Download Quetiapine - Barnsley CCG

Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Quetiapine
Introduction
Licensed indication: Quetiapine (as either the immediate release tablet or the modified release tablet) is
licensed in the treatment of schizophrenia and of manic episodes associated with bipolar disorder either alone
or with mood stabilisers.
NB the modified release preparations are significantly more expensive that the immediate release tablets
Background Information
Quetiapine is an atypical antipsychotic and has a lower incidence of extra-pyramidal side effects than typical
antipsychotics. NICE guidance recommends atypical agents be considered in the choice of first-line treatments
for patients newly diagnosed with schizophrenia or for those patients suffering unacceptable adverse effects
with typical antipsychotics.
As per the guidelines issued by NICE, atypical antipsychotics should be considered:

First choice treatment for individuals with newly diagnosed schizophrenia.
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As an option for individuals currently receiving typical antipsychotic drugs who, despite adequate symptom
control, are experiencing unacceptable side effects.
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For those individuals whose illness is poorly controlled with conventional antipsychotic drugs or those who
relapse whilst using conventional antipsychotics.
Dosage and administration
Quetiapine immediate release tablets should be administered twice daily.
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Schizophrenia, in adults over 18 years: the licensed starting dose of quetiapine is 25mg twice daily on day
1, 50mg twice daily on day 2, 100mg twice daily on day 3, 150mg twice daily on day 4 and then adjusted
according to response, usual range 300–450 mg daily in 2 divided doses; max. 750mg daily.
Mania, in adults over 18 years: the licensed starting dose of quetiapine as either monotherapy or as adjunct
therapy to mood stabilizers is 50mg twice daily on day 1, 100mg twice daily on day 2, 150mg twice daily on
day 3, 200mg twice daily on day 4, and then adjusted according to response in steps of up to 200 mg daily
to max. 800 mg daily; usual range 400–800 mg daily in 2 divided doses.
For elderly patients or in renal or hepatic impairment: start at 25mg daily, and increase cautiously.
Quetiapine modified release tablets should be administered once daily.
(The XL preparations are significantly more expensive than the IR preparations and should only be used in
exceptional circumstances)
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Schizophrenia or mania, in adult over 18 years: 300 mg once daily on day 1, then 600 mg once daily on day
2, then adjusted according to response; dose range 400–800 mg once daily.
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For elderly patients or in renal or hepatic impairment: start at 50 mg once daily adjusted according to
response in steps of 50 mg daily.
quetiapine Shared care Guideline
Date Prepared: November 2015
Page 1 of 7
Review Date: November 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Responsibilities of the specialist initiating treatment
 Initiate and stabilise treatment with quetiapine (this phase is expected to last at least three months). To
initiate therapy, arrange prescription and evaluate over the first 3 months. To establish baseline and
after 3 months of treatment weight, blood pressure, fasting blood glucose or HbA1c and full lipid
screen (where possible). FBC and LFT should be measured where appropriate. Baseline renal function
 Discuss the benefits and side effects of treatment with the patient and DOCUMENT it in their
communications
 Ask the GP whether he or she is willing to participate in shared care and agree with the GP as to who
will discuss the shared care arrangement with the patient.
 Periodically review the patient’s condition and communicate promptly with the GP when treatment is
changed. To review the patient and treatment at least once a year until the patient is discharged
from the mental health service where this is possible.
 Advise the GP on when to adjust the dose, stop treatment, or consult with the specialist
 Report adverse events to the MHRA and GP
 Ensure that clear backup arrangements exist for GPs to obtain advice and support
 Specialists should be clear in their communication (letters) to GPs if they want GP to take over
prescribing or if the letter is just a treatment progress information / feedback to GPs.
 Specialist needs to enclose a completed SC Agreement form with the letter when requesting GP to
take over prescribing.
Responsibilities
of other
 Specialist should
indicateprescribers
specific diagnosis clearly in their letter. They should also make sure the
diagnosis is covered by the SCG before requesting GPs to take over prescribing.
