Prescription Crisis The Adderall Shortage’s Impact on Neurodiversity
Carly Van Syckle, MPA
Introduction
Adderall is a brand name for amphetamines, which are amphetamine sulfate, mixed amphetamine salts, dextroamphetamine, and lisdexamfetamine (National Alliance on Mental Illness, n.d.). These are prescription medications used to treat individuals with attention-deficit hyperactivity disorder (ADHD). Attention-deficit hyperactivity disorder, or ADHD, is a neurodevelopmental disorder that is typically diagnosed in childhood and lasts into adulthood (Centers for Disease Control and Prevention, 2023). Individuals with ADHD may have trouble paying attention and controlling impulsive behaviors. Children with ADHD may also be overly active (Centers for Disease Control and Prevention, 2023). Individuals with ADHD are a part of the neurodiverse community — a community of those with diverse and varying cognitive functioning, which is not considered “typical” (Exceptional Individuals, n.d.).
The shortage of Adderall and other amphetamine mixed salts was originally announced in October of 2022, and by early 2023, 97% of independent pharmacy owners were reporting shortages (Kuntz, 2023). The shortage originally began due to a manufacturing delay of one drug maker (U.S. Food and Drug Administration, 2023). Many attribute the shortage to the ease of telehealth and diagnosis methods during the COVID-19 pandemic, causing an increase in demand. At the same time, the supply and manufacturing chain may have faced problems (Serino, 2023). As a result of shutdowns from the COVID-19 pandemic, the Drug Enforcement Administration (DEA) allowed healthcare providers to prescribe controlled medicine during telehealth appointments without having seen the patient in person first. Originally set to end in May 2023, the regulations are now set to end in November 2023, with patients who receive controlled medications from telehealth prescribers having until November 2024 to comply (Zionts, 2023). According to the CDC (2023), from 2020 to 2021, girls and women aged 15 to 44 and men aged 25 to 44 who received prescription stimulants increased by more than 10 percent. Additionally, 21 years ago, only 2 percent of college students were diagnosed with ADHD; however, that number has now risen to nearly 16 percent worldwide (Kuntz, 2023). It is expected that most amphetamine-mixed salts will be in shortage until December 2023 (Kuntz, 2023). With Adderall as the first line of treatment for individuals with ADHD, the Adderall shortage is having a significant negative impact on the neurodiversity community.
Impact on ADHD Patients
The medical understanding of ADHD has evolved significantly over the past century. In 1902, a British doctor named George Still observed children showing hyperactivity, impulsivity, and inattention symptoms and labeled it as a “defect of moral control” (Scott, 2023). Through medical advances in understanding the brain and human behavior, professionals began to understand that it wasn’t a disorder or human behavior but rather a result of how individuals’ brains worked. As attention-deficit hyperactivity disorder began to be considered a clinical disorder, the medical community began investigating potential treatments. Adderall was approved in 1996, and an extended-release version was approved a few years later (Scott, 2023). Today, several studies examine how an individual’s environment and genetics play a role in developing ADHD (Blum, K. et al., 2008).
Adderall can improve alertness and attention in people with ADHD by increasing the levels of dopamine and norepinephrine in the brain and increasing activity in the central nervous system (The Recovery Village, 2023). Adderall is a significant treatment method for patients with clinical ADHD. It can be particularly helpful for children with the disorder who may struggle to concentrate and perform well in school settings. Additionally, children with ADHD may find it difficult to regulate their emotions, impacting both their school and home life.
As a result of the shortage, parents have reported spending hours hunting down pharmacies with ADHD medication in stock, paying hundreds of dollars for name-brand drugs not covered by insurance, rationing the medication they do have, settling for similar, less effective medications, or going completely without medication (Caron, 2023). Parents reported that when children were forced to go off the medication completely due to the shortage of amphetamine-mixed salts, their performance in school plummeted due to the inability to focus or because their children would have to miss school completely (Caron, 2023).
