DEA and FDA regulations increase shortage of Adderall

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Adderall XR 30mg Tablets from Shire Plc.

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Josh Disbrow is the President and Chief Executive Officer of Aytu BioPharma, which Adzenys makes a competing drug called XR-ODT to treat ADHD.

The nationwide shortage of Adderall has left many patients struggling to manage their attention deficit hyperactivity disorder, better known as ADHD. By all indications, supplies are likely to remain low for several more months.

Blame for these shortfalls has been directed at manufacturers, the rise of telehealth medicine and the increase in prescriptions for Adderall abuse. But finger-pointing does little to help those who depend on constant access to ADHD drugs. Actual solutions are in order.

Given the increasing prevalence of ADHD among patients of all ages, it is time for policymakers to reconsider whether these essential drugs — and the providers who prescribe them and dispense them to patients — are regulated. Only then can we ensure that such lapses do not happen again.

ADHD diagnoses have been increasing significantly in recent decades. For example, between 1999 and 2010, the prevalence of diagnosed cases among adults increased nearly fivefold. Between 2010 and 2017, child diagnoses increased by 31%.

As one might imagine, these trends have greatly increased the demand for stimulant drugs used to treat ADHD, which includes Adderall. Among adults aged 22 to 44, in fact, 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 skyrocketing demand for Adderall, combined with manufacturing delays at Teva, one of the drug’s largest producers, are partially responsible for the current shortage. But the supply chain for Adderall wouldn’t be nearly so fragile if it weren’t for certain federal regulations governing the drug.

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

To set such quotas, the DEA must estimate how much Adderall US patients will need over the next year. Should the agency initially underestimate demand and fail to increase its quota in a timely manner in response to new information, the result could be a widespread shortage. For example, in 2011, the pharmaceutical firm Shire pointed to the DEA’s sluggish process to increase quotas as the underlying reason for that year’s shortage of the related ADHD drug Adderall XR.

Yet even today, as Adderall continues to be in short supply across the country, the DEA shows no signs of increasing its production quota anytime soon.

This isn’t the only way in which cumbersome red tape makes it difficult for ADHD patients to stay current on their medications. Food and Drug Administration regulations are another culprit when it comes to prescription drugs.

If a pharmacy runs out of a drug like Adderall, ideally a pharmacist should be free to substitute a comparable drug. But under current FDA rules, only drugs with so-called A or B equivalent codes can be changed in this way.

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

Such a process is necessary to limit which drugs a pharmacist can dispense without first consulting the patient’s physician. But this can create a significant barrier for patients seeking timely refills. In some cases, the replacement process for a drug like Adderall can stretch for days, forcing patients to go without – sometimes even developing painful and disruptive withdrawal symptoms.

The FDA should explore ways to safely provide greater substitution flexibility for pharmacists within the current framework, especially during times of shortage. The agency may also promote general education for pharmacists and doctors on how to substitute comparable drugs.

Updating federal regulations could help prevent the worst consequences of prolonged drug shortages. Been doing this for a long time.

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