‘Not my problem’: Regulators and drug makers deflect blame in ADHD medication shortage

Published 3/8/2023 5:43 a.m. EST

Persistent stigma and misunderstanding of ADHD may be contributing to the medication shortage.

It was mid-November when Hannah Schmitz found out her pharmacy couldn’t fill her Adderall prescription, which she’s been taking for 13 years for ADHD. The 39-year-old South Baltimore resident had heard about a shortage of stimulant medications from her psychiatrist, and assumed that was the reason.

But after calling other pharmacies and getting nowhere, Schmitz called the Harris Teeter pharmacy at McHenry Row and asked them to explain. Staff said they had hit their “quota” of Adderall patients, based on what they are legally allowed to dispense. Schmitz’s prescription was transferred there when her usual Walgreens pharmacy closed, and Harris Teeter was prioritizing existing customers.

Schmitz was stuck. Other small pharmacies had also filled their quotas, and large chains like CVS and Walgreens would not give her information on their stock by phone, citing restrictions for controlled substances. None of the pharmacies had waitlists or agreed to notify her if a slot opened.

Moreover, the attitude Schmitz encountered was cold and dismissive: “Every pharmacy seemed to take on a ‘not my problem’ attitude and oftentimes they made me feel like an addict, trying to score controlled substances,” Schmitz said.

“Not my problem” has come to characterize the stimulant medication shortage, which has only worsened in recent months, driven by a cocktail of regulatory hurdles, a surge in diagnoses and a seeming lack of political urgency to fix the problem. Regulators and pharmaceutical companies have blamed one another, leaving patients like Schmitz on their own.

Schmitz was finally able to find a different Harris Teeter pharmacy located a half hour away that agreed to take her on as a patient, but went without medication for about five weeks.

Schmitz wonders how someone without access to transportation would get their medication from a far-away pharmacy. Though she does not own a vehicle, Schmitz does have “a flexible job, sufficient income, and a husband with a car who was able to pick [the medication] up for me,” she said. “How are people in this city with less resources supposed to manage when nearby pharmacies can’t supply the prescriptions they need?”

Silence and inaction

Attention deficit hyperactivity disorder, or ADHD, originates in the prefrontal cortex or “control center” of the brain, which governs executive functions — including maintaining focus and motivation, the ability to plan and organize, managing distractions and impulses, and regulating behavior. Stimulant medications improve functioning of the prefrontal cortex by boosting levels of dopamine and norepinephrine, two neurotransmitters in short supply in the ADHD brain.

Though ADHD diagnoses have multiplied in recent years and public awareness about the disorder has improved, it still carries a stigma, said Dr. David Goodman, an assistant professor in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins School of Medicine who specializes in ADHD. This is due to a persistent misperception that the disorder is not real or that symptoms can be overcome with individual effort, he said.

It’s similar to misperceptions that plagued clinical depression in the 1980s, when many people thought it was “normal variation” in mood, and “if you just pulled yourself up by your bootstraps, you’d feel a lot better,” he said.

But the inattention, distractibility, and forgetfulness characterizing ADHD are considered abnormal and impairing. “I often say yelling at an individual [with ADHD] to pay attention is like yelling at a blind person to avoid the furniture,” Goodman said.

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ADHD bias may contribute to the apparent lack of political will to resolve the stimulant medication shortage, said Goodman. Despite growing media coverage and public outcry, only Representative Abigail Spanberger (D-Va.) has publicly called for the shortage to be rectified, in two separate letters addressed to heads of the Drug Enforcement Administration and Food and Drug Administration.

“The ongoing shortage has made it incredibly difficult for ADHD patients to manage their daily lives, and I encourage your agencies to collaborate and do everything possible to alleviate this shortage as quickly as possible,” Spanberger wrote in the first letter.

Federal agencies have stayed silent on the issue.

An Adderall shortage was first announced by the FDA in October 2022, citing “intermittent manufacturing delays,” but has since spread to most stimulant medications used to treat ADHD and narcolepsy, a sleep disorder characterized by inability to stay awake during the day. Some manufacturers have said they petitioned the DEA for an increase in their allotted quota of ingredients needed to produce stimulants, but most have not weighed in.

In a statement, the DEA said “we are aware that the pharmaceutical industry is claiming that there is a quota shortage for the active ingredients in ADHD drugs. Based on DEA’s information — which is provided by ADHD drug manufacturers — this is not true.”

The agency did not respond to a follow-up email from The Banner asking to clarify the difference between “the pharmaceutical industry” and “ADHD drug manufacturers.”

