- FDA News
by Skippack Pharmacy
Imagine the scene. You are a working single parent, tired from your 12-hour shift at the office and ready to head home for the day. As you start mentally checking off your errands, you suddenly recall that your son was almost out of his ADHD medication. While the pharmacy is on the way home, you know that you’ll need to call ahead to have the order ready on time. You’re pulling up the pharmacy’s number when you suddenly get a new notification that stops you in your tracks – “FDA ANNOUNCES ADDERALL SHORTAGE,” reports the New York Times.
This scene, in some shape or form, has happened to many of us. You might have faced a barrier in filling your necessary medication recently and have wondered what this means for you in the long run. Since October 2022, the US Food and Drug Administration has announced a shortage of amphetamine mixed salts, the active ingredient of many ADHD medications, including Adderall and Concerta. Months later, millions of pharmacies continue to face the Adderall shortage.
Patients with ADHD may have a lot more going on than just the occasional trouble paying attention. They can have either hyperactive-impulsive or inattentive symptoms which may cause clinically significant disruption in life. While the exact mechanism is unknown, ADHD is believed to occur due to an imbalance of neurochemicals. Adderall, Concerta, and other medications help restore the balance of these chemicals.
What is Adderall?
Adderall is a combination of amphetamine salts used for the treatment of Attention-Deficit-Hyperactivity Disorder (ADHD) and narcolepsy, or uncontrolled sleepiness. Amphetamines are stimulants – they work in the brain to increase the levels of neurochemicals like dopamine, norepinephrine, and serotonin. Specifically, amphetamines enter the tail end of the neuron (a brain cell) to cause a release of these chemicals. They also disrupt the chemical balance (the electrochemical gradient) needed to transport neurochemicals: this allows these neurochemicals to stay active in certain parts of the brain longer. By working on brain receptors, amphetamines can affect mood and alertness. For a child (or adult) with ADHD, these medicines can provide crucial mood balance to succeed in school, sports, or even at-home.
According to the CDC, from 2016-2019, 6 million children aged 3-17 were living with a diagnosis of ADHD. Additionally, about 3 in 4 US children with ADHD received treatment. With the pandemic’s push for virtual services over the past few years, a diagnosis of ADHD has become more accessible than ever.
Why is There a Shortage?
With the sharp rise in ADHD diagnoses during the pandemic, drug manufacturers have faced an unprecedented demand for Adderall, Concerta, and related products. The emergence of digital health platforms has created mass access to mental health prescribing. Data from healthcare analytics company, TrilliantHealth, shows a sharp rise in Adderall prescriptions in younger adults from 2018-2021, but a stabilization of patients with visits associated with ADHD, indicating that there may be an increase in the number of prescriptions of Adderall without a formal ADHD diagnosis. Online availability for direct-to-consumer cash telehealth services may play a role in this discrepancy. It is important to note that this data does not have the same validity as published literature – we are not able to see exactly where the data comes from (TrilliantHealth states this info comes from their national all-payer claims database). Nonetheless, the standard approach to ADHD treatment and the prescribing has changed over the pandemic.
The FDA claims that they are in frequent communication with all manufacturers of amphetamine mixed salts and provides a program to view all current and resolved drug shortages and discontinuations. Here, reasons for shortage include both an increase in demand and a shortage of the active ingredient. Many of these manufacturers claim that issues will be resolved by March and April of this year. Teva, one of the biggest generic manufacturers, continues to experience ongoing intermittent manufacturing delays. As a result, we may continue to see shortage issues, especially with this company, past April.
What can I do if My Medicine is in Shortage?
Initially, many people switched from the brand Adderall to a generic amphetamine mixed salt preparation or vice versa. With almost all products both brand and generic facing a shortage, this option isn’t as available. Some patients on immediate-release products have seen success in switching to extended-release products or vice versa; however, this will not work for everyone. Since these medications cause changes in your brain, it is important that they are carefully monitored by your provider. These medications can be associated with side effects that include irritability, weight changes, headaches, dizziness, and other impulsive behaviors. Additionally, the illicit drug meth is derived from amphetamines – as such, this class of medication is controlled by stringent legal regulations. This means that there are strict limits to filling and dispensing the medication, even when it is available.
After talking through your specific case, your doctor may decide to switch you to a different medication. This could be an alternative ADHD medication, such as Ritalin (methylphenidate – a non-amphetamine stimulant). They may even prescribe a non-stimulant ADHD medication, such as guanfacine or clonidine. If you do run out of medication and are not able to speak to your doctor, lifestyle remedies could be temporarily effective. This could include more caffeine, exercise, or sunlight – look for things that can increase stimulation.
Even if you see that a specific drug maker has an available supply on the FDA website, our ordering system may or may not work with this supplier. However, Skippack Pharmacy is keeping a constant eye on suppliers and their inventory to try to get the medication you need as promptly as we can. While we do not know exactly when this shortage will end; rest assured, we will strive to help our patients and community navigate this through. Here, you aren’t just a patient – you are family.
If you are searching for ADHD medication for yourself, your child, or a family member and would like us to inform you when we have additional stock of the different medications, please fill out the following link.
The information contained in this article is intended for educational and promotional purposes only. It is not intended as specific medical advice. Call us or visit us in person and speak with a pharmacist for specific medication queries and consult with your physician or provider for your specific medical condition or health goals.
Author: Philip Mathew, Community Pharmacy Practice Extern
Heather SchwartzMarch 13, 2023 at 8:13 pm
Thank you for this information – it is very helpful!
Jen MalecMarch 30, 2023 at 2:43 am
This is the best summary I have seen – i’m sending to my son in CA- thank you