A shortage of medication for sufferers of Attention Deficit/Hyperactivity Disorder (ADHD), many of them children, has persisted for much of 2023, making it sometimes difficult to find medications such as Adderall or Focalin — at least in generic form.
The shortage began in late 2022 and has been particularly frustrating, Dr. Michael Ganio, the senior director of pharmacy practice and quality for the American Society of Health-System Pharmacists, told PBS in July, because the stimulants commonly used to treat ADHD are a controlled substance — most are a type of amphetamine.
“These are really frustrating shortages because you can only get a 30-day supply at a time,” Ganio told PBS. “Patients need a new prescription every 30 days. You can’t get a 90-day supply. You can’t even pay cash for a longer supply if you want to.”
Added to the frustration is that many insurance companies — particularly Medicaid, KanCare in Kansas — often will not pay for the name brand version of the drug if a generic exists.
This has forced some patients to pay out of pocket for the name brand version, which can cost $50 or more.
Moreover, pharmacists may not be aware that Medicaid will pay for the name brand of the drugs, if the pharmacy is out of stock on the generic, instead telling patients they must pay cash for the medication.
Chairwoman of the Kansas Senate Committee on Public Health and Welfare Beverly Gossage learned about some of the difficulties facing ADHD patients when trying to find their medication and reached out to the Kansas Department of Health and Environment to determine if this was in fact the case. KDHE told Gossage that it will pay for the brand name medications.
“Medicaid will pay for the brand name drug if a generic option is out of stock,” Gossage was told. “The pharmacy filling the prescription would need to submit a prior authorization (PA) request form with ‘drug shortage’ indicated as the reason. All PA requests follow the same standard process. Documentation on the PA form is needed for tracking purposes.”
Additionally, patients at some Community Health Clinics — which often have their own pharmacies — may have been told their prescriptions could only be filled at the CHC-owned facility. Gossage was told this, also, was not the case.
KDHE told Gossage that in most cases where a prescription is filled is the patient’s choice. Just request that prescriptions be transferred to another pharmacy that has generic drugs in stock.
However, with controlled substances such as ADHD medications, the original prescription would need to be canceled and then sent to the new pharmacy.
Why is there a shortage of medications?
According to 2016 data from the Centers for Disease Control and Prevention, more than 6 million children have been diagnosed with ADHD and about 60% are being treated with medication; about 4.4% of adults have been diagnosed and about 4.1% treated.
But, as PBS reports, “Exact figures for how many people have ADHD is the subject of debate. Since 2015, more adults have been receiving pharmaceutical treatment for the disorder according to Shire PLC, the former maker of popular medication Vyvanse. That year, the company’s analysis found that 53% of the 63 million prescriptions written for ADHD medications were for adults.”
But while increased demand may be in part responsible for the shortages, it is not the only problem.
Relaxed regulations concerning in-person visits and the rise of telehealth during the pandemic contributed to a sharp rise in the number of prescriptions — and Adderall is not used just to treat ADHD, but other conditions such as narcolepsy as well.
Manufacturers are required to notify the FDA of any shortages, but are not required to report the cause.
And, according to NBC, nearly a year into the shortage both drugmakers and the federal government are pointing fingers at each other.
“The Drug Enforcement Administration, which sets limits on the types of amphetamines that pharmaceutical companies can use to make the pills, says companies have more than enough raw ingredients to produce stimulant ADHD medications,” NBC reported earlier this month. “Drugmakers contest the claim, saying they’ve run out of ingredients and need the DEA’s permission to acquire more.”
Meanwhile, experts say the shortage won’t end any time soon, lasting at least through the end of the year.
“Let’s just say I’m very concerned,” Dr. Max Witznitzer, a pediatric neurologist who treats children with ADHD at University Hospitals Rainbow Babies and Children’s Hospital and Case Western Reserve University told NBC news. “As the kids restart school, we’re going to see the demand for these prescriptions going up.”
The FDA and DEA in a joint letter argued that drugmakers are not manufacturing as many of the pills as they could be.
“According to the DEA and FDA’s letter, the DEA conducted an internal analysis revealing companies used only 70% of their allotted ingredient quota in 2022, which they say could have translated into 1 billion more doses,” NBC reported. “The numbers are trending similarly for 2023, according to the two agencies.
“They requested any leftover amphetamine to be returned to the DEA so it could redistribute it, although the agency can’t legally require the companies to hand it back.”
While some drugmakers may be sitting on unused amphetamines in hopes of increasing production, they also are not required to share if they have any leftover drugs and may not want to disclose the information in order to avoid being pressured to hand the amphetamines over to other companies.
According to NBC News, however, two of the larger ADHD drugmakers Teva Pharmaceuticals and Sandoz “responded that they’d used 100% of the DEA quota allotted to them in 2022 and requested quota increases accordingly.”