MEDICATION SAFETY: Clozapine Initiation Chart Review Safer prescribing, dispensing and administration of medicines to minimise patient harm Delivering a Healthy WA

Top 3 Medications Involved Background The NMAHS-MH (2007-2011) AIMS data found Clozapine the 2nd most frequently involved with a medication incident Top 3 Medications Involved Quetiapine 91 Clozapine 80 Paracetamol 79 Found clozapine involved with the 2nd highest number of medication incidences Adverse reactions Incomplete monitoring Wrong dose Wrong time Wrong patient!!!! Clozapine has the potential for serious ARs which include agran, cardiomyopathy in the long term and has lead to mandatory monitoring via the national database. There are also immediate effects such as tachycardia, elevated temperature, NMS and seizures. We can see that it’s a real concern that clozapine is so frequently involved in incidents and that monitoring is critical Potential for serious adverse reactions gives rise to special considerations in prescribing, administration and monitoring the use of the drug

Concerns We thought Pre-treatment assessments not done clozapine initiation obs not completed Abnormal results not acted on Documentation in multiple locations In addition to the Clinical Incident Report, we were aware that clozapine initiation obs were not being completed in accordance with guidelines; that there were several separate documents, often filed separately; that the responsibility for completing the monitoring was not clearly allocated; and that information, instructions and support material was not readily at hand We knew we needed to create a safety plan

Solution Clozapine initial prescribing, administration and monitoring was not on a standardised chart Clozapine support materials were not readily available Clozapine Initiation Chart We knew we needed to create a safety plan and thought that an initiation chart was the solution Through the Medication Safety Network we discovered that our colleagues at Freo had the same concerns and had come to the same conclusions, and so a collaboration was born.

Concerns We thought OCP thought Pre-treatment assessments not done clozapine initiation obs not completed Abnormal results not acted on Documentation in multiple locations Pre-treatment assessments not done Patient monitoring not completed Abnormal results not acted on Documentation in multiple locations Coincidentally the OCP conducted a thematic review into adherence to clozapine monitoring requirements and they drew the same conclusions We needed a clozapine initiation chart

A chart is born Clozapine Initiation chart: based on current clozapine manufacturer, TGA and hospital guidelines manage pre-treatment screening monitoring, prescribing & administration of clozapine titration provide support material in the safe prescribing & administration of clozapine titration decision support for managing side-effects

Layout of Clozapine Initiation Chart FRONT PAGE: Patient Identification Allergies and Adverse Drug Reactions Pre-commencement documentation and checklist Observations (Temp, Pulse, Blood pressure, Respiratory rate)

Layout of Clozapine Initiation Chart INSIDE PAGE (Opens into A3): Dose Orders Suggested Dosing Regimen Monitoring

Layout of Clozapine Initiation Chart BACK PAGE: Clozapine blood results monitoring Guidelines for recommencing therapy after interruption Guidelines for blood test monitoring after interruption of therapy Alerts on side-effects associated with clozapine

Before Clozapine Chart Clozapine Initiation Chart Review Retrospective review on the adherence to treatment guidelines when initiating clozapine at Graylands Hospital Data collected using a standardised data collection tool designed by the Office of the Chief Psychiatrist Sample demographic: Before Clozapine Chart After Clozapine Chart No Patients 19 38 Male 14 33 Female 5 The “before clozapine chart” – sample taken before the chart started at GH The “ after clozapine chart” – sample taken after the chart started at GH Chart started in GH 1st Feb 2012. Prior to the use of the initiation chart there were a number of separate documents: patient obs chart, variable dose chart, clozapine initiation checklist that covered the pre-initiation requirements eg cardiac monitoring, medical history, other antipsychotics used

Results of Review Pre commencement Data 100% 100% 100% 100% 100% 94% 100% 100% Patients (%) Majority of records provided evidence that the pre commencement criteria were met In the ‘Before Clozapine Chart’ sample, this information is located in a separate file In the ‘After Clozapine Chart’ sample, this information is located on the chart Majority of records provided evidence that the pre commencement criteria were met HOWEVER in the ‘before’ audit this was based on the checklist, in the ‘after’ audit it was on the chart 94%- this was left empty on the chart and was not documented in the notes.

