OPENING KETAMINE CLINICS FOR OFF-LABEL USE
By: Steven Avalon
An increasing number of our cannabis doctors have been reaching out to us about providing ketamine treatments as part of their medical practice. This blog will provide some background on ketamine as well as some of the potential legal issues surrounding ketamine use in the United States.
Ketamine is classified by Drug Enforcement Administration (DEA) as a Schedule III controlled under the Controlled Substances Act (CSA), which means that according to the DEA, the drug in question “has a currently accepted medical use in treatment in the United States; and [a]buse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence (21 U.S.C. § 812(b)(3)).”
With this Schedule III designation, federal regulations require individuals to register with the DEA prior to manufacturing, distributing, dispensing, or otherwise dealing in ketamine, with further rules regarding who can obtain a DEA registration. Only healthcare professionals such as physicians, Mid-level Practitioners (whose definition varies on a state-by-state basis, but generally can include nurse-practitioners and physician assistants), pharmacies, and hospitals/clinics can apply for DEA registration, and these registrations, once acquired, must be renewed at least every few years, and oftentimes annually.
Ketamine’s Food and Drug Administration (FDA) approved use is as a sole anesthetic for surgical procedures. However, many drugs are used for off-label use, which are non-FDA approved uses, which is generally legal unless the off-label use of a drug violates ethical or safety guidelines. Ketamine is being used off-label as a tool for therapy to treat a variety of mental health issues, including addiction, post-traumatic stress disorder (PTSD), anxiety, and depression. This use is legal as long as the prescribing doctor, dispensing pharmacy, and the manufacturer are registered with the DEA as outlined above.
Despite the stringent registration requirements, ketamine clinics are opening at a fast pace, largely in response to the mental health crisis the U.S. is facing, exacerbated by the coronavirus pandemic. When properly registered and run, these clinics can be vital in the fight against mental health issues, but as outlined above, proper navigation of the regulatory landscape is crucial for clinics and physicians to stay compliant with DEA rules.
Beyond regulatory issues, ketamine clinics have liability issues to be mindful of. Like any powerful anesthetic, clinics should ensure that patients do not operate a motor vehicle or engage in any other potentially dangerous activities while taking ketamine; starting with a warning to patients so they know what effects to expect from ketamine treatments, a liability waiver stating that the patient understands the risks and will not engage in any activities until a safe amount of time has passed, and ensuring that the patient has a ride home from any treatment sessions.
A key to expediting ketamine research and widespread use as a therapy tool is breakthrough therapy status, granted by the FDA. This status allows the drug in question (in this case, ketamine) priority review and by extension, approval, by the FDA for the use in question. In the past, the FDA has granted breakthrough therapy status to other psychedelics, including MDMA for the treatment of PTSD and psilocybin for the treatment of severe depression. These designations allow the research of each to flourish, allowing potentially life-saving treatments to be effectively studied, and upon a successful clinical trial, reach the market. Receiving breakthrough therapy status for ketamine therapy to treat mental health issues, especially in light of the coronavirus pandemic, could be essential to curbing the current mental health crisis our country faces.
Could today’s ketamine clinics be tomorrow’s Psychedelic Supervised Therapy Centers?
