RAPID TRANQUILLISATION POLICY Document name: Rapid tranquillisation policy Version 5.3.1 Staff group to whom it applies: Qualified medical staff, qualified nursing staff, pharmacists and pharmacy staff. All staff working on in-patient units. Distribution: Hard copy to in-patient areas Intranet Medical staff on induction Issue date: September 2014 Next review: September 2015 Developed by: Director Lead - Medical Director Contacts for advice or information: Jane Riley, Chief Pharmacist Dr Adrian Berry, Medical Director Mark Payne, Senior Clinical Pharmacist 1 CONTENTS Abbreviations ............................................................................................................................... 3 Rapid Tranquillisation algorithm ................................................................................................. 4 Flowchart ...................................................................................................................................... 5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Introduction ......................................................................................................................... 6 Definitions and Principles ................................................................................................... 7 Preparation Guidance – Information on medicines ............................................................. 10 Risk of Rapid Tranquillisation ............................................................................................ 15 Carrying out Rapid Tranquillisation ................................................................................... 16 Oral therapy for Rapid Tranquillisation .............................................................................. 16 Injectable therapy for Rapid Tranquillisation ..................................................................... 17 The use of zuclopenthixol acetate injection (Clopixol Acuphase) ...................................... 18 Medications not recommended for Rapid Tranquillisation................................................. 19 Doses for Rapid Tranquillisation ........................................................................................ 19 Circumstances for special care (extra care) ......................................................................... 20 Medicines which may prolong the QT interval ................................................................... 20 Physical monitoring before, during and following Rapid Tranquillisation ........................ 21 Managing side effects and complications occurring during Rapid Tranquillisation .......... 23 Rapid Tranquillisation in Older People ............................................................................... 23 Rapid Tranquillisation in people with learning disabilities ................................................ 24 Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 Appendix 7 Appendix 8 Appendix 9 Appendix 10 Appendix 11 Appendix 12 Appendix 13 Appendix 14 Rapid Tranquillisation Episode Criteria and Review Pathway ............................ 25 Rapid Tranquillisation – Assessment and Progress Chart ................................... 26 The Richmond Agitation – Sedation Scale .......................................................... 27 48 Hour Intramuscular Clopixol Acuphase Monitoring Chart ............................. 28 Guidance on the Preparation & Administration of Aripiprazole (Abilify®) ....... 29 Haloperidol Administration.................................................................................. 30 Guidance on the Preparation & Administration of Olanzapine (Zyprexa®)........ 31 Advice on the Preparation & Administration of Lorazepam (Ativan®) .............. 32 Policy for the use of midazolam .......................................................................... 33 Implementation..................................................................................................... 35 Equality Impact Assessment Tool ........................................................................ 36 Checklist for the Review and Approval of Procedural Document ....................... 37 Training Needs ..................................................................................................... 39 Version Control Sheet ......................................................................................... 41 References ................................................................................................................................. 42 2 Abbreviations used in this document BNF CNS CPR CVD D&T ECG EPSE ESR IM IV JARP MDT MHRA MAV NMS PO PRN QT/QTc RT RTP SPC SWYPFT TIA U&Es British National Formulary Central Nervous System Cardiopulmonary resuscitation Cardiovascular Disease Drug and Therapeutics Sub Committee Electrocardiogram Extrapyramidal side effects Electronic Staff Record Intramuscular injection Intravenous injection Justifiable appropriate reasonable and proportionate action Multidisciplinary team Medicines and Healthcare Products Regulatory Agency Managing Aggression and Violence Neuroleptic malignant syndrome Oral/by mouth Medicines to be taken as and when required Interval in the cardiac cycle Rapid Tranquillisation Rapid Tranquillisation Pathway Summary of Product Characteristics South West Yorkshire Partnership NHS Foundation Trust Transient Ischemic Attacks Urea and Electrolytes 3 Version 5.3.1 Sept 14 SOUTH WEST YORKSHIRE PARTNERSHIP NHS FOUNDATION TRUST * Use midazolam IM only when lorazepam IM injection is unavailable Rapid Tranquillisation algorithm – This forms part of the Rapid Tranquillisation Policy Consider de-escalation techniques eg: talking down, distractions, time out + Have access to procyclidine injection for acute dystonic reactions and flumazenil for benzodiazepine induced respiratory depression. Have access to emergency resuscitation facilities Consider starting/increasing regular oral medication No response Consider pharmacological management Seek consultant advice re MHA status. If necessary treatment may continue under common law Try Oral Therapy + Patient refusing oral / Rapid response required / No response to oral Try intramuscular injection+ Adult Drug (oral) Lorazepam 1-2mg or Promethazine 25-50mg Where the use of benzodiazepines is inappropriate Elderly/Physically Frail Drug (oral) Lorazepam 0.5-1mg or Promethazine 25mg Where the use of benzodiazepines is inappropriate And/or another from the list below Olanzapine 5-15mg Haloperidol 3-5mg Risperidone 2mg And/or another from the list below Olanzapine 2.5-5mg Haloperidol 1.5-2.5mg Risperidone 1-2mg Use formulation most appropriate to patient Use formulation most appropriate to patient Adult Drug (IM) Lorazepam Response Continue appropriate oral medication Restart or start oral medication Elderly/Physically Frail Drug (IM) Lorazepam 1-2 mg Or Midazolam 2.5-5mg* Or Promethazine 50mg Where the use of benzodiazepines is inappropriate and/or (if known to