Baseline Tests
. Prolactin, Urea & electrolytes (U&Es), Weight, Blood Pressure (BP) Fasting Plasma Glucose (FPG)/HbA1c or
Oral Glucose Tolerance Test (OGTT) and Blood Lipids
Routine Tests
Prolactin if symptoms occur, U&Es – 6 monthly, Weight – as needed
Disease monitoring
If the service user deteriorates please refer back to secondary care. Intervals of review should be agreed
between primary and secondary care.
General Practitioner Responsibilities
Acceptance of Responsibility by the Primary Care Clinician
It is optional for GPs to participate in taking on responsibility for shared care for the patient. GPs will take on
shared care only if they are willing and able.
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To reply to the request for shared care as soon as possible.
To prescribe and adjust the dose as recommended by the specialist.
To ensure there are no interactions with any other medications initiated in primary care.
To continue monitoring as agreed with secondary care (guideline should include details of monitoring
requirements and what to do when each of the defined parameters alters).
To refer back to the specialist where appropriate. For example:
o
Patient or general practitioner is not comfortable to continue with the existing regime due to either
change in condition or drug side effects.
o
Advice in respect of concordance.
o
Special situations, (e.g. Pregnancy)
Discontinue the drug as directed by the specialist if required
To identify adverse events if the patient presents with any signs and liaise with the hospital specialist
where necessary. To report adverse events to the specialist and where appropriate the Commission on
Human Medicines/MHRA (Yellow card scheme).
quetiapine Shared care Guideline
Date Prepared: November 2015
Page 2 of 7
Review Date: November 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Clinical Particulars
The information given below is not exhaustive and merely is a guide with salient information about
quetiapine preparations. When in doubt, please refer to an up to date copy of the Specific Product
Characteristics, the British National Formulary or The Maudsley Prescribing Guidelines.
BNF therapeutic
class
4.2.1 Antipsychotic drugs; Atypical antipsychotic drugs
Cautions and
Contraindications
Contraindications
Adverse Drug
Reactions

Suicide/suicidal thoughts or clinical worsening. Depression in bipolar disorder is
associated with an increased risk of suicidal thoughts, self-harm and suicide
(suicide-related events).
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Known cardiovascular disease, cerebrovascular disease, or other conditions
predisposing to hypotension.
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Seizures.
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Concomitant prescription with drugs known to prolong the QT c interval, especially
in the elderly.
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Tardive dyskinesia and neuroleptic malignant syndrome are associated with
prescription of antipsychotics.
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Hyperglycaemia or exacerbation of pre-existing diabetes has been reported in
very rare cases during treatment with quetiapine. Appropriate clinical monitoring is
advisable in diabetic patients and in patients with risk factors for the development
of diabetes mellitus.
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Quetiapine is not approved for the treatment of dementia-related psychosis and/or
behavioural disturbances.
Common adverse effects include dizziness, somnolence, leucopoenia, tachycardia,
dry mouth, dyspepsia, constipation, peripheral oedema, asthenia, weight gain,
syncope, orthostatic hypotension, rhinitis, elevated LFTs.
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In common with other antipsychotics, neuroleptic malignant syndrome (NMS) has
occurred; if suspected stop treatment and refer for specialist advice
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Extrapyramidal side effects have been reported.
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As with other antipsychotics there is a potential for tardive dyskinesia after longterm treatment.
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In common with other antipsychotics patients treated with quetiapine should be
monitored for signs and symptoms of hyperglycaemia.
Refer to manufacturer’s SPC and to BNF for a full list of side-effects.
Special precautions:

Neuroleptic malignant syndrome This is a potentially fatal disorder associated
with anti-psychotic use and rare cases have been reported during treatment with
quetiapine. The disorder is characterised by hyper-pyrexia, muscle rigidity,
altered mental status and autonomic instability (irregular pulse or blood pressure,
tachycardia, diaphoresis and cardiac dysrhythmia ). Typically, creatinine kinase
levels are elevated and may develop acute renal failure. All anti-psychotic drugs,
quetiapine Shared care Guideline
Date Prepared: November 2015
Page 3 of 7
Review Date: November 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
including quetiapine, should be immediately stopped and urgent medical opinion /
treatment sought.
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Monitoring
Tardive Dyskinesia – these have been uncommonly reported with quetiapine, in
simple terms this is characterised by abnormal movements, particularly orofacial
movements. Approximately 50% of cases are irreversible once tardive dyskinesia
is established.
