The ADHD drug market is already crowded. Now it is facing a supply shortage for the start of school

Ten milligram tablets of the hyperactivity drug Adderall, manufactured by Shire Plc.

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It’s been 10 months since the Food and Drug Administration first announced a nationwide shortage from Adderall – one of the most commonly used drugs for Attention Deficit Hyperactivity Disorder – and supply shortages could potentially worsen in the coming months.

Though some supply issues have improved, many Americans still struggle to find and fill up recipes for the drug and other medicines for ADHD, which they often rely on to stay focused and complete their daily tasks.

Drug shortage experts told CNBC that the lack of transparency in the pharmaceutical industry makes it extremely difficult to predict how long shortages will last – and some are concerned about the market conditions to which children commonly affected by ADHD are returning School.

“Unfortunately, the shortage could get worse. It’s almost back to school, so I’m concerned it might get worse earlier this season,” said Erin Fox, a pharmacist at the University of Utah and the leading expert on drug shortages in the US, told CNBC.

Adderall is one of more than 300 drugs in short supply in the US, according to data released in June a list by the American Society of Health-System Pharmacists, which represents pharmacists in various health care settings. This list also includes Adderall alternatives like methylphenidatecommonly known by the brand names Ritalin or Concerta.

Adderall and alternative ADHD medications are also available, among other medications schedule 2 controlled substances.

This means that the federal government regulates how these drugs are manufactured, prescribed, and dispensed, as they are believed to have a high potential for abuse and potentially lead to severe psychological or physical addiction. The designation also means that patients must receive new prescriptions for these drugs every one to three months.

Millions of Americans in the US use the drugs to help them focus, control their impulses, and cope with schoolwork, work, or their relationships with others. ADHD is usually diagnosed in childhood and often persists into adulthood.

An estimate 6 million children According to the Centers for Disease Control and Prevention, they were diagnosed with ADHD and 60% were on medication in 2016. Around now 8 million adults They have been diagnosed with the disease, but only about a quarter are receiving treatment.

Supply bottlenecks for the start of school

Many children and young adults with ADHD often go off medication over the summer and rely on it primarily during the school year. This could lead to even more demand in the coming months that may not be met.

Historically, ADHD drug prescriptions increase as the school term begins in the US — and “there’s no indication this year will be any different,” according to David Margraf, a pharmaceutical researcher at the university’s Center for Infectious Disease Research and Policy of Minnesota .

According to an FDA, some drugmakers have said they expect to backorder some ADHD products in August or September Database on bottlenecks. But Margraf said “we have to be cautiously optimistic” as drugmakers aren’t releasing exact figures on how much stock they will have available by then.

Adderall XR 30 mg tablets from Shire Plc.

Jb Reed | Bloomberg | Getty Images

This reflects a bigger problem given the ongoing shortages. Due to the lack of transparency in the pharmaceutical industry, it’s almost impossible to know when they will end – or what exactly can be done to solve them.

“There is very little factual information. I think that’s one of the biggest problems,” says Ozlem Ergun, a professor of mechanical and industrial engineering at Northeastern University and an expert on pharmaceutical supply chains. “How can you understand and solve a complex problem if there is a lack of transparency and information sharing?”

“This is really bad for users, for hospitals and for the healthcare system. They have next to no idea what the future will be like,” Ergun added.

Teva Pharmaceuticals, Amneal Pharmaceuticals, Novartis The proposed spin-off of Sandoz and Purdue Pharma subsidiary Rhodes Pharmaceuticals, all of which make ADHD drugs, are not required to disclose information about where they make drugs, how many of them they make, where the ingredients come from, and what their overall manufacturing capacities are.

And the Drug Enforcement Administration — the federal agency that regulates controlled substances — shares little information about the production quotas it sets for each manufacturer of Adderall and other ADHD drugs.

The DEA specifically limits the amount of raw ingredients, such as amphetamine, that a drugmaker can use to manufacture those drugs.

“We don’t have the quota amount that every company gets. And we don’t have the amount each company is actually producing and whether they’re meeting those quotas,” said Fox of the University of Utah. “There’s no way of understanding which company might not be doing the job and which companies are, so we just don’t know exactly what’s going on.”

production restrictions

Ending the shortage of Adderall and other ADHD medications is no easy task.

“It’s not as simple as a free market, where you just increase production and meet demand,” said Michael Ganio, senior director of pharmacy practice at the American Society of Health-System Pharmacists.

Many manufacturing facilities are operating at or near capacity, producing multiple drugs. That means increasing production of one drug could potentially require reducing production of another drug — and possibly affecting supply — of another drug, Ergun said.

“In general, it’s difficult to scale up production capacity for a drug,” she said. “There’s not a lot of unused capacity anywhere.”

It’s even harder to ramp up production of tightly controlled ADHD drugs.

Drug makers can ask the DEA to increase their production quotas if necessary, but Margraf says it takes “a lot of pressure” for the agency to actually approve it.

And even if the DEA agrees to a supply change, it could take months to happen: “It’s not just about flipping a switch and increasing production by 20%,” ASHP’s Ganio said.

Members of the Drug Enforcement Administration raided two adjacent houses on Jan. 31, 2019 as part of a suspected illegal marijuana operation in Commerce City, Colorado.

RJ Sangosti | MediaNews Group | The Denver Post via Getty Images

Some drugmakers have suggested that DEA rates contribute to, or make it harder to alleviate, ADHD drug shortages. It also includes Aytu BioPharma, which makes an ADHD drug that used to be in short supply.

In a February CNBC commentary, Aytu CEO Josh Disbrow said the DEA could potentially lead to widespread drug shortages if it underestimates demand and doesn’t increase quotas “in a timely manner in response to new information.”

However, the DEA and FDA pointed out another problem joint letter released earlier this month.

Authorities said an internal analysis found drugmakers missed the full amphetamine drug quota by 30% in 2022, leaving about 1 billion potential drug doses on the table. They added that there is a “similar trend” this year.

The DEA and FDA said they have asked manufacturers to confirm they are working to ramp up production to meet their allotted quotas.

“There’s obviously a lot of pointing between the authorities and the manufacturers here,” Fox said.

Increasing demand for Adderall

The lack of Adderall and generic versions of the drug kicked away last August, when major manufacturers reported that their drugs were backordered.

Manufacturers must report a defect to the FDA, but not the cause of the disruption. However, in its initial release, the FDA noted that Teva was experiencing “ongoing temporary manufacturing delays.” announced the Adderall deficiency.

Teva previously said the slowdown in production is partly related to one labor shortage, which was quickly resolved. Teva did not immediately respond to CNBC’s request for comment on the status of Adderall production.

The surge in demand for Adderall and other ADHD drugs also appears to have played a major role.

US prescriptions for Adderall skyrocketed 41.4 million That’s a more than 10% increase in 2021 from 2020, according to IQVIA, a healthcare industry analytics firm.

One possible factor driving demand for experts was the increased use of telehealth services during the Covid public health emergency, which may have allowed for looser ADHD drug prescribing standards.

The pandemic has one too perfect storm Distractions — like the shift to remote work and a rush of anxiety, stress and grief over the uncertainty of Covid — may have made some ADHD sufferers’ symptoms worse or convinced more people they had the condition, prompting them to to be treated.

The increased demand for Adderall due to drug shortages also likely led to a domino effect, with healthcare providers and patients being forced to turn to alternative drugs, which also led to shortages of those drugs.

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