In addition to being used as a treatment for ADHD, Adderall and other amphetamine-mixed salts are used to treat narcolepsy. Narcolepsy is a chronic sleep disorder that can cause sleep attacks, hallucinations, sleep paralysis, excessive daytime sleepiness, and disrupted nighttime sleep (Lillis, 2019). Stimulants, such as Adderall, boost levels of norepinephrine in the brain to promote wakefulness and alertness, so they are an effective line of treatment for narcolepsy (Lillis, 2019). Without these medications, individuals with narcolepsy say that their day-to-day functioning is disrupted. For some narcolepsy patients, it is dangerous for them to drive and perform daily tasks without their medications for fear they may suddenly fall asleep. One woman said, “If I sit down for any length of time, like to read a book or emails, I’ll pretty much fall asleep within five minutes or so” (Morrison, 2023).
Disproportionate Impact on Certain Communities
Some communities are impacted by the Adderall shortage more than others. Medication, even when not in a shortage, can be a cost burden to patients without insurance. According to GoodRx, the cost of thirty 20mg tablets, a typical prescription, can range from $215.28 to $333.00 without insurance at major pharmacies (Bianchini, 2023). The insurance cost depends on the provider and can be covered completely or partially with a co-pay. Additionally, with a shortage, people may resort to obtaining prescriptions from alternative, unverified channels, which have the potential to be counterfeit or altered.
The Role the Government and Policy can take on the shortage.
The Food and Drug Administration (FDA) is responsible for addressing drug shortages in the U.S. This is because, under the Controlled Substances Act, Adderall is a Schedule II controlled substance; as such, the Drug Enforcement Administration (DEA) also regulates the available supply of Adderall (Saco & Sheikh, 2023). The Food and Drug Administration Safety and Innovation Act of 2012 amended the Federal Food, Drug, and Cosmetic Act to require manufacturers of certain drugs to notify the FDA of certain supply disruptions and to require the FDA to publish lists of drug products in shortage (Saco & Sheikh, 2023). The FDA has several avenues to respond to drug shortages. The FDA may “choose to support the extension of expiration dates for products, expedite the approval of new production lines or raw source materials to support the increased manufacturing of a product or work with manufacturing firms to identify additional avenues for increased drug manufacturing” (Saco & Sheikh, 2023). The DEA sets annual aggregate production quotas and individual manufacturing quotes for schedule I and II drugs (Saco & Sheikh, 2023). In terms of Adderall, the DEA sets individual manufacturing quotas for amphetamine/dextroamphetamine, the active ingredient in Adderall (Saco & Sheikh, 2023).
On August 1, 2023, the FDA released an update on their actions to resolve the shortages of Adderall and other prescription stimulant medications. The update clearly states, “The FDA and DEA do not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug” (U.S. Food and Drug Administration, 2023). In the update, the FDA calls on manufacturers, distributors, pharmacies, and payors to “do all they can to ensure access for patients when a medication is appropriately prescribed” while also stating that it is important to ensure that the medication is being properly prescribed (U.S. Food and Drug Administration, 2023). In 2022, the DEA performed an internal analysis of inventory, manufacturing, and sales data of amphetamine products, including prescription stimulant medications, and found that manufacturers only sold 70 percent of their allotted quota for the year, leaving them with approximately 1 billion more doses that they could have produced. Analysis of 2023 data has shown a similar trend so far. As a result of the shortage and their analysis, the DEA and FDA have “called on manufacturers to confirm they are working to increase production to meet their allotted quota amount” (U.S. Food and Drug Administration, 2023). Additionally, because a set amount of quota allotments can be distributed, they have asked manufacturers to relinquish their remaining 2023 quota allotments if they do not wish to increase production. Relinquished allotments can then be redistributed to manufacturers who will increase production U.S. Food and Drug Administration, 2023). As previously mentioned, an increase in ADHD diagnoses likely contributed to the initial shortage as well. To ensure that healthcare providers continue to support the appropriate diagnosis of ADHD, the FDA awarded a grant to the National Academics of Sciences, Engineering, and Medicine (NASEM) to “support a scientific meeting on ADHD in adults and considerations for diagnosis and treatment” (U.S. Food and Drug Administration, 2023). According to the update, the FDA is also beginning to support alternative treatment options, including a game-based digital therapeutic and non-stimulant medication (U.S. Food and Drug Administration, 2023). While the FDA update outlines what is being taken to address the shortage, the responsibility falls on the private sector manufacturing the medication, meaning that they are limited in the actions they can take regarding production.
