Recurring concern

Unreliable safety monitoring and guidance for clozapine treatment

First to latest report 29 Sep 2014 — 14 Jan 2026

Reports that mention this concern
17
Times this concern has been raised
25
Stated actions linked to this concern
52

What this concern includes

Includes failures or unresolved safety deficiencies in controls specifically dedicated to clozapine treatment, including evidence and guidance on serious adverse effects, blood and physical-health monitoring, cardiac monitoring, detection of blood cancers or cardiomyopathies, missed-test tracking, care plans, audit, toxicity warnings and communication to patients, families or staff.

What is not included
  • Excludes medication-safety concerns involving medicines other than clozapine unless the report explicitly ties them to the clozapine safety system.
  • Excludes generic clinical training, communication, record-keeping or monitoring deficiencies that are not specifically dedicated to clozapine treatment.
  • Excludes prescribing, administration, supply or adherence failures where clozapine-specific safety monitoring or guidance is not the unsafe condition.
  • Excludes treatment of an established blood cancer, cardiomyopathy or other adverse effect after the clozapine safety-monitoring process has operated adequately.
  • Excludes general oncology, cardiac-screening or antipsychotic-treatment concerns without a material clozapine connection.

Reports and published responses 17 reports

See individual reports that have raised this concern, and the actions taken in response

  1. West Sussex

    AI-generated summary

    Katharine Eva Stamp · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Katharine Eva Stamp died while detained under the Mental Health Act from sudden cardiac arrhythmia due to hypoxia, with the hypoxia described as involving aspiration pneumonia, probable sleep apnoea, obesity, smoking and clozapine effects. The report raised concerns that clozapine side effects, particularly in relation to smoking and pneumonia, were under-appreciated and that the BNF did not provide sufficient clarity to prescribers; it also stated that the lack of an effective national weight-gain monitoring programme for mental health inpatients was causally linked to her obesity and probable sleep apnoea.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Under-appreciation of clozapine side effects relating to smoking and pneumonia

    Wider context from the report

    “The side effects of clozapine, with specific reference to smoking and pneumonia, are under-appreciated Professor ████████ gave expert evidence to the Court These side effects may be rare, but they are still important The BNF does not provide sufficient clarity to prescribers about these side-effects ”

    Source location

    Katharine Eva Stamp · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report

  2. South Wales Central

    AI-generated summary

    Mr. Christopher Summerhayes · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Mr. Christopher Summerhayes was found deceased at his home address after a significant medical history including double scoliosis, treatment-resistant schizophrenia and a complex regime of around 12 daily medications. The concerns included the prescription of clozapine alongside other medications, substantial weight gain and possible effects on his cardiovascular system, as well as a possible familial lipid disorder. The inquest concluded that the medical cause of death was ischaemic heart disease, with a narrative determination referring to atypical early-onset coronary artery atherosclerosis and complex prescribed medications.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Potential contraindication to clozapine from familial lipid disorder

    Wider context from the report

    “(1) In relation to Christopher Summerhayes, Clozapine was prescribed as a concomitant medication alongside approximately 11 other drugs including another anti-psychotic medication. Either alone or interaction with other prescribed medication, a large increase in weight occurred to >101kg (BMI 33.1) (reported side effect of clozapine) which had a ‘knock-on’ effect for his cholesterol and lipid levels and cardiovascular system. The usual dose is 200-450mg daily with the maximum dose being 900mg (BNF) which does not consider concomitant medications. Signs of prescription overdose include collapse and hallucinations which could be mistaken for unresolved symptoms of schizophrenia i.e. lack of drug efficacy encouraging dose increase. Blood levels of clozapine may rise in response to smoking cessation which Mr. Summerhayes had advised we was commencing. (2) He may have suffered from a familial lipid disorder (present in other family members) which had it been confirmed would likely to have contraindicated Clozapine. ”

    Source location

    Mr. Christopher Summerhayes · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Apply NICE-aligned physical-health monitoring arrangements for patients taking Clozapine.

    Verbatim wording from the response

    “Guidance from the National Institute of Health and Care Excellence (NICE) for assessing physical health of patients on Clozapine is available on their website (www.nice.org.uk) and monitoring arrangements are in place in line with this guidance.”

    Source location

    2019-0263-Response-by-University-Health-Board
    Page 2 · response
    Published 17 October 2019

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Existing medicines reconciliation, pharmacist support, NICE monitoring and promoted polypharmacy reviews address medication interaction and prescribing risks.

    Verbatim wording from the response

    “The UHB has a Medicines Code in place and this was updated in 2018. It contains a section on medicines reconciliation. It sets out the responsibilities of various healthcare professionals in this process, including doctors, the pharmacy team and other prescribers.”

    Source location

    2019-0263-Response-by-University-Health-Board
    Page 2 · response
    Published 17 October 2019

    Open published response

  3. Staffordshire South

    AI-generated summary

    Thomas Paul Arthur JACKSON · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Thomas Paul Arthur Jackson was found in a poorly state in his room at a secure unit within St George’s Hospital, Stafford, in the early hours of 25 August 2016 and was certified dead at 02.25 hours. The inquest recorded clozapine toxicity and pneumonia as causes of death, with treatment-resistant schizophrenia also noted; the substantive concern was the lack of a national policy for regular blood plasma monitoring of patients receiving clozapine.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure of staff to recognise Clozapine significance, side-effects and warning signs of deterioration

    Wider context from the report

    “(3) It is clear that Clozapine is a beneficial drug for many patients and that a large number of patients in the care of the Trust do receive this drug. However it appears that many staff are not aware of the significance of this medication particularly when considering potential side-effects and warning signs of deterioration. ”

    Source location

    Thomas Paul Arthur JACKSON · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of national policy for regular clozapine blood plasma-level testing

    Wider context from the report

    “It is well known that Clozapine is a potentially dangerous drug which needs to be carefully monitored. Monitoring is for both whole blood to look at infection markers and for blood plasma to cheek on Clozapine levels. Since this death the Trust involves has established a policy for the regular checking of blood plasma levels for patients in receipt of Clozapine. However it appears that this is a local policy and that there is no national policy for these checks to be carried out. I wonder if there should be a direction for all trusts to carryout blood plasma tests on patients receiving Clozapine on a regular basis perhaps at least six monthly or yearly. ”

    Source location

    Thomas Paul Arthur JACKSON · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The MHRA is responsible for medicine safety and will assess whether therapeutic drug monitoring supports safer clozapine use.

