The Rx Crisis: The Impact of Ongoing ADHD Medication Shortages

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Class is now in session, but young patients with attention-deficit/hyperactivity disorder (ADHD) might not be ready to face the classroom. Thousands—if not millions—of them may not have their medication.

The US Food and Drug Administration (FDA) originally announced a shortage of immediate- release formulation of amphetamine mixed salts (Adderall) on October 12, 2022.¹ According to the National Community Pharmacists Association, 97% of independent pharmacy owners reported shortages of Adderall in early 2023.² Other generic amphetamine mixed salts are predicted to be in shortage until the end of August 2023, September 2023, and December 2023 (Table).³ Additionally, some methylphenidate extended-release tablets were discontinued in January 2023, whereas others are in shortage due to an active ingredient issue.⁴ This may cause increased concern among young patients with ADHD and their families as the school year starts up, especially amid what is being called the “crisis of our time” in terms of children’s mental health.⁵

Table. Expected Shortages of Amphetamine Mixed Salts³

“We estimate that approximately half of our stimulant prescriptions need to be reissued to an alternative pharmacy due to shortages. The shortages appear to be multifactorial in origin and the solutions complex,” said Timothy Wilens, MD, chief of the Division of Child and Adolescent Psychiatry and codirector of the Center for Addiction Medicine at Massachusetts General Hospital. “Individuals with ADHD may have to go without their medications for periods of time, switch to an alternative preparation of the same class of medication, or change medication classes entirely. In some cases, families are paying out of pocket steep copays to secure branded medications, which is not only a huge cost burden but also exacerbates health care disparities.”

Overdiagnosis in the US

The real question becomes: Is this a shortage of medication or a sudden surplus of those who need the medication? Globally, ADHD affects 5% to 7.2% of youth; in the United States, recent estimates suggest the prevalence is even higher, at 8.7% of youth.^6-8 This translates to approximately 5.3 million children. Of that 5.3 million, 62% of them take medication.⁸ The COVID-19 pandemic may have increased those numbers, with 8% more individuals in the US filling a stimulant prescription in 2021 compared with 2020.⁹

“I think the problem is not so much that we have a shortage of medication, but instead an overdiagnosis of the condition. There is no way that ADHD, as reflected by prescriptions for psychostimulants, can be multiples in frequency to what they are in western Europe and in other parts of the world. The question is: How and why is this happening?” said Jeffrey A. Lieberman, MD, Lawrence C. Kolb Professor of Psychiatry at Columbia University Medical Center and past president of the American Psychiatric Association.

This does seem to be a problem that is unique to the US. The US has the highest consumption rates of amphetamines and clonidine, and is amongst the top 10 countries for consumption of methylphenidate, atomoxetine, and guanfacine (Figure).¹⁰ Furthermore, Adderall, which is one of the most commonly prescribed ADHD medications in the US, is banned in several European countries and Japan as an illegal narcotic.¹⁰

Figure. ADHD Medication Consumption¹⁰

It is also possible that being classified as Schedule II drugs, the limitations by the FDA and Drug Enforcement Administration (DEA) are adding to the current shortages, specifically when it comes to active ingredients that pharmaceutical companies use in producing stimulants. When pharmaceutical companies try to scale up, the DEA calculates how much of an ingredient is needed to meet the demand and doles out only this determined amount—using prescription data from previous years. This becomes a glaring issue when facing an unparalleled number of new prescriptions.¹¹ For example, on the FDA drug shortages site, there is this message under Adderall’s listing, despite the end of the drug’s official shortage: “Teva is manufacturing and distributing consistent with historic levels. We continue to see unprecedented demand.”³

“The shortages of stimulants (largely generics) have been a nightmare to children, families, and their practitioners,” said Wilens. “At a public health level, it is important for policy makers to understand their multifaceted nature and work together to help alleviate such severe, impactful shortages in the future.”

Caregiver Impact

The impact is not just for the patient, with ripple effects being felt by families. In addition to increased caregiver burden, there are concerns for classmates of children who are not receiving medication.

