Guidelines for the use of Zuclopenthixol Acetate Draft 5Final Guidelines 2014_Final.pdf ·...

Guidelines for the use of Zuclopenthixol acetate (Clopixol Acuphase®) Version 1. Date: April 2014 Authors: Naeema Majothi Clinical Pharmacist, Saira Mould Sr Clinical Pharmacist Page 1

Guidelines for the use of Zuclopenthixol Acetate (Clopixol Acuphase®) injection

Version 1

SUMMARY Guidelines for the use of Zuclopenthixol Acetate (Clopixol Acuphase®) injection

POLICY CODE

REPLACES POLICY CODE (IF APPLICAPLE

AUTHOR Naeema Majothi, Clinical Pharmacist Saira Mould, Senior Clinical Pharmacist

TRUST BOARD SUB-COMMITTEE WHICH APPROVED ORIGINAL VERSION

(Name of Committee)

DRUG AND THERAPEUTICS COMMITTEE

DATE OF APPROVAL 8th July 2014

DATE OF NEXT REVIEW

Q2 FY15/16

CURRENT VERSION PLACED ON INTRANET DATE

CHAIR(S) OF APPROVING COMMITTEE

SIGNATURE(S)

TITLE(S) Deputy Chair, DTC

DATE 8th July 2014


Guidelines for the use of Zuclopenthixol Acetate (Clopixol Acuphase®) injection

For In-Patient Use Only

This guideline should be read in conjunction with Trust Policy CP04:

(Rapid Tranquillisation Adults and Older Adults)

Aim of the Guideline:

The aim of this guideline is to provide information to prescribers and mental health practitioners to ensure that Zuclopenthixol acetate (Clopixol Acuphase®) injection is prescribed and administered safely and effectively to adult and elderly service users within Oxford Health NHS Foundation Trust.

Background:

Zuclopenthixol Acetate (Clopixol Acuphase®) is a parenteral antipsychotic which can be prescribed for “the initial treatment of acute psychoses including mania and exacerbation of chronic psychoses, particularly where a rapid onset of action and duration of effect of 2-3 days is desirable”.

As per Trust Policy CP04 (Rapid Tranquillisation Adults and Older Adults), zuclopenthixol acetate should never be considered as a first-line drug for rapid tranquillisation as the onset of action will not be rapid enough in these circumstances.

A Cochrane review published in 2012 advised that the evidence for zuclopenthixol acetate rapidly calming and sedating patients was poor and recommended caution in using zuclopenthixol acetate in psychiatric emergencies.

In addition, the administration of an oil based injection carries significant risk in highly agitated, struggling patients as there is a chance of accidental administration into a vein.

Zuclopenthixol acetate should not be given to patients who are struggling excessively to resist injection who cannot be suitably restrained due to the risk of intravasation and oil embolus.

Zuclopenthixol acetate may be of best use where there is a history of administration to good clinical effect or there is an advance directive in place.

Zuclopenthixol acetate is not recommended for use in the Community because it has a relatively long duration of action (72 hours) and requires a period of physical health monitoring.

Mental Health Act Consideration:

Where “Consent to Treatment” forms (T2 or T3) are in place for a service user, due consideration must be given to whether the use of zuclopenthixol acetate is covered under the Mental Health Act. The Responsible Clinician (RC) may need to complete a Section 62 form prior to prescribing and administration of zuclopenthixol acetate.

Medicines that may be required to treat potential side effects of zuclopenthixol acetate e.g. procyclidine oral or injection should also be included on the Section 62 form if they are not already included on a T2 or T3 form.


Prescribing standards:

Zuclopenthixol acetate may only be prescribed by or under the advice of a Consultant Psychiatrist.

The prescribing decision must be documented in the patient’s electronic progress notes.

Zuclopenthixol acetate should only be prescribed if any of the following circumstances applies:

After an acutely psychotic or manic patient has required repeated injections of short acting antipsychotic drugs, such as haloperidol or olanzapine or sedative drugs such as lorazepam as per Trust Guideline CP04.

