REMS stands for Risk Evaluation and Mitigation Strategy. It is a safety program the FDA requires for certain medications whose benefits are clear but whose risks need extra controls beyond the usual label warnings. Each REMS is tailored to the drug. Some only require patient education materials. Others restrict who can prescribe, where the drug can be dispensed, and how patients are monitored. Clozapine, isotretinoin and buprenorphine products for opioid use disorder all have REMS programs.
Spravato has one of the stricter REMS designs. Because esketamine can cause sedation, dissociation and a temporary rise in blood pressure, and because ketamine has a history of misuse, the FDA requires that Spravato be given only at certified healthcare settings. The clinic, the pharmacy that supplies it, and the patient are all enrolled in the program. You take the spray in the office under observation, never at home, and you stay for at least two hours while staff monitor your blood pressure and alertness. You must arrange a ride, since driving is not permitted until the next day after a restful sleep. The clinic documents each session for the REMS registry. These requirements add some structure to treatment, but they are also what make insurance plans comfortable covering Spravato. Stedfast Psychiatry is a certified Spravato treatment center at three Palm Beach County offices.