Baseline Tests
Prolactin, Urea & electrolytes (U&Es), Weight, Blood Pressure (BP) Fasting Plasma
Glucose (FPG)/HbA1c or Oral Glucose Tolerance Test (OGTT) and Blood Lipids
Routine Tests
Prolactin if symptoms occur, U&Es – 6 monthly, Weight – as needed
Interactions
Include clinically important interactions and their management.
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Use with caution in combination with other centrally acting drugs
(including alcohol).
Co-administration of carbamazepine and phenytoin increase the
clearance of quetiapine.
Concomitant administration of drugs which are potent CYP3A4
inhibitors (such as azole antifungals and macrolide antibiotics), can
significantly increase plasma concentrations of quetiapine.
Caution should be used if quetiapine is being administered
concomitantly with medicinal products known to increase QTc
interval
Communication
Specialist to GP
The specialist will inform the GP when they have initiated drug quetiapine. When the patient is near
completing the satisfactory initiation period, the specialist will write to the GP to request they take over
prescribing and where possible give an indication as to the expected length of treatment. The Specialist will
also send a Shared care request form to support the GP in undertaking shared care. (Appendix A)
GP to specialist
If the GP has concerns over the prescribing of drug quetiapine, they will contact the specialist as soon as
possible.
Contact names and details
Contact Details
Telephone number
Email
Sarah Hudson Lead Pharmacist
01226 434649
[email protected]
Medicines Information
01924 327619
[email protected]
References
Dr S Chari (North Team)
01226 434171
[email protected]
BNF
61Kirk
http://bnf.org
Dr G
(Central Team)
01226 433523
[email protected]
NICE
www.NICE.org.uk
.
Dr A Guidance
Karan (South
Team)
01226 341374
[email protected]
01226 341374
[email protected]
Dr H Malik (Dearne Team)
quetiapine Shared care Guideline
Date Prepared: November 2015
Page 4 of 7
Review Date: November 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
References
1. BNF 70 www.medicinescomplete.org
2. SPC quetiapine accesses EMC 15/12/15. Available at: www.medicines.org.uk
Development Process
This guidance has been produced by Sarah Hudson Lead Pharmacist SWYPFT following an AMBER
classification status of Quetiapine by the Barnsley Area Prescribing Committee. This guideline has been subject
to consultation and endorsement by the Area Prescribing Committee on 9th December 2015 and the LMC on 8th
March 2016.
quetiapine Shared care Guideline
Date Prepared: November 2015
Page 5 of 7
Review Date: November 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Appendix A – Shared Care request form (Amber)
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Specialist to complete when requesting GP to enter a shared care arrangement.
GP to return signed copy of form.
Both parties should retain a signed copy of the form in the patient’s record.
From (Specialist):
To (GP):
Patient details
Name:
ID Number:
Address:
DOB:
Diagnosed condition:
Amber Drug details
Drug name:
Dose:
Date of initiation:
Length of treatment:
The patient will be reviewed by the Consultant on:
Telephone number(s) for contact:
The patient should be reviewed by the GP by:
Consultant:
Date:
Monitoring
The following monitoring should be undertaken by the GP:
Parameter
Date next test due
quetiapine Shared care Guideline
Date Prepared: November 2015
Frequency
Page 6 of 7
Review Date: November 2017
Shared Care Protocol –remains open to review in light of any new evidence
Amber = To be initiated and titrated to a stable dose in secondary care with follow up prescribing and monitoring by primary
care.
Communication
Consultant
Telephone number:
Fax number:
Email address:
Specialist Nurse
Telephone number:
Fax number:
Email address:
Confirmation of acceptance of shared care
Specialist (Doctor/Nurse) name:
Specialist (Doctor/Nurse) signature:
Date:
I, Dr …………………………….., can confirm I :
□
accept the request to participate in shared care for the patient named above.
□
reject the request to participate in shared care for the patient named above. The reason for
this being ………………………………………………………………………………………..
GP signature:
Date:
quetiapine Shared care Guideline
Date Prepared: November 2015
Page 7 of 7
Review Date: November 2017