Case study (Evidence into Practice): Clozapine Monitoring in Medium Secure Services
9 Sep 2026
Excellence in Clinical Audit Awards, part of Clinical Audit Awareness Week 2026, Evidence into Practice Award runner-up
This project was designed as a structured, multi-cycle clinical audit to evaluate compliance with policy and guidelines of Clozapine, an antipsychotic medication with risk of fatal side effects. It combined robust quantitative monitoring with multidisciplinary qualitative analysis, enabling clear identification of issues, to deliver a strong foundation for evidence-informed change. Across three cycles, the audit demonstrated transformational improvements and sustained adoption. Discover much more about the impact of this work in the case study below:
This project was initiated following a catastrophic event at Ty Llewelyn Medium Secure Services involving the death of a patient who was prescribed clozapine, which led to increased scrutiny of clozapine monitoring practices within the service.
Clozapine is a high-risk medication requiring robust and consistent physical health monitoring, including early detection of potentially serious complications such as cardiovascular effects, haematological abnormalities, and severe constipation. The incident highlighted the need to ensure that monitoring processes were fully aligned with BCUHB Policy MM22 and NICE Guideline CG178, and that these were consistently applied in practice.
Although a monthly Clozapine Clinic had been established within the unit since 2021, the first audit cycle of this project identified variation in practice, particularly in documentation, treatment initiation processes, and consistency of monitoring standards. This created a clear need to:
- Strengthen governance and oversight
- Standardise clinical and documentation processes
- Improve staff confidence and clarity regarding expectations
- Reduce the risk of preventable harm
The audit was therefore designed as a multi-cycle quality improvement programme, to systematically identify gaps, implement targeted changes, and ensure improvements were embedded and sustained over time.
The project was delivered by Betsi Cadwaladr University Health Board (BCUHB), Mental Health & Learning Disabilities Division (MHLD), including the following team members:
- Nicky Jones – Forensic Clinical Site Manager
- Sarah Senior – Quality Improvement Lead
- Sian Redfern – Staff Nurse, Clozapine Clinic Nurse
- Sara Szajnowska – Staff Nurse, Clozapine Clinic Nurse
- Emma Shepherd – Staff Nurse, Clozapine Clinic Nurse
- Delyth Owen – Staff Nurse, Clozapine Clinic Nurse
- Jaime Boyd – Deputy Ward Manager
- Annabelle Byrne – Staff Nurse
- Jodi Wynne – Student Nurse
Who is the project designed to support?
The audit focused on all patients across the three wards within Ty Llewelyn Medium Secure Unit who are prescribed clozapine.
It also aimed to support nursing and clinical staff delivering clozapine care and the wider forensic mental health service seeking to standardise safe practice.
What did it set out to achieve?
The overall aim was to ensure all patients prescribed clozapine receive safe, consistent and policy-compliant physical health monitoring in line with BCUHB policy and NICE guidance, ultimately improving patient safety, experience and outcomes in a high-risk, complex care environment.
Key objectives included:
- Assessing compliance with clozapine monitoring standards
- Identifying gaps or inconsistencies in practice
- Understanding contributory factors
- Implementing targeted improvements
- Measuring impact through repeated audit cycles
How did the project work?
A full clinical audit cycle methodology was used, involving a retrospective review of all patients prescribed clozapine, data collection from multiple sources (clinical notes, medication charts, clinic documents, monitoring tools), and measurement against 16 evidence-based criteria drawn from policy and NICE guidance.
The audit was conducted over three cycles:
- Cycle 1: June–August 2024 (data collected September 2024)
- Cycle 2: March–May 2025 (data collected June 2025)
- Cycle 3: November 2025–January 2026 (data collected March 2026)
Following each cycle, results were analysed, Root Cause Analysis (RCA) was undertaken with multidisciplinary involvement, and improvement plans were developed and implemented.
This iterative process enabled continuous quality improvement across the three cycles.
Did the project involve changes to processes in order to implement?
Significant changes to clinical processes and systems were introduced, including the development and implementation of a Clozapine Clinic Checklist aligned to audit standards, standardisation of clinic processes and documentation, improved accessibility and recording of the ZTAS Clozapine Handbook, introduction of individual bowel care plans, standardisation of Bristol Stool Chart use across wards, and improved communication regarding bowel monitoring to reduce patient anxiety and duplication.
These changes focused on embedding consistent, reliable, and auditable processes into routine care.
Did the project succeed and, if so, what is the evidence?
The project demonstrated significant and sustained improvement across the audit cycles.
Compliance improved from 6 out of 15 criteria in Cycle 1 to 14 out of 16 in Cycle 3. 100% compliance was achieved in clinic attendance, GASS assessments, physical observations, side-effect reviews, annual medication reviews and blood monitoring.
Documentation of bowel patterns improved from 10% in Cycle 2 to 100% in Cycle 3.
While most criteria reached full compliance, completion of one documentation element (monitoring guidelines) remained an area for ongoing improvement.
Overall, the audit clearly demonstrated measurable improvements in safety, reliability and governance.
Other insights or learning points
Key learning points include the importance of structured tools, such as checklists, in embedding best practice. Documentation gaps often reflect process and system issues, rather than knowledge deficits. Root Cause Analysis with frontline staff is essential for identifying realistic solutions, while sustained improvement requires ongoing audit, training and leadership oversight. Multidisciplinary collaboration strengthens ownership and long-term success.
The work also highlighted how small process changes can have a significant impact on patient safety.
