Ike Sweritz | | Bloomberg
Adderall shortages across the United States last year began quietly.
Teva Pharmaceutical Industries, the nation’s largest producer of the pill, encountered manufacturing problems but did not announce them.The Food and Drug Administration, which tracks such problems, has warned the public. Is not …
In fact, this news came out almost by accident. In July, he posted that Reddit users were having trouble finding pharmacies that would fill their prescriptions. They contacted his FDA and Teva got the message that they expected a delay of the next two to three months. The company and agency later confirmed the supply issue to Bloomberg News.
It’s been over half a year now and there are very few solutions. Adderall, which treats attention-deficit/hyperactivity disorder and the sleep disorder narcolepsy, continues to be in short supply, with five companies reporting availability issues, according to a recent survey of local pharmacies. And about 97% of pharmacies didn’t have enough medicine in stock.
It’s a drug used regularly by millions of Americans to help them stay focused, but the reasons behind the shortage are mostly a mystery.
The rambling news of the Adderall issue symbolizes the long-existing secrecy and confusion surrounding the manufacture and distribution of pills that have been categorized by regulators in the same category as highly addictive drugs such as oxycodone and fentanyl. is what you do.
As shortages continue, supply chain issues demonstrate the difficulty of tracking tightly controlled medicines that can lead to disruption. It’s all the more frustrating now that technological advances and changing regulations are meant to make it easier for people to fill prescriptions.
Adderall usage is on the rise amid increasing availability through telemedicine and increasing social acceptance of mental health conditions and stimulants as a treatment. It’s not too much. Teva says the production issue has been fixed. Governments and manufacturers have not provided enough information to say exactly where the bottleneck is. , the agencies that set these quotas deny it.
Psychiatrist Sreenivas Katragdda, who has worked in Manchester, New Hampshire for 17 years, said the situation was particularly bad, with repeated shortages of ADHD drugs.
“This is a logistical nightmare,” Katragada said. “I would send the prescription to her one pharmacy, which is the patient’s regular pharmacy. They would say they don’t have it and they would say ‘it might be in Nashua.’
“I send it to Nashua, but before my prescription is filled, I realize that someone else sent another prescription and it was filled first,” he said.
Within the past few months, the University of Utah Drug Information Service, which tracks supplies, has also reported shortages of other types of ADHD stimulants in the methylphenidate class, a category that includes popular brands such as Ritalin and Concerta. . That shortage affects generic versions, which account for the majority of prescriptions prescribed. It is unclear whether the deficiency is caused by the patient switching from Adderall to these drugs.
Much of the reason there is so little information on Adderall is related to its designation as a Schedule 2 controlled substance by the Drug Enforcement Administration. That means the Drug Enforcement Administration has determined that the drug is addictive and has a high potential for abuse. A government study based on data from 2015 and 2016 estimated that 5 million adults misuse prescription stimulants each year and 400,000 have a prescription stimulant use disorder. and sold. After the opioid crisis, caused by irresponsible pharmaceutical company marketing and physician overprescribing, such medicines have become even more scrutinized.
The Wall Street Journal reported in December that DEA officials wrote to manufacturers of Adderall last year that some of the factors that could lead to increased demand for ADHD drugs were “an oversupply of opioids during opioid prescriptions.” reported that it expressed concern that it was similar to the factors that led to crisis. “
This kind of comparison concerns clinicians who say there is a big difference between opioids and ADHD medications. Stimulants like Adderall improve executive function (a set of cognitive skills related to concentration, planning, and task completion) in people with ADHD. When used properly, it is not as addictive as high-dose pain relievers. In fact, according to published studies, stimulants like Adderall reduce substance abuse in people with ADHD.
said Max Wiznitzer, director of pediatric neurology at University Hospitals Rainbow Babies and Children’s Hospital in Cleveland, who treats children and young adults with ADHD.
Because of its Schedule 2 classification, getting Adderall is not as easy as getting a birth control pill or acid reflux medication. Patients must get a new prescription every one, two, or three months, and can usually fill a prescription only within a few days of the previous one running out. If the pharmacy is out of stock, the patient should contact the clinician and request that the prescription be sent to another location. It’s all the more troublesome for someone with her ADHD, a condition that makes it difficult to complete complex administrative tasks.
