Pandemic-era telemedicine rule set to expire as regulators act
The pandemic-era emergency rule that allowed clinicians to prescribe controlled substances, including ketamine, through remote consultations without first meeting a patient in person has been extended several times. The government is reviewing whether to extend it again when it expires at the end of this year, according to the Wall Street Journal.
The DEA is seeking information from medical experts about whether daily use of ketamine and the access telehealth companies provide for patients are medically justified, according to a person familiar with the situation. Ketamine is FDA-approved as an anesthetic but is often prescribed for depression and other mental health conditions off-label, meaning its safety and efficacy have not been vetted by the agency for those uses.
In late June, the FDA sent warning letters to 14 online marketers citing “significant violations” and ordering them to stop selling their ketamine products. The targeted websites include ketaminetroches.com and legitketaminesuppliers.com, which offered ketamine vials, powders, nasal sprays and “troches” — lozenges that dissolve in the mouth. Neither site responded to requests for comment.
“FDA has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision,” the agency wrote in the letters. “The easy availability of unapproved and misbranded ketamine products via the internet puts U.S. consumers at risk for serious adverse events.”
Some telehealth companies offer platforms through which patients interact with clinicians who can prescribe ketamine for at-home use to treat depression, anxiety and other mental health conditions. Some individual clinicians also prescribe the drug remotely. Other sites appear to offer the drug without a prescription, the Journal reported.
The enforcement actions follow a Journal article in March reporting that ketamine use has skyrocketed under loosened pandemic-era regulations, with hundreds of businesses selling the drug for at-home use, often without medical supervision. In some instances, patients have died or harmed others while using the drug.
The American Society of Anesthesiologists in June flagged the death of a 41-year-old New York woman first reported by the Journal and called on policymakers “to address the fast-growing problem of home delivery of ketamine.”
State-level regulation is also evolving. The Texas Medical Board has proposed a ban on in-home use of injectable forms of ketamine, which it said can lead to sudden complications that require specialized medical intervention. The board has also proposed more requirements and training for prescribing physicians.
The proposed ban does not apply to ketamine lozenges, the form telehealth companies generally prescribe. But the Texas medical board has discussed “various forms of administration,” according to a spokesperson who said the board will investigate “any complaint regarding the administration of ketamine regardless of the method.”
Dr. Sandhya Prashad, president of the American Society of Ketamine Physicians, Psychotherapists & Practitioners and a psychiatrist in Texas, said some companies are “using very, very high doses” and that there is “no published data showing high doses or microdoses work or are safe as a psychiatric treatment.” She said in-person treatment allows a clinician to monitor a patient’s blood pressure and other signs.
Telehealth executives and some patients say at-home ketamine can be life-changing for people who have struggled to find effective treatment for depression. But some clinicians recommend taking the lozenges one to three times a week at doses that can leave a patient impaired the rest of the day, according to some patients and psychiatrists. Telehealth patients say they easily obtain refills through online message exchanges or by filling out a survey.