Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the adequacy of laboratory and record-keeping systems supporting Clozapine treatment, and whether they meet the standards expected for equivalent safety-critical medicines in physical healthcare.

NHS England’s National Patient Safety Team collect records of all patient safety incidents recorded by National Health Service trusts via the Learn From Patient Safety Events service. These records are used to identify new and under-recognised risks to patient safety and to understand themes and trends. The insight generated informs work to improve patient safety across the NHS. Further information is available at the following link:

https://www.england.nhs.uk/patient-safety/patient-safety-insight/learning-from-patient-safety-events/using-patient-safety-events-data-to-keep-patients-safe/#

The safety of clozapine is kept under continual review by the Medicines and Healthcare products Regulatory Agency (MHRA) using a number of data sources, including reports of suspected side effects through the Yellow Card Scheme, data from marketing authorisation holders, and research published in the scientific literature.

Each clozapine marketing authorisation holder operates a Patient Monitoring Scheme which focuses on the blood monitoring requirements for clozapine. However, regular contact with healthcare professionals caring for patients receiving clozapine has resulted in a high proportion of suspected side effects being reported through the Yellow Card scheme. These reports are published by the MHRA in the interactive drug analysis profile for clozapine, with further information avaiable at the following link:

https://yellowcard.mhra.gov.uk/idaps/CLOZAPINE

The Summary of Product Characteristics for clozapine outlines the monitoring requirements needed to minimise the risks of possible side effects for healthcare professionals. However, the MHRA does not regulate clinical practice or audit NHS record-keeping systems.