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Antipsychotic Guidelines
Version: 7
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
Version Control
Change Record
Reviewers/contributors
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
CONTENTS
Page
Guideline 4
Pharmacological Management (flow chart) 5
References 6
Guidelines (flowchart) on the Prescribing of Antipsychotic Long Acting 7
Injections
Guidelines on the Prescribing of Antipsychotic Long Acting Injections 8
Appendices
A1a Paliperidone palmitate LAI (Xeplion®) 9
A1b Paliperidone palmitate 3 monthly LAI (Trevicta®) 10
A2 Aripiprazole LAI (Abilify Maintena®) 11
A3a Olanzapine LAI (Zypadhera®) 12
A3b Olanzapine long acting injection Monitoring Form 13
A4 Non formulary request form 14
A5 Zuclopenthixol acetate (Acuphase®) 18
A6 High Dose Antipsychotic Treatment (HDAT) summary sheet 19
Key
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
Guidelines for Prescribing of Antipsychotics (jointly produced by primary and secondary Care)
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Postural hypotension Amisulpride Haloperidol
1
More common in elderly Sulpiride Trifluoperazine
Aripiprazole Olanzapine
2
QTc Prolongation Aripiprazole Flupentixol
Risks higher with high doses. Paliperidone
5
Olanzapine
2
Avoid drugs that prolong QT interval – see ECG guidelines SH CP 204 Risperidone
2
2
Clozapine
2 2
Sedation Amisulpride Risperidone
Review timings of administration with respect to time to peak drug levels Aripiprazole
2
Haloperidol
2
5
Sulpiride
Treatment Resistant Psychosis Clozapine High dose Olanzapine (refer to
1
Psychosis after unsuccessful trials of two antipsychotics (at least one atypical) at (Refer to Clozapine HDAT appendix A6)
maximum tolerated dosages for 6 – 8 weeks Guidelines SH CP 114)
Inadequate response to Clozapine Add Sulpiride Add Haloperidol
Check for co-morbidities (e.g. substance misuse, depression). Check plasma level Add Amisulpride ECT
1
for compliance and interactions. Trial any changes for at least 10 weeks Add Risperidone
Add Aripiprazole
Add Lamotrigine
Pregnancy and Breastfeeding Folic Acid 5mg, 3 months Any previous effective
(see Perinatal Current Evidence and Consensus) Seek advice from/ refer to before and after conception antipsychotic – continue/ restart if
9 1
Perinatal Service. Try to avoid starting depots . Use minimum effective dose, clearly indicated at minimum
12
monotherapy and TDM. Haloperidol effective
Consider risks, gestational diabetes and excessive weight gain. Quetiapine
11
9
Encourage breast feeding unless on clozapine, and monitor baby for side effects. 11
Olanzapine monitor for
gestational diabetes
11
Risperidone
Adolescents Aripiprazole Olanzapine: discuss increased
Use lower doses, titrate slowly. SE may be more pronounced, notably EPSE, Quetiapine risk of greater weight gain
14
hyperprolactinaemia, metabolic and cardiovascular Risperidone
Older persons, learning disability and those with organic brain changes OPMH: use cautiously, monitor closely. For BPSD: follow
Consider lower doses Managing Behaviour Problems in patients with dementia
guideline SH CP 02. Risperidone is the only licensed
antipsychotic in BPSD.
LD: as above. Start at half regular adult dose, be vigilant for side
effects and risk of lowering seizure threshold
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
Pharmacological Management (flowchart) of Schizophrenia-like Psychosis
Review
At least every 2 weeks for response, side effects and
adherence to treatment.
Relapse. If issues with adherence: consider depot/ LAI.
