guidance and teaching for Kata Canada
guidance and teaching for Kata Canada

Guidance on the use of Ketamine, How do Alberta and Saskatchewan Compare

Earlier this year, the associations governing medical doctors in both Saskatchewan (CPSS) and Alberta (CPSA) released information regarding their positions on the use of ketamine for off-label treatments, including chronic pain and a variety of mental health conditions. The CPSS issued a letter to an MD in January, 2021, and the CPSA released a Clinical Toolkit in May, 2021.

While the CPSS doesn’t list specific conditions to be treated with off-label use of ketamine, it does explicitly state that the use of off-label medications is not prohibited. A clinical toolkit released by the CPSA lists specific conditions that have been demonstrated to have positive effects with the treatment of ketamine, including:

  • Major depressive disorder (MDD)
  • Bipolar depression
  • Suicidal ideation
  • PTSD
  • Complex regional pain syndrome (CRPS)
  • Traumatic spinal cord injury pain
  • Chronic neuropathic pain

The CPSA also suggests that the evidence for the use of ketamine in the treatment of certain pain conditions, including fibromyalgia, cancer pain and headaches is weak.

In Saskatchewan, off-label use of ketamine is only permitted in non-hospital treatment facilities (NHTF) when administered subcutaneously (SQ), intramuscularly (IM), or intravenously (IV). Due to differences in legal definitions between the two provinces, only the IV method of ketamine administration requires a NSHF accreditation in Alberta. The CPSA states that all other forms of administration, including subcutaneous, intramuscular, oral, sublingual, or intranasal may be offered in community settings if within the scope of practice of the prescriber, who may be a psychiatrist or family physician with appropriate training in consultation with a psychiatrist.

The prescriber must use a triplicate prescription pad as ketamine is a Schedule 1 drug in Alberta. In addition to listing conditions for which evidence supports the off-label use of ketamine, the Alberta toolkit also lists adverse effects and contraindications for its use. 

According to a discussion with the CPSA, this Clinical Toolkit only applies to existing NHSFs. New NHSF applications for ketamine administration are not currently being processed until a formal IV ketamine ruling is made by the CPSA in the coming year or later.

While the CPSS’s guidance doesn’t discuss clinical coverage required for parenteral (IV, IM, or SQ) administration of ketamine in an NHTF, the CPSA clearly states that IV ketamine administration must be supported by a multidisciplinary team, including an anesthesiologist, and an ACLS-qualified physician or an ACLS-qualified nurse. The CPSA indicates that IM and IV are the most predictable and bioavailable according to literature. The CPSS offers no guidance on this topic.

Both documents discuss the release of Spravato (intranasal esketamine) for treatment resistant depression, which is defined as the “failure of two or more antidepressant medications at adequate doses and duration.” The monograph for Spravato “requires patient monitoring for at least 2 hours during and after administration for any reactions.”

The major difference between the two documents is the difference in ruling around administration of IM and SQ ketamine in community settings, where it is allowed in Alberta, but not Saskatchewan. Neither document acknowledges this difference or discusses differences in risk between IV, IM & SQ administration. 

While the Alberta Clinical Toolkit provides clarity in what is presented, the guidance from the CPSS remains broad and non-specific.  Safety is highlighted as a top priority in both, including recommendations for sufficient documentation of safeguards taken and informed consents to ensure that patients are aware of the risks and benefits.

Ultimately further information is required from both provincial colleges suggesting, recommendations around set and setting, and examples of appropriate safeguards and clinical responsibilities. Also, the documented benefits of ketamine, like neuroplasticity and neurogenesis would be helpful for readers to understand why it is helpful in these off-label uses.

 

Woman writing therapy notes during a Ketamine therapy session
Woman writing therapy notes during a Ketamine therapy session

The Importance of Ethical Guidelines for Ketamine Assisted Therapy

Ketamine Assisted Therapy is Exploding

Ketamine’s use as an alternative to traditional therapies has been exploding over the last few years. Ketamine assisted therapy (KAT) is now being used to treat treatment-resistant depression, post-traumatic stress disorder, bipolar affective disorder, and chronic pain. The indications for the use of ketamine continue to widen as a growing body of evidence is published in the medical literature. With this burgeoning use of KAT to treat serious psychiatric conditions comes concerns about who is providing the treatment and what training they have. Many KAT providers have little to no formal psychological or psychiatric training. Some provide the drug with a promise of it being a “cure” to their patient’s condition or exaggerating the efficacy of ketamine.

Raquel Bennett Responds with Ethical Guidelines

I was very concerned…

In light of this, Dr. Raquel Bennett, Post-Doctoral Fellow in Psychology and the founder of the KRIYA Institute and organizer of the KRIYA Conference, developed the ‘Ethical Guidelines for Ketamine Clinicians. The KRIYA institute is devoted to treating patients with ketamine and educating clinicians who use the medication in their practices in the most scientifically rigorous way possible. The KRIYA conference was the first of its kind to focus specifically on ketamine. According to Dr. Bennett, the guidelines were written because “I was very concerned about the number of ketamine clinics that were popping up that were advertising ketamine treatment for mental health indications but were not providing psychologically-informed care.” These guidelines are specifically geared towards the use of ketamine to treat psychiatric conditions and not for its use in chronic pain conditions or anesthesia. 

According to the guidelines, the ethical KAT provider first acknowledges that ketamine is a powerful psychotropic medication that can cause dissociative and psychedelic effects, both of which can be distressing to some patients. Because of these properties, patients require psychological care before, during, and after receiving the medication. Models of care where patients are given the medication and left in a room by themselves and do not receive psychological after-care would not be considered ethical. 

What do Ethical Ketamine Assisted Therapy Guidelines Entail?

