Guidelines for the use of zuclopenthixol acetate injection (Clopixol Acuphase®)

Version 3.1 – January 2018

GUIDELINE REPLACED Version 3 RATIFYING COMMITTEE Drugs and Therapeutics Group DATE RATIFIED October 2015 NEXT REVIEW DATE January 2021 EXECUTIVE SPONSOR Executive Medical Director ORIGINAL AUTHOR Jed Hewitt – Chief Pharmacist

Review / update – 2015 Helen Manuell – Lead Pharmacist (ESx) Review / update - 2018 Jed Hewitt – Chief Pharmacist

If you require this document in an alternative format, i.e. easy read, large text, audio or Braille please contact the pharmacy team on 01243 623349.

Guidelines for the use of zuclopenthixol acetate injection (Clopixol Acuphase®)

Introduction

In the past, Acuphase® has often been too widely and possibly inappropriately used, sometimes without full regard being given to the fact that it is a potentially hazardous and toxic preparation with very little published information to support its use. Indeed, the Cochrane Library concludes that there is inadequate data on Acuphase® and no convincing evidence to support its use in acute psychiatric emergency. So far as possible, it should therefore be reserved for the minority of patients who have a prior history of previous use and good response, with use defined in an advance directive.

Similarly, as a general rule Acuphase® should not be used for rapid tranquillisation unless such practice is also in accordance with an advance directive.

Normally, Acuphase® should never be considered as a first-line drug for rapid tranquillisation as its onset of action will often not be rapid enough in these circumstances. In addition, the administration of an oil-based injection carries very high risk in a highly agitated patient.

Acuphase® should never be administered:  In an attempt to hasten the antipsychotic effect of other therapy  To a patient who is physically resistant, (due to risk of intravasation & oil embolus), other than in exceptional circumstances.

Acuphase® should never be used for patients:  Who will accept oral antipsychotic medication  Who are antipsychotic naïve  Who are known to be sensitive to extrapyramidal side effects  Who are unconscious  Who are pregnant or are breast-feeding  Who are known to have cardiac disease or renal or hepatic impairment

 Use outside the inpatient setting is not recommended, as the patient will require close monitoring over an extensive period. (See below).

Licensed Use

Acuphase® is licensed as “initial treatment of acute psychoses, including mania and exacerbation of chronic psychoses, particularly where a duration of effect of 2-3 days is desirable”. It is important to recognise that onset of action is not as rapid as may be believed or required, particularly where rapid tranquillisation is needed. Therefore, Acuphase® should only be used after an acutely psychotic patient has required repeated injections of short-acting antipsychotics such as haloperidol or olanzapine, and/or sedative drugs such as lorazepam, and these have not been effective. (Unless there is an advance directive for its use).

Further to this, Acuphase® should be given only when enough time has elapsed to fully assess the response to previously injected drugs, ie. at least 15 minutes after IV injections and at least 60 minutes after those administered intramuscularly. Consideration should be given to zuclopenthixol plasma levels reaching a peak approximately 24-36 hours after administration of an Acuphase® dose. Caution must therefore be applied if consideration is being given to the administration of a short-acting psychotropic IM injection during treatment with Acuphase®, as excessive sedation and/or aggravated adverse events may occur if the patient is exposed to high plasma levels of multiple drugs. Dose Acuphase® is licensed at a dose of 50mg to 150mg, (1-3ml), repeated if necessary after 2 or 3 days. (Some patients may need an additional injection between 1 and 2 days after the first, although at least 24 hours should be left between doses). The maximum dose per injection for an elderly patient is 100mg (2ml). For all patients the accumulated dosage must not exceed 400mg, (or 4 injections), within a 2-week period. Acuphase® should not be viewed as a course of treatment and the patient should be carefully reviewed by a consultant before each dose is prescribed / administered. The maximum licensed duration ensures that a treatment plan is put in place for the patient. More frequent administration or a more prolonged treatment period is not within the terms of the product license and should only occur in very exceptional circumstances. The patient must be carefully monitored after each injection using NEWS documentation (see Appendix 1). Physical health parameters should normally be monitored at the following frequency:

 15 and 30 minutes after injection, then:  1, 2, 4, 6, 8 and 12 hours after injection, then:  Every 6 hours for a further 36 hours – ie. a minimum total of 48 hours after injection

If used to good effect and the patient feels that they may benefit from its use in the future, then consideration should be given to the preparation of an advance directive. Onset and Duration of Action Sedative effects of Acuphase® usually begin to appear within 2 hours of injection and may not reach a peak for another 24 to 36 hours. Significant effects may last for up to 72 hours although full elimination of the drug may not be complete for 7 days.