After 2 trials,
consider
clozapine
Physical Health Monitoring (for normal dosing. additional for HDAT – see appendix 6)
Weight / HbA1C / Lipids Prolactin FBC eGFR/ LFT GASS ECG RC
BMI blood U & Es (ensure use (see review
correct one for Appendix
sugar clozapine) 6)
Baseline
<1
month
<3
months
<6
months
Annual clinical
decision
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
References
1. Barnes TRE and the schizophrenia consensus group of the British Association for Psychopharmacology.
Evidence-based guidelines for the pharmacological treatment of schizophrenia: recommendations from the
British Association of Psychopharmacology. Journal of Psychopharmacology, 2011; 1-54
2- Hasan A, Falkai P, Worbrock T, Liberman J, Glenthoj B, Gattaz WF et al. World Federation of Societies of
Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Schizophrenia, Part 1: Update 2012 on
the acute treatment of schizophrenia and the management of treatment resistance. The World Journal of
Biological Psychiatry, 2012; 13: 318-378
3. Sussex Partnership NHS Foundation Trust. Guidance on the Use of Antipsychotics. Version 3, October 2015.
4. National Prescribing Service. Comparative information for common oral antipsychotic medicines. Accessed
via www.nps.org.au (23/9/16)
5. Clinical Guideline CG178: Psychosis and schizophrenia in adults: prevent and management. National
Institute for Health and Care Excellence 2014. Accessed via www.nice.org.uk (13/9/16)
6. Qiao Y, Yang F, Li C, Guo Q, Wen H, ZZhu S et al. Add-on effects of a low dose aripiprazole in resolving
hyperprolactinemia induced by risperidone or paliperidone. Psychiatry Res, 2016; 30;237: 83-89
7.Cooper SJ, Reynolds GP, Barnes TRE, England E, Haddad PM, Heald A et al. BAP guidelines on the
management of weight gain, metabolic disturbances and cardiovascular risk associated with psychosis and
antipsychotic drug treatment. Journal of Psychopharmacology, 2016; 1-32
8. Bak M, Fransen A, Janssen J, van Os J, Drukker M. Almost all antipsychotics result in weight gain, a meta-
analysis. PLOS One, 2014; 9,4: 1-19
9. Clinical Guideline CG192: Antenatal and postnatal mental health: clinical management and service guidance.
National Institute for Health and Care Excellence 2014. Accessed via www.nice.org.uk (13/9/16)
10. Mizuno Y, Suzuki T, Nakagawa A, Yoshida K, Mimura M, Fleischhacker WW et al. Pharmacological
strategies to counteract antipsychotic-induced weight gain and metabolic adverse effects in schizophrenia: a
systematic review and meta-analysis. Schizophrenia bulletin, 2014; 40,6: 1385-1403
11. BCPT, pregnancy exposure to olanzapine, risperidone, aripiprazole and risk of congenital malformations
12. Hasan A, Falkai P, Worbrock T, Liberman J, Glenthoj B, Gattaz WF et al. World Federation of Societies of
Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Schizophrenia, Part 3: Update 2015
Management of special circumstances: depression, suicidality, substance use disorders and pregnancy and
lactation. The World Journal of Biological Psychiatry, 2015; 16: 142-170
13. Hasan A, Falkai P, Worbrock T, Liberman J, Glenthoj B, Gattaz WF et al. World Federation of Societies of
Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Schizophrenia, Part 2: Update 2012 on
the long-term treatment of schizophrenia and management of antipsychotic-induced side effects. The World
Journal of Biological Psychiatry, 2013; 14: 2-44
14. Clinical Guideline CG155: Psychosis and schizophrenia in children and young people: recognition and
management. National Institute for Health and Care Excellence 2014. Accessed via www.nice.org.uk (13/10/16)
th
Current Maudsley Prescribing Guidelines 12 edition have been used throughout.
rd
BNF 73 edition was used, but always check against the current BNF.
SPCs were accessed from https://www.medicines.org.uk/emc/ from September – January 2017/ 18, but always
check the latest on-line SPC.
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
Guidelines (flowchart) on the Prescribing of Antipsychotic Long Acting Injections
(LAI)/ Depot
Patient
Check;
capacity and risk assessment, record on RiO and review T2/T3 where applicable
there is a successful trial of 2 weeks of the oral as per SPC
First Line
Minimal side effects First Generation Antipsychotic (FGA); Flupentixol Decanoate, Develops side effects
Haloperidol Decanoate or Zuclopenthixol Decanoate.