Before Clozapine Chart Results of Review Commencement Checklist Before Clozapine Chart After Clozapine Chart Clozapine Registration form has been completed 100% Eligibility with PBS has been checked & documented 97.22% Arrangements made for continuation of supply at a registered Clozapine centre after discharge 94.44% Clozapine notification has been viewed CMI and treatment explained Patient Consent Form in patient's file 89.47% Patient Clozapine number in patient's file 31.58% 97.37% “After Clozapine Chart”- PBS eligibility; arrangement for continuation, clozapine notification view, CMI (left blank on the chart) “Before Clozapine Chart”- although ticked as complete could not find evidence in the file. This is the same for “after clozapine chart” Majority of the commencement checklist were ticked Some of the ‘Patient Consent Form’ were ticked but no evidence was located in the file

Results of Review 100% 100% 100% 100% 100% 100% 84% 76% 80% Patients (%) 37% The values in the above chart represent the actual evidence has been sighted in the patient notes. Although physical examination, serum Cr and beta HCG are ticked as complete, there was no supporting evidence of the test in the progress notes performed within 10 days prior to commencement

Results of Review Cardiovascular Indicators Patients (%) 100% 100% 94% 95% 89% Patients (%) 56% 50% 42% 39% 33% 32% 28% 25% 26% 21% 21% 5% 0% 0%

Results of Review Other assessments Other assessments are also recommended to assess the impact of antipsychotic medications on an individual’s physical health 100% 100% 100% 84% Patients (%) 42%

Results of Review Clozapine introduced as per Clopine Titration Schedule This table serves as a guide only and dose titration should be individualised. Patients > 65 years of age may require a slower dose increase titration regime. Titration beyond 200mg/day: If well tolerated, the daily dose may be increased slowly in increments of 25-50mg (maximum100mg/week). Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Morning 12.5mg 25mg 50mg Evening 75mg 100mg 125mg 150mg Clozapine introduced faster than Schedule Clozapine introduced slower than Schedule Before Clozapine Chart 92.31% 7.69% After Clozapine Chart 28.57% 71.43% Patients (%) “before clozapine chart”- 32% of patient files followed the clopine schedule “after clozapine chart”-26% of patient files followed the clopine schedule When looking at it in detail, “before clozapine chart”- titration was faster than schedule & “after clozapine chart”- titration was slower. 32%

Before Clozapine Chart Results of Review Initial Vital Sign Observations (Baseline) Patients (%) Evidence of all Temp, Pulse, BP & RR taken at baseline Before Clozapine Chart 36.84% After Clozapine Chart 68.42% 71% 71% 71% 68% 37% 37% 37% 37% Administration and monitoring - should note that we have a twice yearly clozapine education program that is delivered to nursing staff – ward based, multiple sessions to capture shifts The graph represents each individual obs. The table on the right hand side represents when all 4 obs (Temp, Pulse, BP, RR) are complete.

Before Clozapine Chart Results of Review Initial Vital Sign Observations (First 24 hours) 95% 95% 95% 87% Patients (%) Evidence of all Temp, Pulse, BP & RR taken hourly for first 6 hours then every 6 hours Before Clozapine Chart 15.79% After Clozapine Chart 86.84% 21% 21% 16% 16% Clozapine initiation protocol states: TPR & resps At baseline (ie prior to first dose) Hourly for the first 6 hours Every 6 hours for the rest of the first 24 hours Remember the education program – staff should be aware Big improvement – it’s on the chart, right there in front of you!

Before Clozapine Chart Results of Review Initial Vital Sign Observations (Day 2 to 7) Evidence of all Temp, Pulse, BP & RR taken twice daily Before Clozapine Chart 5.26% After Clozapine Chart 13.16% Patients (%) Not as notable, but some overall improvement In the BEFORE Clozapine Initiation Chart sample, it was noted that 2 patients did not have any vital sign observations taken from Day 1 to 7 HANDWRITE patient name to reduce the risk of wrong identification label being placed on the chart

Reason for not administering not recorded Results of Review Administration Record 100% Patients (%) 68% Reason for not administering not recorded

Results of Review Post Cessation Monitoring Before Clozapine Chart After Clozapine Chart Number of Px that ceased Clozapine 2 5 Px that received post cessation monitoring 0 (0.00 %) 3 (60.00%) Reasons for Clozapine Cessation (documented in the notes) : Increased Troponin Hypotension Incontinence Increased Eosinophils Non compliant with blood monitoring Refused clozapine Severe diarrhoea Weight gain Post cessation monitoring: WCC & neutrophils at cessation and one month later (or weekly if within 1st 18 weeks of treatment) HANDWRITE patient name to reduce the risk of wrong identification label being placed on the chart

Summary Introduction of the Clozapine Initiation Chart resulted in: overall improvements in adherence to guidelines for safe administration of clozapine standardised recording of clozapine titration orders identified areas of the chart that needs to be improved Ongoing education is required to ensure the clozapine chart is completed and evidence is provided in the integrated progress notes where necessary A staff satisfaction survey is underway Chart has been well accepted Chart has resulted in improved adherence to prescribing and monitoring requirements Will be some time before we are able to assess any change in clinical incident reports

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