    Verbatim wording from the response

    “As you may be aware, the Medicines and Healthcare products Regulatory Agency (MHRA), is responsible for the safety of medicines and medical devices. The MHRA seeks independent advice from the Commission on Human Medicines (CHM) which advises on whether the overall balance of benefits and risks of medicines is favourable at the time of licensing and remains so thereafter.”

    Source location

    Response from DHSC
    Page 2 · response
    Published 12 April 2019

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The NICE guideline surveillance team will consider whether guidance on clozapine plasma-level monitoring requires updating.

    Verbatim wording from the response

    “I am informed that clinical guideline CG178 is to undergo a surveillance review to check whether it needs to be updated and given the concerns you raise, the issue of monitoring blood plasma levels in people taking clozapine (or other antipsychotics) has been logged for the consideration of the guideline surveillance team undertaking the review process.”

    Source location

    Response from DHSC
    Page 2 · response
    Published 12 April 2019

    Open published response

  4. Manchester South

    AI-generated summary

    Michael Roy Mahon · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Michael Roy Mahon was found dead at home on 13 September 2016 after a period of deteriorating health and obesity while prescribed clozapine. The inquest heard that he had not received an annual test required for people prescribed clozapine, and that there was no system to identify the missed test or that it had not been noticed during monthly checks. The recorded cause of death was dilated cardiomyopathy, with obesity and clozapine therapy, and alcohol use also listed.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of a system to identify missed annual clozapine tests

    Wider context from the report

    “In the course of the inquest I heard evidence that both annual and monthly tests should be undertaken where clozapine has been prescribed. The annual test was required to identify symptoms and potential side effects that would not necessarily be picked up on monthly tests. Michael Mahon had not had his annual test. This should have taken place in March 2016.It was accepted that there was no system to identify that the test had been missed and it was not noticed at any of his monthly checks. ”

    Source location

    Michael Roy Mahon · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

  5. North London

    AI-generated summary

    Benjamin Thomas Brown · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Benjamin Thomas Brown was a patient detained under section 2 of the Mental Health Act who was found unresponsive at 8.45am after gaps and inaccurate entries in the required 15-minute observation records. He was recognised as having died at 10.06, and the inquest recorded natural causes, with sudden cardiac death due to cardiac arrhythmia. The substantive concerns related to auditing 15-minute observations, staff resuscitation training, and auditing the prescription and management of clozapine.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to audit clozapine prescription and management

    Wider context from the report

    “3, The auditing for the prescription and management of clozapine. ”

    Source location

    Benjamin Thomas Brown · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

  6. North London

    AI-generated summary

    Hana Aisha Abd Elhamid · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Hana Aisha Abd Elhamid was being treated with Clozapine for a mental health condition and developed diabetes, which was likely not identified because routine fasting blood tests were not carried out. She later required intubation for a diabetic coma, self-extubated and sustained airway injury, and died after subsequent breathing difficulties and treatment for a narrowed airway. The principal concerns were the failure to perform routine blood sugar testing and the resulting airway injury during treatment.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to perform routine blood sugar testing during long-term Clozapine treatment

    Wider context from the report

    “that this patient developed diabetes whilst on long term Clozapine treatment and that routine blood tests for sugar in the blood are likely to have prevented events, the need for intubation during treatment for a diabetic coma with resultant trachea injury following self -extubation, that directly led to the patients death ”

    Source location

    Hana Aisha Abd Elhamid · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Share the coroner’s report with NHS England.

    Verbatim wording from the response

    “Your report has also been shared with NHS England. NHS England is currently working with the Royal College of Psychiatrists and the Prescribing Observatory for Mental Health to investigate patient safety incidents associated with Clozapine. Patient monitoring is included within the scope of this work. Should compelling evidence of system failures be found, then NHS England would support work to improve management and minimise harm.”

    Source location

    2015-0194-Response-by-Department-of-Health
    Page 2 · response
    Published 13 May 2015

    Open published response

  7. North Wales (East and Central)

    AI-generated summary

    Christopher Paul Davies · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Christopher Paul Davies was found unresponsive at home on 5 February 2014 and was verified dead that day; the inquest recorded accidental death, with the cause stated as clozapine poisoning. Concerns were raised that information about possible interactions between clozapine, caffeine and changes in smoking, and about warning signs of toxicity, had not been communicated to the deceased or Community Mental Health Team staff.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to communicate the effects of caffeine and smoking changes on clozapine levels

    Wider context from the report

    “He stated that although his son’s clozapine levels were being regularly monitored, at no point was he ever made aware of the possible interaction between caffeine or the cessation/reduction of smoking in relation to clozapine levels, nor was he made aware of the possible warning signs of toxicity. It was therefore felt that there should be greater emphasis placed on the sharing of this knowledge with users and with staff within the Community Mental Health Team. It was also felt that due to memory issues, patients should be regularly reminded of this information. ”

    Source location

    Christopher Paul Davies · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report

Actions and positions describe what organisations say in published responses. Implementation is not independently verified.

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Data last updated 7 September 2026