tolerate typical antipsychotics) Haloperidol 2-5mg 500 micrograms-1mg Or Midazolam 1-2mg* Or Promethazine 50mg Where the use of benzodiazepines is inappropriate and/or (if known to tolerate typical antipsychotics) Haloperidol 1-2.5mg Response Review appropriateness of continuing intramuscular therapy Monitor Patient No response within ½ hour Never mix two drugs in the same syringe. Always dilute lorazepam injection before use Review. Complexity – refer to consultant Outside normal working hours – refer to on-call consultant. The On call pharmacist is also available for advice. Consider repeating IM lorazepam (Adult Max 4 mg in 24 hours) / IM midazolam (Adult Max 15mg in 24 hours) and haloperidol 5mg injections (caution – maximum adult haloperidol dose is 12mg IM in 24 hours, avoid repeating haloperidol In the elderly above a total of 5mg IM without Consultant advice) or any of the following Aripiprazole 5.25-15mg IM (max dose 30mg in 24hrs by any route, however only IM used in Rapid Tranquillisation, do not give when other antipsychotics are prescribed) 4 Zuclopenthixol Acetate (Clopixol Acuphase) • Not recommended for RT due to delayed onset and long duration of action but may be considered as an option when: 1 Service user will be disturbed/violent over extended time period. 2. Past history of good/timely response. 3. Past history of parental administration. 4. Cited in an advance directive. • Never administer to those without previous antipsychotic exposure. • Consult BNF and manufacturer’s SPC regarding its use and SWYPFT guidelines and monitoring charts. RAPID TRANQUILLISATION FLOWCHART Start a rapid tranquillisation pathway (RTP) Identify and record criteria for requiring RT on RTP Check for physical health monitoring, i.e. recent/on admission, ECG, pulse, BP, U&E’s Patient requires rapid tranquillisation (RT) Record results on the Assessment and Progress Chart Record criteria and current medicines on RiO Review need for RT and record on RTP Repeat and record monitoring until patient ambulant. If requiring high doses of medicines or medicines not included in the RT algorithm contact senior staff ideally Consultant Psychiatrist File RT forms into ward RT file and alert ward manager (or use RiO) Carry out RT review meeting for patient 5 SOUTH WEST YORKSHIRE PARTNERSHIP NHS FOUNDATION TRUST Rapid Tranquillisation Policy 1. 1.1 Introduction Scope This policy has been updated to become a Trustwide policy to include practice in Barnsley This policy is intended to support the delivery of appropriate, safe and effective rapid tranquillisation in the context of in-patient care within SWYPFT and identifies which clinical staff need training. This policy replaces all previous local RT related policies or procedures and represents expected (i.e. usual) practice within all districts and the regional forensic service. 1.2 Policy Development The policy was developed by the Medical Director and Chief Pharmacist in consultation with the D&T and Managing Violence and Aggression TAG. The policy of the Bradford District Care Trust was used with permission from Alistair Tinto, lead pharmacist for mental health. It has been updated together with the rapid tranquillisation working group of the D&T. 1.3 Practice Variation Like all guidance, this is a generalisation of best practice and this policy sets out broad standards for RT, which are intended to inform clinicians in reaching the best treatment decision for individual in-patients at the time and in the current circumstances. There will be occasions when there may need to be some variation from this, and these will require an assessment of the balance of potential benefits and potential harm indicated by the prescribing clinician in consultation with other members of the multi-disciplinary team. If a decision is made to vary from this policy, there must be clear documentation of that decision along with the supporting assessments and related consultations. Before all occasions of variance from this policy, the opinion of the consultant psychiatrist or another senior psychiatrist (eg out of hours) should be sought. 1.4 Sources of Guidance A full list of references is given at the end of this document, but this policy takes particular note of NICE Clinical Guidelines 25 and 1 (management of Violence and Schizophrenia respectively) and is a successor to the SWYPFT Rapid Tranquillisation Protocol version 4, May 2010 and the Guidelines for Rapid Tranquillisation for acutely disturbed behaviour for adults in Barnsley approved May 2010. 1.5 Duties Healthcare organisations have an obligation to provide an effective rapid tranquillisation service to their patients and appropriate training to their staff. A suitable infrastructure is required to establish and continue support for these activities. The Chief Executive is responsible for ensuring that resources and mechanisms are in place for the overall implementation, monitoring and review of this policy. 6 2. 2.1 Implementation of this document is outlined in appendix 10, page 35. The Medical Director, the Director of Nursing and the Chief Pharmacist are responsible for ensuring the policy is reviewed, approved and monitored by the appropriate trust-wide group (currently the Drug & Therapeutic Sub Committee). The Executive Management Team will provide policy approval and ratification. The Drug & Therapeutic Sub Committee will consider the monitoring evidence put before them and request actions as appropriate. General Managers are responsible for ensuring that dissemination and implementation of the policy occurs within their own area of responsibility. In addition, they are responsible for providing relevant support for the training required around RT as outlined in the training needs analysis. Ward Managers must ensure staff have access to training on RT (see appendix 13 training needs analysis and training matrix, Section 1 of the Medicine Code). As well as training on RT there must be staff trained on the use of oxygen, pulsoximetry and defibrillators on the wards when RT is employed. Definitions and Principles Rapid Tranquillisation (RT) is used when JARP – a justifiable appropriate reasonable and proportionate action has failed to de-escalate disturbed behaviour. Disturbed behaviour can occur in psychiatric illness, physical illness, substance abuse or personality disorder and may be secondary to psychotic symptoms. See the SWYPFT Policy on Managing Violence and Aggression (Physical Intervention) for further details on physical intervention. These interventions are management strategies and are not regarded as primary treatment techniques. The intervention selected must be a reasonable and proportionate response to the risk posed by the in-patient - JARP. 2.2 Ideally the decision to use RT should be a MDT decision and thus refer to this guidance. A specialist mental health pharmacist should be a member of the wider MDT and should be involved at the earliest opportunity where RT is used. 2.3 This decision, along with a statement as to how long RT should continue before the use of RT is reviewed, must be recorded in notes, as well as commencing use of the SWYPFT ‘Rapid Tranquillisation Episode – Criteria and Review Pathway’ (appended). Reviews of RT should be recorded in the notes, including the decision to cease RT. 2.4 The ward manager must be made aware at the next opportunity that an RT regimen has been used. The ward manager must have systems in place to ensure that a team review to consider the reasons, the effects, any problems and future plans and that this should be recorded in the notes. If possible the patient should be involved in the review. 