In December, the DEA announced that it would not increase production quotas for the ingredients used in stimulant medications from 2022 levels, despite an increase in ADHD diagnoses.

One study of Kaiser Permanente members in California showed more than a twofold increase in prevalence of the disorder among adults aged 25 to 34 years between 2007 and 2016. In 2014, the percentage of prescriptions for ADHD medications for adults exceeded those of children for the first time, at 53%.

During the pandemic, many people, both adults and children, were driven to be evaluated when the scaffolding of work and school environments crumbled and problems with focus and motivation became both more noticeable and harder to remedy in an unstructured home environment.

Though it’s too early for definitive data, 26% of respondents to a survey fielded to readers of the ADHD-focused magazine ADDitude reported receiving a formal diagnosis during the pandemic. Data from research and analytics firm IQVIA shows a 27% jump in Adderall prescriptions in the U.S. between 2019 and 2022, from 35.5 million to 45 million.

Some ADHD evaluations may not have been properly conducted, leading to possible misdiagnosis of some cases during that time period. At the onset of the pandemic, Congress waived a 2008 law requiring an initial in-person evaluation before prescribing controlled substances via telehealth. This fueled a proliferation of online telehealth services focused on treating ADHD. Some of them are under investigation by the DEA for alleged aggressive marketing practices that may have led to over-prescribing of stimulants.

Some experts feel that fallout from the opioid epidemic underlies the lack of response from government agencies, as well as policymakers in resolving the shortage.

“I think the opioid crisis that got away from everybody has had an impact on people now being gun-shy to take up these issues,” Goodman said.

The DEA regulates stimulants as schedule II narcotics, the same category as opiates, which means they’re thought to have the same “high potential for abuse which may lead to severe psychological or physical dependence,” said Anne Schneider, an associate attorney with Fenton Law Group in Los Angeles who specializes in pharmaceutical regulatory issues.

But although stimulants can be abused and guardrails should be put in place, they may not have the same potential for profound dependency as opiates, she said. Stimulants also do not tend to provoke violent crime, such as armed robberies, at nearly the same scale as opioids, Schneider said.

One option would be to downgrade stimulants to schedule III, which contains drugs with risk for “moderate or low physical dependence, or high psychological dependence,” such as Tylenol with codeine or buprenorphine, Schneider said.

Psychiatrist Richard Silver said the DEA should work to determine how many of the prescriptions issued by online telehealth services “were legitimate ADHD patients who’ve been fully diagnosed and can document it,” versus “people who were just looking for stimulant meds.”

Schneider agrees. The DEA “needs to be in conversation” with drug manufacturers, health insurers and psychiatric experts to determine how to remedy the current access problem, she said.

“If there’s more demand, [the DEA] needs to rise to that,” Schneider said.

The bottom of a $400 pill bottle

Regulatory fixes, though, won’t alter the whims of the pharmaceutical market, which threaten to compound the shortage.

Eighteen-year-old Juliet Jones takes Concerta for ADHD, which has been “life-changing” for her, according to her mother, Deborah Jones, a Towson resident. It enabled her “to focus, get her stuff done in a more timely manner and just not have to work so hard,” Deborah said.

Juliet is now a freshman at DePaul University in Chicago and ran out of Concerta when she came home for winter break. Deborah called several pharmacies in the area, but was unable to find it anywhere. She was concerned about how her daughter would cope in school without her medication.

Deborah accompanied Juliet back to Chicago, and they were able to find brand-name Concerta at a pharmacy there. It cost $400 for a 30-day supply, compared to the usual $20-$30 copay for the generic. Insurance would not cover the brand-name medication.

Juliet has since been rationing her medication to make it last: “I basically have to schedule out my week and go, ‘OK, which are the days that I need my brain to be reliable?’” she said.

Concerta manufacturer Janssen discontinued the cheaper, authorized generic version in January through its subsidiary, Patriot Pharmaceuticals.

Although the FDA lists several generic versions of Concerta under its drug name methylphenidate XR, only the brand and its authorized generic form offer its unique, timed-release delivery system. Many people have complained that other generic versions do not work as well. Now, those for whom generic Concerta is ineffective will need to purchase the brand-name drug.

“Patriot’s decision to discontinue its authorized generic was made prior to the current supply shortage in the overall ADHD market, and was made considering many factors, including low overall demand for its product and the availability of generic formulations,” a company spokesperson said. Patients should speak with their prescriber about suitable alternatives, they said.

Juliet Jones will soon need to refill her medication. “It’s stressful when I can see the bottom of the pill bottle because it’s like, dang, how much time am I gonna have left?” she said.

“What if there’s a day that comes up where I need my brain the whole time?” Jones said.