Record discussion around this.
Manage side effects
with anticholinergics
and dose reduction.
Second Line
Consider Paliperidone Monthly Injection (baseline Prolactin), If dose reduction
or increases symptoms
Aripiprazole LAI or side effects are
intolerable.
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
Guidelines on the Prescribing of Antipsychotic Long Acting Injections (LAI)
LAI Drug Licensed Oral trial Test Oral License Duration Time Comment Adult Dosing
Indication dose cross- d Route of action to Frequency
(mg) over (IM) steady
state ~
Flupentixol Maintenance Not specified 20 n/a Gluteal or 3 to 4 9 weeks Caution in agitation 50mg every 4
decanoate in lateral weeks or mood elevation. weeks, to
Schizophrenia thigh C/I if circulatory 400mg/ week
& other collapse or loss of
psychosis consciousness
Haloperidol Maintenance Implied in See n/a Gluteal 6 weeks 14 In adults aim to use 50mg every 4
decanoate in SPC, dosing weeks 10 to 15 times the weeks, increasing
Schizophrenia as it states initial previous daily oral by 50mg
& other dose is dose of haloperidol increments to max
determined by
psychosis for maintenance of 300mg/ 4 weeks
oral dose
required to Elderly, 12.5 to
maintain the 25mg every 4
patient before weeks
starting
Zuclopenthixol Maintenance Not specified 100 n/a Gluteal or 2 to 4 12 High doses used for 200mg to 500mg
decanoate in lateral weeks weeks aggression (off every 1 to 4 weeks,
Schizophrenia thigh licence) max
& other 600mg/ week
psychosis
Paliperidone Maintenance Oral n/a n/a, as Deltoid Depends 20 50 to 150mg
palmitate in risperidone for loading initially for on route/ weeks monthly. Adjust
Schizophrenia 14 days to regimen for loading, dose, 25 to monthly
(Xeplion®) check the LAI then 49 days
response and deltoid or
tolerability gluteal
Paliperidone Maintenance Start with n/a n/a Deltoid or Up to 18 n/a Every
palmitate in adults with monthly gluteal months 3 months
Schizophrenia Paliperidone
(Trevicta®) who are then switch
clinically after 4 months
stable on
monthly
paliperidone
(Xeplion®)
Aripiprazole Maintenance 14 days n/a 14 days, Deltoid or Not 20 300mg or 400mg
maintena® in to check additional to gluteal available weeks monthly.
Schizophrenia response and oral trial (or less dependent
for adults tolerability after 1st on drug/
stabilised on injection pharmacodynamic
the oral interactions – see
Appendix )
Olanzapine Maintenance Check n/a Supplement Gluteal 6 weeks 12 Post injection 2 to 4 weekly.
in response and with oral if weeks syndrome requiring Dose depends on
pamoate Schizophrenia tolerability to clinically 3 hours of oral dose. See
(Zypadhera®) for adults oral first indicated monitoring. appendix 3a.
Non- stabilised on Complete form. Elderly see SPC.
formulary the oral
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
Appendix 1a: Paliperidone palmitate LAI (Xeplion®)
Prescribing information
The patient must have been stabilised on and tolerate oral risperidone.
®
Should be prescribed as Paliperidone (Xeplion ).
Target maintenance dose is 75mg per month (range 25mg-150mg) MONTHLY.
Consider lower doses in the elderly and patients with diminished renal function. If creatinine clearance is
50 to 80 mls/min the dose must be reduced. Caution if severe hepatic impairment. No data available for
<18years old. Refer to SPC for more details.
Switching; there is no need for oral supplementation.