2.5 The aims of the management of the acute psychiatric emergency are to: Calm the patient quickly, rather than to sedate to unconsciousness. 7 Control extreme agitation, aggression and potential violent, behaviour that may place the patient or others at risk of physical harm. Reduce psychological suffering. Maintain a safe environment for the patient and others. Prescribe safe regimens and monitor physical health. Sudden cardiac death has been associated with the use of antipsychotic medication especially in young, fit, struggling individuals. Above all cause no harm. 2.6 The use of medication in RT is not underpinned by a strong evidence base so recommendations are based on a mixture of research, theoretical considerations and clinical experience. It is inappropriate to prescribe medicines ‘just in case’ unless a need has been specifically identified. 2.7 RT should not be routinely employed and is not intended to treat the underlying condition. Such medications tend not to be part of the regular treatment since it is an interim management instigated by staff in a pro-active manner, rather than at the request of the patient. Such treatment should therefore only be given for the minimum time needed to control the patient’s behaviour and should be followed with the normal planning and giving of care. 2.8 Patients may occasionally require physical restraint to prevent violence to themselves or others. Swift, safe and effective drug treatment may then be needed to effect RT and to allow subsequent evaluation and appropriate management. Medication should be used in the context of a combination of approaches to the management of the agitated patient and at all stages continue talking and using nondrug approaches and use oral rather than IM medication if the patient will accept it. When IM medication is used ensure the rapid tranquillisation assessment and progress chart is completed. Copies are available in the ward RT file. Patients should not be prescribed haloperidol in the event of it being required in the future for RT. It should only be prescribed when the MDT has determined it is required or very likely to be required. 2.9 Some antipsychotics have been withdrawn when reviews of their safety data identified the risk of prolonging the QT interval in the cardiac cycle. This may lead to Torsade de Pointes which can then advance on to ventricular tachycardia (palpitations, dizziness, fainting), ventricular fibrillation and sudden death. Other medications may also have this effect including phenothiazines, chlorpromazine and butyrophenones such as haloperidol (see section 12, page 20, for list of medications which increase the QT interval). Care is always needed in using these medications particularly in high doses or in combination and consideration given to the physical status of the patient (see section 12.2, page 21, maximum dose chart). 2.10 The benzodiazepine of choice for rapid tranquillisation is lorazepam. At times lorazepam intra muscular injection has become unavailable. In January 2013 lorazepam intra muscular injection is available again. Both midazolam IM injection and lorazepam IM injection are available to purchase. The preferred benzodiazepine is lorazepam IM injection which is available as 4mg/ml ampoule and requires dilution before use (see appendix 8 page 32). 8 2.11 When considering the medication to be used in the emergency situation, besides efficacy and safety concerns, also relevant are time of onset of action and possible route of administration. The actual choice of medication will depend upon the drug history of the person being treated. Review current and past known drug therapy and rationalise appropriately. Review the diagnosis – this may indicate the required treatment e.g. in delirium tremens prescribe benzodiazepines rather than antipsychotics. 2.12 It is essential, when dealing with psychiatric emergencies that a multidisciplinary approach is taken and that all factors are considered. Seek advice from the duty Consultant or responsible clinician if initial measures have not been successful. Review the Mental Health Act Status of the patient. Review any ‘PRN’ drugs charted and increase or start regular oral antipsychotics if indicated. If a patient’s response to medication in an emergency is known it may be advisable to give what has worked before. See the previous medication history of the service user and always consider the current medication administered on the in-patient prescription chart. Any current advance directive should be considered prior to RT commencing. 2.13 Older people, the elderly and other groups may require smaller doses of medication. Particularly consider: a) Altered levels of metabolism b) Existence of physical illness c) Use of concurrent medications 2.14 All medical staff, ward based qualified nursing staff and pharmacists should be familiar with the use and dangers of RT, the medications used in RT as well as those used to reverse the effects (e.g. flumazenil in respiratory depression). 2.15 All professionally qualified staff should be trained to CPR, Basic Life Support and Advisory De-fibrillation. They should be trained to use the oxygen available on the ward and in puloximetry. 9 3 Preparation Guidance - Information on medicines Route & Pharmacokinetics Medicine/Dose Major Side Effects Practice Points Respiratory depression IM absorption is the same as oral absorption, but is more rapid in an active patient. Preparation Lorazepam Dose Adult 1 - 2mg Elderly 0.5 -1mg Max dose in 24 hours Adult 4mg Elderly 2mg The only reason to give lorazepam IM is if the patient refuses oral. Oral tablets 1mg Onset 10-30mins Peak 60-90mins IM injection 4mg/ml Half-life 8-25hrs see instructions for preparation Appendix 8, page 32) The pharmacokinetics of lorazepam are similar whether given orally or IM. Disinhibition (more likely to occur in those with organic brain disease, including learning difficulties, the under 18s and the over 65s and, perhaps, those with impulse control problems). The injection should be diluted 50:50 with water for injections before administration. There is no accumulation of lorazepam with repeated doses or in impaired liver function. A wide therapeutic index. Respiratory depression is readily reversed with the specific antagonist flumazenil. Oral and IM doses are equivalent MIDAZOLAM INJECTION ONLY TO BE USED AS PER APPENDIX 9 WHEN LORAZEPAM IM INJECTION IS NOT AVAILABLE Midazolam Store in Controlled drug Cupboard. IM injection Onset 10-30mins Dose This product is unlicensed and Adult 2.5 to 7.5mg 5mg/5ml Peak within 30 minutes. Caution in the elderly or in those with physical only to be used when Elderly 1-2mg illnesses. lorazepam IM is unavailable Half-life 2-3 hours (may Max dose in 24 hours .