GUIDANCE FOR THE USE OF ZUCLOPENTHIXOL ACETATE (CLOPIXOL ACUPHASE) IN ADULTS MAY 2017

Transcription

1 GUIDANCE FOR THE USE OF ZUCLOPENTHIXOL ACETATE (CLOPIXOL ACUPHASE) IN ADULTS MAY 2017 This policy supersedes all previous Guidance for the use of clopixol acuphase (zuclopenthixol acetate) in adults. GUIDANCE ON THE USE OF CLOPIXOL ACUPHASE _PHA11_MAY 2017

2 Policy title Guidance for the use of zuclopenthixol acetate (clopixol acuphase) In adults Policy PHA11. reference Policy category Clinical - Medicines Relevant to All Trust Staff involved in the use of zuclopenthixol acetate (clopixol acuphase). Date published May Implementation May date Date last February 2017 reviewed Next review April date Policy lead Lucy Reeves, Chief Pharmacist. Contact details lucy.reeves@candi.nhs.uk Telephone: Accountable director Approved by (Group): Approved by (Committee): Document history Membership of the policy development/ review team Dr Vincent Kirchner, Medical Director. Drugs And Therapeutics Committee. Quality Committee. Date Version Summary of amendments Mar New Guidelines Mar Routine review Mar Routine review Feb Routine review May Routine review Audrey Coker, Lead Pharmacist for Clinical Services. Consultation Drugs And Therapeutics Committee Members DO NOT AMEND THIS DOCUMENT Further copies of this document can be found on the Trust intranet. i

3 Contents Page 1 Introduction 1 2 Aims and objectives 1 3 Scope of the policy 1 4 Indication 1 5 Zuclopenthixol acetate and the mental health act 2 6 Assessment prior to consideration of zuclopenthixol acetate 2 7 Long term management 4 8 Contraindications 4 9 Precautions 5 10 Dosage and administration 5 11 Physical monitoring 5 12 Equipment 7 13 Management of side effects and complications 8 14 Recording and incident reporting 9 15 Dissemination and implementation arrangements 9 16 Training requirements 9 17 Monitoring and audit arrangements 9 18 Review of the policy References Associated documents 12 Appendix 1: Practice guidance for the use of lorazepam injection 13 Appendix 2: High dose antipsychotic therapy form 14 Appendix 3: Zuclopenthixol acetate algorithm 16 Appendix 4: Equality impact assessment tool 17 ii

4 1. Introduction Careful thought must be given to ways of anticipating and minimising the emergence of dangerously disturbed behaviour. More proactive and assertive treatment of an underlying disorder (e.g. psychosis), or pre-empting adverse environmental factors (e.g. interpersonal conflict) may prevent the situation arising in the first place. The use of medication should not be seen as the first and only response to the management of disturbed violent patients but rather as one aspect of the total plan of management with contributions from all members of the multidisciplinary team. The use of zuclopenthixol acetate is not a first line treatment option in managing violent and aggressive behaviour. Zuclopenthixol is a potentially toxic preparation with very little published information to support its use Aims and objectives To provide guidance to prescribers and nursing staff on the safe, effective and appropriate use of zuclopenthixol acetate in acutely disturbed patients. 3. Scope of the guideline This policy is aimed at all clinical, nursing and medical staff, who are directly involved in the management of acutely disturbed patients. The guidance covers the prescribing and administration of zuclopenthixol acetate to service users from the age of 18 in inpatient settings. Zuclopenthixol acetate should not be prescribed or administered to outpatients. 4. Indication Zuclopenthixol acetate injection is licensed for the short term management of acute psychosis, mania or exacerbations of chronic psychosis, but does not treat the underlying condition. NICE does not recommend its use for rapid tranquilisation due to long onset and duration of action. However, zuclopenthixol acetate injection may be considered as an option for disturbed behaviour when: It is clearly expected that the service user will be disturbed/violent over an extended period of time. A service user has a past history of good and timely response to zuclopenthixol acetate injection 1. A service user has a past history of repeated parenteral injection 1. An advance directive has been made indicating that this is a treatment choice. It should never be administered to those without any previous exposure to antipsychotic medication. The BNF and manufacturer s Summary of Product Characteristics (SPC) should be consulted regarding its use 2,3. If shorter acting parental medicines (i.e. lorazepam, haloperidol, aripiprazole) have already been administered for rapid tranquillisation, then sufficient time must be allowed to assess the full response to these medicines before zuclopenthixol acetate is administered. This should be at least 60 minutes 1. Zuclopenthixol acetate must only be initiated on the recommendation of a consultant psychiatrist or an SPR/ST4-1