The guidelines outline the three roles that are present in every KAT session: the mental health professional, the medical professional, and the patient. The mental health professional is responsible for doing a clinical intake interview and assessment before the medication is provided, providing psychological support before, during, and after the session; and managing any mental health emergencies that arise during the session. The medical professional’s responsibilities are to assess the patient’s physical condition before, during, and after the treatment, and to manage any adverse reactions to the treatment. Finally, the patient should communicate clearly and honestly with the team and actively participate in the integration process.

The ethical provider is familiar with the various conceptual paradigms within which ketamine is used in its therapeutic application, the usual ways ketamine is administered, and its dose for each route of administration. With these factors in mind, the provider can tailor the KAT process to the patient’s unique circumstances and goals for therapy.

Recognizing that there are many professions involved in KAT, each with its own governing body and regulations, the guidelines ask that each professional practice within their scope of practice. Consultations and referrals with other professionals and good communication with these professionals are encouraged. In addition, keeping accurate medical records, obtaining informed consent, maintaining professional boundaries and professional conduct are all important parts of being an ethical KAT provider.

The guidelines also address the accessibility of KAT, which can be an expensive modality and is not always covered by provincial or private insurances. Because of this, it can often be limited to those with significant financial resources. The guidelines ask that providers actively try to make KAT available to those with limited financial resources who need it.

Transparency is crucial in earning the trust of patients who seek out KAT

Honouring this, the guidelines ask the ketamine clinician to be truthful when advertising the claims around ketamine and to follow the FDA guidelines. In Canada, one should follow the guidelines in the province within which the professional is practicing. Asked whether the guidelines are applicable in countries outside of the United States, Dr. Bennett says “These ethical guidelines can and should be used by patients, providers, and healthcare organizations worldwide.”

Finally, the guidelines emphasize the need for “substantial education”, training and mentorship for ketamine providers including the medical, psychological, and psychedelic aspects of KAT which are all skills that can be learned.  There is a list of available training on our KATA Canada Resources for Professionals page as well as at the KRIYA website.

Breastfeeding mother with her child
Breastfeeding mother with her child

New Study Shows Safe Levels of Ketamine in Breast Milk

A recently published study The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women: Quantification of ketamine and metabolites is the first study conducted on this subject providing data that supports the safety of ketamine administration for the treatment of postpartum depression (PPD) and other emotional disorders during breastfeeding.

Full text article and references available here.

Post-Partum depression is a significant issue world-wide and affects up to 15% of mothers, with collateral damage to families. Evidence suggests that this condition is both under-recognized and under-treated. Moreover, treatment is often ineffective and PPD can persist causing long term harm to the patient and their relationships.

Ketamine is in ever widening use for a variety of psychiatric disorders and its potency in improving and eliminating depressive disorders in sub-anesthetic doses has been extensively documented. Much of the expanding clinical use of ketamine has focused on its ability to exert a potent and rapid antidepressant effect in patients with severe treatment resistant depression.

Ketamine a Potential Solution to an Impossible Decision

The outcomes of this study have huge implications for future treatment of women with PPD whose current options are limited and pose significant moral dilemmas. Conventional first-line treatment for PPD is the use of SSRIs which are known to have a long list of side-effects.  When it comes to infant exposure to this class of medication through breastmilk, the data is so limited that no conclusions can be made about the long term effects on cognition, behaviour or emotional changes.  A few of the common side effects of SSRIs include: agitation, anxiety, loss of appetite and weight loss, dizziness, blurred vision, headaches and sleeping problems.  It is understandable why so many women choose to forego this option.

In my clinical work with women who are having to make this choice, I see them face an impossible risk vs benefit scenario. Most societal norms instruct women to be “selfless;” they should put their children’s needs before their own. If a new mother chooses to take an SSRI to treat symptoms of a postpartum mood disorder, she may worry she is being selfish. Ultimately, if a woman has significant fear about the risk to her infant, any benefit from the medicine itself may not be sufficient to treat the postpartum mood disorder. And she may fear that if she chooses to medicate, she will have to wean her baby off of breastfeeding—a loss to both.

– Melissa Whippo

If a woman does choose to take SSRIs, these medications can take months before their effect is known and often people need to cycle through more than one medication before finding one that is possibly effective on their depressive symptoms.  The reality is that infants may be exposed to potentially risky levels of SSRIs without any positive effect on the mother’s depression or emotional disorder. However, it is important to note that the decision to forgo, discontinue or start medications should be made between the mother and her healthcare team.

Level of Ketamine is Safe for Infants

During the Wolfson study, the 4 breastfeeding women received 2 different intramuscular doses of ketamine—0.5mg/kg and 1.0mg/kg during a period of 12 hours where breastfeeding was postponed.  Breast milk was collected at baseline, 3, 6, 9 and 12 hours post ketamine administration.  The amount of ketamine in the women’s breast milk at the 12 hour mark was insignificant.  For the woman who received the highest dose of 76 milligrams of ketamine, only 24 micrograms (0.024 mg) of ketamine was secreted in the 12 hour period.

These findings show only small concentrations of ketamine in breast milk which decline rapidly within hours.  This data supports that women may continue to breastfeed after a brief interruption limited to hours. This offers symptomatic women a new choice for treatment where they can continue breastfeeding, a fundamental aspect of the mother-child nurturing relationship.

 

The current treatment models of ketamine psychotherapy include infrequent dosing which avoids accumulation of ketamine levels in infants’ plasma levels.

Moving forward

This study represents a huge first step to begin the systematic study of the potential use of ketamine and Ketamine Assisted Psychotherapy for postpartum emotional disorders.


It is the hope that with further study an important new method to treat postpartum depression and other postpartum emotional disorders will become available. The Wolfson team believes ketamine presents great promise for women suffering with postpartum emotional difficulties.