(see appendix 9 page 33) Adults 15mg be prolonged to 10 hours Side effects as for lorazepam but Repeated doses may lead to accumulation of Elderly 7.5mg or more in the elderly with additional risk of retrograde midazolam and increased risk of adverse effects, and concurrent physical amnesia following including respiratory depression. If renal, hepatic, illness. administration. Always ensure that emergency recovery medication cardiovascular or (ie flumazenil) is present before administration. respiratory function is impaired dose as for elderly 10 Medicine/Dose Route & Preparation Pharmacokinetics Major Side Effects Practice Points Oral tablets / capsules 0.5 mg 1.5 mg 5mg Oral Onset 1-2 hrs Peak 4hrs Half life 21 hrs EPSE Hypotension NMS Increased QT Arrhythmias Seizures Sudden Death Risk of acute dystonias. IM Injection 5mg/ml IM Onset 20 mins Peak 1 hr Half life 21hrs Baseline ECG recommended in all patients, especially in the elderly and in those with positive family or personal history of cardiac disease or abnormal findings on cardiac clinical examination. The bioavailability of both formulations is different and this must be taken into account when considering the total dose per 24 hr period. i.e. 5mg PO = 3mg IM Hypotension Bradycardia Syncope Not licensed for use in dementia-related psychosis/ behavioural disturbances Not licensed for use in children/ adolescents. Haloperidol Dose Oral Adult 1.5-5mg Elderly 1-2.5mg IM Adult 2-5mg Elderly 1-2.5mg Max dose in 24 hours Oral 20mg IM 12mg Avoid giving more than 5mg in elderly patients without consultant advice See instructions in Appendix 6,page 30 Can be advisable to administer an antimuscarinic agent such as procyclidine with the first dose of haloperidol to avoid EPSE. Use SEPARATE LINES on the prescription sheet for each route of administration. Not recommended for IV use because of the risk of arrhythmias. Olanzapine Dose Adult 5-15mg Elderly 2.5-5mg Max dose in 24 hours 20mg by any route Oral tablets / orodispersible tablets 2.5mg, 5mg 7.5mg, 10mg 15mg, 20mg IM injection 10 mg Oral Onset 5-8hrs Peak 5-8hrs Half-life 32-50hrs IM Onset 15-45mins Peak 15-45mins See instructions in Half-life 30hrs Less likely to cause EPSE than haloperidol. N.B. IM must not be given within 1 hour of injected benzodiazepines IM route results in initial maximum plasma concentration 5 times higher than same dose given orally. Appendix 7 page 31. 11 Route & Preparation Pharmacokinetics Major Side Effects Practice Points IM injection 7.5mg/ml Onset 45mins-2hrs Peak 1-3hrs Not suitable in combination with other antipsychotics see instructions for preparation Appendix 5 page 29 Half-life 75 - 146hrs Not likely to cause sedation Comes as 9.75mg in 1.3ml (7.5mg/ml) The recommended initial dose is 9.75mg (1.3ml) as a single IM dose. Range is 5.25mg (0.7ml) to 15mg (2ml) as a single injection. A lower dose of 5.25mg (0.7ml) may be given on the basis of clinical need. A second injection may be administered 2 hours after the first injection, on the basis of clinical need, No more than three injections should be given in a 24hour period. Oral tablets / orodispersible tablets 500microgram 1mg, 2mg Oral solution 1mg/ml Peak 2hrs Half-life 18hrs EPSE Risk of Hypotension Dose 25-50mg oral or by deep IM Oral tablets 25mg Oral Onset / Peak 2-3hrs Half-life 7-15hrs Max dose in 24hours 100mg. IM injection 25mg/ml Medicine/Dose Aripiprazole Dose IM only for RT 5.25mg to 15mg. Max dose in 24 hours 30mg by any route Oral not used in RT Risperidone Dose Adult 2mg Elderly 1-2mg Dementia 250-500 micrograms Max dose in 24hrs 2mg/day Use in Dementia is licensed. Use for other indications is unlicensed. Use recommended where Risperidone prescribed routinely Promethazine Prolonged sedation Seizures Cardio respiratory depression Antimuscarinic effects Use is unlicensed. Limited evidence for efficacy but may be of use in patients who are benzodiazepine tolerant. IM Onset / Peak 1-2hrs Half-life 7-15hrs 12 The following drugs are not used routinelyin RT but have been used in specialist circumstances (not routinely stocked on wards). Medicine/Dose Route Pharmacokinetics IM Onset 2-8hrs Peak 24-36hrs Major Side Effects Practice Points EPSE Sudden death Cardiac arrest Arrhythmias Give by deep IM injection into the gluteal muscle, taking care not to give into a vein, as it can be fatal. Zuclopenthixol Acetate Dose Adult 50- 150mg Elderly 50-100mg Max dose 150mg as a single dose 400mg over 14 days Half-life 60hrs Can be repeated after 2 to 3 days Never use in pregnancy, in those who are neuroleptic naïve, who are struggling, who are sensitive to EPSE, those with cardiac disease, hepatic or renal impairment. Monitor for 48 hours after each injection using appendix 4 page 28 This is not an appropriate drug for use in RT due to long duration of action. It may occasionally be used as part of a medium term strategy. Chlorpromazine Dose Oral Adult 50-100mg Elderly25-50mg Oral IM not recommended but 25-50mg has been used in adults IM Peak 2-4 hrs Half life 16-30hrs Hypotension Arrhythmias Seizures Prolonged sedation Cardiac arrest Sudden death No longer recommended in RT Not normally given IM because of the risk of severe hypotension and prolonged unconsciousness, as well as the reported association of high doses with sudden death. Painful at injection site Diazepam Dose range 2-10mg–lower range in the elderly IM do not use Oral I.V must be given by a Dr Peak 60mins Half life 24-48hrs Respiratory depression IM not recommended due to variable absorption Disinhibition Lorazepam is the benzodiazepine of choice. Peak 8mins 13 The following drugs are not used routinely in RT but have been used in specialist circumstances(not routinely stocked on wards). Medicine Route Pharmacokinetics Major Side Effects Practice Points IM Peak 30-40mins This product is poorly tolerated and is associated with high incidence of cardiac arrhythmias Only for specialist use. Highly sedating Hypotension Arrhythmias Seizures Prolonged sedation Cardiac arrest This is used occasionally in RT when a sedating effect is required but should not be used without Consultant Psychiatrist and Senior Clinical Pharmacist advice. Paraldehyde 5-10ml initially Can repeat after 2 hrs if necessary Max daily dose 20ml Max 3 injections Avoid prolonged contact with rubber or plastics. Levomepromazine (Methotrimeprazine) Dose Oral Adult 25-50mg Elderly not suitable Oral IM has been used 12.525mg in adults IM 14 4 Risks of Rapid Tranquillisation Prescribers should understand the cardiovascular effects of the acute administration of the tranquillising drugs and the need to titrate the dose with caution. All staff involved in administering or