5 6. This must be documented in the patient s records and include the reasons for use. Zuclopenthixol acetate is not licensed for the treatment of dementia-related behavioural disturbances Zuclopenthixol acetate and the Mental Health Act This guideline aims to ensure zuclopenthixol acetate is administered to patients in line with current NICE guidance and best practice recommendations. Administration of zuclopenthixol acetate should be undertaken in accordance with the Mental Health Act Code of Practice (DH, 2008). This policy complies with the Code of Practice 5. It also takes into account 'Positive and Proactive Care: Reducing the need for restrictive interventions'(dh, 2014). In line with Positive and proactive care... (DH, 2014) 6 use of zuclopenthixol acetate should be a last resort. Those patients for whom zuclopenthixol acetate might be used should have comprehensive behavioural support plans, detailing the range of strategies for dealing with disturbed behaviour that may be used as less restrictive options. These should be followed. The use of restrictive interventions must take place only under appropriate legal authority. Use of restraint implies that the person is not consenting to treatment. Informal patients should not be restrained. If a patient is not detained, but restraint in any form has been deemed necessary (whether as an emergency or as part of the patient s treatment plan), immediate consideration should be given to whether formal detention under the Act is appropriate (subject to the criteria being met). Where a patient is deprived of liberty in a hospital for mental health treatment under the deprivation of liberty safeguards in the MCA5, the use of restraint may well indicate that the patient objects to treatment or to being in hospital. The patient is therefore no longer eligible to be held under those safeguards. If so, consideration will need to be given to whether the patient can and should be detained under the Mental Health Act instead. The decision to use restraint should first be discussed with the clinical team and must be recorded in the patient s EPR (Care tes), along with the justification for it. An incident form must also be completed. 5.2 Restraint as an indicator of the need for detention under the Act If a patient is not detained, but restraint in any form has been deemed necessary (whether as an emergency or as part of the patient s treatment plan), consideration should be given to whether formal detention under the Act is appropriate (subject to the criteria being met). Where a patient is deprived of liberty in a hospital for mental health treatment under the deprivation of liberty safeguards in the MCA 7, the use of restraint may well indicate that the patient objects to treatment or to being in hospital. The patient is therefore no longer eligible to be held under those safeguards. If so, consideration will need to be given to whether the patient can and should be detained under the Mental Health Act instead. 6. Assessment prior to consideration of zuclopenthixol acetate. 6.1 The assessment of the patient to ascertain the following. The assessment must be documented in the EPR. In reaching the decision to use zuclopenthixol acetate, the senior nurse and doctor should undertake a risk assessment of the situation, including the risks to the patient, other patients, staff and the environment and the patient s current mental state. 2

6 The patient must be informed that zuclopenthixol acetate is going to be given. Physical health, age and ability to do a physical examination. Past and current medical history, especially cardiorespiratory disease, organic syndromes, acute confusional states, CNS infection, epilepsy, head injury, advanced renal or hepatic disease, Parkinsons disease and falls. Consider the possibility of a physical examination to ascertain the information including state of hydration, illicit drug intoxication and urine drug screens, delirium, hypoglycaemia, pregnancy 8. Allergies and sensitivities and severity of extrapyramidal side effects. Recent and current medication. Medicine interactions are possible with a number of medicines including alcohol, CNS depressants, general anaesthetics, tricyclic antidepressants, antipsychotics, levodopa, metoclopramide, piperazine, lithium salts, and enzyme inhibitors which may result in potentiated QT prolongation. Medicines with particular modes of action that involve electrolyte or fluid disturbances e.g. diuretics may affect blood potassium levels. Hypo- or hyperkalaemia can induce cardiac arrhythmias which can manifest as QT interval prolongation 3. Refer to a current copy of the Maudsley prescribing guidelines for a list of medicines associated with QT prolongation 1. This is not an exhaustive list and further information can be obtained from the Pharmacy department or by referring to the current BNF. The amount of antipsychotic and benzodiazepine medication administered to the patient in the preceding 72 hours. Recent and chronic use of illicit substances and/or alcohol. Previous exposure to antipsychotic medication. Previous response to zuclopenthixol acetate where appropriate. Current physical observations. Recent ECG findings, U&Es and LFTs. Every effort should be made to obtain baseline measurements of temperature, blood pressure, pulse rate, respiratory rate and the level of consciousness prior to the administration of zuclopenthixol acetate. A pre-treatment ECG should also be offered if possible. Emergency resuscitation equipment, procyclidine injection and flumazenil injection must be available before treatment. Ensure the patient is monitored (see section 11 Physical Monitoring ). The patient should be able to respond to communication throughout. 6.2 Zuclopenthixol acetate should not be administered: in an attempt to hasten the antipsychotic effect of other antipsychotic therapy. 1 for rapid tranquillisation (onset of effect is too slow). 1 at the same time as other parenteral antipsychotics (may lead to oversedation which is difficult to reverse). 1 as a test dose for zuclopenthixol decanoate depot Zuclopenthixol acetate should not be used for, or in, the following: Patients whose physical state gives cause for concern. Patients who accept oral antipsychotic or benzodiazepines and are adherent. Patients who are neuroleptic naïve. 1 3

