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Adderall XR 30mg Tablets by Shire Plc.
JB Reed | Bloomberg | Getty Images
Josh Disbrow is the President and Chief Executive Officer of Aytu BioPharma, which makes a competing ADHD drug called Adzenys XR-ODT.
A nationwide Adderall shortage which makes many sufferers struggle to manage their attention deficit hyperactivity disorder, better known as ADHD. All things considered, it appears that supplies will probably remain low for several months.
The blame for this lack was aimed at the manufacturers, the rise of telemedicine, and the increase in Adderall prescriptions and abuse. But finger-pointing does little to help many who depend on constant access to ADHD medication. The right solutions are in place.
Given the rising prevalence of ADHD among patients of all ages, it’s time for policymakers to rethink how these essential medications—and the providers who prescribe and dispense them to patients—are regulated. This is the only way to ensure that such shortages will not happen again.
ADHD diagnoses have increased dramatically in recent decades. Between 1999 and 2010, for example, the prevalence of diagnosed cases among adults increased nearly fivefold. Between 2010 and 2017, diagnoses in children increased by 31%.
As you might imagine, these trends have greatly increased the demand for stimulant medications used to treat ADHD, including Adderall. Among adults aged 22 to 44, prescriptions for Adderall increased by 7.4% between 2019 and 2020. The following year, prescriptions in this age group jumped by more than 15%.
There’s no denying that soaring demand for Adderall, along with production delays at Teva, one of the drug’s largest manufacturers, is partly responsible for the current shortage. But the supply chains for Adderall wouldn’t be nearly as fragile if it weren’t for some federal regulations governing the drug.
Consider the role of the Drug Enforcement Administration in managing the general availability of ADHD medications. Because Adderall is designated as a Schedule II controlled substance, the DEA imposes aggregate production quotas that limit how much manufacturers can produce each year.
To set such quotas, the DEA must estimate how much Adderall American patients will need next year. If the agency initially underestimated demand and failed to increase its quota in time in response to new information, the result could be a general shortage. In 2011, for example, pharmaceutical company Shire pointed to the DEA’s slow process for approving quota increases as the root cause of that year’s shortage of Adderall XR, a related ADHD drug.
However, even today, with Adderall still in short supply across the country, the DEA shows no signs of increasing its production quota anytime soon.
That’s not the only way that cumbersome bureaucracy makes it difficult for ADHD patients to stay on top of their medications. Food and Drug Administration regulations regarding drug substitutability are another culprit.
In the event that the pharmacy runs out of a drug such as Adderall, the pharmacist should ideally be able to substitute a comparable drug. But under current FDA regulations, only drugs with so-called A or B equivalence codes can be exchanged in this way.
For drugs that do not meet this strict standard, pharmacists must contact the prescribing physician, obtain a new prescription, and cancel the previous one before issuing a replacement.
This type of procedure is necessary to limit which drugs a pharmacist can dispense without first consulting a doctor. But it can create significant barriers for patients seeking timely refills. In some cases, the replacement process with a drug like Adderall can drag on for days, forcing patients to go without — sometimes even developing painful and distressing withdrawal symptoms.
FDA should explore ways to safely provide more substitution flexibility for pharmacists under the current framework, especially during times of shortage. The agency can also strengthen the general education of pharmacists and doctors about which comparable drugs can be substituted.
Updating federal regulations could help prevent the worst consequences of prolonged drug shortages. It was long overdue.
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