When there is an advance directive for the use of zuclopenthixol acetate

When there is a documented history that the patient experienced a good clinical effect and good tolerability.

Zuclopenthixol acetate should not be administered:

In an attempt to “hasten” the antipsychotic effect of other prescribed antipsychotics.

As a test dose for zuclopenthixol decanoate

At the same time as other parenteral antipsychotics or benzodiazepines (see NOTE) as this may lead to over sedation, which may be difficult to reverse.

Zuclopenthixol acetate should only be administered when enough time has elapsed to assess the full response to previously injected drugs. Allow a minimum of 60 minutes after intramuscular injections.

NOTE: Administration of parenteral benzodiazepines in addition to zuclopenthixol acetate may be appropriate in some circumstances:

E.g.

Where the sedative effect of a benzodiazepine is desirable in the period of time before the zuclopenthixol acetate has a chance to take effect and this is part of a management plan agreed by the treating Consultant.

Where there is documented evidence that the patient has experienced a good clinical effect from the combination of parenteral benzodiazepines and zuclopenthixol acetate and has demonstrated tolerability to the combination,

Flumazenil is available on all Mental Health Units in case there is a need to reverse the effects of benzodiazepines (see CP04).

A single dose should be prescribed on the “Medication to be given once only” section of the Trust drug chart.

The prescribing of other parenteral antipsychotics to be administered as required (prn) should be ceased for the duration of action of the zuclopenthixol acetate.

The Multi-disciplinary team should consider withholding other antipsychotics for the duration of action of the zuclopenthixol acetate (72 hours).

Intramuscular and oral procyclidine should be prescribed in case of the occurrence of treatment emergent extrapyramidal side effects e.g. acute dystonic reaction or pseudo-parkinsonism.


IM procyclidine should not be administered as prophylaxis at the same time as zuclopenthixol acetate administration, to “prevent” the occurrence of dystonic reactions as it has a significantly shorter half-life than zuclopenthixol acetate.

Zuclopenthixol acetate must not be prescribed as a course, and after an initial dose has been administered, an assessment of the service user by the prescribing doctor must be carried out prior to prescription and administration of any further doses.

Therefore faxed orders or verbal orders for zuclopenthixol acetate are not acceptable.

Care must be taken not to confuse zuclopentixol acetate (Clopixol Acuphase®) with zuclopenthixol decanoate as the latter is the long acting injection used in the maintenance treatment of schizophrenia.

ALWAYS PRESCRIBE AS ZUCLOPENTHIXOL ACETATE

ALWAYS CHECK THE PACKAGING AS CLOPIXOL ACUPHASE®, CLOPIXOL INJECTION® AND CLOPIXOL CONC ®INJECTION LOOK VERY SIMILAR

Prescribing Precautions:

Zuclopenthixol acetate should never be prescribed for the following:

Patients who accept oral medication prescribed to relieve agitation or aggression / manage psychosis e.g., antipsychotics

Patients who are neuroleptic naïve

Patients who are sensitive to extrapyramidal symptoms (EPS)

Patients who are pregnant

Patients who are unconscious

Patients who have advanced hepatic or renal impairment

Patients with a history of seizures or epilepsy

Patients with cardiac disease

This group includes but is not exclusive to those with QT prolongation, recent acute myocardial infarction, significant bradycardia (<50 beats per minute), uncompensated heart failure or cardiac arrhythmias.

Hypokalaemia, hypomagnesia and those with a genetic risk of cardiac arrhythmia may also be at risk of cardiac side effects.

Licensed use:

Zuclopenthixol acetate is licensed for initial treatment of acute psychoses including mania and exacerbation of chronic psychoses, particularly where a rapid onset of action and duration of effect of 2-3 days is desirable.

Zuclopenthixol Acetate is not licensed for use in children and adolescents.

Dose:

Adults: 50mg-150mg of Zuclopenthixol Acetate (1-3ml) can be prescribed. Repeat if necessary after two or three days. Some patients may need an additional injection between 1 and 2 days after the first injection.


