In an August 1 letter to the American public, the US Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) contend that unprecedented demand, potential overprescribing, and a lack of full production by manufacturers are the primary factors causing a shortage of stimulant drugs to treat attention deficit hyperactivity disorder (ADHD).
While the shortage “began last fall due to a manufacturing delay experienced by one drug maker,” a huge increase in prescribing of amphetamine mixed salts is a major factor in the ongoing shortage of medications such as Adderall, Vyvanse, and Ritalin, as well as their generic counterparts, the agencies write.
Access to stimulant medications is important, but “it is also an appropriate time to take a closer look at how we can best ensure these drugs are being prescribed thoughtfully and responsibly,” they write.
Citing US Centers for Disease Control and Prevention (CDC) data, the agencies said that when virtual prescribing was widely permitted during 2020-2021 because of the COVID-19 Public Health Emergency, prescriptions increased by 10% for both women aged 15-44 and men aged 25-44.
The DEA noted in the letter that it sets limits on how much of a drug of abuse can be manufactured. Amphetamine mixed salts are schedule II controlled drugs. But manufacturers came nowhere near those limits in 2022, said the agency.
The DEA estimated that drug makers sold only about 70% of their allotted quota in 2022, leaving almost 1 billion tablets un-made and un-sold. Numbers for 2023 indicate a similar trend, the agencies note.
Congress has been pressuring the DEA and the FDA to explain the continuing ADHD medication shortages. In May, Abigail Spanberger, Democratic representative from Virginia, wrote to the DEA urging the agency to do more, and noting that she had not yet received a response to a December letter.
Citing data from IQVIA, Spanberger said that the number of Adderall and generic-equivalent prescriptions increased 16% from 35.5 million in 2019 to 41.2 million in 2021.
Ron Wyden, Democratic senator from Oregon, has also been pressing FDA and DEA, and in June demanded more clarity and a better response.
‘Unprecedented Demand’
In the letter, the DEA and the FDA said they “have called on manufacturers to confirm they are working to increase production to meet their allotted quota amount.”
The agencies added that if a manufacturer did not want to increase production, they would be asked to give up their remaining 2023 quota allotment so that it could be redistributed to a drug maker that would increase production.
The FDA said it is “asking professional groups and healthcare providers to accelerate efforts to support appropriate diagnosis and treatment of ADHD, such as further development of additional clinical guidelines for ADHD in adults.”
Consumers first began reporting that they were encountering shortages in mid-2022, but the FDA did not confirm a national shortage until October. At the time, the agency noted that alternative therapies, including extended-release medications, were available.
But the shortages have persisted, in both immediate-release and extended-release formulations, brand and generic. On its drug shortages page, the FDA continues to list many amphetamine mixed salt formulations as unavailable, with some companies estimating December 2023 as the date when they will resolve the shortage.
Teva, one of the largest generic manufacturers, states on the FDA site that it is “manufacturing and distributing consistent with historic levels,” adding that it continues to see “unprecedented demand.”
The American Society of Health-System Pharmacists (ASHP) also tracks drug shortages and lists the same formulations as being in short supply.
According to the ASHP site, some manufacturers have discontinued making immediate- or extended-release pills or both, while others have given no reason for a shortage or refuse to comment.
Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in publications including JAMA and Smithsonian.com. You can find her on Twitter @aliciaault.
For more Medscape Psychiatry news, join us on Twitter and Facebook.
Source: Read Full Article