Nearly a year into a nationwide shortage of ADHD drugs, federal agencies and drug companies are blaming each other for emptying pharmacy shelves.
The Drug Enforcement Administration, which sets limits on the types of amphetamines that drug companies can use to make pills, says drug companies have enough raw material to make them. Stimulant ADHD treatment drug. The drug company disputes this claim, saying it lacks the ingredient and needs DEA approval to obtain more.
Experts doubt that supplies of Attention Deficit Hyperactivity Disorder drug Adderall and other ADHD medications will increase soon, and shortages could last until the end of the year.
“Let’s just say we’re very concerned,” said Max, a pediatric neurologist who treats children with ADHD at University Hospital Rainbow Babies and Children’s Hospital and Case Western Reserve University. Dr. Witznitzer says. “As children return to school, demand for these prescriptions will increase even more.”
Dr. Leila Javidi, a primary care physician in Gahanna, Ohio, fielded hundreds of calls and messages each month from patients who say finding a stocked pharmacy is time-consuming and frustrating.
“Everyone is angry,” Javidi said. “Panic is the norm for my patients. Everything is a mess.”
Why is there a shortage of ADHD drugs?
As of Tuesday, American Association of Health-System PharmacistsA group representing hospital and clinic pharmacists reported supply issues affecting 141 different doses or prescriptions of stimulant ADHD medications.of The shortage started with Adderall. It was launched last fall, but since then there has been a domino effect, with long-acting and short-acting forms of methylphenidate (Ritalin and Concerta), Focalin, Vyvanse, and numerous generic equivalents of these drugs is currently in short supply.
In late August, The Food and Drug Administration has approved several generic versions of Vyvanse However, it is too early to say what impact it will have on the situation.
Millions of children and adults in the United States are prescribed ADHD medications, which increase dopamine levels in the brain and improve concentration. For some, scarcity is an inconvenience. For many others, the lack of access to medicine is impacting their jobs, relationships, and physical and mental health.
Jessica Argo, 38, recently drove two hours from her home in Denver to pick up Adderall, which had only 10 pills left in stock. For Argo, who says her disability makes it difficult for her to communicate, running out of her medication has strained her relationship with her husband and strained her friendship.
Jeremy Didier, 52, a board-certified clinician in Kansas City, Kansas, said he recently waited eight hours at his local Walgreens store to ask if they had Concerta in stock. Didier and four of his five children are taking medication for his ADHD. She has been concerned about the safety risks of drug shortages ever since her teenage son was caught driving 20 miles over the speed limit without taking his medication.
“If people don’t have access to the medicine they need to stay focused, their lives can be at risk,” she says.
More news on ADHD drugs and shortages
In early August, the DEA and FDA released the following report: joint letter In it, they acknowledged that the shortage of prescription stimulants, including Adderall, is “understandably frustrating for patients and their families.” The letter pointed to record high prescription rates for stimulants and a pandemic-era rule allowing doctors to prescribe drugs via telemedicine visits as contributing factors to the current situation.
Federal authorities then claimed that in the face of this surge in demand, ADHD drug manufacturers were not producing as many drugs as possible.
According to the DEA and FDA letter, the DEA conducted an internal analysis and found that companies were only using 70% of their allotted ingredient equivalents in 2022, which would amount to an additional 1 billion doses. It is possible that the conversion could have been done. Both agencies say the numbers will remain the same in 2023.
They asked the DEA to return any remaining amphetamine so it could be redistributed, but the DEA cannot legally require companies to return the amphetamines.
A DEA spokesperson confirmed to NBC News that the ADHD drug manufacturer had at least 34,980 kilograms (about 77,000 pounds) of amphetamines remaining at the end of 2022. The spokesperson said the DEA has set an allotment of 42,400 kilograms (estimated at 93,280 pounds) of amphetamines, and an estimated 38,000 kilograms (about 83,600 pounds) to meet demand for ADHD drugs. He also said he needed amphetamines. The DEA’s amphetamine quota is First reported by Bloomberg.
Of the 16 ADHD drug manufacturers contacted by NBC News, none said they had excess amphetamines to make more ADHD drugs. However, companies are not required to share this information.