Cross-Reference

This guidance document should be read in conjunction with the Trust’s Rapid Tranquillisation Policy.

References

 Summary of Product Characteristics – Clopixol Acuphase®. Lundbeck Ltd, January 2017  The Maudsley Prescribing Guidelines, 12th Edition, 2015.  The Psychotropic Drug Directory 2016. Stephen Bazire.

Version 3.1: January 2018

APPENDIX 1 NEWS ACUPHASE PROTOCOL- PHYSICAL HEALTH OBSERVATIONS First Name: Surname Ward CIS Number: Date of birth Consultant

Frequency: Baseline, 15 mins, 30 mins then at 1, 2 , 4, 6, 8, and 12 hours after the injection Then every 6 hours up to 48 hours. If you are unable to carry out Physical Health observations, or the patient refuses you must complete Non- Contact Observations of respiratory rate and level of consciousness using AVPU and record these on this chart.

Please record patient specific variants in column below and note: This protocol should NOT prevent a practitioner making an appropriate response based upon their clinical judgement. Variants - Patient NEWS Frequency of Monitoring Clinical Response Specific

Please specify Routine monitoring of physical • Continue routine NEWS monitoring with every 0 frequency of observations set of physical health observations monitoring physical observations: • Inform Registered Nurse who must assess the patient; Total score 1 - 4 • Registered Nurse to decide if increased Twice daily physical observations & (if 3 in one frequency of monitoring and / or escalation of discuss with Medical Team parameter, see clinical care is required; below) • Discuss with Medical Team / Out Of Hours (guidance required)

Increase frequency of physical • Registered Nurse to urgently inform the Medical observations to a minimum of 1 hourly & Team caring for the patient. discuss urgently with the Medical Team. • Urgent assessment by Medical Team (give ...... SICK! handover using the *SBARD tool) SEPSIS RED FLAG SIGNS Total NEWS 5-6 • Assess if transfer of the patient is required Slurred speech or 3 in one • Consider 999 call for ambulance assistance if Extreme shivering/muscle pain parameter doctor is unable to assess within 20 minutes / or Passing no urine (in a day) Consider sepsis if concerns remain over the patient’s Physical Severe breathlessness red flag signs Wellbeing. I feel like I might die • • CONSIDER SEPSIS SCREENING TOOL Skin mottled/discoloured

• Registered Nurse to immediately inform the Medical Team caring for the patient – again out of hours; Continuous monitoring of patient’s ACT NOW! • 999 call for emergency ambulance assistance to Physical Observations & Initiate an Total NEWS 7 or transfer patient to the nearest District General emergency call more Hospital • Contact patient’s Consultant / nominated Deputy • CONSIDER SEPSIS SCREENING TOOL

Escalation Protocol SBARD

S Your name / designation / ward The patient’s name is .. I am concerned because … The NEWS score trigger is. Situation B Treatment Date Background Brief history Admission Date MHA Status Medication / therapy A Is the patient talking? Any airway noises; e.g. gurgling/stridor A Airway Assessment B Respiratory Rate (RR)? Any respiratory noises e.g. wheeze? Is breathing laboured? Oxygen Breathing saturation levels (SpO2)? C Heart Rate (HR)? Capillary Refill Time (CRT)? Blood Pressure (BP)? Circulation Temperature? D Level of consciousness (AVPU)? Blood sugar levels? Pupil reactions? Disability E Exposure & environment Bleeding / rashes, etc.? Any other abnormal signs? Exposure

R I would like you to do /What would you like me to do? Recommend D Record what has been agreed on the patient’s notes. Decision

*Use SBARD Tool (above) to notify Medical Team