Recurring concern
Unreliable safety monitoring and guidance for clozapine treatment
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Request correctionFirst reported 29 Sep 2014•Latest report 14 Jan 2026
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.
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
- 17
- Individual concerns
- 25
- Date range
- 2014–2026
- Stated actions
- 52
Distinct published reports
A report can raise multiple concerns
First to latest report issue date
Described in published responses
Reports over time
Reports over time
Reports about this concern issued each year.
* 2026 is projected from reports observed to 7 Sep 2026.
Most frequent recipients
Most frequent recipients
Reports about this concern sent to each recipient.
Concerns and responses across reports
Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.
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Concerns raised1
Under-appreciation of clozapine side effects relating to smoking and pneumonia
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
No linked response statementsNo respondent-stated action or position is linked to these concerns in the published data.
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Concerns raised1
Potential contraindication to clozapine from familial lipid disorder
This report raised 3 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1
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Action
Apply NICE-aligned physical-health monitoring arrangements for patients taking Clozapine.
Stated by Cardiff & Vale University LHB
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.1
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Position
Existing medicines reconciliation, pharmacist support, NICE monitoring and promoted polypharmacy reviews address medication interaction and prescribing risks.
Stated by Cardiff & Vale University LHB
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Concerns raised2
Failure of staff to recognise Clozapine significance, side-effects and warning signs of deterioration
Lack of national policy for regular clozapine blood plasma-level testing
This report raised 9 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.2
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Position
The MHRA is responsible for medicine safety and will assess whether therapeutic drug monitoring supports safer clozapine use.
Stated by Nicola Blackwood
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Position
The NICE guideline surveillance team will consider whether guidance on clozapine plasma-level monitoring requires updating.
Stated by Nicola Blackwood
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Concerns raised1
Lack of a system to identify missed annual clozapine tests
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
No linked response statementsNo respondent-stated action or position is linked to these concerns in the published data.
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Concerns raised1
Failure to audit clozapine prescription and management
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
No linked response statementsNo respondent-stated action or position is linked to these concerns in the published data.
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Concerns raised1
Failure to perform routine blood sugar testing during long-term Clozapine treatment
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1
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Action
Share the coroner’s report with NHS England.
Stated by Department of Health and Social Care
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Concerns raised1
Failure to communicate the effects of caffeine and smoking changes on clozapine levels
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concernsEach statement is shown once, even when linked to more than one concern.
No linked response statementsNo respondent-stated action or position is linked to these concerns in the published data.
Data last updated 7 September 2026