prescribing rapid tranquillisation, or monitoring patients to whom injected rapid tranquillisation has been administered, should receive yearly training to a minimum of basic life support (including CPR, Automated External Defibrillator and Suction Machine). Best practice (NICE guidelines) recommended the presence of a practitioner trained in Immediate Life Support throughout the use of rapid tranquillisation. Resuscitation equipment (including an automatic external defibrillator, an ambu-bag mask, oxygen suction, first line resuscitation medications and Flumazenil) should be available immediately in healthcare settings where rapid tranquillisation, physical intervention and seclusion might be used. The equipment should be maintained and checked weekly by Ward Managers and Pharmacy staff. RISK IS INCREASED BY COMBINING RAPID TRANQUILLISATION WITH PHYSICAL RESTRAINT 4.1 Medication for RT, particularly in the context of physical intervention, should be used with caution owing to the following risks:a) b) c) d) e) f) g) loss of consciousness instead of tranquillisation sedation with loss of alertness loss of airway cardiovascular and respiratory collapse interaction with medicines already prescribed or illicit substances taken possible damage to patient-staff relationship underlying coincidental physical disorders There are specific risks associated with the different classes of medications that are used in RT. The specific properties of the individual drugs should be taken into consideration. When combinations are used, risks may be compounded. 4.2 Benzodiazepines: a) b) c) 4.3 Loss of consciousness Respiratory depression or arrest Cardiovascular collapse (e.g. in service users receiving both clozapine and benzodiazepines) Antihistamines: a) b) c) Excessive sedation Painful injection Additional anti-muscarinic effects 15 4.4 Antipsychotics: a) b) c) d) e) f) g) h) 5 Loss of consciousness Cardiovascular and respiratory complications and collapse – QT prolongation Seizures Subjective experience of restlessness (akathisia) Acute muscular rigidity (dystonia) Involuntary movements (dyskinesia) Neuroleptic malignant syndrome Excessive sedation Carrying out Rapid Tranquillisation Complete the rapid tranquillisation assessment and progress chart. 5.1 The ward doctor or duty doctor, depending on the time of day, should be called to the location of the psychiatric emergency as soon as is practicable. 5.2 The advice of the senior psychiatrist or consultant should be available at all times and should be used accordingly. 5.3 The patient should be able to respond to communication throughout. 5.4 The aim is to achieve a state of calm sufficient to minimise the risk posed to the patient or to others. 5.5 Keep the drug regimen simple and document the treatment plan. 5.6 The initial doses of medicine should be small and within the recommended BNF limits unless the patient is categorically known from previous episodes to require larger doses. 5.7 Sufficient time must be allowed for the therapeutic response before doses are repeated. 5.8 When a patient is transferred between units, a full medical history, including the patient’s response to medications, any adverse effects, and an advance directive should accompany them. Where possible, the patient’s account of their experience of RT should also be included. 5.9 On discharge, all such information should be filed in their healthcare record and be subject to regular review. 6 Oral therapy for Rapid Tranquillisation 6.1 Oral medication should be offered before injectable medication as far as possible. 6.2 All medication given in the short-term management of disturbed/violent behaviour should be considered as part of RT (Inc PRN taken from an agreed RT protocol or as part of an advance directive). 16 6.3 The bioavailability differs between routes of administration so prescriptions for oral and intramuscular medications should be prescribed separately and the abbreviation of PO/IM should not be used. 6.4 When the behavioural disturbance occurs in a non-psychotic context it is preferable to initially use oral lorazepam alone or intramuscularly if necessary. 6.5 To achieve early onset of calming/sedation, or to achieve a lower dose of antipsychotic, an oral antipsychotic in combination with oral lorazepam, should be considered in the first instance. Combinations may be beneficial because it reduces the dose of the more toxic antipsychotic that is required. It has been suggested that the two classes of the drug have a synergistic action and that benzodiazepines may counteract the lowering of seizure threshold by antipsychotics (Bottalgia et al, 1997). 6.6 Antipsychotics are best avoided in those with cardiovascular disease, benzodiazepines are best avoided in those with compromised respiratory function and haloperidol is best avoided in those who are neuroleptic naïve or who have a history of severe extrapyramidal side effects. 6.7 MHRA has warned against the use of risperidone or olanzapine in the treatment of behavioural symptoms of dementia, due to increased risk of stroke and death. 6.8 Sufficient time should be allowed for clinical response between oral doses of medication for RT. 7 Injectable therapy for Rapid Tranquillisation 7.1 If injectable treatment proves necessary when oral therapy is refused, the intramuscular route is preferred over the intravenous route from a safety point of view. Nursing staff in the Mental Health Services in th Trust are not normally trained to administer IV injections. 7.2 The patient should be transferred to the oral route of administration at the earliest opportunity. 7.3 Lorazepam should be considered as first choice. There have been difficulties purchasing lorazepam injection. If this is unavailable it may be suitable to use IM midazolam. 7.4 Olanzapine can be used where an antipsychotic is required in moderate disturbance with psychosis (IM lorazepam should not be given within 1 hour of IM olanzapine). 7.5 Where haloperidol is to be used there should ideally be recent ECG. If there is not one available and it is not possible to get one the D&T recommend that patient’s pulse, BP and respiration should be monitored regularly and extreme caution should be taken to ensure doses do not escalate above BNF maximum (see haloperidol communication). When using IM haloperidol for managing disturbed/violent behaviour, an antimuscarinic agent such as procyclidine should be immediately available to reduce the risk of dystonia and other extrapyramidal side effects. 7.6 Aripiprazole can be considered only by IM injection. 17 7.7 Care must be taken when giving IM injections particularly to highly aroused and/or violent individuals. The provision of adequate staff trained on the Trust Managing Aggression and Violence Teamwork course should always be on standby even when patients agree to IM treatment, as there are the inadvertent risks of intra-arterial injection, bolus dosing, nerve damage, bruising, needle breakage in patients who may struggle or are resistive, and also a higher than expected absorption rate due to the increased blood flow to the muscles in a highly aroused individual 7.8 Zuclopenthixol acetate (Clopixol Acuphase) IM should be only used in specific circumstances only. See section 8 for further information. 