Missed doses
Paliperidone Xeplion® can be given +/- 4 days with the second initiation dose, and +/-1week of the maintenance
dose date. Otherwise follow guidance below;
Missed second
Action
initiation dose
<4 weeks 100mg (deltoid) as soon as possible, then 75mg five weeks after first
injection, then continue the normal monthly cycle
4-7 weeks 100mg (deltoid) as soon as possible, then 100mg (deltoid) one week later,
then continue the normal monthly cycle
>7 weeks Re-initiate with Paliperidone Xeplion®
Missed maintenance
Action
dose
1 month-6 weeks Regular maintenance dose as soon as possible, then resume monthly
6 weeks to 6 months Regular maintenance dose as soon as possible (deltoid), repeated after one
25-100mg/month week (deltoid) then continue the usual dose monthly
6 weeks to 6 months As soon as possible give 100mg (deltoid), then 100mg after one week (deltoid)
150mg/month then resume usual monthly dose
>6months Re-initiate with Paliperidone Xeplion®
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
Appendix 1b: Paliperidone palmitate 3 monthly LAI (Trevicta®)
Prescribing information
®
The patient must be maintained on Paliperidone monthly for at least 4 months prior to starting Trevicta
and at least 2 of the depots should be of the same dose.
®
Should be prescribed as Paliperidone (Trevicta ).
Should be started when the next Paliperidone monthly is due +/- 7 days.
The dose is 3.5 fold higher than the monthly injection, hence dose as follows;
Missed doses
®
Paliperidone Trevicta can be given +/- 2weeks of the due date. Otherwise follow guidance below;
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
Appendix 2: Aripiprazole LAI (Abilify Maintena®)
Prescribing Information
Patients should have a history of response and tolerability to oral aripiprazole for at least two to four
weeks before initiation.
Aripiprazole LAI is licensed for ONCE MONTHLY (one dose per calendar month NOT 4 weekly).
There should be a gap of at least 26 days between injections.
The usual recommended starting and maintenance dose is 400mg monthly. Dose adjustment to 300mg
should be considered if there are adverse reactions or the patient is on concomitant interacting drugs
e.g. fluoxetine or erythromycin.
After the first injection, treatment with 10 mg to 20 mg oral aripiprazole should be continued for 14
consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy.
Missed doses –
nd rd
If 2 or 3 dose is missed and time
Action
since last injection is:
> 4 weeks and < 5 weeks The injection should be administered as soon as possible and then
resume monthly injection schedule.
> 5 weeks Concomitant oral aripiprazole should be restarted for 14 days with next
administered injection and then resume monthly injection schedule.
th
If 4 or subsequent doses are
missed (i.e. after attainment of
Action
steady state) and time since last
injection is:
> 4 weeks and < 6 weeks The injection should be administered as soon as possible and then
resume monthly injection schedule.
> 6 weeks Concomitant oral aripiprazole should be restarted for 14 days with next
administered injection and then resume monthly injection schedule.
SPC Aripiprazole
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
Appendix 3a: Olanzapine LAI (Zypadhera®)
Prescribing information
The patient must have been stabilised on and tolerate oral olanzapine. There is no need for oral
supplementation.
A lower starting dose (150mg/ 4wks) should be considered, in the elderly and those with hepatic or renal
impairment.
It is essential to ensure that long-term plans for administration and observation are in place before
prescribing / administering this product.
Target oral Recommended starting dose of Maintenance dose after two months
olanzapine dose. olanzapine LAI. of treatment.
10mg / day 210mg / 2 weeks or 405mg / 4 weeks 150mg / 2 weeks or 300mg / 4 weeks
15mg / day 300mg / 2 weeks 210mg / 2 weeks or 405mg / 4 weeks
20mg / day 300mg / 2 weeks 300mg / 2 weeks
Other information
Adolescents are more likely than adults to suffer from weight gain, increased appetite, sedation, dry mouth,
elevated levels of; triglyceride, cholesterol, LFTs (ALT/AST/GGT) and prolactin.
