Tuesday, 28 May, 2024
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Critical shortage of ADHD medication in US and demand rises

As America’s nationwide Adderall shortage enters its fifth month, people relying on medication for ADHD are finding few, if any, available alternatives, and pharmaceutical experts say there is no solution in sight.

Widespread scarcity has hit Adderall alternatives, too. As of January, the American Society of Health-System Pharmacists (ASHP), which tracks drug availability, reported shortages affecting nearly 40 different doses or formulations of generic Concerta, a long-acting form of methylphenidate, the drug in Ritalin.

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 reached by NBC News, Vyvanse has been on intermittent backorder for months.

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

“All of our drug shortage infrastructure, and everything in place to mitigate the impact of shortages, is based on potential disruptions in supply,” he said. “It’s been very unusual to have a shortage based on increase in demand.”

In recent years, ADHD medication prescriptions have risen more than the drug companies or government agencies predicted. Health data company Trilliant Health said Adderall prescriptions for adults rose 15.1% during 2020, double the 7.4% rise the year before.

In October, the US Food and Drug Administration (FDA) announced a national shortage of Adderall, citing “ongoing intermittent manufacturing delays”.

Dr Sarah Cheyette began switching patients to alternative ADHD medications like Focalin, Vyvanse, Concerta and Ritalin when she learned pharmacies were out of Adderall late last year. The alternative drugs didn’t always work out, but for many patients, switching prescriptions made more sense than going without ADHD medication altogether.

“There’s a spillover from people who couldn’t get Adderall and have turned to other drugs,” said Cheyette, a paediatric neurologist who treats both children and adults with ADHD at the Palo Alto Medical Foundation. “And it’s just getting worse.”

Alvogen, which manufactures generic Adderall, expects its shortage to last until mid-April, while Teva Pharmaceuticals, the country’s largest Adderall supplier, reports that issues with some of its Adderall dosages, particularly the more expensive brand-name versions of its fast-acting tablets, are now resolved but lists recovery dates for others as TBD (to be determined).

Making more not so easy

Most ADHD medications fall into a class of controlled substances called central nervous system stimulants. Because the medications have a well-documented history of abuse and addiction, the FDA and Drug Enforcement Administration limit how many pills a pharmacy can dispense at once and how frequently patients can refill their prescriptions.

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

“The DEA is involved if any manufacturers try to scale up production,” Ganio said. The DEA calculates how much of a given drug ingredient is needed to meet demand, then allocates that precise amount. The problem, according to Ganio, is how DEA uses historical data – meaning prescription numbers from previous years – to set these amounts.

Demand forecasts based on historical data couldn’t predict the sharp rise in ADHD diagnoses during the pandemic, Ganio said. Now there’s a mismatch between DEA quotas and prescription numbers.

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

“Since mid-2022, we found when a customer ordered more from us than what they forecast, we were unable to fulfil those orders,”

Leslie Pott, a Sandoz spokesperson, told NBC News. “We petitioned the DEA for an increase in volume, with some requests accepted and some denied.”

He said this was “unbelievably unprecedented”.

Ganio said the DEA is often willing to increase quotas if there’s legitimate patient demand. But it’s difficult to measure a demand increase while it’s happening. There’s no real-time coordinated system for tracking ADHD diagnoses on a national level as there is for Covid or the flu.

“Making more drugs is not as easy as just flipping a switch,” Ganio said. “The FDA and DEA are seeing more demand, but how much more?”

Covid, social media, 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 pandemic lockdowns began.

As people began working from home or helping children with virtual school, they started to recognise ADHD symptoms, said Dr Max Wiznitzer, a paediatric neurologist at University Hospitals Rainbow Babies and Children’s Hospital and Case Western Reserve University in Cleveland. This was especially true for adult women.

“All of a sudden, parents saw their children had difficulties staying focused, and we were identifying more kids who were symptomatic and needed intervention,” Wiznitzer said. Since the pandemic began, Wiznitzer said he’s also been prescribing ADHD medication to more adults.

When will Adderall shortage end?

The scarcity of ADHD medication has addiction experts on high alert now, too. Dr Eric Kutscher, an addiction medicine specialist at NYU Grossman School of Medicine, said the same reason these drugs are controlled substances in the first place – their potential for abuse – has him fearing the continued shortage.

Without access to prescription stimulants, Kutscher said people with substance use disorders might “turn to a drug supply that’s more dangerous than ever.” Deaths from counterfeit Adderall laced with fentanyl have already been reported.

“We have a limited safe supply, and an available, very dangerous supply that could hurt a lot of people,” Kutscher said. “From a public health perspective, this is an emergency.”

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, co-ordinated systems for forecasting drug demand.

 

NBC News article – The ADHD medication shortage is getting worse. What went wrong? (Open access)

 

See more from MedicalBrief archives:

 

Adult-onset ADHD may not exist, study suggests

 

Prescription ‘smart drugs’ have opposite effect in healthy adults – Australian study

 

Benefits of long-term use of ADHD medications questioned

 

No conclusive CVD risk link to ADHD medicines – Swedish meta-analysis

 

 

 

 

 

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