The Adderall shortage and supply chain transparency
Diego Martinez
Dec 2, 2022
For 10 years, I have depended on Adderall to help me function. But in February, for the first time, the pharmacy down the street was unable to fill my prescription. In fact, 19 pharmacies in a row told me that they were out of stock. Thankfully, the 20th was able to fill it — though it meant a 50-minute drive.
The quest to find my daily medication left me struggling to function and feeling utterly helpless. My doctor confirmed I was not alone. Many of his Adderall-prescribed patients faced similar shortages, and I was fortunate to find any medication at all.
The demand for Adderall has surged, with U.S. prescriptions rocketing to 41.4 million in 2021 — a 10.4% increase from 2020, according to IQVIA, a life sciences industry analytics provider. According to the Food and Drug Administration, the spike in demand, coupled with “intermittent manufacturing delays,” have created a national shortage. In an August 2022 survey, almost two-thirds of respondents said they were having trouble securing their Adderall.
I’m not only a patient struggling to find my prescribed medication. I’m also a biopharmaceutical supply chain specialist. It’s increasingly clear to me that to prevent such a crisis from continuing and reoccurring, we must increase transparency in the supply chain of Adderall and, indeed, all medications. This will foster efficiency, reliability, and the ability to identify potential risks before they spiral out of control, as has happened now with not just Adderall but other ADHD medications.
The supply chain encompasses the entire drug manufacturing, distribution, and delivery process to the end user, involving multiple stakeholders such as drug manufacturers, distributors, wholesalers, pharmacies, and prescribers. Achieving transparency means providing access to accurate and timely information about each step in the supply chain, including raw material availability, production capacity, inventory levels, demand forecasts, prescription patterns, and patient needs.
Currently, the transparency in Adderall’s supply chain is woefully inadequate, as consumers are left at the mercy of drug companies when it comes to learning about the causes of shortages and their potential resolutions. The supply chain of Adderall involves several steps, from sourcing the active pharmaceutical ingredients to manufacturing the final product and distributing it to pharmacies. The active pharmaceutical ingredients for Adderall are primarily produced in China and India, subject to FDA regulatory oversight. However, the FDA lacks full visibility into these foreign suppliers’ production capacity and quality standards, posing risks to Adderall’s availability and safety.
This lack of transparency makes it challenging for patients, health care professionals, and policymakers to understand the root causes of the shortage and explore alternative solutions. While the FDA has posted information on its drug shortage website saying that ADHD medications supplies are limited because of “Unprecedented increase in demand” and “Shortage of active ingredient,” it does not explain in detail why manufacturers face delays or when they will be resolved. The FDA also lacks the authority to force drug companies to disclose their production plans or prevent them from discontinuing certain products.
Health care providers and pharmacies can optimize their inventory management processes with better visibility into the supply chain. This reduces the risk of stockpiling expired or soon-to-expire medications, which can result in waste, and ensures a more efficient allocation of resources. Moreover, it can help identify problems and risks before they become crises and facilitate faster, more effective responses when they do occur. For example, with transparency in the Adderall supply chain, we could monitor production status and quality standards, track inventory levels and expiration dates, predict demand, allocate and distribute the drug according to patient needs, communicate with patients and prescribers about availability and alternatives, and report any shortages or disruptions to the FDA and other authorities.
Collaboration and coordination among all stakeholders are essential for achieving transparency in the supply chain of Adderall and other medicines in general. Furthermore, we need regulation and oversight from government agencies responsible for ensuring drug safety and availability. Key steps include creating a national database for the ADHD medication supply chain, strengthening FDA oversight of foreign active pharmaceutical ingredients suppliers, and mandating regular reporting from drug manufacturers, distributors, wholesalers, pharmacies, and prescribers. By implementing strategic changes to existing policies and legislation, we can create a more transparent and secure system that benefits all stakeholders.
Firstly, it is crucial to amend the Food, Drug, and Cosmetic Act to establish a national database for ADHD and other medication supply chain information. By centralizing critical data, we can enhance communication and collaboration among stakeholders while ensuring privacy and data protection. Integrating data sharing and reporting requirements into the law fosters supply chain transparency and traceability, ultimately guaranteeing that patients receive essential medications.
Secondly, we must bolster the FDA’s authority to inspect and regulate foreign active pharmaceutical ingredients suppliers, particularly those producing ADHD and other medications. New legislation is required to increase inspection frequency, impose stringent quality control standards, and provide the FDA with the resources needed for effective inspections. These actions will strengthen confidence in the safety and quality of medications sourced internationally.
Lastly, it is imperative to mandate regular reporting from all stakeholders in ADHD and other medication supply chains. Enacting legislation that necessitates consistent reporting on supply, distribution, and prescribing patterns by drug manufacturers, distributors, wholesalers, pharmacies, and prescribers will allow for industrywide monitoring. Incorporating this data into the national database will facilitate better tracking of medication use and enable identifying and resolving potential issues, ultimately optimizing resource allocation.
As I write this, I am down to my last 10 pills. While my anxiety mounts, I’m scrambling to secure my next supply of essential medication. The pharmacy that is 50 minutes away from home has informed me that they do not have it in stock. Frustration and worry consume me as I embark on yet another exhaustive search.
Guadalupe Hayes-Mota is Healr Solutions’ CEO, an MIT lecturer, and a Center for Public Leadership fellow at Harvard University.