Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how learning from serious incidents involving accidental Clozapine withdrawal is being recorded and shared nationally across NHS mental health services.

Clozapine is used to treat people with schizophrenia in whom other medicines have not worked. It is also used to treat severe disturbances in the thoughts, emotions, and behaviour of people with Parkinson’s disease in whom other medicines have not worked.

The known side effects of clozapine are outlined in the product information, the Summary of Product Characteristics (SPC) for healthcare professionals, and the Patient Information Leaflet which is provided in each pack of the medicine. The SPC states that clozapine should be stopped in a number of clinical situations including after developing a low white blood cell count, fever above 38^oC, high blood glucose, also known as hyperglycaemia, as well as jaundice or clinically relevant increases in liver enzymes. If clozapine is restarted it must be carefully titrated and monitoring requirements followed.

Inadvertent withdrawal of clozapine is an issue that is included in the National Health Service’s Time Critical Medicines Safety Improvement Programme, with further information avaiable at the following link:

https://www.sps.nhs.uk/articles/safer-use-of-time-critical-medicines-programme/

The programme is supporting over 50 NHS hospitals to improve the reliability of administration of Time Critical Medicines such as clozapine.

In July 2024 a thematic review of clozapine safety conducted in the North West of England was shared with the NHS England National Medication Safety Officer Network. This included a range of clozapine safety resources published online, such as:

- Managing the risks associated with patients prescribed clozapine, which is avaiable at the following link:
https://www.sps.nhs.uk/articles/managing-the-risks-associated-with-patients-prescribed-clozapine/;

- Clinical considerations for patients prescribed clozapine, which is avaiable at the following link:
https://www.sps.nhs.uk/articles/clinical-considerations-for-patients-prescribed-clozapine/;

- Managing constipation in people taking clozapine, which is avaiable at the following link:
https://www.sps.nhs.uk/articles/managing-constipation-in-people-taking-clozapine/;

- Clozapine use in adults with swallowing difficulties, which is avaiable at the following link:
https://www.sps.nhs.uk/articles/clozapine-use-in-adults-with-swallowing-difficulties/;

- Managing specific interactions with smoking, which is avaiable at the following link:
https://www.sps.nhs.uk/articles/managing-specific-interactions-with-smoking/; and

- Managing complexities of medication use across care boundaries, which includes a podcast on clozapine safety and which is avaiable at the following link:
https://www.sps.nhs.uk/articles/managing-complexities-of-medication-use-across-care-boundaries/.

As with all medicines, the safety of clozapine is kept under continual review by the Medicines and Healthcare products Regulatory Agency (MHRA) using a number of data sources. The MHRA is currently reviewing the blood monitoring requirements associated with clozapine.