For instance, after her twin 7-year-old daughters with severe ADHD had to go without their medication, a mother reported they were “hitting teachers, throwing dirt, and destroying the classroom.” She added it caused “hell” in her family.¹²

Another mother in Brooklyn, New York, claimed to call more than 50 pharmacies trying to find ADHD medication for her 17-year-old son. She says she felt “like a drug addict” after she began to suspect pharmacists were looking down on her when she called every month.¹³

Other parents, after failing to find ADHD medication for their children, reported saving up doses for school days and limiting weekend doses.¹⁴

Psychiatric Times’ Editor in Chief, John J. Miller, MD, noted his patients have struggled to obtain their medication. “Some of my patients have to drive hours away to get their Adderall. One patient drove over an hour, but by the time he got to there, they had already run out. It is incredibly frustrating, both for our patients and us as clinicians,” he said.

“When children fail to get their prescribed medication for ADHD, their symptoms become more prominent and may become difficult for them and their parents or teachers to manage. There are psychological ramifications for the child because they will be experiencing difficulties with completing tasks they are used to doing, and they may become anxious or depressed as a result. I have seen several patients whose grades dropped in school and whose behavior worsened at home to the point where they were in crisis,” said Anthony L. Rostain, MD, MA, chair of the Department of Psychiatry and Behavioral Health Cooper University Health Care and professor of psychiatry and pediatrics at Cooper Medical School of Rowan University. “Clinicians should make sure the patient understands that these problems are manageable, and work with families to support the child or adolescent when they are experiencing complications from not having access to their usual medications. It is also important to find alternative medications so that the ADHD symptoms are better controlled as quickly as possible.”

Increased Need in College

Approximately 21 years ago, only 2% of college students were diagnosed with ADHD; now, the percentage is closer to 16% worldwide.¹⁵

“We did a study through the National Network of Depression Centers on use of prescription drugs in college. It is rising and has been for a number of years—ADHD medications in particular,” said Michelle B. Riba, MD, MS, deputy editor in chief emeritus of Psychiatric Times and clinical professor in the Department of Psychiatry at the University of Michigan in Ann Arbor.

Research also suggests that college students with ADHD had lower grade point averages,^16,17 a higher likelihood of academic probation,¹⁸ less confidence regarding their ability to academically succeed,^16,17,19 an increased tendency of procrastination,²⁰ and greater alcohol and drug use than their peers without ADHD.^17,21

“Most college counseling services are overwhelmed, and this is just going to add to it. I think a lot of college services are trying to change how they handle and triage students, which may cause some concern for students and families,” Riba said. “Finding out what is available and how to access it is very important for each student. Clinicians need to make themselves aware of how their patients can access care.”

What’s a Clinician to Do?

Once a proper diagnosis is confirmed, what should clinicians advise families as they prepare for the school season? Two experts shared their recommendations.

Timothy Wilens, MD: “[Remind] parents they can assist greatly in their child’s transition back to school. Guidance counselors are also excellent resources within school systems who can support the child, help with the transition back to class, and act as a liaison within the school.” Parents should:

• Reintroduce more structure indicative of school 1 to 2 weeks prior to the onset of school
• Reset the child’s sleep cycle (eg, waking them earlier)
• Restart their medication(s)
• Touch up on summer assignments
• Talk to their kids about their children’s concerns
• Visit the school prior to the first day back in class , especially if the school is new to the child

Anthony L. Rostain, MD, MA: “Work with patients and their families to avoid underdosing of medications. Furthermore, encourage them to find pharmacies that are supportive and willing to notify them when shipments of medications arrive.” Clinicians should:

• Review how medication(s) worked over the vacation and focus on how well patients were able to complete their summer reading assignments
• Define target symptoms for medication management
• Consider the question of whether to start school on the same dose as last year
• Review what goals your patient has for the coming school year. What are they doing to get ready to return? What do they hope to achieve in school and in extracurricular activities? What are they most worried about? What might help them address these worries?
• Work with parents to identify psychosocial intervention programs such as homework support/after-school, social skills, dialectical behavior therapy (for emotional dysregulation), and cognitive behavioral therapy
• Have parents consult the school about resources for their children, (eg, organizational skills class, 504 accommodations, or an individualized education plan)
• Have the patient and their parents discuss strategies for maximizing a smooth transition back to school

What challenges and recommendations do you have for youth heading back to school? Let us know at PTEditor@MMHGroup.com.