7.9 Sufficient time should be allowed for clinical response between IM doses of medications for RT. 7.10 The use of two drugs of the same class for the purpose of RT should not occur. 7.11 Medications should never be mixed in the same syringe. 7.12 The manufacturers warn that the use of medication outside the SPC may increase the risk of fatality and medication should only be given intramuscularly or intravenously according to the manufacturer’s recommendations. 7.13 The IV administration of benzodiazepines or haloperidol should not be considered. Absorption of diazepam by the IM route is erratic and this should be avoided if possible. 8 The use of zuclopenthixol acetate injection (Clopixol Acuphase) 8.1 Zuclopenthixol acetate injection is not recommended for RT due to its significantly delayed onset and relatively long duration of action. Onset of action is about 8 hours and it reaches peak levels in between 24 to 36 hours. The effects of sedation usually begin after about 2 hours and peak after 12 hours. 8.2 However, it may be considered as an option in the management of RT when:a) b) c) d) 8.3 8.4 Initial calming has been achieved and it is likely that repeated doses of IM antipsychotics will be necessary. It is clearly expected that the patient will be disturbed/violent over an extended period of time and will refuse oral medication. A patient has a past history of good and timely response to it. An advance directive indicates that it is the treatment of choice. If prescribed, it is important to consider the pharmacokinetics of other drugs previously administered e.g. caution is necessary in a patient who has recently received a dose of depot antipsychotic which has not yet reached peak levels. Zuclopenthixol acetate SHOULD NOT BE USED on individuals who: a) Are antipsychotic (neuroleptic) naïve i.e. patients without any previous exposure to antipsychotic medication b) Are sensitive to extrapyramidal side effects c) Have cardiac disease d) Have hepatic or renal impairment 18 e) f) g) Are struggling Are pregnant Are not detained under the Mental Health Act 8.5 Prior to administering zuclopenthixol acetate (Clopixol Acuphase) to an informal patient, consideration must be given to the risk of the patient leaving the ward before the effect of the medicine can be fully established. Adverse reactions such as extrapyramidal side effects (EPSE) or hypotension may not peak until 24 hours after giving the injection. A minimum of 48 hours should elapse following the administration of Acuphase before any leave is considered. Informal patients wishing to leave within the 48 hours must be assessed under the Mental Health Act. Evidence that the patient is not suffering any adverse reactions to the medication must be documented in the case notes prior to the patient being granted any leave, regardless of time elapsed following an injection of Acuphase. Complete the 48 hour monitoring chart. 8.6 There is no such thing as “a course of Acuphase”. Once a first dose has been prescribed the treatment plan should clearly document the circumstances when further doses may be administered. Subsequent doses should not be written up on the drug chart until the patient has been reassessed by a clinician and it has been decided that they are going to be required. 8.6 Doses of 50-150mgs (elderly 50-100 mg) may be given up to a maximum of 400mgs in 2 weeks (and a maximum of 4 separate injections), with at least 24 hours between doses. 9 Medications Not Recommended for Rapid Tranquillisation a) b) c) d) e) IM or oral chlorpromazine due to risk of hypotension and problems at injection site. IM diazepam due to erratic absorption. IM depot antipsychotics. Risperidone and in particular risperidone long acting injection – Risperdal Consta®. Antipsychotics in the management of disturbed/violent behaviour in service users with dementia. 10 Doses for Rapid Tranquillisation 10.1 When using RT there may be certain circumstances in which the current BNF uses, limits and SPC may be knowingly exceeded. This decision should not be taken lightly and the risks should not be underestimated. A risk-benefit analysis should be recorded in the case notes (or on RiO) and a rationale should be recorded in the care plan. Where the risk-benefit is unclear, advice should be sought from clinicians not directly involved in the patient’s care. If current BNF or SPC doses are exceeded, frequent and intensive monitoring is needed along with important regular checks of airway, level of consciousness, pulse, blood pressure, respiratory effort, temperature and hydration. 10.2 In all circumstances of RT, the prescriber and medication administrator should pay attention to: The total dose of medication prescribed. 19 Arrangements for review. Issues of consent, BNF and SPC and physical and mental status of the patient. The progress of the service user, following the rapid tranquillisation assessment and progress chart. 10.3 The dose of antipsychotic medication should be individualised for each patient. This will be dependent on several factors including: a) b) c) Age (older patients generally require lower doses). Concomitant physical disorders (such as renal, hepatic, cardiovascular or neurological). Concomitant medication. 11 Circumstances for special care (extra care) 11.1 11.2 The presence of congenital prolonged QT syndromes. The concurrent prescription or use of other medication that lengthens QT intervals both directly and indirectly. The presence of certain disorders affecting metabolism, such as hypo- and hyperthermia, stress and extreme emotions, and extreme physical exertion. 11.3 12 Medicines which may prolong the QT interval 12.1 Within normal dosage range Moderate effect Tricyclic antidepressants Lofexidine Buprenorphine (Subutex) Methadone Thioridazine Pimozide High Effect The QT prolongation effect is dose dependant; therefore any above recommended doses should be considered a risk. Antibiotics Erythromycin Clarithromycin Ampicillin Moxifloxacin Norfloxacin Antimalarials Chloroquine Mefloquine Quinine Antiarrythmics Quinidine Disopyramide Procainamide Sotalol Amiodarone Chlorpromazine Quetiapine Sertindole antipsychotic used at Others Amantadine Ciclosporin Diphenhydramine Hydroxyzine Nicardipine Tamoxifen NB: many psychoactive illicit substances and over the counter herbal remedies can have effects on cardiac function. This is not an exhaustive list; for further information contact med.information@swyt.nhs.uk 20 12.2 High Dose antipsychotics and combinations of antipsychotics Antipsychotic Maximum Dose chart This table gives the maximum dose - these may be greater than those used in day to day practice. Drug Trade Name Maximum dose in Maximum depot dose 24 hours oral (mg) (mg/ Asenapine Sycrest 20 Chlorpromazine Largactil 1000 Flupenthixol Depixol 18 400 every 1/52 Fluphenazine Modecate 20 100 every 2/52 Haloperidol Serenace 20 300 every 4/52 Pimozide Orap 20 Sulpiride Dolmatil 2400 Trifluoperazine Stelazine Not stated , Maudsley suggests 50mg Zuclopenthixol Clopixol 150 600 every 1/52 Amisulpride Solian 1200 Aripiprazole Abilify 30 Olanzapine Zyprexa 20 Paliperidone Zeplion 12 150 every 4/52 Quetiapine Seroquel 750 Risperidone Risperdal 16 50 every 2/52 Clozapine Clozaril 900 (Seek advice if a patient on clozapine requires emergency psychiatric treatment as there is an increased risk of respiratory depression with benzodiazepines) Drug charts should show what people have actually had in 24 hours with the maximum allowable dose. Consider what oral medications have been taken and also consider whether a depot has been given. If you are looking at a rewritten chart please ask to check any discontinued charts. 