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Update to Health Canada’s guidance for clozapine

November 16, 2022
Healthcare providers may continue to use their best clinical judgement to decide whether to dispense clozapine in absence of a blood test.

On March 20, 2020, Health Canada issued interim recommendations to be implemented by healthcare providers who are managing patients being treated with products containing clozapine. At the time, Health Canada had requested the manufacturer to inform stakeholders that as an interim measure during the COVID-19 crisis, it would be reasonable for healthcare providers to use their best medical judgement to allow continued dispensing of clozapine even if patients are late in getting or unable to get their blood tested.

Health Canada recognizes under extenuating circumstances related to the COVID-19 pandemic, challenges may still exist that hinder access to testing for some patients.

Health Canada recommends that, if possible, patients continue to have white blood cell (WBC) counts and absolute neutrophil counts (ANC) testing as per their regular schedule for hematologic monitoring. However, if necessary, healthcare providers should continue to use their best clinical judgement in weighing the benefits and risks of continuing treatment in the absence of laboratory testing. Healthcare providers should collaborate with their patients to reach a decision and discuss the associated risks.

Upon assessing the current situation, Health Canada has extended the current flexibility around hematological testing by an additional 12 months (until September 30, 2023). However, this recommendation is subject to change. Hematological testing requirements will continue to be reassessed by Health Canada with the progression of the COVID-19 pandemic. It is anticipated that blood testing requirements will eventually return to their usual pre-pandemic status. You will be updated about any future changes to the requirements.