7 Patients who are unconscious. 1 Patients who are pregnant. 1 Patients with organic illnesses 4. Patients with Parkinson s disease Zuclopenthixol acetate should be used with caution (and consider alternatives) in the following circumstances (table 1): Table 1: Cautions Situation At the same time as benzodiazepines (may lead to over-sedation which is difficult to reverse) 9. To a patient who is physically struggling 9. Patients who are sensitive to extrapyramidal side effects 9. Patients with hepatic or renal impairment 9. Patients with cardiac disease 9. Patients prescribed barbiturates or opiates 9. Patients with recent exposure to illicit substances and/or alcohol 9. Patients with convulsive disorders 9. Patients with respiratory disease 9. Patients in seclusion. Patients with learning disabilities 4. Consider If a benzodiazepine is required, lorazepam is the preferred choice as it is a shorter acting agent. This should be at the same time as the first dose of zuclopenthixol acetate only 9,10. Additional haloperidol should not be given 10. The risk of physical or psychological trauma from multiple short acting injections. The risk of self injury or injury to others 9. A view should be taken on sensitivity to previous short acting injections or previous administration of zuclopenthixol acetate. Procyclidine IM/PO should be available if required. Risk assessment in each individual patient based on the severity of the physical illness 9. Monitoring should take place as per these guidelines and any other relevant Trust guidelines (the rapid tranquillisation policy, the seclusion policy and the observation policy). Caution. 7. Long term management Treatment with zuclopenthixol acetate should not extend beyond a two week period 4. During that time a long term treatment plan should be put in place. There are no specific guidelines as to when to commence oral or depot antipsychotic medication after the last dose of zuclopenthixol acetate. Advice can be obtained from the Pharmacy department for individual cases. 8. Contraindications Hypersensitivity to zuclopenthixol acetate, circulatory collapse, comatose states, including acute alcohol, barbiturate or opiate intoxication 4. 4

8 9. Precautions As with other antipsychotic medication, including patients with risk factors for stroke. 10. Dosage and administration 10.1 When zuclopenthixol acetate is prescribed, medical staff should communicate with nursing staff on any medicines management issues including the threshold for feedback to medical staff. This should also be documented in the EPR, including the rationale Dose (adults years) mg by deep intramuscular injection (in the upper outer buttock or lateral thigh), repeated if necessary after two to three days 4. Maximum of 400mg in a two week period. The number of injections should not exceed four. 2 The injections should be spaced at least twenty-four hours apart 1. There is no such thing as a course of Acuphase. The patient should be assessed before each individual dose is prescribed and administered Dose (elderly) The dosage may need to be reduced in the elderly due to reduced rates of metabolism and elimination. Maximum dosage per injection should be 100mg 4. Zuclopenthixol acetate should be prescribed as stat doses. As required prescriptions are not acceptable given the need for patient assessment by medical staff prior to administration of each dose. THE MAXIMUM LICENSED DOSE REGIME SHOULD NOT BE EXCEEDED Administration by deep intramuscular injection only Onset and duration of action. Onset: Sedative effects usually begin to be seen two hours after the injection. 1 Peak of action: twelve to thirty-six hours. 1,11, Duration of action of first injection: seventy-two hours 1, Physical monitoring After administration of zuclopenthixol acetate 11.1 Intermittent (every half an hour) visual observation should be used for seventy two hours after each dose. Observations should be documented in the patients EPR. Monitor the patient for extrapyramidal or any other side effects. Every effort should be made to obtain baseline measurement of temperature, blood pressure, pulse rate, respiratory rate and level of consciousness prior to administration. All patients receiving zuclopenthixol acetate must be physically monitored following administration as below and documented on the MEWS monitoring chart and in the 5

