Have your patients been having difficulty getting their ADHD meds from the pharmacy in the past few years? Has it been difficult to tell patients you are uncertain when their meds will arrive?

As healthcare clinicians, we are all far too familiar with the ADHD medication shortage that our patients have been affected by for the last few years. The frustrations are shared across the board.

I wanted to explain this issue, some of the reasons why it is occurring, and what you can do to help your patients in the meantime.

 

The Role of the DEA and Aggregate Production Quotas (APQs)

To begin our discussion, it is imperative to understand the role of the DEA and the Aggregate Production Quota.

In collaboration with the Food and Drug Administration (FDA), the Drug Enforcement Agency (DEA) sets an annual production limit called the Aggregate Production Quota (APQ) for all Schedule I and II substances. The APQ indicates how much of a particular active ingredient can be produced within a calendar year. The DEA determines the APQ for a particular ingredient by gathering data from numerous sources to predict the expected demand for the products that utilize said ingredient and to ensure there is not much excess product available for misuse.  Once the APQ for an ingredient is determined, the DEA allocates portions of this quota to individual manufacturers based on their market share and production capabilities. This allocation limits the amount of the ingredient a single manufacturer can produce. These production caps are intended to prevent potential misuse and are rigid and inflexible to adapt to patient demands. The DEA establishes annual production caps for each pharmaceutical company based on predictions made nearly 2 years in advance.¹

Unfortunately, the APQ and its allocations do not always reflect market demands. Certain manufacturers who can produce well beyond their allocation are capped once they meet their limit. In contrast, others cannot produce enough to meet their allocation, or there simply may not be a demand for that specific product due to cost, dosage form, etc. —and the other manufacturers cannot make up for it. This discrepancy between allocated APQ and actual demand may lead to a surplus of branded medications available for patients but not enough of the more cost-friendly generic options, leading to drug shortages of those products with higher demand.  As a result, patients cannot receive their prescriptions from pharmacies due to inventory issues.

This trend has been observed among several stimulant agents since 2022, when a shortage of the immediate-release formulation of amphetamine mixed salts, which includes the brand-name Adderall^®, was first identified.^2,3 These shortages prevent patients from accessing their prescribed medications, forcing them to go without treatment or undergo unnecessary and stressful medication changes. At this point, many patients and providers have felt the impact of this shortage first-hand for nearly three years. However, there is now some hope for change in the near future.

How is the APQ for controlled substances determined?

The FDA determines an APQ for a particular ingredient using several factors and measures to estimate demand.⁴

1. Assessment of medical need: The DEA evaluates the medical need for the controlled substance based on prescription data and trends in usage. This assessment takes into account the prevalence of conditions for which a controlled substance is prescribed, in this case – the prevalence of ADHD for stimulant agents.
2. Estimating demand: The DEA gathers information on current and projected demand for the substance, which includes historical data on prescribing patterns, potential misuse rates, and factors that may impact consumption.
3. Review of manufacturing capacity: The DEA considers pharmaceutical companies’ manufacturing capabilities and their ability to produce the controlled substance in sufficient quantities to meet the assessed demand.

 

Based on all of this information, the DEA sets an annual aggregate production quota that dictates how much of the controlled substance manufacturers can produce for that year. The quota is then monitored, and adjustments may be made in subsequent years based on changes in medical needs or patterns of abuse.

By following this process, the DEA aims to balance the legitimate medical needs for stimulant medications while attempting to minimize the potential for misuse and diversion.

Increased Demand for Stimulants

Stimulant prescriptions within the United States have been increasing each year since 2012. From 2012 to 2022, overall dispensing of stimulants in the U.S. increased by 57.9%.^5,6 This increase in prescribing has contributed to the APQ not being high enough to meet the demands of the patient population, as the APQs are determined years in advance. Unforeseen circumstances have also contributed to the increased prevalence of stimulant use, including the rise of telehealth services⁵ expanding access to clinicians for patients who might not have otherwise seen a clinician and the COVID-19 pandemic which led to a surge in prescription stimulant medications dispensed for ADHD amongst young adults and women.⁷

Impact in WV

As a Clinical Educator, I have seen firsthand the impact of this shortage in West Virginia and have spoken with clinicians and pharmacists about how it has affected their patients. Every single pharmacy I have stepped into to discuss safer stimulant use has told me that they have felt the impact of the shortage and that many of their patients were affected. Patients were made to go weeks without receiving their medications and were subject to changes in their treatment plan despite having found the right agents and dosing that worked best to control their symptoms. In addition to these difficulties, many of the available alternatives were often more expensive than their original regimen – adding an extra layer of financial burden to patients already struggling with the fact they had to switch medications for reasons that have nothing to do with their condition.

Changes for the Upcoming year:

As a result of public outreach and re-evaluation of demand, the DEA has adjusted the APQ for both lisdexamfetamine dimesylate, the active ingredient in Vyvanse^®, and dextroamphetamine, which is used for conversion into lisdexamfetamine.

To account for domestic and foreign market demands, the DEA has approved a 23.5%⁸ adjustment increase in the quota for lisdexamfetamine dimesylate – bringing its APQ to 32,736,000 grams from its original 26,500,000. A 15.6% increase was granted for dextroamphetamine (for conversion) – bringing its APQ to 23,688,235 grams from its original 20,000,000 grams.⁸

This quantity is to be divided and allocated to manufacturers based on their market share and production capabilities. Manufacturers are able to submit for adjustment of their allocation to be reviewed on a semi-annual basis. This comes as a change from the previous quarterly review system, which exacerbated manufacturing difficulties for pharmaceutical manufacturers. The quarterly review system made it more difficult for drug manufacturers to predict the next quarter’s manufacturing plan, and removed the flexibility offered by annual allocation. In addition to this, manufacturers were given little notice of their allocation before the next quarter begins. For example, manufacturers were alerted on December 29, 2023, of their 2024 Quarter One APQ, which began on January 1, 2024. Recognizing these issues, the DEA has again altered the process for quota allocation, shifting it from quarterly to semi-annually. Representatives of the Committee on Oversight and Accountability assess the change to represent a welcome shift, though it highlights the ongoing uncertainty for manufacturers which is likely to extend shortage concerns.⁹

With these changes put in place, increased availability of medications that utilize these active ingredients is hoped to be observed for our patients.

