CLOZAPINE PATIENT PROTOCOL - 4 WEEKLY GP SHARED CARE	Ref. SA Health MR-77D Form	

	Affix patient identification label in this box (for CMHS use)	

Patient UR No:<<Operation:UR No>>	
Gender: <<Patient Demographics:Gender>>	

4 WEEKLY CLOZAPINE PATIENT PROTOCOL
GP Mental Health SHARED CARE	Family Name: <<Patient Demographics:Surname>>	

Given Name: <<Patient Demographics:First Name>>	

GP Details: 
<<Doctor:Name>>
<<Doctor:Provider Number>>
Practice Name: <<Practice/Location:Name>>
Address: <<Practice/Location:Address>>
Phone: <<Practice/Location:Phone>>	DOB: <<Patient Demographics:DOB>>	
Blood Group: <<Clinical Details:Blood Group>>	

Clozapine Patient No (CPN): <<Clozapine Patient No (CPN): >>	

Clozapine Coordinator (CC): <<Clozapine Coordinator (CC): >>	

Streamlined Code:   4998	Consultant Psychiatrist: <<Consultant Psychiatrist: >>	
Pharmacy: <<Pharmacy: >>	
	
CLINICAL OBSERVATIONS Protocol completed by Medical officer or designated Registered Nurse	
Note: The SA Health Clozapine Questionnaire can assist with the assessment process	
DATE		
						
Dosage/day (mg)	4 weekly	
						
Number of spare tablets 	4 weekly							
Temp/Fever assessment	4 weekly							
Pulse (manual)	4 weekly	
						
Respirations / O2 sats.	4 weekly							
Blood Pressure	4 weekly	
						
Blood glucose
(random)	3 monthly	
						
Weight (kg)	4 weekly	
						
Waist (cm)	4 weekly	
						
BMI (wt/ht²)	4 weekly	
						
Height (m) 	annual	
						
Cigarettes/day	4 weekly	
						
Constipation Ax

Seizure Activity Ax

Hypersalivation Ax

Sedation Ax

	
4weekly (Y/N)	

	

	

	

	

	

	

	

	

	

CLOZAPINE PATIENT PROTOCOL - 4 WEEKLY GP SHARED CARE	Ref. SA Health MR-77D Form	
PATHOLOGY Protocol: please consult with the treating psychiatrist when results are outside the recommended range	
Blood Count Assessment
	White Blood Cell and Neutrophil Count	
Range	
Action	

WBC >3∙5 x 109/L and NC > 2.0 x 109/L	
Green	
Clozapine therapy can continue 	

WBC 3∙0 – 3.5 x 109/L and/or NC 1.5 – 2.0 x 109/L	
Amber	
Requires increased monitoring to twice weekly	

WBC < 3∙0 x 109/L and/or NC < 1.5 x 10/L	
Red	
STOP clozapine immediately and repeat blood test within 24 hours.  Contact consultant psychiatrist, arrange urgent medical review	

DATE								
White Cell Count
	4 weekly							
Neutrophil Count
	4 weekly							
Clozapine Level	6 monthly							
Fasting Glucose	6 monthly							
Fasting Lipids	6 monthly							
Liver Function	6 monthly							
Electrolytes	6 monthly							
CRP	6 monthly							
Troponin T or I	6 monthly							
	
*Please include this monitoring data with the psychiatrist review request for a holistic assessment and recommendation.
For consistency of monitoring either troponin I or T levels must be performed by the same pathology company, particularly the first 12 weeks of initiation. 	

Additional Monitoring	Frequency	Date	Note	
Echocardiogram 	annual			
ECG 	annual			
Psychiatry review	6 monthly			
GP Contact Coordinator	1 – 3 months			

Information Sharing	Frequency	Date	Note	
GP contact with CC	1 – 3 monthly 			
Data sent to CC	1 – 3 monthly			
Current medications list	6 monthly			
* Please notify Clozapine Coordinator if consumer is COVID-19 positive. 
Note for Clozapine Coordinator:

	
Date:                                                                Signature:_________________________________	
* When completed please email or fax return to Clozapine Coordinator / persons local Mental Health Service	