9 EPR. Refusals should be documented. If patients are fully ambulatory, then frequent monitoring is not required. Table 2: Physical monitoring schedule. Prior to Administration 1 hour post administration 2 hours post administration 2 37 hours post administration hours TPR, BP, degree of hydration, level of consciousness, oxygen status if asleep. Where possible, obtain Us & Es, LFTs including GGT and an ECG. TPR, BP, degree of hydration and level of consciousness. If an ECG was not taken previously, this should be obtained when the patient is calm. TPR, BP, degree of hydration and level of consciousness. If an ECG was not taken previously, this should be obtained when the patient is calm. TPR, BP, degree of hydration, level of consciousness should be monitored every half an hour. TPR, BP, degree of hydration, level of consciousness should be monitored every two to four hours. Where further injections have been given, restart monitoring schedule from the beginning after each dose. Emergency resuscitation equipment, procyclidine injection and flumazenil injection must be available before treatment. Where concurrent intramuscular lorazepam was given with the first dose of zuclopenthixol acetate, physical monitoring should take place every fifteen minutes, for two hours then every half an hour until ambulatory (as per the Trust rapid tranquillisation guidelines). Then continue as above. Any clinical concerns should be discussed with the medical staff. Thereafter, monitoring should be carried out as above and any clinical concerns discussed with the medical team. Where monitoring is offered and refused, this should be documented in the EPR. Fluid balance & electrolyte balance should be monitored as clinically indicated and documented. ECG monitoring an ECG should be offered when the patient is calm. If a patient is unconscious the airway must be protected. Continuous pulse oximetry is recommended to monitor oxygen levels. The level of alertness and respiratory effort should be assessed by attempting to wake a sleeping patient. Unconscious patients must not be secluded and must be observed by an appropriately trained member of staff at all times. Seclusion: When a patient is in seclusion a nurse must constantly observe the patient using either direct observation or audio-visual equipment. At a minimum, every hour the patient s respiratory rate and level of consciousness must be monitored through the window of the seclusion room. These observations must be documented. Staff must enter the seclusion room once every two hours to perform a seclusion review to assess the patient and decide on whether continued seclusion is needed. Staff must attempt to make physical observations (heart rate, temperature, oxygen saturations, blood pressure and level of consciousness) at each seclusion review. The nurse responsible for directly observing the patient throughout the period of seclusion is responsible for initiating an earlier than planned review if any concerns about the patient s physical welfare arise. If any urgent concerns about a patient s physical health arise then seclusion must be terminated 6

10 immediately. Unconscious patients must not be secluded and must be observed by an appropriately trained member of staff at all times. In the following circumstances, more frequent monitoring and intensive monitoring may be required: The patient appears to be or is asleep / sedated. The BNF limit is exceeded. An older adult s mobility is affected or they are at risk of falls. The patient has been recently misusing substances or alcohol The administration and monitoring of zuclopenthixol acetate should be discussed at handover meetings and feedback to the ward doctor and at ward round Caution should be exercised if seclusion is used following zuclopenthixol acetate. If the patient is asleep, then seclusion ends. The door should be left open and the patient observed on a one to one basis The individual should be reviewed by a doctor at the earliest opportunity, but within twenty four hours of receiving zuclopenthixol acetate An ECG should be offered to patients after administration of zuclopenthixol acetate if there is no recent record. This should be done when the patient is calm. Consider conducting an ECG following the administration of zuclopenthixol acetate if the following apply: High doses are used. When used in combination with any other medicines known to prolong the QTc interval (see the Maudsley prescribing guidelines). If the baseline ECG was abnormal or a baseline ECG was not available. If there was any clinical indication to repeat the ECG Consider checking electrolytes if not checked within the last three to four days Check for signs of dehydration e.g. thirst, dry mouth, lips and a reduction in urine output Equipment The following equipment should be available in all settings where zuclopenthixol acetate may be given (are stored): Pulse oximeters. ECG machines should be available on site. A grab bag, automatic external defibrillator and oxygen must be available and easily accessible. This equipment should be maintained and checked in accordance with the Trust cardiopulmonary resuscitation (CPR) policy and staff should be familiar with their use. First-line resuscitation medicines should be available. Procyclidine injection should be available. 7