Elderly: The dosage may need to be reduced in the elderly owing to reduced rates of metabolism and elimination. Maximum dosage per injection should be 100mg

Zuclopenthixol Acetate is not intended for long term use and duration of treatment should not be more than two weeks. For all patients the accumulated dosage must not exceed 400mg in a 2 week period and the number of injections should not exceed four. During this two week period a treatment plan must be made to manage the service user beyond this period.

Zuclopenthixol Acetate should not be viewed as a course of treatment.

Administration:

Zuclopenthixol acetate is to be administered by deep intramuscular injection, into the upper outer buttock or lateral thigh.

Onset and duration of Action:

The sedative effects usually begin to be seen 2 hours after the injection and peak at around 36 hours. The effects usually last for up to 72 hours although full elimination of the drug may take 7 days.

Adverse Reactions:

Consult the specific product characteristics for full list of adverse reactions and prescribing information.

Common:

Drowsiness

Movement disorders ( akathisia, dystonia, parkinsonian symptoms)

Raised Prolactin

Constipation

Less Common

Tachycardia

Urinary retention

Prolong QT interval

Neuroleptic malignant syndrome (NMS)

Physical Health Monitoring Standards

Due to the extended release profile of zuclopenthixol acetate observations should be continued for 72 hours. Complete physical health monitoring as per guidance in Appendix 2.

Documentation:

In addition to a clear zuclopenthixol acetate prescription, prescribers should document instructions for the use of zuclopenthixol acetate and the physical monitoring of zuclopenthixol acetate in the patient’s electronic progress notes.


In addition to documenting administration of zuclopenthixol acetate on the prescription chart, nursing staff must document service-user response to zuclopenthixol acetate, recording any adverse events and the actions taken as well as the level of response to the medication. Physical health monitoring should be carried out in accordance with the guidance in Appendix 2 and recorded on a M-EWS Modified Early Warning Scoring System) form as per Trust Policy. If there is any deterioration in the condition of the service user, nursing staff must contact medical staff and actions taken should be documented in the service user’s electronic progress notes.

In the event that the administration of Acuphase has to be carried out under restraint, post-incident review must be recorded in the patient’s electronic progress notes. Appropriate records should be kept of any post-incident staff and/or patient debriefing.

Other relevant polices and guidance:

• National institute for Health and Clinical Excellence (NICE). Violence – The short term management of disturbed/ violent behaviour in in-patient psychiatric setting and emergency departments. Guidelines No 25, 2005

• CP04 Rapid Tranquilisation (Adults and Older Adults). December 2011.

• MM01 Medicines Management Policy

• Risk Note 11:Seclusion reviews and physical health care: Risk

References:

• Summary of Product Characteristics, Clopixol Acuphase Injection, Lundbeck Ltd. (Accessed 10/4/14)

• National institute for Health and Clinical Excellence (NICE). Violence – The short term management of disturbed/ violent behaviour in in-patient psychiatric setting and emergency departments. Guidelines No 25, 2005. (Accessed 10/4/14)

• D.Taylor et al. The Maudsley Prescribing Guidelines in Psychiatry 11th Edition, Wiley-Blackwell, 2012.

• Sussex Partnerships NHS Trust ;Guidelines for the use of zuclopenthixol acetate (Clopixol Acuphase®) injection Version 2 – amended appendix – January 2012

• Jakody K et al. Zuclopenthixol acetate for acute schizophrenia and similar serious mental illness (Review). The Cochrane Library 2012, Issue 4

Thanks:

Many Thanks to Dr Ashley Rule for his advice in preparing this document.


Appendix 1:

Treatment Algorithm & Guidance for the use of Zuclopenthixol acetate (Clopixol Acuphase®) in Adults and Older Adults (18+)

This algorithm should be implemented in any of the following situations : • Use of repeated doses of short acting parenteral antipsychotics e.g. haloperidol, olanzapine,

aripiprazole and/or benzodiazepines has been unsuccessful. • An antipsychotic with a duration of action of 2-3 days is required. • The patient has a documented history of previous good response to the use of zuclopenthixol

acetate. The need to continue following this algorithm should be under constant review and a return to managing acute agitation using oral medication, if necessary, should be undertaken at the earliest opportunity.

