnosing and prescribing stimulants for ADHD. The mental health startup Cerebral is under investigation by the Department of Justice and the DEA for “possible violations” of the Controlled Substances Act. The company has since stopped writing prescriptions for Adderall, Ritalin, and other controlled substances for new ADHD patients, and is transitioning many of its patients to in-person care.
Some experts, including Erin Fox, senior pharmacy director at University of Utah Health, in an interview with The Washington Post, cautioned against blaming telehealth for the shortage until there is further data on stimulant prescriptions and their sources.
Doctors and Patients Pivot
Whatever the cause, the stimulant medication shortage is prompting many doctors and patients to rethink their current treatment strategies.
When asked what clinicians might do to help their patients through the shortage, Dr Maletic recommended “appropriate adjustments of treatment plan [that] may include transition to approved non-stimulant medication, inclusion of underutilized psychotherapies and greater emphasis on improved nutrition, sleep patterns and exercise activities."
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