番茄社区

Patients who rely on medication to treat their attention deficit-hyperactivity disorder (ADHD) are struggling to fill their prescriptions because of a national shortage of amphetamine/dextroamphetamine (Adderall).

On Reddit, one user wrote, "I tried 2 mom & pops on top of I don't even know how many regular pharmacies earlier today and nada. I've been trying to fill for over a week. I honestly have no idea what to do."

Others said they had tried to switch to lisdexamfetamine dimesylate (Vyvanse) or methylphenidate (Ritalin), two other drugs used to treat ADHD.

and drugmakers, the shortage stems from manufacturing problems at Teva Pharmaceuticals, a leading supplier of amphetamine/dextroamphetamine in the U.S., as well as the Drug Enforcement Agency's (DEA) quota system, which is intended to control the supply of schedule I and II substances (amphetamine/dextroamphetamine is a schedule II substance).

Underlying these problems is the increase in demand for amphetamine/dextroamphetamine as more patients are diagnosed with ADHD, with telehealth companies prescribing the drug springing up in a regulatory lull during the COVID-19 pandemic.

According to Trilliant Health, a , amphetamine/dextroamphetamine prescriptions for patients ages 22 to 44 increased by 15.1% from 2020 to 2021. Prescriptions for those younger than 22 decreased slightly.

Even as digital health companies and drew scrutiny for enabling potential overprescribing of stimulants, the demand has strained drugmakers and pharmacies.

In a , the FDA singled out Teva specifically, citing its "ongoing intermittent manufacturing delays." Although other manufacturers produce the drug, the FDA wrote that "there is not sufficient supply to continue to meet U.S. market demand through those producers."

"Teva has active supply of both branded Adderall and its generic version and continues to produce and refill the channel regularly at levels above historical demand," Teva wrote in a statement shared with 番茄社区. "It is possible that some people may encounter a backorder (intermittently) based on timing and demand, but these are only temporary."

They noted that they expect to recover from the shortage in "the coming months."

In a second email to 番茄社区, Teva elaborated that "delays were the downstream effect of a past labor shortage on the packaging line which has since been resolved."

An executive at another drug company, who asked to remain unnamed because of concerns about his company's relationship with Teva, told 番茄社区 that when the drug giant experiences a problem, it has a ripple effect on other manufacturers, including his company. Complicating matters is the DEA's quota system, which controls the amount of drug materials that a company is authorized to use in a year.

"Teva had a production issue earlier in the year, which prevented them from producing," he said. "Therefore, they were not using [up] their quota and other companies had to take up the production to resolve the issues they were having."

The executive said he understood the DEA's position, which is to avoid flooding the market with a controlled substance. "From the DEA's perspective, they've given enough quota for the year for everybody. Just because somebody is not using it, it is not necessarily something they can easily resolve."

The agency can make adjustments to quotas for various manufacturers, but the executive said that his company had reached their limit 3 months ago, and they had requested their quota be adjusted a month and a half prior to that. A small additional allowance the DEA granted already ran out. "We asked for an appropriate amount to cover through the end of the year," he said.

The DEA did not respond to questions from 番茄社区 in time for publication.

Meanwhile, other manufacturers have Adderall and its generic versions available and are not experiencing problems. A representative from one manufacturer, Sandoz, for example, wrote in an email to 番茄社区 that they are meeting all current customer orders, and have no shortage. Sandoz noted that the FDA is checking in frequently on their supply.

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