Ten milligram tablets of the hyperactivity drug, Adderall, made by Shire Plc.
Jb Reed | Bloomberg | Getty Images
It’s been 10 months since the Food and Drug Administration first announced a nationwide shortage of Adderall — one of the most widely used medications for attention deficit hyperactivity disorder — and the supply strain could potentially worsen in the months ahead.
While some supply issues have improved, many Americans are still struggling to find and fill prescriptions for the drug and other medications for ADHD that they often rely on to stay focused and complete daily tasks.
Drug-shortage experts told CNBC that it’s extremely difficult to forecast how much longer the shortages will last because of the lack of transparency in the pharmaceutical industry — and some are concerned about market conditions as children, who are commonly affected by ADHD, head back to school.
“Unfortunately, we might see the shortage worsen. We are heading into back-to-school time, so I am worried about it worsening as we go into that season,” Erin Fox, a pharmacist at the University of Utah and leading expert on U.S. drug shortages, told CNBC.
Adderall is one of more than 300 drugs in short supply in the U.S. as of June, according to a list from the American Society of Health-System Pharmacists, which represents pharmacists in a variety of health-care settings. This list includes Adderall substitutes like methylphenidate (also known as Ritalin and Concerta). Adderall, alternative ADHD medications and other drugs fall under Schedule 2 controlled substances. The federal government regulates the way these drugs are prescribed, manufactured and dispensed. They’ve been determined to be high-risk for abuse and to cause severe psychological and physical dependence. This designation means patients must get a new prescription for these drugs every three to six months. The drugs are used by millions of Americans to improve their concentration, manage their emotions, and better manage their work, schoolwork or relationships. According to the Centers for Disease Control and Prevention, 6 million children were diagnosed with ADHD in 2016, and 60% of them were receiving medication. Meanwhile, around 8 million adults have been diagnosed with the condition, but only about a quarter of that number are getting treatment for it.
Back-to-school supply strain
Many children and young adults with ADHD often take the summer off medication and primarily rely on it during the school year. This could result in an increase in demand for ADHD medications that cannot be met.
Historically, prescriptions for ADHD medications increase as the school semester starts around the U.S. — and “there is no indication this year will be different,” according to David Margraf, a pharmaceutical research scientist at the University of Minnesota’s Center for Infectious Disease Research and Policy. According to an FDA shortage database, some drugmakers expect to resupply ADHD products by August or September. Margraf, however, said that “we should be cautiously optimistic,” because drugmakers do not disclose the exact number of stock they will have by that time. Bloomberg The lack of transparency within the pharmaceutical industry makes it difficult to predict when shortages will end or what can be done about them. “Very little information is available. I think this is one of the biggest issues,” says Ozlem Ergun, a mechanical- and industrial-engineering professor at Northeastern University and an expert in pharmaceutical supply chains. How can you solve a complex problem without transparency and information sharing? This is a real, serious problem for the patients and hospitals as well as the healthcare system. “They have no idea what the future will look like,” Ergun said.
planned spinoff Sandoz and Purdue Pharma subsidiary Rhodes Pharmaceuticals, which all manufacture drugs targeting ADHD, don’t need to publicly share information about where they manufacture medications, how much of them they make, where ingredients are sourced and their overall production capacities.
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 DEA specifically limits the amount of raw ingredients, such as amphetamine, a drugmaker can get to manufacture those drugs.
“We don’t have the quota amount that each company is given. We don’t know how much each company produces and whether they are meeting their quotas. There’s no way of knowing which companies may not be doing their job, and which are. We don’t really know what’s happening.”
Ending the shortages of Adderall and other ADHD medications is no easy task.“It’s not as simple as a free market where you just boost up production and meet demand,” said Michael Ganio, the senior director of pharmacy practice at the American Society of Health-System Pharmacists. Many manufacturing plants are operating at capacity or close to it and produce multiple drugs. According to Ergun, increasing production of a drug may require reducing the production of another drug. This could have a negative impact on supply. She said that it was difficult to increase a drug’s manufacturing capacity in general. There isn’t a lot of unutilized production capacity. “It’s even harder to scale up the production of tightly controlled ADHD medications.Drugmakers can request for the DEA to increase their production quotas if necessary, but it takes “a lot of push” for the agency to actually approve that, according to Margraf. Even if the DEA approves a change in quote, it may take months before that happens: “It is not as simple as flipping a button and increasing your output by 20 percent,” ASHP’s Ganio explained. The Denver Post via Getty ImagesSome drugmakers have suggested that DEA quotas are contributing to the ADHD medication shortages or making it harder to alleviate them. Aytu, a company that makes an ADHD medication which was once in short supply, is one of those companies. Aytu CEO Josh Disbrow wrote in a CNBC op/ed that the DEA may cause drug shortages if they underestimate demand and fail to increase quotas “timeously in response to new data.” In a letter sent earlier this month, the DEA and FDA cited a different issue. The agencies stated that an internal analysis revealed that drugmakers would fall 30% short of the full quota in 2022 for amphetamine medication, leaving approximately 1 billion possible drug doses unfilled. The agencies said that a “similar pattern” is occurring this year. The DEA and FDA said they called on manufacturers to confirm they are working to increase production to meet their allotted quotas.
“There’s obviously a lot of finger-pointing going on here between the agencies and manufacturers,” Fox said.
Increased demand for Adderall
The shortages in Adderall, and generic versions began last August when major manufacturers announced that they were out of stock.
Manufacturers are required to notify the FDA of a shortage, but not the cause of the interruption. When Teva first announced its Adderall shortage, the FDA cited “ongoing intermittent production delays” by Teva.
Teva had previously stated that the manufacturing slowdown could be attributed to a temporary labor shortage. Teva didn’t immediately respond to CNBC’s request for comments about the status of Adderall production.
An increase in the demand for Adderall, and other ADHD medication seems to be a major factor. Experts believe that the increased use of telehealth services during the Covid public health emergency may have been a factor in driving up demand.
One possible factor sending demand up, according to experts, was the increased use of telehealth services during the Covid public health emergency that may have allowed for more relaxed prescribing standards for ADHD medications.
The pandemic also created a perfect storm of distractions — such as the shift to remote work and a thrum of anxiety, stress and grief over the uncertainty of Covid — that may have exacerbated some ADHD patients’ symptoms or convinced more people that they have the condition, prompting them to seek treatment. The shortage of Adderall likely led to a domino-effect, as health-care professionals and patients were forced to seek alternative medications. This, in turn, caused shortages for those drugs.