DEA and FDA guidelines exacerbate Adderall deficiency

30 mg tablets Adderall XR from Shire Plc.

JB Reed | Bloomberg | Getty Images

Josh Disbrow is Chairman and CEO of Aytu BioPharma, which makes a competing drug used to treat ADHD called Adzenys XR-ODT.

A nationwide shortage of Adderall has left many patients struggling to manage their Attention Deficit Hyperactivity Disorder, better known as ADHD. According to all indications, deliveries are likely to remain tight for a few more months.

Blame for these shortages has been placed on manufacturers, the rise of telemedicine, and an increase in Adderall prescriptions and abuse. But finger pointing is of little help to the many who depend on constant access to ADHD medication. Real solutions are announced.

With the increasing prevalence of ADHD in patients of all ages, it’s time for policymakers to reconsider how these essential drugs—and the providers who prescribe and administer them to patients—are regulated. This is the only way we can ensure that such bottlenecks do not occur again.

ADHD diagnoses have increased dramatically in recent decades. For example, between 1999 and 2010, the prevalence of diagnosed cases in adults almost quintupled. Between 2010 and 2017, diagnoses in children increased by 31%.

As you can imagine, these trends have greatly increased the demand for stimulants to treat ADHD, including Adderall. Among adults aged 22 to 44, Adderall prescriptions increased by 7.4% between 2019 and 2020. The following year, prescriptions in this age group increased by more than 15%.

There’s no denying that exploding demand for Adderall, coupled with manufacturing delays at Teva, one of the drug’s largest manufacturers, is partly to blame for the current shortage. But the supply chains for Adderall wouldn’t be nearly as fragile if it weren’t for some of the federal regulations on the drug.

Consider the role of the Drug Enforcement Administration in managing overall ADHD drug availability. Because Adderall is designated a Schedule II controlled substance, the DEA imposes aggregate production quotas that limit how much manufacturers can manufacture each year.

To set such quotas, the DEA must estimate how much Adderall American patients will need in the following year. If the agency initially underestimates the demand and does not increase its quota in good time due to new information, bottlenecks can occur across the board. In 2011, for example, pharmaceutical company Shire pointed to the DEA’s slow process of approving quota increases as the underlying cause of that year’s shortage of Adderall XR, a related ADHD drug.

But even today, with Adderall still in short supply across the country, the DEA shows no signs of increasing its production quota anytime soon.

This isn’t the only way that cumbersome bureaucracy makes it difficult for ADHD sufferers to keep track of their medications. The Food and Drug Administration’s regulations on drug substitutability are another culprit.

Ideally, in the event that a pharmacy runs out of a drug like Adderall, a pharmacist should be free to substitute a comparable drug. However, under current FDA regulations, only drugs with so-called A or B equivalence codes can be exchanged in this way.

For medicines that do not meet this strict standard, pharmacists must contact the prescribing doctor, obtain a new prescription and cancel the previous one before dispensing the substitute.

This type of process is necessary to limit what medications a pharmacist can dispense without first consulting a patient’s doctor. But it can create significant obstacles for patients who want timely refills. In some cases, the process of substituting a drug like Adderall can drag on for days, forcing patients to give up – sometimes even developing painful and annoying withdrawal symptoms.

The FDA should explore ways to provide pharmacists with more substitution flexibility within the current framework, particularly during times of shortage. The agency can also strengthen the general education of pharmacists and physicians to which they can exchange comparable medicines.

Updating federal regulations could help prevent the worst consequences of an ongoing drug shortage. It is high time to do so.

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