Download Barnsley Area Prescribing Committee

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.
Shared Care Guideline for Aripiprazole
Introduction
Indication/Licensing information
Aripiprazole is a newer atypical antipsychotic licensed for the treatment of schizophrenia. On the current
evidence available, it is no more efficacious than existing therapies and there is limited data comparing it
directly with other atypical antipsychotics. Aripiprazole should not currently be selected as a first line choice of
treatment. It is recommended that the use of Aripiprazole should be reserved for:
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Patients suffering from intolerable side effects resulting from existing antipsychotic medication.
Schizophrenia in people over 15 years
Mania (associated with bi-polar disorder) in adults over 18 years.
NICE recommends aripiprazole as a possible treatment (for up to 12 weeks) for moderate to severe manic
episodes in young people aged 13 and older with bipolar I disorder. This prescribing will be retained by
secondary care services
Dosage and administration
Schizophrenia, by mouth, ADULT over 18 years 10–15 mg once daily, usual maintenance 15 mg once
daily; max. 30 mg once daily; CHILD 15–18 years, initially 2 mg once daily for 2 days, then 5 mg once daily
for 2 days, then 10 mg daily; thereafter increased if necessary in steps of 5 mg to max. 30 mg daily
Mania, by mouth, ADULT over 18 years, 15 mg once daily, increased if necessary; max. 30 mg once daily
Responsibilities of the specialist initiating treatment
 Initiate and stabilise treatment with aripiprazole (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, Fasting Plasma Glucose (FPG)/HbA1c or Oral Glucose
Tolerance Test (OGTT) and Blood Lipids
Aripirazole Shared care Guideline
Date Prepared: November 2015
Page 1 of 6
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.
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).
Clinical Particulars
The information given below is not exhaustive and merely is a guide with salient information about
aripiprazole preparations. When in doubt, please refer to an up to date copy of the Specific Product
Characteristics, the British National Formulary5 or The Maudsley Prescribing Guidelines.6
BNF therapeutic
class
4.2.1 Antipsychotic drugs; Atypical antipsychotic drugs
Cautions and
Contraindications
Contraindications
Tardive dyskinesia: In premarketing studies of one year or less duration, there were
uncommon reports of treatment-emergent dyskinesia during treatment with
aripiprazole. If signs and symptoms of tardive dyskinesia appear in a patient on
aripiprazole, dose reduction or discontinuation should be considered promptly. These
symptoms can temporarily deteriorate or can even arise after discontinuation of
treatment.
Neuroleptic malignant syndrome (NMS): NMS is a potentially fatal symptom
associated with antipsychotic medicinal products. In premarketing studies, rare cases
of NMS were reported during treatment with aripiprazole. Clinical manifestations of
NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of
autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and
cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase,
myoglobinuria (rhabdomyolysis), and acute renal failure. If a patient develops signs
and symptoms indicative of NMS, or presents with unexplained high fever without
additional clinical manifestations of NMS, all antipsychotic drugs, including
aripiprazole, must be discontinued.
Cautions
 Renal and hepatic impairment – refer back for specialist advice. Initial doses of
Aripirazole Shared care Guideline
Page 2 of 6
Date Prepared: November 2015
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.
5mg daily have been used. Baseline renal function tests and 6 monthly monitoring
are recommended.
Adverse Drug
Reactions
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Pregnancy - refer back for specialist advice, manufacturers recommend
avoidance.
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Breast feeding - refer back for specialist advice. No information available.
Recommended to avoid.
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Hepatic impairment dose reduction NOT necessary.
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Seizure: In premarketing studies, uncommon cases of seizure were reported
during treatment with aripiprazole. Therefore, aripiprazole should be used with
caution in patients who have a history of seizure disorder or have conditions
associated with seizures.
Gastro-intestinal disturbances; tachycardia; fatigue, insomnia, akathisia, drowsiness,
restlessness, tremor, headache, asthenia; blurred vision; less commonly depression;
very rarely anorexia, dysphagia, oropharyngeal spasm, laryngospasm, hepatitis,
jaundice, hypersalivation, pancreatitis, oedema, thromboembolism, arrhythmias,
bradycardia, hypertension, chest pain, agitation, anxiety, speech disorder, suicidal
ideation, seizures, hyponatraemia, stiffness, myalgia, rhabdomyolysis, priapism,
urinary retention and incontinence, blood disorders, sweating, alopecia,
photosensitivity reactions, rash, weight loss, and impaired temperature regulation; with
injection, dry mouth
Pregnancy and Lactation
In pregnancy use only if potential benefit outweighs risk—no information available
In lactation avoid—present in milk in animal studies
Monitoring
Baseline
Prolactin
Urea & electrolytes (U&Es)
Weight
Fasting Plasma Glucose (FPG)/HbA1c or Oral Glucose Tolerance Test (OGTT)
Blood Lipids
Continuation
Prolactin if symtoms occur
U&Es – 6 monthly
Weight – as needed
Interactions
Include clinically important interactions and their management.
Drug Interactions
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Concomitant use of quinidine, ketoconazole and potentially
fluoxetine and paroxetine of aripiprazole to be reduced to
approximately half the usual dose.
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Concomitant use of carbamazepine necessitates the dose of
aripiprazole to be increased, see full SPC for details
http://emc.medicines.org.uk/.
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Use with caution in combination with other centrally acting drugs.
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Use with caution in combination with other drugs which may lower
blood pressure.
Aripirazole Shared care Guideline
Page 3 of 6
Date Prepared: November 2015
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.
Effects on ability to drive and use machines
Atypical antipsychotic drugs may affect performance of skilled tasks
(e.g. driving); effects of alcohol are enhanced
Communication
Specialist to GP
The specialist will inform the GP when they have initiated drug aripiprazole. 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 aripiprazole, 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)
References
1. SPC Abilify®. May 2015. Available at: http://www.medicines.org.uk/emc/medicine/30369 Accessed
02/10/15
2. BNF 69 www.medicinescomplete.org
Development Process
This guidance has been produced by Sarah Hudson Lead Pharmacist SWYPFT following an AMBER
classification status of Aripiprazole 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.
Aripirazole Shared care Guideline
Date Prepared: November 2015
Page 4 of 6
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
Aripirazole Shared care Guideline
Date Prepared: November 2015
Frequency
Page 5 of 6
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:
Aripirazole Shared care Guideline
Date Prepared: November 2015
Page 6 of 6
Review Date: November 2017