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®) 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 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. 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 2 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: ¾ 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. ¾ When there is an advance directive for the use of zuclopenthixol acetate ¾ When there is a documented history that the patient experienced a good clinical effect and good tolerability. Zuclopenthixol acetate should not be administered: ¾ In an attempt to “hasten” the antipsychotic effect of other prescribed antipsychotics. ¾ As a test dose for zuclopenthixol decanoate ¾ 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. ¾ 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. ¾ 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. 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 3 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: ¾ Patients who accept oral medication prescribed to relieve agitation or aggression / manage psychosis e.g., antipsychotics ¾ Patients who are neuroleptic naïve ¾ Patients who are sensitive to extrapyramidal symptoms (EPS) ¾ Patients who are pregnant ¾ Patients who are unconscious ¾ Patients who have advanced hepatic or renal impairment ¾ Patients with a history of seizures or epilepsy ¾ 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: ¾ 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. 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 4 ¾ 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 ¾ 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. ¾ 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