11 13. TABLE 3: Management of side effects and complications COMPLICATION SYMPTOMS/SIGNS MANAGEMENT Acute dystonia Severe painful muscular stiffness and/or oculogyric crisis. Procyclidine 5-10 mg i.m 1,12. Repeat after twenty minutes if necessary 8. If not severe, syrup may be given. Hypotension Fall in blood pressure (30mmHg orthostatic drop or <50mmHg diastolic) 1,12. Lie patient flat and raise legs 1. Monitor closely 1. Neuroleptic Malignant Syndrome (NMS) Arrhythmias Respiratory depression Increasing temperature, fluctuating blood pressure, tachycardia, incontinence/retention, sweating, muscular rigidity or confusion/altered consciousness 1. Slow (<50/minute) or irregular pulse. 1 Reducing respiratory rate, reducing consciousness. Call the duty doctor or the ward doctor immediately. Withhold antipsychotics. Monitor closely. Send bloods for the creatine phosphokinase level 1. Call the duty doctor or the ward doctor immediately 1. An ECG should be done. Withhold antipsychotics. Monitor closely. Call an ambulance via 999. Call the duty doctor or the ward doctor immediately Bring the resuscitation equipment. Give oxygen, if patient able to sit upright, this will assist breathing. If unconscious, position in recovery position and protect the airway. Give oxygen. If respiratory rate drops below 10/minute or Oxygen Saturation <90% 1,12, consider manual ventilation after inserting an airway if necessary. If patient received benzodiazepines, use flumazenil 1. (May rarely cause seizures in benzodiazepine dependant patients, in epileptic patients or those with head injuries). How to give flumazenil: mcg i.v. over 15 seconds. 2. If consciousness not resumed within 60 seconds give 100mcg IV over 10 seconds. 3. Repeat at 60 second intervals. Maximum dose 1mg/24 hour 1. Continue to monitor after respiratory rate returns to normal. Flumazenil has a short duration of action so further doses may be required as above 13. Patients may become agitated or anxious on wakening. If respiratory depression is induced by other agent patient will require mechanical ventilation 1 obtain emergency medical assistance. 8

12 14. Recording and incident reporting The use of zuclopenthixol acetate should be reported in the patient s EPR and on a datix electronic incident reporting form if the use of control and restraint was required. There should be a full multidisciplinary review after the event. 15. Dissemination and implementation arrangements This document will be circulated to all managers who will be required to cascade the information to members of their teams and to confirm receipt of the procedure and destruction of previous procedures/policies which this supersedes. It will be available to all staff via the Trust intranet. Managers will ensure that all staff are briefed on its contents and on what it means for them. 16. Training requirements Medicines Management Training for Nurses is provided to Nurses once a year on each site. There is a junior doctors induction programme which signposts key prescribing procedures and medicines management policies. There is also access to the policy folder on the Trust intranet via the induction package. 17. Monitoring and audit arrangements Elements to be monitored Lead How trust will monitor compliance Freque ncy Reporting arrangements Acting on recommendations and Lead(s) Change in practice and lessons to be shared Prescribing Administration Chief Pharmacist Director of Nursing / Chief Pharmacist Audit: as part of RT audit. Clinical Pharmacy prescription monitoring Audit: as part of RT audit. Clinical Pharmacy prescription monitoring Annually Ongoing Annually Ongoing Drugs & Therapeutics Committee, Quality Committee Drugs & Therapeutics Committee, Quality Committee Required actions will be identified and completed in a specified timeframe Required actions will be identified and completed in a specified timeframe Required changes to practice will be identified and actioned within a specific time frame. A lead member of the team will be identified to take each change forward where appropriate. Lessons will be shared with all the relevant stakeholders. Monitoring Director of Nursing / Chief Pharmacist Audit: as part of RT audit. Clinical Pharmacy prescription monitoring Annually Ongoing Drugs & Therapeutics Committee, Quality Committee Required actions will be identified and completed in a specified timeframe 9

