Abstract
On a background of the rapidly expanding clinical use of ketamine and esketamine for treatment of depression and other conditions, we examined safety monitoring, seeking to identify knowledge gaps relevant to clinical practice.
An international group of psychiatrists discussed the issue of safety of ketamine and esketamine and came to a consensus on key safety gaps.
There is no standard safety monitoring for off-label generic ketamine. For intranasal esketamine, each jurisdiction providing regulatory approval may specify monitoring. Treatment is often provided beyond the period for which safety has been demonstrated, with no agreed framework for monitoring of longer term side effects for either generic ketamine or intranasal esketamine.
The KSET has established face and content validity, however it has not been validated against other measures of safety.
We recommend the Ketamine Side Effect Tool (KSET) as a comprehensive safety monitoring tool for acute and longer term side effects.
•Generic ketamine should be prescribed in the context of a robust safety framework.•Monitor cumulative and longer-term side effects if ketamine/esketamine is prescribed beyond the period for which safety data is available.•The KSET is a measurement-based safety monitoring system which can be used to capture acute, cumulative and longer term side effects.•Longer term safety data on intranasal esketamine is forthcoming.•The KSET has established face and content validity, though it has not been validated against other safety measures.