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

2. Top 3 Medications Involved
Background
The NMAHS-MH ( ) 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

3. 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

4. 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.

5. 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

6. 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

7. 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)

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

9. 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

10. 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

11. 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.

12. 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

13. 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

14. 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%

15. 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%

16. 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%

17. 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.

18. 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!

19. 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

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

21. 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

22. 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

23. Questions and Comments