13 18. Review of the policy Review date: April

14 19. References 1. The South London and Maudsley NHS Foundation Trust; Oxelas NHS Foundation Trust. Prescribing Guidelines. 12 th Edition. Taylor D., Paton C. and Kapur S. 2. Rachel Ryan. British National Formulary. Number 72. London. BMJ Group and Pharmaceutical Press NICE Clinical Guideline 25: Violence: The short term management of disturbed/violent behaviour in psychiatric in-patient settings and emergency departments. National Institute for Clinical Excellence, February At 4. Lundbeck Ltd. The specification of product characteristics. Clopixol acuphase injection Injection (07 January 2012). (online). Available: (accessed vember 2014) 5. Department of Health. Code of Practice; Mental Health Act London. The Stationery Office ISBN Department of Health. Positive and proactive care: reducing the need for restrictive interventions. (April 2014) (online). Available: 93/JRA_DoH_Guidance_on_RP_web_accessible.pdf (accessed 9th of December 2014). 7. Code of Practice; Mental Capacity Act 2005, Section 5. London. Published by the Stationery Office. 8. Devonshire Partnership NHS Trust. Protocol for prescribing and administration of injectable drugs for rapid tranquillisation (RT), physical health assessment and monitoring, including prescribing guidelines on the drugs to be used for RT. May ProtocolForRapidTranquilisation_Jul12.pdf (accessed 19 th January 2013). 9. Keedwell P.(paul.keedwell@candi.nhs.uk). Re: Clopixol acuphase guidelines. Personal communication. to A. Coker (Audrey.coker@canis.nhs.uk). 06 February Barnes C. et al. The development of clinical guidelines for the use of zuclopenthixol acetate. Australasian Psychiatry. Vol March rthamptonshire healthcare NHS Foundation Trust. Rapid tranquillisation policy. May anquillisation%20policy%20(%20may12-may13).pdf (accessed 19 th January 2013.). 11

15 12. Macpherson R. et al. A growing evidence base for management guidelines. Revisiting.Guidelines for the management of acutely disturbed psychiatric patients. Advances in Psychiatric Treatment , p Actavis. The specification of product characteristics. Flumazenil injection (27 th October 2011). (online). Available: (accessed 10th of January 2017). 14. Pfizer Ltd. The specification of product characteristics. Ativan injection (May 2014) (online). Available: (accessed 10th of January 2017). 20. Associated documents Rapid Tranquillisation Policy. Therapeutic Management of Violence And Aggression Policy. Seclusion Policy. Observation and Engagement Policy. 12

16 Appendix 1 Practice guidance for the use of lorazepam injection Place in Therapy: Lorazepam IM is the preferred first line option in most circumstances. It may be used with the first dose of zuclopenthixol acetate (not in the same syringe). It is a short acting benzodiazepine, therefore carries the least risk of accumulation on repeated dosing. Attention should be paid to the patients total daily dose of benzodiazepine. In overdose the effect of benzodiazepines can be reversed by flumazenil. Situations where administration is not recommended: Avoid in patients who are tolerant to benzodiazepines. Solutions of lorazepam should not be used if they are discoloured or contain a precipitate, or have been outside of refrigeration ((2 C to 8 C) for >30minutes. Dosing in adults Single dose is mg 2 as a single intramuscular (IM) injection (at the same time the first dose of zuclopenthixol acetate is given). A repeat dose is not recommended if used in conjunction with zuclopenthixol acetate. Dosing in older adults Single dose is 250micrograms -1mg as a single intramuscular (IM) injection. A repeat dose is not recommended if used in conjunction with zuclopenthixol acetate. Side effects of the injection formulation: Hypersensitivity reactions, anaphylactic/oid reactions, angioedema are rare. Rarely, pain and redness have been reported after lorazepam injection. Respiratory depression may occasionally occur. The extent of respiratory depression is dose dependent. Hypotension may occasionally occur. Formulation and Administration: Lorazepam injection must be stored in a refrigerator (2 C to 8 C) 14. After removing from the refrigerator, the injection should be used within 30 minutes. Solutions of lorazepam should not be used if they are discoloured or contain a precipitate. Lorazepam is a clear concentrated solution of 4mg/1ml in a 2mL ampoule. It must be diluted 1:1 with WFI or 0.9% NACL before IM injection 11 as the excipients can cause pain if administered undiluted. Administer by deep intramuscular injection, routinely water for injections should be used After dilution, gently mix the contents thoroughly. To avoid air bubbles, do not shake vigorously. Administer immediately after reconstitution. NEVER mix medicines in the same syringe. Lorazepam solution for injection is slightly viscid when cool. Any unused solution should be disposed of as clinical waste. Other Medicines: Simultaneous injection of IM benzodiazepines is not recommended with IM olanzapine. Summary: The product does not have a good stability profile and begins to degrade quickly at room temperature, with the risk of precipitation. (Adapted from the monograph in the Trust rapid tranquillisation guidelines). 13

