Robert Pollack MD – CEO and head psychiatrist at PASWFL, is a certified Risk Evaluation Mitigation Strategy provider. The REMS program that Dr. Pollack is certified in was approved by the US Food and Drug Administration (FDA). You can read more about the particular parameters that must be met for the safe administration of esketamine (an enantiomer of ketamine) treatments – all of which PASWFL is thrilled to say we adhere to for both our esketamine and ketamine treatments.

Risk Management Requirements are a Necessary Part of Safe Psychiatric Practice

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

REMS include a risk mitigation goal, THAT HAS  information communicated to and/or required activities to be undertaken by, one or more participants (e.g., health care providers, pharmacists, patients) who prescribe, dispense or take the medication.  Together, the goal, communications and/or activities make up the safety strategy.

PASWFL Goes the Extra-Mile to Ensure Safe Administration of Ketamine Treatment

The FDA has criteria for the use of Esketamine which is an enantiomer of Ketamine. PASWFL voluntarily chooses to use that REMS protocol for Ketamine even though the FDA has no ruling on it. My goal is to show how we go the extra mile for safety and use the REMS that Esketamine was mandated to use. At PASWFL we feel that ketamine treatment providers should apply the Risk Management processes outlined by the FDA for the use of esketamine to ketamine treatments as well – sadly, many do not.

PASWFL’s goal of the REMS is to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by ketamine and esketamine administration, and abuse and misuse of the treatment by:

  • Ensuring that ketamine and esketamine are only dispensed and administered to patients in a medically supervised healthcare setting that monitors these patients
  • Ensuring pharmacies and healthcare settings that dispense  esketamine are certified and that those providers treating with Ketamine use at least the same REMS process
  • Ensuring that each patient is informed about the serious adverse outcomes resulting from sedation and dissociation and need for monitoring
  • Enrollment of all patients in a registry to further characterize the risks and support safe use

Insight into PASWFL’s use of the FDA Approved Processes for Administering Ketamine/Ketamine derivative Treatment:

  1. The patient must be prepared to not eat less than 5 hours before visit
  2. Instructed as to how to use current medication
  3. Vital signs are taken prior to infusion
  4. Patient is monitored by the Caretaker System (Blood Pressure, Pulse, EKG, Respiration Rate) throughout treatment.
  5. Post Infusion Patient remains for at least 90 minutes and all vitals returned to baseline
  6. Patient is discharged to care of significant person.

At PASWFL we are dedicated to patient safety when it comes to all of our advanced treatments for treatment-resistant depression. When it comes to ketamine treatment, we distinguish ourselves by administering ketamine treatment according to the safety regulations outlined by the FDA for esketamine (an enantiomer of ketamine).

[Read the FDA’s full parameters for the safe administration of Esketamine]