13 Physical monitoring before, during and following Rapid Tranquillisation 13.1 BEFORE RT Before prescribing RT, the prescribing doctor should: Scrutinise the patient’s notes with regard to his/her general medical history and consider the possibility of a physical examination. Check for recent ECG, U&Es and urine drug screen results, a previous history of severe extrapyramidal effects, previous response to RT or other methods of managing imminent violence. Review current prescribed medication and recently administered medication, taking note of administrations of PRN prescriptions. 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 drugs. Those patients who are heavily sedated or using illicit drugs or alcohol should not be secluded. If seclusion is used there should be an increased vigilance. 21 13.2 If the patient is on regular antipsychotics, antidepressants and lithium as combination therapies there is an increased risk of CNS toxicity. Caution with young male patients as they are prone to dystonic reactions (consider antimuscarinic i.e. procyclidine). Older patients (ie greater than 65 years) should commence on no more than half the recommended adult dose, and special care is required. Lower doses may be needed if alcohol/drug abuse is suspected, if patients are naïve to antipsychotics, older patients and with learning disabilities. Emergency resuscitation equipment, procyclidine injection and flumazenil injection must be available before treatment. Ensure the patient is monitored using assessment and progress chart. DURING RT During RT the patient should be monitored by trained staff Close monitoring (observation of patient within eyesight) by nursing staff is required. Observations should be particularly frequent when a patient is sedated. After administration by injection, the monitoring of blood pressure, pulse, temperature and respirations are essential. Suggested every 15 minutes for 1 hour then half hourly until the patient is ambulatory (the minimum screening time is 2 hours). Some observations may be difficult if a patient remains agitated or aggressive. Problems in this regard should be clearly documented and discussed with the prescriber or the clinical team. It is particularly important to ensure that well being is maintained if the patient is asleep or appears to be asleep, then the monitoring of vital signs including oxygen saturation via pulsoximetry continues. 13.3 FOLLOWING RT The following should be recorded regularly in the patient’s notes, on RiO and using assessment progress chart, at the intervals agreed by the multidisciplinary team, until the patient becomes active again. a) Alertness b) Pulse c) Respiratory rate d) Blood pressure e) Temperature f) Hydration Fluid balance and electrolyte balance should be monitored as clinically indicated. ECG monitoring is recommended when injected antipsychotics have been given in high doses. If a patient is unconsciousness continuous pulse oximetry is recommended. Following the episode of RT there should be a review meeting held and the reasons for the RT and any activities required to prevent the need occurring documented. Actions should be taken that could prevent future episodes of RT. 22 14 Managing side Tranquillisation Complications Acute dystonias including oculogyric crisis Hypotension (orthostatic or <50mmHg diastolic) effects and Symptoms/Signs Severe painful muscular stiffness and Parkinsons complications occurring during Rapid Management Procyclidine 5-10mg I.M (if not severe oral may be given). Fall in blood pressure Lie patient flat and raise legs Monitor closely. Seek medical advice. Neuroleptic Malignant Syndrome (NMS) Increasing temperature, fluctuating blood pressure, muscular rigidity, confusion, altered consciousness Withhold antipsychotics. Monitor closely. Liaise with general medical team. Arrhythmias Slow (<50/minute) or irregular pulse An ECG should be done. Withhold antipsychotics. Monitor closely and liaise with specialist medical team immediately. Respiratory Depression Reducing respiratory rate, reducing consciousness Give oxygen. Raise legs. If necessary ventilate mechanically. 14.1 If respiratory rate drops below 10/minute or Oxygen Saturation <90% ring emergency services as per cardiopulmonary resuscitation procedures. If patient has received benzodiazepines e.g. lorazepam it is important to have flumazenil available. Flumazenil is required to be given by IV injection so this is only possible by trained medical personnel. How to give flumazenil: 1) 200 micrograms IV over 15 seconds. 2) If consciousness is not resumed within 60 seconds give 100 micrograms over 10 seconds. 3) Repeat at 60 second intervals. Maximum dose 1mg/24 hours. Continue to monitor after respiratory rate returns to normal. Flumazenil has a short duration of action so further doses may be required. Patients may become agitated or anxious on awakening. 15 Rapid Tranquillisation in Older People 23 As RT of older patients is infrequent and it is advisable to contact the patient’s Consultant or the Duty Consultant if there is any uncertainty over their management. Check for treatable causes of the crisis and initiate treatment as soon as possible. It is important to consider that older people may: 15.1 Require smaller doses of medication. Have altered levels of metabolism and may be more frail. Have pre-existing general medical illnesses and taking several medications (check medical history up to date). Be more likely to develop extrapyramidal side effects. If suffering from dementia, be more likely to develop increased cognitive impairment with high doses of medication. Be naïve to antipsychotics and/or benzodiazepines. Prescribing in dementia Haloperidol can be unsuitable in patients with Lewy Body Dementia and should also be avoided if the patient is suffering from Parkinson’s disease. Lorazepam is usually the most appropriate initial medication, but care if known or suspected respiratory disease, and if used it must be monitored more closely. Lorazepam should be used as a monotherapy where possible. If possible, use of antipsychotics should be discussed with the patient’s consultant before initiating in this group. Both haloperidol and procyclidine can increase cognitive impairment in patients with dementia. Use of antipsychotics should be discussed with the patient’s consultant before initiating in this group. Both haloperidol and procyclidine can increase cognitive impairment in patients with dementia. Following MHRA advice, the use of antipsychotics is no longer recommended in people with a previous history of cardiovascular disease, TIA or stroke. They are not to be used in dementia-related psychosis or behavioural disturbance. 