“Parenteral Use of Ketamine for the Treatment of Mood Disorders” – COLLEGE OF PHYSICIANS AND SURGEONS OF BC FEEDBACK REQUEST DEADLINE PASSED

The College of Physicians and Surgeons of British Columbia’s Non-Hospital Medical and Surgical Facilities Accreditation Program recently put out a set of draft standards for “Parenteral use of Ketamine for the Treatment of Mood Disorders.”  This document will eventually become the mandatory guidelines for Ketamine IV/IM/SC therapies for depression.  They accepted feedback in the form of letters and surveys ending on Feb 17, 2021.  

The draft standards outline that IV/IM/SC ketamine treatments must be conducted in a “non-hospital accredited facility” with an anaesthesiologist present on site. This standard does not apply to intranasal esketamine (SPRAVATO®) administered in non-accredited facilities. 

Below is a summary of the most important standards by section, please see the CPSBC website for most up to date information at www.CPSBC.ca

Summary of Proposed College Guidelines on Ketamine

Pre-admission and Evaluation:

  •  Ketamine should only be considered when standard conventional pharmacological treatment(s) and psychotherapy (e.g. cognitive behavioral therapy, interpersonal therapy) have been unsuccessful.
  • Patients must be screened and have a pre-admission evaluation including laboratory and diagnostic testing (ECG, renal function and liver function tests). Screening process includes sleep apnea screening using a validated tool (e.g. STOP-BANG)

Psychiatric Assessment Documentation:

  • Includes comprehensive psychiatric and medical history, allergies, drug sensitivities, medication history, substance use history.
  • Physical exam must be documented including mental status and review of systems
  • A management plan including clinical impression, treatment and follow-up plan including the rationale for ketamine therapy, and documentation of consent discussion (consent discussion must inform the patient of the off-label status of ketamine therapy).

Admission and Pre-treatment Care:

  • Admission and pre-treatment care must be in accordance with the Admission and Pre-Procedure Care standard with the exception of surgical marking and pre-operative checklist
  • Patients should be fasting prior to ketamine administration.  For IN esketamine patients should refrain from eating for 2 hours prior and avoid drinking fluids for 30 mins prior.
  • IV access is established (Including all routes of administration of ketamine in a NHMSFAP)

Consent:

  • Both the psychiatrist and anesthesiologist administering treatment are required to have a consent discussion with the patient.  This must be documented on the chart, consent must be written.

Dosing limits are:

  • Intravenous (IV)  infusion dosing is restricted to a weight-based dose limit of 0.5 mg/kg IV over 40 minutes **can be initiated by an RN with a patient specific order as long as there are no bolus doses and infusion is run using an infusion control device
  • Intramuscular (IM) dosing is restricted to a weight-based dose limit of 0.1-0.4 mg/kg **must be administered by an anesthesiologist
  • Subcutaneous (SC)  dosing is restricted to a weight-based dose limit of 0.1-0.5 mg/kg SC **must be administered by an anesthesiologist
  • Intranasal (IN) esketamine dosing is restricted to the dosage recommendations per the product monograph for SPRAVATO® **doses administered under direct supervision of anesthesiologist, psychiatrist or registered nurse. 

Anesthesiologist qualifications:

Registered Nurse qualifications:

  • Each registered nurse must have current BLS/ACLS and additional critical care or post anesthesia care training or equivalent experience

Appropriate Staffing:

  • Two registered nurses or one registered nurse and one anesthesiologist are present in the treatment unit/area/room at all times when a patient is receiving care.
  • One-to-one (1:1) regulated health professional to patient ratios are observed.
  • There is a third regulated health professional immediately available
  • Prescribing psychiatrist must be available at minimum by telephone 

Treatment Room and Equipment:

  • Each treatment chair/bed/stretcher is equipped with cardiac monitoring, capnography, automatic BP monitoring, pulse oximetry, suction, oxygen and equipment, a bag mask valve device, artificial airways.
  • Clinical support supplies (IV supplies, stethoscope, medications etc.) and temperature monitoring equipment is readily available

Patient Assessment Supports Safety:

  • Continuous cardiac and pulse oximetry monitoring in place during and post-monitoring phase
  • ETCO2 monitored if sedation scale ≥ 2.
  • Oxygen saturation frequently assessed during and after treatment
  • Blood Pressure, respiratory rate, and level of consciousness assessed and documented at baseline, then every 5 mins x3, then every 15 mins.
  • Patient remains in the treatment room/area/unit for 30 mins after IV discontinued or after IM/SC injection and 2 hours after IN.
  • Patient remains in the facility for an additional 60-90 mins after the initial minimum length of stay.

Medical and Non-Medical Emergencies:

  • Emergency cart is stocked in accordance with NHMSFAP Class 1 General Anesthesia Facility Emergency Cart with the exception of succinylcholine.

For further information on: safe discharge, medical record keeping, safe medication practices, medical patient and care equipment, infection prevention and control, facility design/ layout, human resources, policies and procedures, and quality improvement strategies sections of this standard please visit the Parenteral Use of Ketamine for Mood Disorders standard.

KATA wrote to the CPSBC in response to this draft standards document to inform the college that we are preparing policy recommendations and are looking to discuss and provide consultation in regards to the regulation of ketamine therapies in BC. Thank you to those who submitted feedback.