References

1. FDA announces shortage of Adderall. FDA. October 12, 2022. Accessed July 13, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-shortage-adderall

2. NCPA releases latest survey on drug shortages and staffing. News release. National Community Pharmacists Association. February 1, 2023. Accessed July 13, 2023. https://ncpa.org/newsroom/news-releases/2023/02/01/ncpa-releases-latest-survey-drug-shortages-and-staffing

3. FDA drug shortages. FDA. Updated July 5, 2023. Accessed July 13, 2023. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Amphetamine%20Aspartate;%20Amphetamine%20Sulfate;%20Dextroamphetamine%20Saccharate;%20Dextroamphetamine%20Sulfate%20Tablets&st=c

4. Methylphenidate extended release oral presentations. American Society of Health-System Pharmacists. July 11, 2023. Accessed July 13, 2023. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=896#:~:text=Patriot%20discontinued%20methylphenidate%20extended%2Drelease,to%20an%20active%20ingredient%20issue

5. Peetz C. Kids’ declining mental health is the ‘crisis of our time,’ surgeon general says. Education Week. April 25, 2023. Accessed July 13, 2023. https://www.edweek.org/leadership/kids-declining-mental-health-is-the-crisis-of-our-time-surgeon-general-says/2023/04

6. Thomas R, Sanders S, Doust J, et al. Prevalence of attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. Pediatrics. 2015;135(4):e994-1001.

7. Abdelnour E, Jansen MO, Gold JA. ADHD diagnostic trends: increased recognition or overdiagnosis? Mo Med. 2022;119(5):467-473.

8. Bozinovic K, McLamb F, O’Connell K, et al. U.S. national, regional, and state-specific socioeconomic factors correlate with child and adolescent ADHD diagnoses pre-COVID-19 pandemic. Sci Rep. 2021;11(1):22008.

9. Ducharme J. What’s driving the demand for ADHD drugs like Adderall. TIME. April 12, 2023. July 13, 2023. https://time.com/6271049/adhd-diagnoses-rising/

10. Chan AYL, Ma TT, Lau WCY, et al. Attention-deficit/hyperactivity disorder medication consumption in 64 countries and regions from 2015 to 2019: a longitudinal study. EClinicalMedicine. 2023;58:101780.

11. Hopkins C. The ADHD medication shortage is getting worse. What went wrong? NBC News. February 6, 2023. Accessed July 13, 2023. https://www.nbcnews.com/health/health-news/adderall-shortage-adhd-drugs-affected-will-end-rcna66766

12. Chapman B. Students struggle academically, fight in schools amid Adderall shortage. Wall Street Journal. March 24, 2023. Accessed July 13, 2023. https://www.wsj.com/articles/students-struggle-academically-fight-in-schools-amid-adderall-shortage-209d01e0

13. Diaz A. My teen son needs Adderall, but all the pharmacies are out: it’s really scary. New York Post. April 13, 2023. Accessed July 13, 2023. https://nypost.com/2023/04/13/adderall-shortage-impacting-both-parents-and-adhd-children/

14. Spinner J. Amid ADHD med shortage, parents fear sending unmedicated kids to school. Washington Post. April 17, 2023. Accessed July 13, 2023. https://www.washingtonpost.com/parenting/2023/04/17/adhd-shortage-children-school/

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16. Heiligenstein E, Guenther G, Levy A, et al. Psychological and academic functioning in college students with attention deficit hyperactivity disorder. J Am Coll Health. 1999;47(4):181-185.

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18. Conners CK. Conners’ continuous performance test. Multi-Health Systems; 1995.

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21. Baker L, Prevatt F, Proctor B. Drug and alcohol use in college students with and without ADHD. J Atten Disord. 2012;16(3):255-263.