CLOZAPINE PROTOCOL INFORMATION

Clozapine is a medication regulated by the TGA, under the Highly Specialised Drugs Program. It is a third line treatment for chronic schizophrenia refractory to treatment with other medications. Patients may only be prescribed clozapine when mandatory blood testing and other monitoring can be achieved in the community as per the Clozaril® Patient Monitoring Service (CPMS) Protocol 2019. This is not an exhaustive guide and more information can be found in the SA Heath Clozapine Management Clinical Guideline at www.sahealth.sa.gov.au/clozapine. 
NB: Clozapine dose can only be changed in consultation with the treating Psychiatrist
It is essential that the clozapine care cycle be monitored according to the schedule on this form.
Forwarding the completed attendance data to the community team after each assessment facilitates shared care and adds valuable information for the 6 monthly psychiatry review. 

POTENTIAL ADVERSE EFFECTS: (Medical Emergency) 	Please seek specialist advice and notify the Clozapine Coordinator	
Effect	Duration / time course	Action	
Fever and any infections 
	More common during initiation and is a significant ongoing risk 	Temperatures greater than 38° must be investigated with immediate CBE, Troponin T or I and high sensitivity CRP to rule out myocarditis, agranulocytosis and any severe infection that may lead to clozapine toxicity	
Agranulocytosis / neutropenia	More common during initiation. Risk is ongoing	ED assessment and full medical review.
Cease clozapine until cleared by CPMS	
Myocarditis: If Troponin >60ng/L and CRP elevated	
Most common during initiation	

Acute coronary syndrome:
Troponin 30-60ng/L and elevated CRP 	
Can occur at any time	

	Urgent transfer to Emergency department for investigation
Cardiology consultation, CPMS
Notify treating team and psychiatrist	
Tachycardia	Common and can persist	Monitor for signs and symptoms. May require ECG, cardiology review, discussion with psychiatrist	
Hypertension and hypotension	Can occur at any time	Check for dizziness, dehydration or chest pain. Check blood pressure and manual pulse at each review	
Cardiomyopathy	May occur later in treatment	Annual Echocardiogram and may require cardiologist review	
ECG changes – prolonged QTc	An ongoing risk factor	Consult cardiologist, psychiatrist and SA Health Clozapine Cardiac Guidelines	
Metabolic syndrome, weight gain, diabetes	Common and can persist	Chronic disease management plan Medicare items 721 – 732. 
Positive cardiometabolic algorithm.  	
Constipation / bowel obstruction 	Very common and usually persists	Actively Treat first line with softeners, stimulants and osmotic laxatives	
Hypersalivation	Very common and more noticeable at night	Consider hyoscine, suggest towel on pillow. Atropine is no longer recommended. 	
Nocturnal enuresis / urinary retention	Can occur at any time	Dose may need psychiatrist review	
Nausea, reflux	More common in first 6 weeks	Use antiemetics with caution	
Sedation	More common during initial phase but can be ongoing	Assess for compliance (missed doses), changes to smoking, drug interactions or infection. Discuss with psychiatrist  	
Seizures	More common with elevated levels>600 ug/L	Monitor levels 6 monthly or as clinically indicated. Check smoking status	
Myoclonic jerks 	Not uncommon and worse in the first few months	Investigate serum level and signs of toxicity	
Obsessional traits	Not uncommon	Supportive care and CBT approach	

Please contact the local mental health service for support if there are concerning side effects, symptoms, problems:
•	Deterioration in mental state and/or medication compliance
•	Significant changes to clozapine serum levels and other blood test results
•	If additional medication (dispensation) is required 
•	Transfer of the patient to another region
•	If you are moving and no other GP is available
•	Introduction of new medication that may affect serum levels
•	Treatment interruptions of greater than 48 hours that must be managed according to CPMS protocol below:
Period of Interruption since the last dose was taken	Dosage / Monitoring Requirements	
≤ 48 hours	No change to dosage or monitoring	
> 48 hours & ≤ 72 hours	Notify Clozapine Coordinator / psychiatrist and CPMS
Start on 12.5mg and titrate up. No additional monitoring requirements	
> 72 hours & ≤ 28 days	Notify Clozapine Coordinator / psychiatrist and CPMS 
Start on 12.5mg and titrate up. Weekly monitoring for 6 weeks.	
> 28 days	Is treated as a complete restart through the mental health team.