Adderall Shortage Persists as Opioid Settlement Triggers Pharmacy Constraints
The Adderall shortage is dragging on, in part, because of an opioid settlement agreement that restricts pharmacies’ ability to fill orders for controlled substances including ADHD stimulants and medications for anxiety.
December 15, 2022
The months-long Adderall shortage persists nationwide and is now compounded by new restrictions on pharmacists related to the opioid crisis. As part of a recent $21 billion settlement, three U.S. pharmaceutical wholesalers accused of contributing to the opioid epidemic agreed to increased monitoring of pharmacy orders thought to be suspicious. A consequence of this, according to Reuters, has been that pharmacists across the country are being prevented from filling prescriptions for both stimulants, like Adderall, and sedatives, like Xanax, for the same patient.
While Xanax and Adderall are not opioids, their high risk for abuse and addiction causes them to be categorized as Schedule II controlled substances, regulated by the government. Guidance on identifying illicit drug use from the U.S. Drug Enforcement Administration (DEA) points to the combination prescription of sedatives and stimulants as a possible red flag. In an effort to mitigate the abuse of controlled substances post-settlement, wholesalers have broadened the scope of their monitoring, which began with opioid orders, to include stimulants. As a result, Reuters reports, several pharmacists who have dispensed both Adderall, for attention deficit hyperactivity disorder (ADHD), and Xanax, for anxiety, have been banned from distributing all controlled substances.
Anxiety and ADHD, however, are conditions that frequently co-occur in patients. According to the CDC, 33% of patients with ADHD also have anxiety; a study published in the Journal of Affective Disorders1 found that adults with ADHD were four times more likely to have Generalized Anxiety Disorder (GAD) than are peers without ADHD. Because of this close correlation, prescribing both stimulants and sedatives to patients is a standard medical practice. In fact, in some cases, sedatives may be prescribed to address side-effects of stimulants, such as heightened anxiety and insomnia.
Reuters reports that, in the absence of clear rules from the DEA regarding which combinations of drugs are restricted, many pharmacists have grown wary of filling these combination prescriptions and are directing patients to seek either stimulants or sedatives elsewhere. This has added yet another hurdle to filling stimulant prescriptions for some patients already struggling to locate ADHD medication.
At the same time, the Food and Drug Administration (FDA) is advising patients and practitioners impacted by the Adderall shortage to “expect the supply issues to resolve in the next 30-60 days.” Though the FDA’s database of drug shortages does show backorders and other supply issues with several manufacturers, it appears seven manufacturers had available products at the time of reporting.
For now, many patients with ADHD across the country continue to encounter roadblocks and frustrations while trying to fill their prescriptions for Adderall. The FDA officially announced an Adderall shortage in mid-October, after labor constraints at a plant operated by Teva Pharmaceuticals, one of the main manufacturers of Adderall. These constraints dovetailed with a surge in demand due to the rise in prescriptions from telehealth companies like Cerebral, and by early fall, three additional drug manufacturers of generic Adderall — Sandoz, Amneal, and Rhodes — reported supply issues as well, according to the American Society of Health-System Pharmacists (ASHP).
Rectifying this shortage has been a challenge, in part, because Adderall (dextroamphetamine-amphetamine, or amphetamine salts) is a Schedule II controlled substance, and, as such, the amount that can be manufactured by each company is limited by the federal government. As patients have scrambled to find alternative medications to manage their ADHD symptoms, demand for other stimulants, such as Ritalin and Focalin, has increased and caused a trickle-down effect in the market.
In September, 80% of ADDitude survey respondents reported trouble filling their prescription for ADHD medication. In November, ADHD professionals weighed in to say the majority of their patients prescribed Adderall were encountering some problems at the pharmacy.
“My patients have told me they are blocked from fulfilling their prescriptions,” wrote one licensed social worker specializing in ADHD. “Doctors I have consulted told me that it is not just the shortage that is the barrier, but it is also becoming more difficult to access Adderall due to restrictions on its use.”
Source
1Fuller-Thomson, E., Carrique, L., & MacNeil, A. (2021). Generalized anxiety disorder among adults with attention deficit hyperactivity disorder. Journal of affective disorders, S0165-0327(21)01096-X. Advance online publication. https://doi.org/10.1016/j.jad.2021.10.020