Conclusion
In conclusion, the Adderall shortage has a profound and detrimental impact on the neurodiversity community, particularly those with ADHD and narcolepsy who rely on this medication for their daily functioning and well-being. The shortage has led to significant disruptions in the lives of patients and their families and has disproportionately impacted underserved communities that may already struggle to afford essential medication. As the shortage persists with no end in sight, the Food and Drug Administration must take action to address this issue. The FDA must work to further incentivize manufacturers to meet their allotted quotas. Additionally, exploring the possibility of establishing publicly owned and operated manufacturers for generic pharmaceuticals could help alleviate shortages and provide a more stable supply of essential medications in the future. During this time of medical uncertainty, stakeholders must collectively advocate for policy changes that prioritize the well-being of the neurodiversity community to ensure that no one is left without the treatment they require to live a fulfilling life.
References
Bianchini, T. (2023, July 8). How much does Adderall cost without insurance in 2023? Mira. https://www.talktomira.com/post/how-much-does-adderall-cost-without-insurance-in-2021
Blum, K., Chen, A. L., Braverman, E. R., Comings, D. E., Chen, T. J., Arcuri, V., Blum, S. H., Downs, B. W., Waite, R. L., Notaro, A., Lubar, J., Williams, L., Prihoda, T. J., Palomo, T., & Oscar-Berman, M. (2008). Attention-deficit-hyperactivity disorder and reward deficiency syndrome. Neuropsychiatric disease and treatment, 4(5), 893–918. https://doi.org/10.2147/ndt.s2627
Caron, C. (2023, August 15). The collateral damage of A.D.H.D. drug shortages. The New York Times. https://www.nytimes.com/2023/08/15/well/mind/adhd-adderall-shortage-children.html
Centers for Disease Control and Prevention. (2023, September 27). What is ADHD? Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/adhd/facts.html
Danielson, M.L., Bohm, M.K., Newsome, K., et al. (2023, March 31). Trends in Stimulant Prescription Fills Among Commercially Insured Children and Adults — United States, 2016–2021. MMWR Morb Mortal Wkly Rep 2023; 72:327–332. https://www.cdc.gov/mmwr/volumes/72/wr/mm7213a1.htm?s_cid=mm7213a1_w
How Adderall helps ADHD & effects of Adderall usage without ADHD. The Recovery Village Drug and Alcohol Rehab. (2023, July 12). https://www.therecoveryvillage.com/adderall-addiction/adhd-and-adderall/#:~:text=Adderall%20affects%20ADHD%20by%20reducing,brains%20with%20low%20dopamine%20function
Kuntz, L. (n.d.). The RX crisis: The impact of ongoing ADHD medication shortages. Psychiatric Times. https://www.psychiatrictimes.com/view/the-rx-crisis-the-impact-of-ongoing-adhd
MediLexicon International. (n.d.). Adderall: Uses, side effects, and dosage. Medical News Today. https://www.medicalnewstoday.com/articles/325646
Morrison, S. (2023, February 10). The forgotten victims of the Adderall shortage. Vox. https://www.vox.com/recode/2023/2/10/23593261/adderall-concerta-ritalin-shortage-adhd-narcolepsy
National Alliance on Mental Illness. (n.d.). Amphetamine (Adderall). https://www.nami.org/About-Mental-Illness/Treatments/Mental-Health-Medications/Types-of-Medication/Amphetamine-(Adderall)
Sacco, L.N. Sheikh, H.Z. (2023). The Federal Role in Addressing the Adderall Drug Shortage. Congressional Research Service. https://crsreports.congress.gov/product/pdf/IN/IN12156
Scott, D. (2023, April 10). The ongoing, unnecessary Adderall shortage, explained. Vox. https://www.vox.com/policy/2023/4/10/23671128/adhd-medication-adderall-shortage-2023
Serino, K. (2023, July 18). A “perfect storm” led to an ADHD medication shortage. here’s why. PBS. https://www.pbs.org/newshour/health/a-perfect-storm-led-to-an-adhd-medication-shortage-heres-why
U.S. Food and Drug Administration. (2023). Joint DEA FDA Letter. https://www.fda.gov/media/170736/download?attachment
Zionts, A. (2023, June 27). The DEA Relaxed Online Prescribing Rules During Covid. Now It Wants to Rein Them In. KFF Health News. https://kffhealthnews.org/news/article/dea-online-prescribing-rules-telehealth-changes/
