Download Shared Care Guidelines available. For the treatment

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 (Seroquel®▼* or Seroquel®▼XL) -
AstraZeneca
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 13th February 2013
 The LMC on 12th March 2013
Introduction
Licensed indication: Quetiapine (as either the immediate release Seroquel®▼* tablet or the modified
release Seroquel®▼XL tablet) is licensed in the treatment of schizophrenia and of manic episodes
associated with bipolar disorder either alone or with mood stabilisers.
* Intensive monitoring of immediate release Seroquel® tablet is requested only when used for the
recently licensed indication of bipolar depression.
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.
 As an option for individuals currently receiving typical antipsychotic drugs who, despite adequate
symptom control, are experiencing unacceptable side effects.
 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 (Seroquel®) should be administered twice daily.
 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 Shared care Guideline
Date Prepared: 31/1/13
Page 1 of 6
Review Date: January 2015
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 modified release tablets (Seroquel® XL) should be administered once daily.
 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.
 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.
Responsibilities of the specialist initiating treatment
1. Initiate and stabilise treatment with quetiapine (this phase is expected to last at least six 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. FBC’s and LFT’s should be measured where appropriate. Baseline renal function, U & Es.
Send baseline test results and routine test results to the GP.
2. Discuss the benefits and side effects of treatment with the patient.
3. 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.
4. 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.
5. Advise the GP on when to adjust the dose, stop treatment, or consult with the specialist.
6. Report serious adverse events to the MHRA and GP.
.
Responsibilities of other prescribers
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.
Summary
1. Reply to the request for shared care as soon as practicable.
2. Prescribe quetiapine at the dose recommended.
3. Adjust the dose as advised by the specialist.
4. To monitor physical parameters such as weight, fasting blood sugar, BP, smoking status and full lipid
screen where necessary (at least annually)
5. To request earlier specialist review or seek specialist advice when necessary.
6. Report to and seek advice from the specialist on any aspect of patient care that is of concern to the GP and
may affect treatment.
7. Refer back to specialist if the patient’s condition deteriorates, as advised.
8. Stop treatment on the advice of the specialist or immediately if an urgent need to stop treatment arises.
Page 2 of 6
9. Report serious adverse events to the specialist and MHRA.
Quetiapine Shared care Guideline
Date Prepared: 31/1/13
Review Date: January 2015
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
BNF therapeutic
class
4.2.1. Atypical antipsychotic drugs.
Cautions and
Contraindications

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).

Known cardiovascular disease, cerebrovascular disease, or other conditions
predisposing to hypotension.

Seizures.

Concomitant prescription with drugs known to prolong the QT c interval, especially
in the elderly.

Tardive dyskinesia and neuroleptic malignant syndrome are associated with
prescription of antipsychotics.

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.

Quetiapine is not approved for the treatment of dementia-related psychosis and/or
behavioural disturbances.
Adverse Drug
Reactions
Common adverse effects include dizziness, somnolence, leucopoenia, tachycardia,
dry mouth, dyspepsia, constipation, peripheral oedema, asthenia, weight gain,
syncope, orthostatic hypotension, rhinitis, elevated LFTs.

In common with other antipsychotics, neuroleptic malignant syndrome (NMS) has
occurred; if suspected stop treatment and refer for specialist advice

Extrapyramidal side effects have been reported.

As with other antipsychotics there is a potential for tardive dyskinesia after longterm treatment.

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,
including quetiapine, should be immediately stopped and urgent medical opinion /
treatment sought.

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.
Quetiapine Shared care Guideline
Date Prepared: 31/1/13
Page 3 of 6
Review Date: January 2015
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.
Action
Referral for urgent psychiatric opinion, as the drug may need to be discontinued or
dose reduced. The symptoms can temporarily worsen or decline in severity after
reducing or stopping the drug.
Monitoring
weight, blood pressure, fasting blood glucose or HbA1c and full lipid screen. FBC’s
and LFT’s should be measured where appropriate. Renal function, U & Es.
These should be done initially at 3 months and then at least annually.
Interactions




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 X. 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 X, they will contact the specialist as soon as possible.
Contact names and details
PCT Pharmaceutical
01226 433798
[email protected]
SWYPFT Lead Pharmacist
01226 434649
[email protected]
Medicines Information
01226 432857
[email protected]
Specialist: CMHT Sector Consultant
Hospital: Oakwell reception
01226 341374
01226 43666
References

British National Formulary. www.BNF.Org
 Quetiapine (Seroquel® and Seroquel® XL) Summary of Product Characteristics.
http://www.medicines.org.uk/EMC/medicine/26582/SPC/Quetiapine+100+mg+Filmcoated+Tablets/
Quetiapine Shared care Guideline
Date Prepared: 31/1/13
Page 4 of 6
Review Date: January 2015
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)



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: 31/1/13
Frequency
Page 5 of 6
Review Date: January 2015
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: 31/1/13
Page 6 of 6
Review Date: January 2015