Appendix 2: Physical Health Monitoring Record

Zuclopenthixol Acetate Physical Health Monitoring Form

Appendix 2

Doctor to review the patient and assess need for further prescription of zuclopenthixol acetate. Discuss with Consultant and repeat dose if necessary after two or three days. Document plan in patient’s progress notes Total dose must not be greater than 400mg in 2 a week period and the number of injection should not exceed FOUR. Maintain Physical Health Monitoring and upload completed M-EWS forms into patient’s electronic health

Doctor to review patient and previous psychotropic management Assess symptoms and need for antipsychotic treatment with 2-3 day effect. Discuss with Consultant. Document plan in patient’s progress notes Prescribe Zuclopenthixol acetate 50-150mg as ONCE only dose 1, 2, 3, 4, 5

Complete physical monitoring for 72 hours.9 Refer any concerns to doctor and document in patient’s progress notes. When monitoring form complete (M-EWS), upload into patient’s electronic health record.

Competent registered nurse to administer zuclopenthixol acetate injection.6, 7

1. Check BNF/SPC for zuclopenthixol acetate for dosing.2. Maximum dose in older adults is 100mg per injection. 3. Zuclopenthixol acetate should never be prescribed for the following:

Patients who accept oral medication to treat agitation or psychosis e.g. antipsychotics Patients who are neuroleptic naïve Patients who are sensitive to extrapyramidal symptoms (EPS) Patients who are pregnant Patients who are unconscious Patients who have advanced hepatic or renal impairment Patients with cardiac disease e.g. QT prolongation, recent MI, heart failure, cardiac arrhythmia,

bradycardia (see SPC for further information) Patients with a history of seizures or epilepsy

4. Ensure that the appropriate Mental Health Act paperwork has been completed e.g. Section 62, to enable legal administration of zuclopenthixol acetate and any other prescribed medications e.g. procyclidine, benzodiazepines.

5. Caution: Always prescribe as ZUCLOPENTHIXOL ACETATE to avoid confusion with zuclopenthixol decanoate (Clopixol depot injection). Ensure that the correct product is chosen –NOTE SIMILAR PACKAGING TO OTHER IM & DEPOT PREPARATIONS.

6. Ensure both oral and I/M procyclidine are prescribed in case of treatment emergent dystonia and other EPS. Do not administer IM procyclidine for prophylaxis

7. Zuclopenthixol acetate should not be given to patients who are struggling excessively to resist injection who cannot be suitably restrained due to risk of intra-vasation & oil embolus. Consider administering IM lorazepam & waiting until the patient is calmer before administering zuclopenthixol acetate

8. Unless planned co-administration of benzodiazepine, check that 60 minutes have elapsed since administration of the last antipsychotic or benzodiazepine intra muscular injection

9. See Appendix 2 for monitoring

Guidance and Precautions


Monitoring Guideline for the Use of Zuclopenthixol Acetate

Oxford Health NHS Foundation Trust uses M-EWS (Modified Early Warning Scoring System) to monitor the physical health of patients.

Where zuclopenthixol acetate is prescribed and administered, the M-EWS must be used to record the following clinical observations:

• blood pressure (BP),

• pulse,

• temperature

• respiration rate

• Sp02

Monitoring should be carried out at the following time intervals after administration of zuclopenthixol acetate and recorded on the M-EWS form.

15 minutes 6 hours 28 hours 52 hours

30 minutes 8 hours 32 hours 56 hours

1 hours 12 hours 36 hours 60 hours




In the event that physical monitoring of a patient cannot be carried out e.g. due to aggression, AVPU scoring must be used until it is possible to carry out the required monitoring.

Alert

Voice

Pain

Unresponsive

Once completed, the monitoring information must be uploaded into the patient’s electronic health record.

