It’s been 10 months since the Food and Drug Administration first announced it shortage nationwide to Adderall – one of the most used pharmaceutical to Attention deficit hyperactivity disorder Supply pressures are likely to intensify in the coming months.
And while some supply problems have improved, many Americans still struggle to find and fill oil Prescriptions for medication and Other medications For ADHD they often rely on it to maintain focus and complete daily tasks.
Drug shortage experts told CNBC that it’s very difficult to predict how long shortages will last due to a lack of transparency in the drug industry — and some worry about market conditions as children, who are often affected by ADHD, go back to school.
“Unfortunately, we may see a worsening of shortages. We’re heading into back-to-school time, so I’m worried it’s going to get worse as we go into the season,” says Erin Fox, a University of Utah pharmacist and leading health expert. drug shortages in the United States, he told CNBC.
Adderall is one of more than 300 drugs in short supply in the United States as of June, according to the existing From the American Association of Health System Pharmacists, which represents pharmacists in a variety of health care settings. This list also includes Adderall alternatives such as methylphenidateIt is commonly known under the brand names Ritalin or Concerta.
Adderall and alternative ADHD medications apart from other medications Table 2 controlled substances.
This means that the federal government regulates how these drugs are made, prescribed and dispensed because they are considered to have a high potential for abuse and can lead to severe psychological or physical dependence. The designation also means that patients need to get new prescriptions for these drugs every one to three months.
Millions of Americans in the United States use these drugs to help them focus, control their impulses, and manage their homework, jobs, or relationships with others. ADHD is usually diagnosed in childhood and often continues into adulthood.
appreciate 6 million children Diagnosed with ADHD, 60% were treated with medication as of 2016, according to the Centers for Disease Control and Prevention. Meanwhile, around 8 million adults They are diagnosed with the condition, but only about a quarter of them receive treatment.
Back-to-school supplies strained
Many children and young adults with ADHD often take medication in the summer and are primarily dependent on it during the school year. This could lead to more demand in the coming months that may not be met.
Historically, prescriptions for ADHD medications have increased with the start of the semester across the United States — and “there’s no indication this year will be any different,” according to David Margraff, a pharmaceutical research scientist at the University of Minnesota’s Center for Infectious Disease Research and Policy. . .
Some drugmakers have said they expect to restock a few ADHD products in August or September, according to the FDA. Database on the deficiency. But Margraff said “we need to be cautiously optimistic” because drugmakers don’t disclose exact numbers for how much stock they have on hand by then.
Adderall XR 30mg tablets from Shire Plc.
JB Reed | bloomberg | Getty Images
This reflects a larger problem of persistent shortages. It is almost impossible to know when it will end – or what exactly can be done to resolve it – due to the lack of transparency in the pharmaceutical industry.
“There is very little information out there,” says Ozlem Ergun, a professor of mechanical and industrial engineering at Northeastern University and an expert on pharmaceutical supply chains. “I think this is one of the biggest issues.” “When you don’t have transparency or information sharing, how do you understand and solve a complex problem?”
Ergun added, “This is really hurting users, hospitals and the health care system. They don’t have any vision of what the future will be like.”
Teva Pharmaceuticals, Amnell Pharmaceutical Industries, Novartis Sandoz and Purdue Pharma’s Rhodes Pharmaceuticals, which all manufacture drugs for ADHD, do not need to publicly share information about where the drugs are manufactured, how much is produced, where the ingredients are sourced and their overall production capabilities.
And the Drug Enforcement Administration — the federal agency that regulates controlled substances — shares little information about the production quotas it sets for each manufacturer of Adderall and other ADHD medications.
The Drug Enforcement Administration specifically limits the amount of raw ingredients, such as amphetamine, that a drugmaker can obtain to manufacture those drugs.
“We don’t have how much quota each company is given. We also don’t have how much each company actually produces and whether they meet those quotas,” said Fox of the University of Utah. “There’s no way to understand which company might not be doing this job and what companies are doing the job, so we don’t know exactly what’s going on.”
Ending a shortage of Adderall and other ADHD medications is no easy task.
“It’s not as simple as a free market where you can just ramp up production and meet demand,” said Michael Janio, senior director of pharmacy practice for the American Association of Health System Pharmacists.
Many manufacturing plants are operating at or near full capacity and producing multiple pharmaceutical products. This means that increasing production of one drug may require decreasing production of another — and potentially affecting supply, according to Ergon.
“In general, it is difficult to increase the manufacturing capacity of the drug,” she said. “There’s not a lot of untapped potential anywhere.”
It’s also difficult to ramp up production of tightly controlled ADHD medications.
Drug makers can ask the DEA to increase their production quotas if needed, but it takes “a lot of pressure” for the agency to actually agree to that, according to Margraff.
And even if the DEA agreed to change the price, it could take months to do so: “It’s not just about hitting a switch and increasing your production by 20%,” said ASHP’s Janio.
Members of the Drug Enforcement Administration raided two homes side by side, in a supposed illegal marijuana operation, on January 31, 2019 in Commerce City, Colorado.
RJ Sangosti | Media News Group | Denver Post via Getty Images
Some drug makers have suggested that servings of DEA contribute to shortages of ADHD medications or make them more difficult to relieve. This includes Aytu BioPharma, which makes an ADHD drug that was previously in short supply.
And in an op-ed for CNBC in February, Aytu CEO Josh Disbrow said the DEA could cause widespread drug shortages if it reduces demand and fails to increase rations in a timely manner in response to new information.
However, the Drug Enforcement Administration and the Food and Drug Administration have pointed out a different problem with A common message Released earlier this month.
The agencies said an internal analysis found drugmakers failed by 30% to meet the full quota for amphetamine drugs in 2022, leaving about 1 billion potential drug doses on the table. They added that a “similar trend” was occurring this year.
The Drug Enforcement Administration and the US Food and Drug Administration said they called on manufacturers to confirm that they are increasing production to meet their quotas.
“There’s obviously a lot of recrimination going on here between the agencies and the manufacturers,” Fox said.
High demand for Adderall
Shortages of Adderall and generic versions of the drug Launched Last August, when the major manufacturers reported that their drugs were on order.
Manufacturers are required to notify the FDA of the shortage, but not the reason for the cutoff. However, the FDA noted “ongoing intermittent manufacturing delays” at Teva when it was first launched. announce Adderall deficiency.
Teva said earlier that the manufacturing slowdown was partly related to the crisis Labor shortage, which was quickly resolved. Teva did not immediately respond to CNBC’s request for comment on Adderall’s manufacturing status.
The increase in demand for Adderall and other ADHD medications also appears to have played a role.
US prescriptions for Adderall soared 41.4 million in 2021, up more than 10% from 2020, according to IQVIA, a health industry analytics company.
One of the possible factors that has led to the high demand, according to experts, is the increased use of Telehealth services During the covid public health emergency that may have allowed for more relaxed prescribing standards for ADHD medications.
As the epidemic created a perfect storm Distractions — such as the shift to remote work and a wave of anxiety, stress, and grief over the uncertainty of COVID — that may have worsened symptoms for some ADHD patients or convinced more people they had the condition, prompting them to seek treatment.
The increased demand for Adderall amid drug shortages is also likely to lead to a domino effect, as healthcare providers and patients are pushed to turn to alternative medications, leading to shortages of those as well.