- It’s been 10 months since the Food and Drug Administration first announced a nationwide Adderall shortage, but the shortage could get worse in the coming months.
- Some experts said they were concerned about market conditions as children commonly affected by ADHD return to school.
- The lack of transparency in the pharmaceutical industry makes it nearly impossible to know when the shortage will end or what exactly can be done to address it.
10 mg tablets of the hyperactive drug “Adderall” manufactured by Shire Plc.
JB Reed | Bloomberg | Getty Images
It’s been 10 months since the Food and Drug Administration first announced: nationwide shortage Adderall — one of the most widely used drugs attention deficit hyperactivity disorder And the tight supply could get even worse in the coming months.
While some supply issues have improved, many Americans still struggle to secure and supply supplies. prescription medicine and other drugs People with ADHD often rely on it to stay focused and complete their daily tasks.
Drug shortage experts told CNBC that the lack of transparency in the pharmaceutical industry makes it very difficult to predict how long the shortage will last. Others are concerned about market conditions as children commonly affected by ADHD return to hospital. school.
“Unfortunately, the shortage could get worse. We’re heading into the new school year, and I’m worried that the situation will get even worse heading into that season,” said a pharmacist at the University of Utah. Erin Fox, a drug shortage guru, said: CNBC talks about drug shortages in the US.
Adderall was one of more than 300 medicines in short supply in the United States as of June, according to the company. list It is an award from the American Association of Health System Pharmacists, which represents pharmacists in various medical settings.This list also includes Adderall alternatives such as methylphenidatecommonly known by the trade names Ritalin or Concerta.
Apart from Adderall and other drugs, alternative treatments for ADHD include: Schedule 2 Controlled substance.
The federal government regulates how these drugs are manufactured, prescribed, and dispensed because they are believed to have a high potential for abuse and can lead to severe mental or physical dependence. Thing. This designation also means that the patient will need to be re-prescribed those drugs every one to three months of her life.
Millions of Americans living in the United States use this drug to improve focus, control impulses, and manage schoolwork, work, and relationships. ADHD is usually diagnosed in childhood and often persists into adulthood.
Estimate 6 million children According to the Centers for Disease Control and Prevention, 60% of people diagnosed with ADHD were on medication as of 2016.Meanwhile, around 8 million adults Only about a quarter of those diagnosed with the disease receive treatment.
Many children and young people with ADHD take medication during the summer vacation and often rely primarily on medication during the school year. This could lead to even more demand in the coming months that will go unmet.
Historically, prescribing of ADHD medications has increased with the start of the new school year across the United States, but “there’s no sign of that changing this year,” said David Margraf, a pharmacy researcher at the Center for Infectious Disease Research and Policy at the University of Minnesota. .
FDA says some drug companies plan to resupply some ADHD products in August or September database about shortages. But Margraf said the drug companies have not given exact figures on how much stock will be available by then, so “we need to be cautiously optimistic.”
Shire Plc’s Adderall XR 30mg Tablets.
JB Reed | Bloomberg | Getty Images
This reflects the larger problem of continued shortages. The lack of transparency in the pharmaceutical industry makes it nearly impossible to know when these problems will end or what specifically can be done to solve them.
“There’s very little factual information out there. I think that’s one of the biggest problems,” said Ozrem Ergun, a professor of mechanical and industrial engineering at Northeastern University and an expert on the pharmaceutical supply chain. “Without transparency and information sharing, how can we understand and solve complex problems?”
“This is a really, really big blow to users, hospitals and healthcare systems. They have very little vision of what the future holds,” Ergun added.
Teva Pharmaceuticals, Amnir Pharmaceuticals, Sandoz, which is planning to spin off Novartis, and Rose Pharmaceuticals, a subsidiary of Purdue Pharma, all make drugs for ADHD. , information about where a drug is manufactured, how much it is manufactured, where its ingredients are sourced, and where the drug is manufactured. overall production capacity.
And the Drug Enforcement Administration, the federal agency that regulates controlled substances, shares little information about the quotas it sets for manufacturers of Adderall and other ADHD drugs.
The DEA specifically limits the amount of raw materials, such as amphetamines, that pharmaceutical companies can obtain to manufacture drugs.
“We don’t know how much quota each company is given, and we don’t know how much each company is actually producing or whether they are meeting that quota,” said Fox of the University of Utah. Ta. “We don’t know exactly what’s going on because we have no way of understanding which companies are not working and which companies are.”
Closing the Adderall and other ADHD drug shortages is no easy task.
“It’s not as simple as a free market that just ramps up production to meet demand,” says Michael Ganio, senior director of pharmacy operations at the American Association of Health System Pharmacists.
Many manufacturing plants are running near capacity and producing multiple drugs. Ergun said this means that increasing production of one drug would require reducing production of another, which could potentially impact supply.
“In general, it’s hard to increase drug manufacturing capacity,” she says. “There is no unused capacity anywhere.”
Scaling up the production of tightly controlled ADHD drugs is even more difficult.
Drug companies can ask the DEA to increase production quotas if needed, but it would take a “significant effort” for the DEA to actually approve them, Margraf said.
And even if the DEA approves the change to the quote, it could take months to approve. “It’s not just about flipping a switch and increasing production by 20%,” said ASHP’s Ganio.
On January 31, 2019, Drug Enforcement Administration agents raided two side-by-side homes in Commerce City, Colorado, in what they described as an illegal marijuana operation.
RJ Sangosti | Media Newsgroups | Denver Post (via Getty Images)
Some pharmaceutical companies have suggested that DEA allocations are contributing to, or making it more difficult to alleviate, the ADHD drug shortage. Among them is Aytu BioPharma, which manufactures a previously scarce ADHD drug.
Aytu CEO Josh DiBrow said in a February CNBC op-ed that if the DEA underestimated demand and failed to increase allocations “in response to new information in a timely said it could cause shortages.
But the DEA and FDA point to another problem. joint letter It went on sale earlier this month.
The agency said an internal analysis found that drug companies could not meet the full quota of amphetamine drugs in 2022, leaving about 1 billion potential drug doses. They added that a “similar trend” is happening this year.
The DEA and FDA said they asked manufacturers to confirm they were working to ramp up production to meet the allotted quotas.
“There’s obviously a lot of accusation going on between the distributors and the manufacturers,” Fox said.
Adderall and Generic Drug Shortages kicked off Last August, a major manufacturer reported that its drugs were backordered.
Manufacturers are required to notify FDA of shortages, but not of the cause of the suspension. However, the FDA initially noted that Teva “continues to experience intermittent manufacturing delays.” announced Insufficient Adderall.
Teva previously said the manufacturing slowdown was partly labor shortage, was quickly resolved. Teva did not immediately respond to CNBC’s request for comment on the status of Adderall manufacturing.
The surge in demand for Adderall and other ADHD drugs also appears to play a role.
US Prescriptions for Adderall Soared 41.4 million Sales in 2021 are up more than 10% from 2020, according to medical industry analytics firm IQVIA.
Experts say one of the possible factors driving the demand is Telemedicine service During the COVID-19 public health emergency, prescribing standards for ADHD drugs could have been more relaxed.
The pandemic has also perfect storm Distractions, such as the shift to remote work and the wave of anxiety, stress and sadness associated with COVID-19 uncertainty, exacerbate symptoms in some ADHD patients and make more people It may have convinced them that they had ADHD and encouraged them to seek treatment.
Increased demand due to shortages of Adderall also likely had a domino effect, driving healthcare providers and patients to turn to alternative drugs, causing shortages of those drugs as well.