At-Home Ketamine Therapy Ending Soon And New Survey Finds Overdosing All Too Common

DEA’s Proposed Telehealth Rules For Prescribing Controlled Substances

Ketamine is the only psychedelic that can be lawfully prescribed (off-label) to treat mental health indications. It has also presented positive outcomes for a variety of conditions by individuals who were able to access ketamine-assisted therapy online via distance treatment modalities, especially during the pandemic.

The publication of the Ryan Haight Act (RHA) during the period of Public Health Emergency (PHE) left room for ketamine telehealth clinics to exponentially grow, as no first in-person consultation was required for physicians to begin prescribing ketamine to patients.

However, the Biden administration recently announced an end to many measures taken during the pandemic, effective as of May 11, 2023. 

The DEA proposed new rules for telehealth on Feb. 24, 2023. After the 30-day consultation period, the agency will consider public comments and may reevaluate or change rules. 

Set to “bridge between the DEA’s current PHE waivers and a post-PHE environment” (see Foley’s analysis), the regulations address several issues.

US-based practitioners with DEA permits to issue schedule III, IV and V controlled substances via telehealth will be able to continue doing so. Nonetheless, the RHA’s reincorporation will require a prior in-person consult unless a specified exception applies.

The aforementioned cases would be the qualifying telemedicine referral of a patient among practitioners including a performed in-person medical evaluation or a telemedicine relationship established during the PHE declaration (see Harris Bricken analysis.) 

Normally, practitioners would be able to issue online ketamine prescriptions for a 30-day supply, excluding cases of PHE declaration relationships, VA relationships, or when a medical evaluation is done.

Another newly-introduced restriction involves prescribers would now have to first review Prescription Drug Monitoring Program (PDMP) data in the state where the patient lives and, should no info be available, the prescription supply will be limited to 7 days. 

Further, practitioners will have to conduct a qualifying medical evaluation within 30 days after the first prescription, or else no additional telehealth prescriptions will be allowed (except for the cases of PHE declaration relationships and VA relationships.)

Also, practitioners providing telehealth services will have to keep patients’ records at their DEA registration location.

The PHE declaration will end before the DEA rules are finalized, which foresees a transition period with not necessarily clear rules. Local law should also be contemplated, as states have varying requirements on medical providers. 

In view of this, regulations for providers, practitioners and patients seem likely to eventually unwind on a state-by-state, almost case-by-case basis, at least for the time being.

Report: Nearly 60% Of Millennials Use More Than Recommended Dose Of Ketamine For Therapy

Healthcare company All Points North (APN)’s new report on at-home use of ketamine therapy showed that among some 2,000 US at-home users over 16, nearly 6 in 10 either accidentally or purposely used more than the recommended dose, and 55% of all Americans said the same, per the online survey.

As for self-medicating: 

• 21% of all surveyed participants acknowledged having used ketamine or another psychedelic for treating mental health conditions like anxiety and depression. 

• 2 in 5 Gen Zers reported self-medicating with psychedelics, and 1 in 3 millennials said they've used the substances for recreation or experimentation purposes.

The report suggests this situation may be triggered by the still existent stigma surrounding mental health treatments with psychedelics as well as lack of education:

• As few as 20% of total responders said they are familiar with and open to trying ketamine-assisted psychotherapy (KAP), yet 45% cannot be persuaded into trying it even with a physician’s recommendation. 

• 27% of participants said they are only aware of ketamine as a party drug and believe it has no mental health benefits. 

• 32% of Americans responded that they would likely be judged by family, friends or co-workers for trying ketamine therapy. 

• Of those participants who have tried it, 64% said it helped with their symptoms.

On the bright side: 

• 48% of participants said they would consider trying ketamine therapy if they knew it would make them feel better and less depressed or anxious. 

• 26% of total responders agree they would rather use ketamine than anti-depressants or anti-anxiety medication to treat their mental health symptoms.

In view of the results and risks of self-medication, APN’s stance is that both care and treatment using ketamine should be clinically and comprehensively supervised instead of being a standalone option and that education is key to expanding access to these medicines.

“It’s disheartening when patients are sold on a dream drug only to be discouraged when it doesn’t work because it was not administered correctly,” stated APN’s founder and CEO Noah Nordheimer.

“Mental health therapies should only be used in the way peer-reviewed studies for clinical validation have deemed them safe. Even then, we should carefully evaluate who is best suited for which treatments, as mental health is not one size fits all. Oversimplified at-home ketamine offerings can result in patients irresponsibly self-medicating or becoming dependent; it’s also less likely to help them in the long run." 

Nordheimer also believes that the hesitancy in behavioral health space to accept the efficacy and safety of new treatments like ketamine is due to a lack of education and generational stigma around mental health. He added that providers have the responsibility to demonstrate the successful results obtained with emerging treatments for improving symptoms of conditions like anxiety, depression, PTSD, OCD and addiction.

Photo: Benzinga edit with photo by MART PRODUCTION on Pexels and Jü on Wikimedia Commons.