A few weeks ago, Hilary Bricken wrote about the proliferation of ketamine clinics in the United States and the logistics and legalities of operating a ketamine infusion clinic. As Hilary explained, the only FDA approved use of ketamine is for the induction and maintenance of anesthesia, though it also used for off-label infusions in the management of psychiatric disorders and chronic pain management.
Ketamine is listed as Schedule III controlled substance under the federal Controlled Substances Act. Its use is also restricted by various state laws and regulations. But because there is no FDA regulation on the control and oversight of clinics, patient safety protocols may vary and the liabilities (e.g. medical malpractice) for off-label use of ketamine are fairly far-reaching. Perhaps as a result, there have been multiple reports of safety and abuse problems related to the drug.
An example of the kinds of liabilities faced by ketamine clinics, prescribing physicians, hospital systems, pharmacies and others came to light this week in an $8.2 million medical negligence lawsuit filed in Oregon state court. The defendants are a prescriber of a ketamine nasal spray for use in pain management and the pharmacy that produced the spray. Branchflower v. Oregon