MEDICATION SAFETY:
Clozapine Initiation Chart Review
Safer prescribing, dispensing and administration of medicines to minimise patient harm
Delivering a Healthy WA
Background
 The NMAHS-MH (2007-2011) AIMS data found Clozapine the
2nd most frequently involved with a medication incident
100
Number of Incidents
90
80
70
60
50
Top 3 Medications Involved
Quetiapine
91
Clozapine
80
Paracetamol
79
40
30
20
10
0
 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
Solution
 Clozapine initial prescribing, administration and
monitoring was not on a standardised chart
 Clozapine support materials were not readily available
 Clozapine Initiation Chart
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
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
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
5
Results of Review
Pre commencement Data
100%
100% 100%
100%
100%
100%
94%
100% 100%
Patients (%)
90%
80%
70%
60%
50%
40%
30%
20%
10%
Trialled on 2 or more
other antipsychotics
Questioned about having Questioned about history Questioned about having
a chronic medical
of CVD
a history of epileptic
condition
seizures
Before Clozapine Chart
After Clozapine Chart
 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
Results of Review
Commencement Checklist
Before Clozapine
Chart
After Clozapine
Chart
Clozapine Registration form has been completed
100%
100%
Eligibility with PBS has been checked & documented
Arrangements made for continuation of supply at a
registered Clozapine centre after discharge
100%
97.22%
100%
94.44%
Clozapine notification has been viewed
100%
94.44%
CMI and treatment explained
100%
94.44%
Patient Consent Form in patient's file
89.47%
94.44%
Patient Clozapine number in patient's file
31.58%
97.37%
 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%
100%
84%
90%
76%
80%
80%
70%
Patients (%)
60%
50%
37%
40%
30%
20%
10%
0%
Physical
Examination
Full Blood Count
Blood group
Before Clozapine Chart
Serum Cr
Beta HCG
After Clozapine Chart
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
100%
100%100%
100%
94%
95%
89%
90%
80%
Patients (%)
70%
56%
60%
50%
50%
42%
39%
40%
33%
32%
30%
25%
28%
26%
21%
21%
20%
5%
10%
0%
0%
0%
Weight
Height
BMI
Waist
Lipids (f)
Before Clozapine Chart
Troponin
ECG
After Clozapine Chart
Cardiac
Echo
Dietician
Review
Smoking
Status
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%
100%
Patients (%)
90%
84%
84%
80%
70%
60%
42%
50%
40%
30%
20%
10%
0%
LFT
U& E
Before Clozapine Chart
After Clozapine Chart
BSL (f)
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
Morning
12.5mg
2
3
25mg
25mg
Evening
4
5
6
7
8
9
10
11
12
13
14
25mg
25mg
25mg
25mg
25mg
50mg
50mg
50mg
50mg
50mg
50mg
25mg
25mg
50mg
75mg
100mg
100mg
100mg
125mg
125mg
125mg
150mg
100%
90%
Clozapine
Clozapine
introduced faster introduced slower
than Schedule
than Schedule
80%
Patients (%)
70%
60%
50%
40%
32%
30%
26%
20%
10%
0%
Before Clozapine Chart
After Clozapine Chart
Before Clozapine
Chart
92.31%
7.69%
After Clozapine
Chart
28.57%
71.43%
Results of Review
Initial Vital Sign Observations (Baseline)
100%
90%
Patients (%)
80%
71%
70%
71%
71%
Evidence of all
Temp, Pulse, BP &
RR taken at baseline
68%
60%
50%
37%
37%
37%
37%
40%
30%
20%
10%
0%
Temp
Pulse
Before Clozapine Chart
BP
After Clozapine Chart
RR
Before Clozapine
Chart
36.84%
After Clozapine
Chart
68.42%
Results of Review
Initial Vital Sign Observations (First 24 hours)
95%
100%
95%
95%
87%
90%
Patients (%)
80%
Evidence of all
Temp, Pulse, BP & RR
taken hourly for first 6
hours then every 6 hours
70%
60%
50%
40%
30%
20%
21%
21%
16%
16%
10%
0%
Temp
Pulse
Before Clozapine Chart
BP
After Clozapine Chart
RR
Before Clozapine
Chart
15.79%
After Clozapine
Chart
86.84%
Results of Review
Initial Vital Sign Observations (Day 2 to 7)
100%
90%
80%
Evidence of all
Temp, Pulse, BP & RR
taken twice daily
Patients (%)
70%
60%
50%
40%
26%
30%
20%
16%
21% 21%
21% 26%
16%
Before Clozapine
Chart
5.26%
After Clozapine
Chart
13.16%
5%
10%
0%
Temp
Pulse
Before Clozapine Chart
BP
RR
After Clozapine Chart
In the BEFOREHANDWRITE
Clozapine Initiation
it was
that
2
patientChart
namesample,
to reduce
thenoted
risk of
wrong
patients did not have
any vital sign
observations
takenon
from
1 to 7
identification
label
being placed
theDay
chart
Results of Review
Administration Record
100%
100%
90%
Patients (%)
80%
70%
68%
60%
50%
40%
30%
20%
10%
0%
Before Clozapine Chart
After Clozapine Chart
Reason for not administering
not recorded
Results of Review
Post Cessation Monitoring
Before Clozapine Chart
Number of Px that ceased Clozapine
Px that received post cessation monitoring
After Clozapine Chart
2
5
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
HANDWRITE patient name to reduce the risk of wrong

Weight gain
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
Questions and
Comments