Pharmaceutical companies may be reluctant to disclose that amphetamines remain in their allotments to avoid pressure to hand them over to other companies, said Michael Ganio, senior director of pharmacy operations at the American Society of Health-System Pharmacists. It is said that there is. The amphetamines companies abandon are amphetamines that cannot be manufactured and sold for profit.
“Some individual manufacturers may be leaving unused quotas in the hope of increasing production,” he said.
Spokespeople for the five major ADHD drug makers told NBC News in an email that the companies have asked the DEA to increase their quotas.
Teva Pharmaceuticals and Sandoz, two major companies that manufacture ADHD drugs, responded that they had used 100% of their allotted quotas to the DEA in 2022 and requested an increase in their quotas accordingly.
Sandoz, Granule Pharmaceutical, Sun Pharma A company spokesperson said the DEA did not respond to requests for increased quotas.
Attorney William Newman, who represents Ascent Pharmaceuticals with partner Nick Oberheiden, said in an email that the company is still awaiting this year’s allocation requested by the DEA in 2022. Ascent Pharmaceuticals makes generic versions of Adderall, Ritalin, Focalin, and Concerta. ,
“We stopped manufacturing ADHD stimulants completely due to quota issues because we didn’t have any available to begin with,” Newman said.
A DEA spokesperson said the agency does not comment on amounts allocated to manufacturers.
“It ends when supply matches demand.”
Ganio said the discrepancy between the DEA’s announcement and the companies’ announcements is likely because the DEA’s allocation tally is industry-wide and not company-specific.
“In the big picture, this is what the FDA and DEA are looking at, but it doesn’t give us any insight into what individual manufacturers are looking at,” he said.
Individual companies may be over their quotas, but others are silent about having even more inventory. As of 2022, there were 107 U.S. companies involved in manufacturing ADHD drugs, according to market research firm IBISWorld.
Ganio said that even if the overall allocation is sufficient, the DEA needs to do a better job of allocating the allocation to the right companies. Government agencies cannot achieve this without transparency into companies’ individual supply and manufacturing capabilities. Companies rarely make these internal details public, he said.
Ganio said supply likely won’t increase as long as the DEA and manufacturers continue to confuse and mismatch allocations.
“Very simply, this ends when supply matches demand,” Ganio said.
Block access to telemedicine
Experts say telemedicine prescription changes could be one way to stabilize demand for ADHD drugs. At the very least, this will allow the DEA and drug companies to accurately predict how much they will need in the coming years.
Ganio said the DEA sets quotas based on previous year’s numbers.
Doctors are allowed to continue prescribing stimulants via telemedicine, but US public health emergency The allowance expires in May and is scheduled to end on November 11th. At that point, initial prescribing of stimulants via telemedicine will no longer be allowed.
The DEA will allow patients who are already receiving their prescriptions via telemedicine to continue receiving their prescriptions for an additional year. After Nov. 11, 2024, all patients will be required to come in-person to continue their ADHD prescriptions, but the DEA says this plan is subject to change.
“We continue to work toward finalizing telehealth regulations,” a DEA spokesperson said in an email.
Some argue that the downside to these changes is that they risk exacerbating health inequalities.
“This is going to be a problem for people who live in rural areas or who work long hours and can’t get to a clinic,” Javidi said.
Case Western’s Witznitzer said he hopes the agency finds a way to regulate telemedicine prescribing while ensuring equitable access.
“We’re hoping the DEA can meet us halfway,” he said. This could mean requiring doctors to provide the same quality of care and spend as much time with patients via virtual connections as they would in the office. In Wisnitzer’s in-person visits, his first ADHD visit is about an hour and a half, but with telehealth visits, he takes 30 minutes.
Wiznitzer said he wouldn’t be surprised if ADHD drug shortages continue into the fall and potentially into the end of the year, even if changes in telemedicine reduce demand.
However, people say they have developed their own ways of coping. For some people, that means splitting pills, adjusting doses, or supplementing with extra caffeine. For Michelle Czarnecki, 35, also of Denver, that means drinking lots of sugary soda and choosing her words carefully when talking to others about what she’s going through.
“I started telling people, ‘I’m having trouble getting my medicine,'” she says. “I’ll leave it at that and have people wonder if it’s my blood pressure medication. It’s easier than telling the truth and dealing with all the assumptions people make.”