How Can You Help?

In the instance that a patient is unable to receive their ADHD medication due to limited inventory as a result of these shortages, there are a few things one can do as a clinician to help.

Suppose a medication switch to an available agent needs to be done. In that case, the stimulant conversion aid in the WV ACC Guidelines can be utilized to identify a comparable dose to the one the patient had previously received. Several resources can also be utilized to identify any potential side effects or nuances in care that were not present with their original treatment option, such as the ADHD medication resource and the ADHD medication side effect and monitoring/management aid. The FDA also keeps a list of medications currently identified to be in a state of shortage and has information regarding when the availability of certain NDCs is estimated to return.

Our duty as clinicians is to do everything we can to ensure our patients get the most appropriate treatment, regardless of any external struggles. We hope that with these resources and the increase in APQ for these active ingredients, you and your patients do not feel the impact of the shortage as strongly as you have these last few years.

 

References:

1. Grossi G. US ADHD Stimulant Shortage Highlights Growing Challenges in Adult Treatment. AJMC. November 27, 2024. https://www.ajmc.com/view/us-adhd-stimulant-shortage-highlights-growing-challenges-in-adult-treatment
2. U.S. Food & Drug Administration. FDA Announces Shortage of Adderall. FDA. Published online October 12, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-shortage-adderall
3. Dodson, W., M.D., & LF-APA. (2024, April 26). The DEA’s manufactured crisis. ADDitude. https://www.additudemag.com/adderall-shortage-dea-stimulants-adhd-medication/
4. 21 CFR 1303.13 — Adjustments of aggregate production quotas. Ecfr.gov. Published 2015. Accessed February 13, 2025. https://www.ecfr.gov/current/title-21/chapter-II/part-1303/subject-group-ECFR2b8c25396f0c33e/section-1303.13#p-1303.13(b)
5. Hilas O. Rising Trends in Stimulant Prescriptions. Uspharmacist.com. Published January 15, 2025. Accessed February 6, 2025. https://www.uspharmacist.com/article/rising-trends-in-stimulant-prescriptions#:~:text=From%202012%20to%202022%2C%20there,to%200.9%20million%2C%20respectively).
6. IQVIA Government Solutions, Inc. Stimulant Prescription Trends in the United States.; 2012. https://www.deadiversion.usdoj.gov/drug_chem_info/stimulants/IQVIA_Report_on_Stimulant_Trends_from_2012-2022.pdf
7. Chai G, Xu J, Goyal S, et al. Trends in Incident Prescriptions for Behavioral Health Medications in the US, 2018-2022. JAMA Psychiatry. Published online 2018. https://doi.org/10.1001/jamapsychiatry.2023.5045
8. Drug Enforcement Administration. Adjustment to the Aggregate Production Quota for Lisdexamfetamine and d-Amphetamine (For conversion) for 2024. (2024, September 5). Federal Register. https://www.federalregister.gov/documents/2024/09/05/2024-20114/adjustment-to-the-aggregate-production-quota-for-lisdexamfetamine-and-d-amphetamine-for-conversion
9. James Comer and Lisa McClain to Anne Millgram, May 13, 2024, Correspondence from Chairman of the Committee on Oversight and Accountability (Kentucky)/Chairwoman of the Subcommittee on Health Care and Financial Services and Administrator of the Drug Enforcement Administration, Letter-to-DEA-drug-shortages.pdf

 

Other Resources Used:

1.  ‌Mole B. ADHD med shortages push DEA to up drug allotment by 23.5%. Ars Technica. Published September 6, 2024. ADHD med shortages push DEA to up drug allotment by 23.5% – Ars Technica
2. Kritz F. The Adderall Shortage: What to Do if You Can’t Get Your Meds. EverydayHealth.com. Published June 23, 2023. https://www.everydayhealth.com/adhd/the-adderall-shortage-why-its-still-happening-and-what-to-do/
3. Tin A. Why is there an ADHD medication shortage in 2024? What’s making generics of Vyvanse, Adderall and more so scarce – CBS News. https://www.cbsnews.com/news/adhd-medication-shortage-cause/
4. Danielson ML, Bohm MK, Newsome K, et al. Trends in Stimulant Prescription Fills Among Commercially Insured Children and Adults — United States, 2016–2021. MMWR Morbidity and Mortality Weekly Report. 2023;72(13):327-332. doi: https://www.cdc.gov/mmwr/volumes/72/wr/mm7213a1.htm
5. Wachsman MW. Vyvanse Shortage Update: DEA OKs Expanded Production of the ADHD Medication. ADDitude. Published September 12, 2024. https://www.additudemag.com/vyvanse-shortage-lisdexamfetamine-dimesylate-adhd-medication/
6. Billing Code 4410-09-P DEPARTMENT of JUSTICE Drug Enforcement Administration Adjustment to the Aggregate Production Quota for Lisdexamfetamine and D- Amphetamine (for Conversion) for 2024. Accessed February 6, 2025. https://public-inspection.federalregister.gov/2024-20114.pdf

 

Letters referenced:
1. Anne Milgram to Americans, November 1, 2023, Correspondence from the Office of the Administrator of the U.S. Department of Justice and the Drug Enforcement Administration, Quota-Shortages Letter.pdf