The FDA generally does not release information about beer shortages. Because doing so can lead to hoarding and make the situation worse. That’s why the FDA didn’t proactively warn the public about Teva’s problems over the summer. “Usually when people go to the pharmacy they notice a shortage,” said Erin Fox, who runs the Drug Information Service at the University of Utah.
Previous shortages have led to accountability. During the 2011 and 2012 shortages, the FDA reportedly blamed the DEA, and the DEA blamed the drug companies. We listed Adderall as in short supply from September 2019 to May 2022. The FDA declared him short again in October.
Teva, which produced one of four branded and generic Adderall tablets dispensed in U.S. pharmacies last year, said supply problems were caused by a shortage of workers on packaging lines, a surge in demand, and federal production. It says it’s related to restrictions. Teva’s then-CEO Kale Schultz said in November that the labor issues were caused by “Covid workforce-related” issues. That he had resolved by August, he said, Teva spokeswoman Kelley Dougherty.
Teva, the sole maker of branded immediate-release Adderall, said last year that it expected its branded pills to be in full supply sooner than cheaper, common generics.According to the FDA,1 By the end of the month, all Teva-branded Adderall tablets were fully available, while all generics were in limited supply. About 87% of prescriptions dispensed in the US last year were for generic immediate- or sustained-release versions, according to Symphony Health data.
Dougherty said production of Teva’s generic and branded Adderall has recovered to expected levels and quotas, “continuing unprecedented demand.”
Pharmaceutical companies are not always able to rapidly increase supplies of controlled substances due to government systems that limit the amount of raw material in a drug each manufacturer can have. The quota is intended to limit the amount of controlled substance produced to ensure that it is sufficient to meet medical needs, but not so much that it leaks onto the black market.
But the DEA does not disclose how much of amphetamine, the raw material of Adderall, is allocated to which companies, so it is difficult to grasp the role of allocation in the shortage. can be requested.
Teva’s Dougherty said in October that the DEA’s quota was part of the shortfall. Robert Jaffe, a spokesman for Lannett, Inc., which makes Adderall generics and is the third-largest producer of Adderall, said in December that the DEA’s allocation would allow the company to respond meaningfully to the shortage. said it was unable to expand production to Neither company responded to questions about whether they had requested a quota increase. Sandoz, the generics arm of Novartis AG and the second-largest manufacturer, granted some of the requested increases and denied some, said spokeswoman Leslie Potts. She said federal agencies have been working with industry.
In a statement, the DEA said, “We are aware that the pharmaceutical industry is claiming an under-allocation of active ingredients for ADHD medications.” is not true.”
An agency spokesperson, who requested anonymity due to agency policy, said that as of the end of 2022, the manufacturers of Adderall and the ingredients in its drug had products on hand that contained at least 34,980 kilograms of amphetamines (about 83%). I said I left it. of the total quota that the DEA allowed production for that year. At the end of last year, at least 29,700 kilograms of methylphenidate, which is used in drugs such as Ritalin and Concerta, remained, or about 71% of the quota, according to a spokesperson.
Disagreement between manufacturers and the DEA presents challenges for resolving confusion. Meanwhile, patients like his 7-year-old James Ash in Las Vegas are suffering.
Ash has ADHD and autism and usually takes regular slow-release Adderall. Without treatment, he may have difficulty concentrating in school, become aggressive, and start hurting himself.
I have run out of prescriptions 4 times in the last 7 months. In late December, Ash’s pediatrician tried to prescribe another type of ADHD medication for her, but the family’s insurance refused to pay for it. As recently as she did, until February 2nd, CVS didn’t have enough pills to fill her prescription.
Ash’s mother, Jennifer Jolie, said, “It’s so frustrating. I just want the best for my child. It’s a shame because there’s nothing you can do.”
https://www.ocregister.com/2023/02/16/adderalls-disappearing-act-has-left-millions-without-treatment/ Adderall’s Disappearance Act Leaves Millions Without Care – Orange County Register