A nationwide shortage of stimulant drugs used to treat attention deficit hyperactivity disorder (ADHD) may have less roots in prescribing practices or federal manufacturing quotas than in global supply chain disruptions. analysis Released late last week JAMA Health Forum.
The study, led by researchers at Yale University, looked at possible reasons for the U.S. stimulus shortage in 2022 and 2023, when many patients reported problems filling their prescriptions.
Public debate often focuses on increasing diagnoses, growing telehealth offerings, and Drug Enforcement Administration (DEA) production restrictions as reasons for the decline, but new findings suggest these explanations are flawed—and highlight just how vulnerable U.S. drug production is to global supply.
About a third of the engines for the United States are made in single facilities
ADHD is common among US adults, with an estimated 15.5 million (6% of adults) reporting the diagnosis in 2023. Nearly one-third of adults took stimulant medication that year, but access to the drug was a challenge: More than 70% reported difficulty filling their prescriptions during the shortage.
Although the analysis primarily looked at imports of amphetamine, it also looked at imports of two other stimulants, lisdexamfetamine and methylphenidate, as the United States experienced a shortage of these drugs in July 2023. Together, these three medications account for more than 90% of ADHD prescriptions.
More than 70% reported problems filling their prescriptions during the shortage.
“Accelerated by several medium and small producers in late 2022 and early 2023, the simultaneous production decline coincided with a significant contraction in US imports of crude amphetamines and a very small decline in phenytoin, a key [stimulant] Foreword, the authors write. This drop in imports points to “what appears to be a supply chain failure.”
Supply chain disruptions have occurred in the European Union, according to the analysis, and supply chain vulnerabilities likely stem from a degree of concentration among facilities producing amphetamines for the U.S. market. “One study found that 33.7% of generic APIs [active pharmaceutical ingredients] For the US market in 2020 and 2021 were produced by a single facility, and another 30.4% were produced by only 2 or 3 facilities,” they write.
The authors argue that additional studies should focus on manufacturing concentration as a source of supply chain disruption. “Future research should identify APIs supplied to the US market—whether they are produced domestically or abroad—produced by fewer than 4 or 5 facilities because these may represent the most vulnerable points in the pharmaceutical supply chain,” they write.
A drop in imports has led to demand not being met
The reasons for the decline are being debated. Some experts have attributed this to increased prescribing, especially during the COVID-19 pandemic, when telehealth expanded access to ADHD diagnosis and treatment. Others have pointed to the DEA’s quota system, which manufacturers of controlled substances can produce.
But the study suggests that these factors alone cannot explain the decline, noting that overall, drug producers have met only 70% of their production in 2022. “It is likely that the sudden decline in US imports of the active ingredient, and at the same time a slight decrease in its imports of precursors, has led to a significant reduction, at least in 2022, according to the DEA. Manufacturers to meet the demand,” they write.
Addressing the shortage of ADHD stimulants will require policies that go beyond prescribing practices or setting quotas, the authors say. Strengthening domestic production capacity and diversifying sources of APIs can help reduce the risk of future disruptions.
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