Monitoring and dosing implicated in fatal clozapine case


In March earlier this year Louise Hunt, Senior Coroner for Birmingham and Solihull, commenced an investigation into the death of Mr Ian Allen. The investigation concluded at the end of an inquest on 17th August 2020 that Mr Allen died from clozapine toxicity due to blood levels not being monitored and doses not being adjusted effectively.


Mr Allen collapsed suddenly and unexpectedly at the nursing home where he resided at around 13.50 on 31st December 2019. He was taken to hospital where he was sadly pronounced deceased soon after arrival.


He suffered from paranoid schizophrenia and was prescribed clozapine, risperidone and fluoxetine. Toxicology examination after death confirmed a toxic level of clozapine.


The most likely cause of the clozapine toxicity was down to not monitoring the levels sufficiently following cessation of smoking and not adjusting the levels prescribed.


A raised clozapine level in February 2019 had not been acted upon which should have resulted in a lower dose which would have avoided his death. Following a post mortem, the medical cause of death was determined to be clozapine toxicity.


Commenting on the case and specifically why she thought there was a risk of future deaths the Senior Coroner for Birmingham and Solihull Louise Hunt said:


“During the course of the inquest, the evidence revealed matters giving rise to concern. In my opinion, there is a risk that future deaths will occur unless action is taken.


“The matters of concern relating to Birmingham and Solihull Mental Health Foundation Trust include the following:


“In February 2019 a blood test result confirmed that Mr Allen had a high level of clozapine in his blood. This was not acted upon and no further blood test was taken. The clozapine dose was not adjusted as it should have been.


“There was no system in place at the time to ensure blood test results were escalated to the consultant to ensure action was taken.


“There was a general lack of understanding at the inquest about the importance of monitoring clozapine levels and how frequently these levels should be monitored.


“The matters of concern relating to the Department of Health including the following:


“I heard evidence at the inquest that there was a general lack of understanding about clozapine monitoring, which blood test to undertake and the general effect this drug can have on patients. I heard evidence that national guidance was required to clearly set out how frequently clozapine levels should be monitored and what type of blood test should be undertaken.


“Further education is required of Mental Health practitioners on the importance of clozapine monitoring and level adjustment.


“In my opinion action should be taken to prevent future deaths and I believe you have the power to take such action.”


This circular is being shared under the Open Government Copyright licence.


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