Guidance on the use of M-EWS and AVPU can be accessed via the following link:

MONITORING

M-EWS forms can be accessed by following the link:

M-EWS V5

Extra-pyramidal symptoms

Patients administered zuclopenthixol acetate must also be monitored for the emergence of extrapyramidal symptoms such as acute dystonia, akathisia and pseudo-parkinsonism which can be managed with oral anticholinergic agents e.g. procyclidine, or parenteral anticholinergics e.g. IM procyclidine in an emergency.

Name:...........................................Date of Birth:............................

ID Number / NHS number………../................ (Affix label)

January 2014 M-EWS V5 Author: Resuscitation Service 1

Baseline clinical observations & calculation of M-EWS to be recorded every 12 hours for the first 72 hours after admission (More frequently if score rating indicates or recommended by doctor) Baseline observations include; Respirations, Pulse Oximetry, Pulse, Manual BP, Conscious Level, Blood glucose and weight. Observations should be recommenced in the following situations: rapid tranquilisation or physical intervention; falls; seizures; the commencement of new/increased medication; signs of recent confusion or agitation; or if staff, carers or the service user states that they suspect the patient maybe becoming physically unwell.

If unable to carry out an observation record: R = refused A = absent

Modified –Early Warning Score (M-EWS)

Scores Grading Response Action Plan for the Adult Patient at Risk

Table 1 Example recommendations: Supportive measures to consider

A. Maintain a patent airway, suction if required, give oxygen if emergency B. Monitor saturations. Sit patient up (not if unconscious or BP low) C. Monitor ECG. Check urine output, fluid balance and for haemorrhage D. Check pupil reaction, conscious level, blood glucose. If unconscious place in lateral position E. If in pain give analgesia. If Pyrexia present - cool & give antipyretic. If hypothermic - warm

Document all actions & a clear management plan following a review, including when the next review should occur IF PATIENT DETERIORATES AND YOU ARE UNABLE TO GET IMMEDIATE MEDICAL AID, TELEPHONE 9999.

IF YOUR PATIENT IS NOT BREATHING and NO SIGNS OF LIFE TELEPHONE 9999 & PROVIDE BASIC LIFE SUPPORT

S Situation: I am (name) a RMN with (X team/ward); I am calling about (patient X); I am calling because I am concerned they are unwell (e.g. they have difficulty breathing, chest pain )

B Background: Patient (X) has been under our team since (X) date with (X) problem They have been receiving (X) medicines/intervention, Their medical history is (X) Their condition has changed in the last (X )mins/hours

A Assessment: I think the problem is (X): Airway –clear/partially/completely obstructed Breathing – Colour, RR, Sp02, noises such as coughing wheezing, sputum, use of accessory muscles Circulation – Pulse, BP, CR, sweaty/clammy, pain, bleeding, nausea+/-vomiting Disability – AVPU, GCS, pupil reaction, confused/ disorientated, blood glucose, Exposure – rashes/injuries, temperature M-EWS score is (X) OR: I am not sure what the problem is but I am concerned

R Recommendation: I have done (X) I need you to; See the patient (when?)/Consider prescribing (X) drug/Make a referral to/Advise me what to do next (When?) AND is there anything I can do in the meantime?

D Decision: So we have agreed that I will (X) AND/OR you will (X)

Continue observations as before & inform nurse in charge

Potential for deterioration

Inform nurse in charge that patient has triggered a M-EWS

Check and record observations minimum interval 4 hourly (Nurse in charge to decide frequency)

If there is single observation score rating of 3 provide supportive measures -Table 1

Nurse in charge to decide to contact medical

team

Observation Score 2-3 Yes

No

Patient deteriorating & at risk of critical illness

Inform nurse in charge & medical staff of patient deterioration, report & document using the SBARD format.

