Leading change

The Medicines Safety and Governance Pharmacist and Deputy Chief Nurse for Northern Devon Healthcare NHS Trust led the development and implementation of clinical pathways and standard operating procedures to improve clozapine use across the Trust.

Where to look

NICE (2015) guidance advises that Clozapine is a specialist medication, indicated to treat schizophrenia in patients unresponsive to, or intolerant of, conventional antipsychotic drugs. NICE (2015) suggests that Clozapine is the only drug with established efficacy in reducing symptoms and the risk of relapse for adults with treatment‑resistant schizophrenia.

The Royal Pharmaceutical Society (2019) highlights that safe management and use of medicines is essential to ensure that patients derive the maximum benefit from treatment and are not put at risk of avoidable side-effects or medication errors. Poor management of medicines leads to increased morbidity, poor quality of life and poor health outcomes. Moreover, poor management of medicines also has cost implications due to wasted medicines resulting from poor adherence or inappropriate prescribing.

NHS Improvement identify that when things go wrong in care, it is vital incidents are recorded to ensure learning can take place. By learning, we mean people working out what has gone wrong and why it has gone wrong, so that effective and sustainable actions are then taken locally to reduce the risk of similar incidents occurring again.

To learn lessons from three suggested medication incidents for patients taking clozapine, the Medicines Safety and Governance Pharmacist and Deputy Chief Nurse at the Northern Devon Healthcare NHS Trust led a review of the cases. They identified that patients admitted to the Trust for acute medical care had not necessarily receiving their clozapine on time, with unwarranted variation in prescribing, dispensing and treatment delays, which was leading to extended hospital stays, sub-optimal treatment and associated patient distress.

What to change

As clozapine is a highly specialist treatment, pharmacy staff were aware of the importance of ensuring that clozapine needed to be prescribed, dispensed, supplied and administered on time, and also flagged when problems were identified with the timely supply of clozapine to patients. These incidents were reported on the Trust incident reporting system.

Incidents investigations by nursing leads however identified lower awareness levels within medical and nursing staff. In particular whilst there were a number of different contributing factors key themes included junior medical staff confidence in prescribing clozapine and nursing staff were not always aware of the implications of delaying clozapine for more than 48 hours. In particular that treatment delays of more than 48 hours required dose re-titration of clozapine, usually over a 14 day period as an in-patient. Recognising these unwarranted variations from best practice, nurses and pharmacists leads took the opportunity to lead change and improve practice.

A review of local and national prescribing guidelines also highlighted that the local mental health Trusts supported taking clozapine safely, with service user support information and prescribing information which resulted in far lower numbers of incidents.

How to change

It was agreed across the Multi-disciplinary team (MDT) that learning needed to be taken from this cluster of incidents to ensure that, when admitted to Northern Devon Healthcare Trust for acute episodes of care patients taking clozapine were safeguarded from harm.

Data suggested that junior doctors and nursing staff would benefit from education and increased awareness of their roles and responsibilities in relation to clozapine including:

• Initial prescribing of clozapine,
• pending specialist review;
• prompt supply of clozapine together with appropriate clinical checks and bloods,
• The safe and timely administration of clozapine.

The Trust Medicines Governance Group retains oversight of medicines related incidents and learning from these and with strong membership from medical, nursing and pharmacy teams became of forum for driving forward change in clozapine practices, in addition to wider stakeholder engagement, particularly with key nursing groups (ward managers’ meetings and the senior nurse forum).

Discussions with nursing staff identified that the system could benefit from a robust documented pathway for staff to follow, in relation to clozapine usage and this could reduce the unwarranted variations seen in practice. With this in mind a ‘Getting Clozapine Right’ Standard Operating Procedure (SOP) was developed with wide nursing and pharmacy stakeholder engagement. The SOP includes a clozapine checklist for staff to use, to ensure that staff ‘Get Clozapine Right’ and patients get clozapine on time.

The SOP now provides a clear pathway and checklist to follow for admitted patients who require clozapine, to ensure that it is prescribed, supplied and administered on time. The checklist includes information about referral to liaison psychiatry and pharmacy both in and out of hours.

The pharmacy team also worked with the pathology department, to ensure that patients already known to the Trust were identified and easily identifiable on the Trust’s digital Patient Administration System should they need acute admissions or care in the future.  GP practices were also asked to ensure that clozapine was included on the primary care patient care record.

Staff engagement via Trust Senior Nursing Forums and Ward Nurse Managers meetings raised awareness of the importance of clozapine, as a highly specialised and infrequently encountered medication in the acute secondary care setting and of the new SOP for use in practice.

Ward Nurse Managers and senior nurses briefed their ward nursing teams to highlight the clozapine checklist and SOP as did pharmacy leads and medical leads supporting the wards.

Engagement with wider stakeholders such as nursing and pharmacy staff from the local mental health Trust in Devon allowed the SOP to be further developed to include where to source specialist advice and practical details such as how to contact the psychiatric liaison team both in and out of hours / at weekends.

The SOP has also been included in the published ‘Getting Medicines Right’ bulletin for staff, which is available in the Trusts website to further raise awareness.

Adding value

Better outcomes – The Trust incident reporting system was used to monitor medication incidents for clozapine although incidents reports continue to be flagged none of the incidents reported since the implementation of the Standard Operating Procedures resulted in patient harm. The continued reporting of the incidents is felt to be appropriate as nursing and medical staff awareness of clozapine and the prescribing and dispensing guidelines has been increased and staff are keen to highlight areas of learning to further support the Trust to maximise safety within this area. The SOP’s success has also been measured in the significant reduction of patients needing clozapine dose re-titration due to delays in prescribing, dispensing or administration to zero. This has also had a positive impact upon patient well-being, length of hospital stays as well as wider outcomes as they continue to receive evidence based best practice care as they move between services.

Better experience – The new approach has been welcomed by both staff and patients using services as this has supported them to improve safety in clozapine use as well as more generally within the wards. For example;

“It is fantastic to see that small, simple changes have made a difference to the care and treatment that patients at our trust have received.”

Better use of resources – since the introduction of the SOP, there have been no extended patient stays in the acute setting to re-titrate clozapine which is positive and has freed up bed space for other unwell individuals to use.

Challenges and lessons learnt for implementation

Wide stakeholder engagement provides an opportunity for education as well as encouraging staff to learn from incidents.  Stakeholder engagement also generates momentum and encourages staff to support the initiative / work, as they ‘own’ the final product/s / documents.

The exercise of describing what should happen each time, to ensure patients received their clozapine on time was invaluable; asking, finding out and documenting each step; describing the roles and responsibilities of those involved; thinking laterally and including partner organisations in the development of the SOP and keeping the document up to date when systems changed all increased ownership.

The final document provides the organisational memory and audit standards.  The SOP also provides the nursing and medical teams with the knowledge and understanding of the steps and actions to take when a patient taking clozapine presents.  This allows staff to be confident as well as competent in their roles, and to provide safe, high quality care for patients.

Due to the success of the programme learning has also been shared via the South West Region Medicines Safety Officer (MSO) network, which includes acute and mental health Trusts in its membership.

Find out more

For more information contact:

• Joy Davey, Medicines Governance and Safety Pharmacist, Northern Devon Healthcare NHS Trust, Joy.davey2@nhs.net
• Andrea Bell, Deputy Chief Nurse, Northern Devon Healthcare NHS Trust, andreabell@nhs.net