It’s been five months since the U.S. Food and Drug Administration (FDA) announced a shortage of Adderall, a prescription medication millions of Americans use to treat and control attention-deficit/hyperactivity disorder, a neurodevelopmental disorder typically diagnosed in childhood. There’s no end to the shortage in sight, and that’s a big problem for the millions of Americans who depend on the medication and its generics to help them manage their ADHD. This problem is at least partly exacerbated by the fact that while the shortage is being discussed at length, the solution— bioequivalent drugs— so far, isn’t being discussed at all, leaving patients and doctors without important knowledge.
Bioequivalence means that two different drugs, typically made by different manufacturers, have the same active ingredients, similar absorption rates, and the same intended patient outcomes. Dr. Ann Childress, the president of the Center for Psychiatry and Behavioral Medicine, Inc. in Las Vegas, Nevada, and a board-certified psychiatrist with a subspecialty in child and adolescent psychiatry, believes that bioequivalent drugs are the answer to the Adderall shortage. “Bioequivalent drugs to Adderall and Adderall XR have the same ratio of d- and l-amphetamine as Adderall and Adderall XR,” she said, adding that to be considered bioequivalent, stimulants must meet strict FDA standards.
“For most medications to be bioequivalent, the formulation must have blood levels between 80 percent and 125 percent during a time period, say 24 hours after dosing, of the reference or branded product,” she said. “For Adderall XR, drugs such as Adzenys XR and Dyanavel XR must also meet bioequivalence standards during shorter periods of time to ensure that onset and duration of effect are equivalent.”
Generic drugs for Adderall and Adderall XR are considered bioequivalent and are also more readily covered by insurance companies. The problem is that generics are also experiencing a shortage, putting even patients in a difficult position. According to Childress, branded bioequivalent drugs are currently available and can serve either as a bridge or a permanent solution.
“Many branded products, such as Adzenys XR and Dyanavel XR are available, and some companies have co-pay coupons to help reduce the cost of these branded medications,” she said. Childress added that the differences between branded products also give patients more options for managing their ADHD, and this may be a good opportunity to learn and explore those differences. “Patients may switch back to their original medication but may also prefer the new branded medication. I have some patients that prefer Adzenys XR because of the way it is formulated with millions of microparticles that are continuously released. In contrast, Adderall XR capsules are composed of a few hundred beads, half released immediately, and half released about four hours after dosing. And I encourage patients to discuss their medication options with their provider.”
And that’s a discussion that millions of Americans can’t continue to put off while waiting for medication to become once again widely available to patients. The Adderall shortage, which was first reported by the U.S. Food and Drug Administration on October 12, 2022, has left millions of patients and doctors wondering what to do now, what to do next, and what to do for the long term. The shortage will only be solved when supply can once again meet the demands of the patient population.
According to health research firm IQVIA, more than 41.4 million Adderall prescriptions were dispensed in the U.S. in 2021 to treat ADHD. And despite the critical medication shortage, the need keeps growing, particularly in children. The Centers for Disease Control and Prevention (CDC) report that ADHD impacts more than 10 percent of children— that’s 2.4 million— between the ages of six and 11, and more than 13 percent of adolescents— or, 3.3 million— between the ages of 12 and 17.
ADHD is known to cause a wide variety of developmental issues in children, including low self-esteem, limited attention span, hyperactivity, and difficulty in forming and maintaining meaningful relationships. Whether diagnosed or not, these issues can persist into adulthood, requiring a combination of medication and therapy to manage the condition and its symptoms over time. Because unmanaged ADHD can cause academic and behavioral issues in children and adolescents, any shortage in the supply of medications can significantly impact schoolwork and relationships with friends and family.
A board-certified psychiatrist with a subspecialty in child and adolescent psychiatry, Dr. Childress has witnessed the negative impacts of both ADHD and the Adderall shortage first-hand. “ADHD symptoms return when the medication wears off. A child who was disruptive and unable to focus without medication will have those symptoms return without medications,” said Dr. Childress. “These behaviors may cause significant problems socially, academically, and with family very quickly after medication discontinuation.”
As far as what the future holds and whether patients should expect more shortages and to switch between bioequivalent drugs continuously, Childress said that we can’t worry about hypotheticals. “Our patients need help now.”