Review & rescore assessment of patient within 30 minutes

Provide supportive measures –Table 1

Observation Score 4 or above Yes

(single observation rating 3)

Observation Score 0-1

Yes

No




Date

Time (24hour)

Resp

irati

on

s

(12 -

20)

≥ 30 ≥ 30 3

Resp

irato

ry R

ate

21-29 21-29 2

17-20 17-20 0

12-16 12-16 0

10-11 10-11 1

9 9 2

≤ 8 ≤ 8 3

Respirations Respirations

SP

O2 97-100 97-100 0

SP

O2

94 - 96 94-96 0

≤ 93 ≤ 93 3

Oxygen Saturation

Oxygen Saturation

Oxygen Y/N Oxygen Y/N

Pu

lse

51 -

100)

130 > 130> 3

Pu

lse

(51-1

00)

120 120 3

110 110 2

100 100 1

90 90 0

80 80 0

70 70 0

60 60 0

50 50 1

≤40 ≤40 3

Pulse Pulse

SY

ST

OL

IC B

loo

d P

ressu

re

(100 -

139)

≥ 200 3 ≥ 200 3

DIA

ST

OL

IC B

loo

d P

ressu

re

(60 -

89)

190 2 190 3

180 2 180 3

170 2 170 3

160 1 160 3

150 1 150 3

140 1 140 3

130 0 130 3

120 0 120 3

110 0 110 3

100 0 100 3

90 1 90 2

80 1 80 0

70 3 70 0

60 3 60 0

50 3 50 2

40 3 40 3

Systolic BP Systolic BP

Diastolic BP Diastolic BP

Blood Glucose Level

Blood Glucose level

FILL IN THE ACTUAL VALUE IN MMOL/L (No score ) If outside of normal parameters (4-7mmol/L) seek medical advice

Co

ns

cio

us

Le

vel

Alert

A 0

Co

ns

cio

us

Level

Voice V 1

Pain P 2

Unresponsive U 3

Conscious Level Conscious Level

Te

mpera

ture

(36.1

– 3

7.4

°C

)

40 40 3

Te

mpera

ture

(3

6.1

– 3

7.4

°C

)

39 39 3

38 38 3

37.5 37.5 2

36- 37 37 0

35 35 1

34 34 3

Temperature Temperature

TOTAL MEWS

TOTAL MEWS

Signature/Initials




Glasgow Coma Scale (GCS)

DATE

TIME (24HOUR)

Ey

es

op

en

Spontaneously 4

To speech 3

To pain 2

None 1

Ve

rbal

res

po

ns

e Orientated 5

Sentences 4

Words 3

Sounds 2

None 1

Be

st

mo

tor

res

po

ns

e

Obey Commands

6

Localise pain 5

Normal flexion 4

Abnormal flexion 3

Extension 2

None 1

Total GCS

Pupil guide

1mm 2mm 3mm 4mm 5mm 6mm 7mm 8mm

Response: +reacts - no reaction S sluggish C closed

Pu

pil

s L Size (mm)

Response

R Size (mm)

Response

Lim

b M

ovem

en

ts

Arms

Normal power

Mild weakness

Severe weakness

Spastic flexion

Extension

None

Legs

Normal power

Mild weakness

Severe weakness

Spastic flexion

Extension

None

Record findings for RIGHT ('R') and LEFT ('L') separately if different

ACTIONS

GCS of 8 or less - severe injury - urgent 999

GCS of 9 - 12 moderate injury - urgent 999

GCS of 13 - 14 minor injury - urgent medical review

GCS of 15 minor injury - monitor observations




WEIGHT CHART BMI………………………………………. (kg/m2) on admission

Measure and record weight in kg. Choose day to weigh and preferably before breakfast

Start by plotting the admission weight in the first column between the centre two ‘-00’ points. This will enable you to

record future weight loss or gain without running quickly out of chart space

Weight KGS

Date Date Date Date Date Date Date Date Date Date Date Date Date Date Date Date

-00

9

8

7

6

5

4

3

2

1

-00

9

8

7

6

5

4

3

2

1

-00

9

8

7

6

5

4

3

2

1

-00

WM

Initials

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