DEA and FDA rules exacerbate Adderall shortage

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

A nationwide shortage of Adderall has left many patients struggling to administer their attention deficit hyperactivity disorder, higher often called ADHD. From all indications, supplies are more likely to remain scarce for several more months.

The blame for these shortages has been directed at manufacturers, the rise of telehealth medicine, and a rise in prescriptions for and abuse of Adderall. But finger-pointing does little to assist the various who rely upon consistent access to ADHD medications. Real solutions are so as.

Given the growing prevalence of ADHD amongst patients of all ages, it is time for policymakers to rethink how these essential medicines — and the providers who prescribe and dispense them to patients — are regulated. Only then can we be certain that shortages like this one don’t occur again.

ADHD diagnoses have been increasing considerably in recent a long time. Between 1999 and 2010, for example, the prevalence of diagnosed cases amongst adults rose nearly fivefold. Between 2010 and 2017, diagnoses amongst children grew by 31%.

As one may think, these trends have vastly increased demand for the stimulant medications used to treat ADHD, including Adderall. Amongst adults aged 22 to 44, in actual fact, Adderall prescriptions increased by 7.4% between 2019 and 2020. The next yr, prescriptions on this age group leapt by greater than 15%.

There is not any denying that skyrocketing demand for Adderall combined with manufacturing delays at Teva, one in every of the drug’s biggest producers, are partly accountable for the present shortage. But supply chains for Adderall would not be nearly so fragile were it not for a number of the federal regulations governing the drug.

Consider the Drug Enforcement Administration’s role in managing the general availability of ADHD medicines. Because Adderall is designated a Schedule II controlled substance, the DEA imposes aggregate production quotas limiting how much manufacturers could make annually.

With the intention to set such quotas, the DEA must estimate how much Adderall American patients would require the next yr. Should the agency initially underestimate demand and fail to extend its quota in a timely manner in response to recent information, the result will be widespread shortages. In 2011, for example, the pharmaceutical firm Shire pointed to the DEA’s sluggish process for approving quota increases because the underlying reason behind that yr’s shortage of Adderall XR, a related ADHD medication.

Yet even today, as Adderall continues in brief supply across the country, the DEA shows no sign of accelerating its production quota anytime soon.

This is not the one way during which cumbersome red tape makes it difficult for ADHD patients to stay current on their medications. Food and Drug Administration regulations regarding the substitutability of medicine are one other wrongdoer.

Within the event a pharmacy runs out of a drugs like Adderall, ideally a pharmacist ought to be free to substitute a comparable medicine. But under current FDA regulations, only drugs with so-called A or B equivalence codes will be interchanged in this manner.

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

This kind of process is essential to limit which medicines a pharmacist can dispense without first consulting a patient’s physician. But it might probably create significant barriers for patients looking for a timely refill. In some cases, the technique of substituting for a drug like Adderall can drag on for days, forcing patients to go without — sometimes even to develop painful and disruptive withdrawal symptoms.

The FDA should explore ways to securely provide more substitution flexibility for pharmacists throughout the current framework, particularly in times of shortages. The agency may also bolster general education for pharmacists and doctors on which comparable medications they’ll swap.

Updating federal regulations could help prevent the worst consequences of prolonged drug shortages. It’s gone time to accomplish that.