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Why is the ADHD drug shortage getting worse and when will it end?


Neither drug makers nor the DEA anticipated a sharp increase in ADHD diagnoses during the pandemic. These are the reasons.

By Caroline Hopkins -

NBC News

As the nationwide Adderall shortage enters its fifth month, people who rely on medication to manage attention deficit hyperactivity disorder (ADHD) find few, if any, alternatives.

Pharmaceutical experts say that there are still no signs of relief or an easy solution to the problem.

Widespread shortages have also affected alternatives to Adderall. 

In January, the American Society of Health System Pharmacists (ASHP), which tracks drug availability, reported shortages of nearly 40 different strengths or formulations of generic Concerta, a form of long-acting methylphenidate, the drug in Ritalin.

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Takeda Pharmaceuticals, which makes Vyvanse, also known as lisdexamfetamine, its generic, says there is no shortage of that drug, but according to dozens of pharmacies contacted by NBC News, Noticias Telemundo's sister network, Vyvanse has been on intermittent stock for months.

Michael Ganio, senior director of pharmaceutical practice and quality at ASHP, said an unexpected spike in demand was more to blame than manufacturing equipment or drug quality issues. 

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“All of our drug shortage infrastructure, and everything we have in place in this country to mitigate the impact of shortages is based on potential supply disruptions,” Ganio said.

“It has been very unusual to have a stock-out based on increased demand,” he added.

In recent years, ADHD medication prescriptions have increased more than pharmaceutical companies or government agencies anticipated.

According to health data company Trilliant Health, Adderall prescriptions for adults increased 15.1% during 2020, double the 7.4% the previous year.

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In October, the Food and Drug Administration (FDA) announced a nationwide shortage of Adderall, citing "continued intermittent manufacturing delays."

Dr. Sarah Cheyette began switching her patients to alternative ADHD medications, such as Focalin, Vyvanse, Concerta and Ritalin, when she learned that pharmacies had run out of Adderall late last year.

Alternative drugs didn't always work, but for many patients, switching prescriptions made more sense than going off ADHD medication altogether. 

“There is an overflow of people who couldn't get Adderall and have turned to other drugs,” said Cheyette, a pediatric neurologist who treats children and adults with ADHD at the Palo Alto Medical Foundation.

"And things only get worse."

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Some drug companies now say supply problems could last well into spring.

Alvogen, which makes generic Adderall, expects its shortage to last until mid-April, according to the FDA's database.

Teva Pharmaceuticals, the nation's largest supplier of Adderall, reports that the problems with some of its Adderall strengths, particularly the more expensive branded versions of its short-acting tablets, have now been resolved, but indicates that the delivery dates recovery of others are TBD (to be determined).  

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Most ADHD medications belong to a class of controlled substances called central nervous system stimulants.

Because these drugs have a well-documented history of abuse and addiction, the FDA and DEA limit the number of pills a pharmacy can dispense at one time and how often patients can refill their prescriptions.

The DEA also limits each year the active ingredients that pharmaceutical companies use to make these drugs. 

“The DEA steps in if any manufacturer tries to increase production,” Ganio explains.

The DEA calculates how much of a certain active ingredient is needed to meet the demand, and then allocates that exact amount.

The problem, according to Ganio, is how the DEA uses historical data - that is, the number of prescriptions from previous years - to set these amounts.

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Demand forecasts based on historical data could not predict the sharp increase in ADHD diagnoses during the pandemic, according to Ganio.

Now there is a mismatch between the DEA quotas and the number of prescriptions.  

The quotas have been problematic for companies like Novartis-owned Sandoz, which makes generic Adderall and Concerta. 

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"Since mid-2022, we've realized that when a customer asked us for more than anticipated, we couldn't meet those orders," Leslie Pott, a Sandoz spokeswoman, told NBC News in an email.

“We petitioned the DEA for a volume increase, with some requests granted and others denied.”

According to Pott, these customers range from hospitals and institutions to retail pharmacies, specialty pharmacies and wholesalers.

Ganio said the DEA is usually willing to increase fees if there is a legitimate demand from patients.

But it's hard to measure an increase in demand while it's happening.

There is no coordinated, real-time system for tracking ADHD diagnoses nationwide, like there is for coronavirus or the flu. 

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“Making more drugs is not as easy as flipping a switch,” says Ganio.

“The FDA and DEA see more demand, but how much more?” he wondered.

COVID-19, social networks and telehealth drive demand

Doctors can't cite exact numbers either, but many say they've noticed a clear increase in patients seeking ADHD treatment since the pandemic began.

“As in many crises, many factors came together to create a perfect storm,” said Cheyette, who herself saw many more ADHD patients recently than in the years before the pandemic.

"This is unprecedented."

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As people started working from home or helping kids with virtual school, they began to recognize the symptoms of ADHD, said Dr. Max Wiznitzer, a pediatric neurologist at Rainbow Babies and Children's Hospital at University and University Hospitals. Case Western Reserve of Cleveland.

This was especially true of adult women. 

“Suddenly, parents were seeing that their children were having difficulty staying focused, and we were identifying more symptomatic children who needed intervention,” Wiznitzer explains.

"Parents of my patients have asked about ADHD more often."

Since the pandemic began, Wiznitzer said he has been prescribing ADHD medication to more adults. 

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Ashley Gandy, 39, who lives in Carrollton, Texas, takes Vyvanse for her ADHD, a prescription she got through a telehealth doctor.

Her 6-year-old son takes Concerta, which is prescribed by her pediatrician.

In the fall, Gandy went several weeks without Vyvanse, and now her regular pharmacy is out of Concerta for her son. 

“The CVS person told me they hadn't had any for a month and they didn't expect to have it anytime soon,” he explains.

When will the Adderall shortage end?

In late December, Rep. Abigail Spanberger, whose Virginia congressional district encompasses Fredericksburg and other cities in the northeast region of the state, wrote a letter calling on the FDA and DEA to coordinate a federal response to the shortage. .

ASHP's advocacy arm has also been lobbying the government to improve the way it addresses issues of drug supply and demand.

The shortage of ADHD medication has also put addiction experts on alert.

According to Dr. Eric Kutscher, a specialist in addiction medicine at NYU Grossman School of Medicine, the very reason these drugs are controlled substances in the first place -- their potential for abuse -- makes him fear that the shortage will continue.

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Without access to prescription stimulants, Kutscher said people with substance use disorders could "turn to a drug supply that is more dangerous than ever."

Deaths have already been reported from counterfeit Adderall mixed with fentanyl.

“We have a limited safe supply, and a very dangerous available supply that could hurt a lot of people,” Kutscher said.

“From a public health standpoint, this is an emergency,” he said.

A quick fix is ​​unlikely, experts acknowledge.

From Ganio's perspective, addressing the ADHD drug shortage is going to require much more transparency from drug companies and better, coordinated systems to forecast drug demand.

Cheyette worries that the solution won't come soon.  

“It's not about Beanie Babies [of which there was a shortage and a rush to get them in the 1990s] that people can't find.

These are drugs that people depend on to function,” he recalled.

Source: telemundo

All news articles on 2023-02-06

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