17 Consultant: Appendix 2 High dose antipsychotic therapy form. Date high dose therapy began: Name of Doctor: Grade: HO SHO SPR Consultant Other Date: Antipsychotic Medication (regular) 2,3 Medicine Dose %BNF Max Please, specify reason(s) for High Dose Antipsychotic Therapy (HDAT) 4,5 Other Medication: CAUTION INCREASED RISK IN FOLLOWING CATEGORIES OF PATIENTS: Old Age: Hepatic/Renal Impairment: Obesity: Weight:.. Heavy user of Tobacco or Alcohol: History of Arrhythmia: History of Myocardial Infarction or IHD: Medicine interactions (inc. medicines with additive ECG effects) Other Baseline Month 1 Month 3 Month 6 Month 9 Month 12 ECG QT interval QTc Interval LFTs Alk Phos ALT Total Bilirubin U & Es Na K Urea Creatinine BP, Pulse Temp Please, record daily for one week - on initiation of HDAT, and after each increase in dose of antipsychotic. Review Date(s) Has patient/carers been informed of the high dose nature of therapy Is high dose therapy covered on the consent form (where applicable) Yes/ Yes/ The Consensus Statement on high dose antipsychotic medication. Council Report CR190, vember2014 should be consulted for further advice and may be obtained via the Royal College of Psychiatrists website

18 1. The Consensus Working Group agreed to take the following as a definition of a high dose: A total daily dose of a single antipsychotic which exceeds the upper limit stated in the summary of product characteristics or BNF and a total daily dose of two or more antipsychotics which exceeds the SPC or BNF maximum using the percentage method. 2. To evaluate if a patient is on high dose antipsychotic therapy: express the dose of each antipsychotic as a percentage of its BNF maximum and add. If the total exceeds 100% - then patient is on High Dose Antipsychotic therapy (HDAT). For example: a patient on olanzapine 20 mg nocte and Clopixol 400 mg i.m each week is on 100% of maximum Olanzapine dose and 66% of maximum zuclopenthixol dose: a total of 166% - thus, this Rx does constitute high dose. Such therapy CAN be given but it must be documented as such in the patient s notes. The Royal College of Psychiatric Guidelines (RCPsych) must then be followed. Any further increases in dose/dosages of antipsychotic(s). Should be done slowly waiting at least two weeks, before each subsequent dose increase. (Please note: both Consensus Statement on The use of high dose Antipsychotic Medication and Council Report CR57 The Association between antipsychotic drugs and sudden death do not recommend use of more than one antipsychotic at a time. Additionally, NICE guidance on use of Atypicals does not recommend combining the latter with typical antipsychotics. 3. If the use of prn antipsychotic medication (whether p.o or i.m) pushes patient s therapy into HDAT, please record use of such medication in notes. If this occurs for three or more consecutive days then: review therapy, and if it is decided to continue with the same prescription, please, implement these guidelines. 4. Before high dose therapy is commenced the possibilities of substance misuse, personality disorder, inadequate time to respond, poor compliance, misdiagnosis of psychosis, akathisia and response to Clozapine should be eliminated. Other management techniques should be considered e.g. de-escalation. 6. Decision to initiate high dose therapy should ONLY be made by an consultant, or Registrar with MRCPsych following an individual risk benefit assessment on consultation with the clinical team. Obtaining a second medical opinion should be considered. The decision, risks & benefits, aims and how the outcomes will be assessed must be documented in the case notes. 7. RCPsych guidelines emphasise the importance of CAUTION to high dose antipsychotic therapy. These include: Old Age History of myocardial infarction Medicine interactions Hepatic/Renal impairment History of arrhythmia Medicines with additive ECG effects Obesity History of ischaemic heart disease Heavy users of tobacco/alcohol These patients need to be monitored more closely as some patients may be contraindicated to HDAT. Patients should be assessed for cardiovascular disease prior to antipsychotic treatment regardless of dose. Modifiable risk factors for ischaemic heart disease inc. smoking, hypertension, hyperlipidaemia, sedentary lifestyle and obesity) should be identified and managed appropriately. Under the circumstances of rapid tranquillisation where an assessment is difficult and ECGs impossible, it is prudent to avoid high doses. 8. Prior to commencing such therapy a baseline ECG should be obtained. QT and QTc should be noted and the ECG signed. An ECG should be repeated after a few days after initiation and during dose escalation. This is because high dose antipsychotic therapy has been associated with QTc lengthening raising the risk of clinically significant arrhythmias. As long as the dose of antipsychotic remains high an ECG should be carried out every one to three months. In summary ECGs should be obtained at baseline, one, three, six, nine and twelve months later (if patient continues on high dose therapy for this period of time) or more frequently if clinically indicated. Cardiology advice should be sought if any abnormalities manifest. (Please note that if a patient on antipsychotic therapy (regardless of dose), presents with palpitations, syncope or dizziness an ECG should be performed as soon as possible). 9. RCPsych guidelines also specify that hydration should be regularly checked and that impaired hepatic/renal function be taken into account before initiating therapy (hence, the need for U & Es, and LFTs). These indices should be repeated every three months or more frequently if clinically indicated. That is, please check these indices one-, three, six, nine and twelve months after initiation of high dose therapy or more frequently if clinically indicated. 10. RCPsych guidelines also advise regular checks on pulse, BP and temperature. Please check all three parameters daily for one week upon initiation of High Dose Antipsychotic Therapy and after an increase in antipsychotic dose (once patient is on regular HDAT). 11. A care plan should be specified in the notes re: outcomes and dates of review. If there is no improvement in mental state (on high dose therapy) in three months, then RCPsych guidelines specify that high dose therapy should be abandoned. In summary, review should take place in one, three, six, nine and twelve months later (if patient remains on high dose therapy) or more frequently if clinically indicated. 12. Where possible discuss the decision to commence high dose antipsychotic therapy with the patient and/or patient s carers. 15

