CDC Issues HAN Health Advisory Following DOJ Indictment of Digital Health Provider of Adderall

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The Centers for Disease Control and Prevention (CDC) has issued a Health Alert Network (HAN) Health Advisory to inform public health officials, clinicians, and patients about possible disruptions in access to prescription stimulant medications used to treat attention-deficit/hyperactivity disorder (ADHD). This advisory follows a federal health care fraud indictment against Done Global, a subscription-based telehealth company that provides ADHD treatment for adults.¹

The indictment, announced by the U.S. Department of Justice (DOJ), alleges that the defendants and other parties involved distributed more than 40 million pills, including Adderall and other stimulants, to generate $100 million in revenue.² According to a DOJ release,³ the defendants solicited subscribers by targeting drug seekers and spending millions of dollars on deceptive advertisements on social media platforms.²

The indictment also claims that the defendants intentionally designed the telehealth platform, Done, to facilitate easy access to Adderall and other stimulants. This included limiting the information available to prescribers, instructing clinicians to prescribe these medications even if the patient did not meet the necessary qualifications, and mandating that initial consultations be kept under 30 minutes. The company also allegedly implemented an auto-refill function that was purportedly designed to discourage follow-up medical care.²

This indictment may affect between 30,000 to 50,000 patients across the United States who depend on this telehealth service for their ADHD medication. The potential disruption coincides with an existing shortage of several stimulant medications, including the immediate-release formulation of amphetamine mixed salts (Adderall).¹ According to the National Community Pharmacists Association, 97% of independent pharmacy owners reported experiencing shortages of Adderall in 2023.⁴

“Some of my patients have to drive hours away to get their Adderall,” said Psychiatric Times® Editor in Chief, John J. Miller, MD. “One patient drove over an hour, but by the time he got there, they had already run out. It is incredibly frustrating, both for our patients and us as clinicians.”⁴

According to the CDC, the impact of the indictment on patients with ADHD remains uncertain. They report that patients may need to find new clinicians, or they may struggle to fill prescriptions, which may lead them to seek alternatives outside the regulated health care system. This may significantly increase the risk of overdose due to counterfeit pills in the illegal drug market, which frequently contain substances like fentanyl. The Drug Enforcement Administration (DEA) has reported that 7 out of every 10 pills seized from the illegal market contain a potentially lethal dose of fentanyl. Overdose deaths involving stimulants have been rising since 2014, often in combination with opioids, and 14.5% of college students report misuse of fentanyl and other illegal substances.¹

According to NBC News, the US Food and Drug Administration (FDA) “expects additional supply [of ADHD medications] will be returning in the coming months,” adding that, “the public should rest assured the FDA is working closely with numerous manufacturers and others in the supply chain to understand, mitigate, and prevent or reduce the impact of intermittent or reduced availability of certain products.”⁵

In the meantime, the CDC advises psychiatric clinicians to communicate the potential overdose risks to affected patients and partner organizations; help patients find new pharmacies where appropriate; educate patients about the dangers of using drugs from unregulated sources, including those from family, friends, and online contacts; prescribe naloxone and provide overdose prevention education to patients who may have difficulty accessing their medications; and refer patients to substance use disorder treatment services if needed.¹

Stay up-to-date on news related to research on promising new interventions and developments in the treatment of a wide variety of other psychiatric disorders at psychiatrictimes.com.

References

1. Disrupted access to prescription stimulant medications could increase risk of injury and overdose. US Centers for Disease Control and Prevention. News release. June 13, 2024. Accessed June 14, 2024. https://emergency.cdc.gov/han/2024/han00510.asp?utm_source=MarketingCloud&utm_medium=email&utm_campaign=PT+Daily+June+14&utm_content=PT+Daily+June+14

2. Biscaldi L. After DOJ indictment, CDC urges caution around ADHD medications. Drug Topics. June 14, 2024. Accessed June 14, 2024. https://www.drugtopics.com/view/after-doj-indictment-cdc-urges-caution-around-adhd-medications

3. Founder/CEO and clinical president of digital health company arrested for $100M Adderall distribution and health care fraud scheme. U.S. Department of Justice. News release. June 13, 2024. Accessed June 14, 2024. https://www.justice.gov/opa/pr/founderceo-and-clinical-president-digital-health-company-arrested-100m-adderall-distribution

4. Kuntz L. The Rx crisis: the impact of ongoing ADHD medication shortages. Psychiatric Times. August 7, 2023. Accessed June 14, 2024. https://www.psychiatrictimes.com/view/the-rx-crisis-the-impact-of-ongoing-adhd

5. Lovelace Jr B. ADHD drug shortage shows signs of letting up, but some patients still struggle. NBC News. May 19, 2024. Accessed June 14, 2024. https://www.nbcnews.com/health/health-news/adhd-drug-shortages-fda-easing-affecting-patients-rcna152570