Adderall bottle on shelf.

Losing Control of Controlled Substances? The Case of Telehealth Prescriptions 

By Minsoo Kwon

Telehealth services that specialize in the treatment of mental health concerns, such as Cerebral Inc., highlight the ongoing challenge of appropriately balancing accessibility of care with patient safety.

While increased accessibility of mental health care services through telehealth is a valuable goal, if our aim is the well-being of patients, safety must be paramount.

About Cerebral Inc.

As the COVID-19 pandemic and its concomitant social-distancing efforts rendered many, if not most, health visits inaccessible, telehealth platforms and companies swiftly stepped in to allow for virtual patient-doctor consultations. One such platform is Cerebral Inc., a mental-health startup which focuses primarily on behavioral health, specifically the treatment of depression and ADHD. After launching in January 2020, Cerebral pushed widespread advertisements on social media and was able to amass rapid growth in both customer base and funding.

Key Policy Changes Concerning Controlled Substances

Pandemic policy changes concerning the prescription of controlled substances allowed for such telehealth business models to thrive. With the Secretary of Health and Human Services declaring a public health emergency due to COVID-19 on 1/31/2020, practitioners were permitted by state law to “dispense controlled substances not only in their home states but also in states with which their home states have reciprocity.” Additionally, during the Public Health Emergency, the Drug Enforcement Administration (DEA) waived the Ryan-Haight Online Pharmacy Consumer Protection Act of 2008, which requires at least one in-person visit prior to the prescription of controlled substances. These key policy changes concerning controlled substances meant that telehealth services like Cerebral could prescribe controlled substances such as Adderall to patients entirely through online interactions.

Losing Control

Neither quality of care nor safety were consistent. To date, many families of deceased Cerebral patients have spoken up against what they believe to be mishandling of their loved ones’ mental health and prescriptions. A 51-year-old patient died by suicide after Cerebral allegedly overlooked his alcoholism and prescribed an antidepressant that is known to potentially increase suicidal thoughts when consumed with alcohol. Another patient attempted to take her life, only to realize later with her new health care provider that Cerebral had ordered a medically unsuitable combination of prescriptions. Former Cerebral employees began speaking up about company practices they found alarming, such as nurse practitioners being pressured to prescribe stimulants after just a single thirty-minute virtual visit. In May 2022, the Department of Justice began investigating Cerebral for “possible violations” of the Controlled Substances Act, specifically regarding allegations that the company over-prescribed stimulants. On December 15, 2022, the DEA issued an Order to Show – an administrative action to determine whether a certificate of registration should be revoked – on Truepill, the pharmacy that filled Cerebral prescriptions. However, until a determination is reached, this order will not affect Truepill’s status to handle or distribute controlled substances.

Additionally, telehealth prescriptions of Adderall may affect offline patients: Adderall production has not met surging demand. This shortage poses public health risks; Congresswoman Abigail Spanberger (D-VA) has urged the DEA and the U.S. Food and Drug Administration to address the shortage.

Going Forward

Despite the concerns raised by companies like Cerebral, the trend toward telehealth prescribing has received strong backing by major players in health care. The American Psychiatric Association, alongside many other organizations, has urged the DEA to revise telehealth controlled-substance rules, and permanently waive the in-person evaluation requirement for controlled substances prescriptions via telehealth. Doing so would arguably improve accessibility for mental health care services, but at what cost? While an ideal regulatory framework would guarantee both widespread accessibility and safety, the latter should be the mainstay of policy.

Minsoo Kwon

Minsoo Kwon is a Junior at Harvard University studying Neuroscience and an intern at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

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