19 Appendix 3 Zuclopenthixol acetate algorithm. SUMMARY General principles: Where it is documented in the patient s care plan that there is a preferred treatment option in the event of an acute illness, this should be adhered to if clinically appropriate. Zuclopenthixol acetate should never be administered to those without any previous exposure to antipsychotic medication. All prescriptions for zuclopenthixol acetate should be tailored to the individual patient. Consider the interaction between zuclopenthixol acetate and co-existing medical illnesses, other prescribed medicines, and concurrent substance misuse. In older patients there is a risk of accumulation of sedatives or delirium. Consider the physical fitness of the individual considered. Medical team: Inform the medical team if more than one dose of IM RT is required. The doctor should review the patient and prescription. Nursing observation: Constant visual observation. BP, pulse, temperature, respiratory rate, po2, level of consciousness. Ensure availability of: Resuscitation equipment. Flumazenil IV (if lorazepam was given). Procyclidine injection. Cautions: The use of zuclopenthixol acetate in an unknown or antipsychotic naïve patient. Consider the total dose of medicines given Do not: Mix medicines in the same syringe. Prescribe IM diazepam. Prescribe IM/IV chlorpromazine. Prescribe IM haloperidol (simultaneously) Give antipsychotics to patients with Dementia with Lewy Body or Parkinson s Disease. 16

20 Appendix 4 Equality impact assessment tool Yes/ Comments 1. Does the policy/guidance affect one group less or more favourably than another on the basis of: Race Ethnic origins (including gypsies and travellers) Nationality Gender Culture Religion or belief Sexual orientation including lesbian, gay and bisexual people Age Disability - learning disabilities, physical disability, sensory impairment and mental health problems 2. Is there any evidence that some groups are affected differently? 3. If you have identified potential discrimination, are any exceptions valid, N/A legal and/or justifiable? 4. Is the impact of the policy/guidance likely to be negative? 5. If so can the impact be avoided? N/A 6. What alternatives are there to achieving the policy/guidance without the impact? 7. Can we reduce the impact by taking different action? N/A N/A 17