October 22, 2020

Clarification on College requirements for intranasal esketamine

Intranasal esketamine (SPRAVATO®) has been approved for use in Canada following a Notice of Compliance from Health Canada. SPRAVATO® is indicated for use in combination with an oral antidepressant (that is either a SSRI or SNRI) for the treatment of major depressive disorder (MDD) in adults who have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current moderate to severe depressive episode.

Psychiatrists may prescribe SPRAVATO® to patients who meet the appropriate criteria in a community setting, as long as they have appropriate training and knowledge and are doing so in accordance with requirements set out by Health Canada and the SPRAVATO® Canadian product monograph. In settings where there is limited availability of psychiatry specialist care, and complex TRD patients are managed by family practitioners in consultation with a psychiatrist, the family practitioner could provide treatment under the same requirements.

Pursuant to the Canadian product monograph, SPRAVATO® is only available through a controlled distribution program called the Janssen Journey™ Program. The goal of the Janssen Journey™ Program is to mitigate the risks of adverse outcomes related to sedation, dissociation, blood pressure changes, and the risk of misuse and abuse.

  • SPRAVATO® can only be prescribed by a physician who is experienced and proficient in the management of major depressive disorder and enrolled in the Janssen Journey™ Program.
  • Only pharmacists enrolled in the Janssen Journey™ Program can dispense SPRAVATO®.
  • Physicians who prescribe SPRAVATO® and pharmacists who dispense SPRAVATO® must complete training on the risks of the product and agree to adhere to the requirements of the Janssen Journey™ Program.
  • Prior to being prescribed SPRAVATO®, patients must be enrolled in the Janssen Journey™ Program.
  • Prescribers must ensure that the patients are informed of and understand the conditions of use and risks of treatment with SPRAVATO®.
  • SPRAVATO® can only be dispensed to sites of care where patients self-administer the product under the direct supervision of a health-care professional and are monitored by a health-care professional post-administration.

Parenteral administration of ketamine, including subcutaneous (SQ), intramuscular (IM), and intravenous (IV) as an off-label use of ketamine for depression continue to only be permitted in accredited non-hospital facilities. As ketamine is a dissociative anesthetic agent, capable of producing amnesia, analgesia, and all levels of sedation, it has a serious side effect and risk profile. Ketamine can cause significant hypertension requiring frequent monitoring of blood pressure and treatment, if indicated, and may also cause serious dissociative effects that may require intervention.

The College does not explicitly prohibit the off-label uses of medications as this often falls under research and, occasionally, complementary medicine. However, it is expected that patients be fully informed of the risks, benefits (and unknown nature of risks and benefits) of any off-label treatments.

Questions may be directed to Health Canada at hcinfo.infosc@canada.ca, or the Janssen Journey Program at 1-833-257-7191 or online at www.JanssenJourneyHCP.ca.