®
After administering the injection the nurse / doctor must check that the patient has a Zypadhera patient information
card in their possession. Cards can be obtained from Lilly Medicines Information 01256 31500
SPC Olanazpine
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
Appendix 3b: Olanzapine long acting injection Monitoring Form
Observations for post injection syndrome – to be carried out for at least THREE HOURS after olanzapine
depot injection
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
Appendix 4: Non – formulary request form
Southern Health NHS Foundation Trust (SHFT) is responsible through the Medicines Management
Committee (MMC) for evaluating new drugs and indications for mental health drugs and making
formulary recommendations both within the Trust and in the wider health community. Approved drugs
are added to the Portsmouth and South East Hampshire formulary and Basingstoke, Southampton
and Winchester district formulary.
Non-formulary drugs are often associated with higher costs and limited benefits over formulary
alternatives. On admission therapy should be reviewed especially with regard to non-formulary drugs
which should be changed to a formulary alternative whenever possible. If it is considered essential to
prescribe a non-formulary drug then this form should be completed before the drug can be ordered or
dispensed. This applies to both community and inpatients.
It should not be assumed that a drug will be approved and patients must not be promised the
medication.
The product will only be supplied after this form has been completed and authorisation received by
the supplying pharmacy. Any unused stock purchased may be charged to the consultant’s cost centre
when it expires. For mental health drugs if usage extends to more than TWO patients in a 12 month
period then a formal submission to the SHFT MMC should be made.
For urgent requests the aim is for a decision to be made within 72 working hours (Monday to Friday)
The application should be completed accurately, fully and legibly with all sections completed to avoid
delays in obtaining a decision.
Procedure – follow A or B
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SH CP 111 Antipsychotic Guidelines
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June 2018
B - Request for a new or unauthorised non-formulary drug
NON-
URGENT
URGENT
Added to the agenda of the
next MMC meeting for review.
.
Chief Pharmacist’s office sends a copy
of the application form to the service’s
Not Principal Pharmacist (or deputy), and
Approved Clinical Services Director (CSD)by
approved
NHS email for review and response
and notifies them by SHFT email.
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
NON-FORMULARY DRUG APPLICATION FORM
Patient’s details
Patient’s GP:
Drug details
Generic name and dosage form (e.g. tablet):
Indication
Is this an unlicensed drug or a licensed drug for an unlicensed indication/route? Yes/No
(NB. There is a separate form for IM clozapine. Please contact the Chief Pharmacist’s
office.)
If your answer is YES then you have accepted FULL RESPONSIBILITY for the use of this drug
when initiated by your prescription.
Previous relevant medication (doses, duration, effectiveness, tolerability, reasons for stopping)
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SH CP 111 Antipsychotic Guidelines
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June 2018
AUTHORISATION
Authorisation
Ward Pharmacist: Signature Date
Printed name
Consultant details
Name: Signature Base:
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
Appendix 5: Zuclopenthixol acetate (Acuphase®)
Prescribing information
Should only be prescribed;
on the recommendation of a senior psychiatrist, after assessment
for short term management of acute psychosis and mania
if the patient is refusing oral medication and requires repeated injections (allowing adequate time to see
the effects of previous medications)
reduce the dose in renal/ hepatic impairment. In renal/hepatic failure half the dose and consider serum-
level monitoring.
SPC zuclopenthixol
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018
Appendix 6: High Dose Antipsychotic Treatment (HDAT) summary
sheet
Before considering HDAT you must consider the following:
Has the patient been trialled on treatment for sufficient time to show response?
Have you tried at least 2 antipsychotics (one FGA, if possible)?
Has clozapine been considered/ trialled and found to be insufficiently effective/ not
suitable?
Has the patient’s adherence to treatment been reviewed?
Have adjunctive treatments shown insufficient response?
Have psychological treatments shown insufficient response or are they deemed
inappropriate?
You must:
Involve the senior psychiatrist and MDT, including pharmacist,
Have the patient’s consent (if possible),
Have the correct T2/3 in place (if applicable), and
Make appropriate documentation in the PMR.
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SH CP 111 Antipsychotic Guidelines
Version: 7
June 2018