16 Rapid Tranquillisation in people with a Learning Disability 16.1 Additional care needed with those with Cerebral Palsy as they may be at risk of postural deformities and hip dislocation. There may be a higher rate of under detected visual and hearing problems in the learning disability population. A high proportion of people with learning disabilities may have an altered pain threshold. Many have an increased risk of certain physical health complications such as cardiac and respiratory disorders, which contribute to potential hazards associated with restraint. The choice between using physical intervention and rapid tranquillisation as a method of managing violent behaviour in those with a learning disability should be part of an overall care plan. 16.2 16.3 16.4 16.5 24 Appendix 1 RAPID TRANQUILLISATION EPISODE CRITERIA AND REVIEW PATHWAY, SWYPFT NAME WARD RiO NUMBER MHA STATUS Inf/5(2), 4, 3, 2, other ETHNICITY DOB (OR AFFIX LABEL HERE) Criteria of Need for RT episode: The patient currently is suffering from: (ring all episodes) Severe Aggression Severe Agitation Severe Disinhibition There is an immediate risk to self or others (tick box) Non-pharmacological interventions not de-escalated behaviour There is an immediate need for Rapid Tranquillisation Joint medical and nursing consultation agree Nurse – name, grade commencement of RT RT commenced Doctor – name, grade Signed Signed Date Time Reviews of need for RT (enter next due review and time after each review so long as RT continued) Date & time review Actual review Continue RT Nursing Medical due time Yes/No signature signature RT documentation reviewed by Ward Manager/ Deputy within 6 (signed – WM) hours of commencement of RT? RT documentation copied within 48 hours of ending RT to Ward (signed – WM) Managers, Pharmacy and Senior Manager 25 Appendix 2 PP RAPID TRANQUILLISATION – ASSESSMENT AND PROGRESS CHART Patient name RiO Number Before RT commences, the following has been considered Physical examination Recent U & E Recent Drug Screen Recent ECG History of EPSE Past response to RT This review led to these investigations or actions (specify any deemed necessary) Step Actual date and time Temp BP Pulse bpm Resprn. Per min RASS score* Comments Signature Pre-RT Review num 1* 2 3 4 5 6 7 8 9 10 11 12 13 14 * Every 15 minutes for first hour then half hourly until patient is ambulatory (minimum screening time 2hrs) 26 Appendix 3 The Richmond Agitation – Sedation Scale (SWYPFT adaptations) Score Term Description +4 Combative: Overtly combative or violent; immediate danger to staff +3 Very agitated Frequently irritable/aggressive. damaging property. +2 Agitated Marked restlessness such as pacing, some irritability. +1 Restless: Anxious or apprehensive but movements not aggressive or vigorous 0 Alert and calm -1 Drowsy: Not fully alert, but has sustained (more than 10 seconds) awakening, with eye contact to voice -2 Light sedation: Briefly (less than 10 seconds) awakens with eye contact to voice -3 Moderate sedation: Any movement (but no eye contact) to voice -4 Deep sedation: No response to voice, but any movement to physical stimulation -5 Unarousable: No response to voice or physical stimulation Procedure 1. Observe patient. Is patient alert and calm? (score 0) Does patient have behaviour that is consistent with restlessness or agitation? 2. If patient is not alert, in a loud speaking voice state patient’s name and direct patient to open eyes and look at speaker. Repeat once if necessary. Can prompt patient to continue looking at speaker. 27 Appendix 4 48 hour Intramuscular Clopixol Acuphase Monitoring Chart Date of injection……………………………..Time of injection…………………………..Dose……………….. Date Time Temp Pulse Resp BP EPSE’s Comment/Action Within 2 hours 1 4 hourly onwards 2 3 4 5 6 7 8 28 Appendix 5 Guidance on the Preparation and Administration of Aripiprazole (Abilify®) Intramuscular (IM) Injection Indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or in patients with manic episodes in Bipolar I Disorder, when oral therapy is not appropriate. For intramuscular use only. Do not administer intravenously or subcutaneously. The aripiprazole injection strength is 7.5mg/ml The aripiprazole vial contains 9.75mg in 1.3ml The recommended initial dose for aripiprazole solution for injection is 9.75 mg (1.3 ml), administered as a single intramuscular injection. The effective dose range of aripiprazole solution for injection is 5.25-15 mg as a single injection. Patients with hepatic impairment should be managed cautiously. A lower dose of 5.25 mg (0.7 ml) may be given, on the basis of individual clinical status, which should also include consideration other medication already administered either for maintenance or acute treatment. A second injection may be administered 2 hours after the first injection, on the basis of individual clinical status. No more than three injections should be given in any 24-hour period. The maximum dose in 24 hours of aripiprazole is 30 mg (including all formulations of aripiprazole). The following shows the volume required for doses of aripiprazole injection: Dose of aripirazole required 5.25mg 9.75mg 15mg Volume of aripiprazole inj. (7.5mg/ml) 0.7ml 1.3ml (complete vial) 2ml (2 vials needed) 29 Appendix 6 HALOPERIDOL ADMINISTRATION – ORAL and INTRAMUSCULAR EQUIVALENT DOSES Intramuscular doses generally have a greater bioavailability than oral doses, therefore the maximum recommended daily dose for each route of administration is different. Use separate lines on the treatment sheet for each route of administration . Maximum oral dose in 24 hours is 20mg Maximum IM dose in 24 hours is 12mg Any doses above these should be monitored according to High Dose Antipsychotic guidance If a patient has received both haloperidol IM and oral in the last 24 hours. Use the conversion chart below to calculate how much the patient has received in total: APPROXIMATE EQUIVALENT DOSES (mg) Oral Haloperidol 0.5 1 1.5 2.5 4.2 5 7.5 8.3 10 12.5 16.7 20 IM Haloperidol 0.3 0.6 0.9 1.5 2.5 3 4.5 5 6 7.5 10 12 For example: Patient has been given 1 x 5mg haloperidol IM, followed 30 minutes later by 5mg orally, then 30 minutes later by another 5mg orally. Convert to all oral doses, i.e. 8.3mg + 5mg + 5mg = 18.3mg oral equivalent OR Convert to all IM doses, i.e. 5mg + 3mg + 3mg = 11mg IM equivalent Therefore the patient may receive a further 10mg oral equivalent or 5mg IM equivalent haloperidol within the 24 hour period. References - Psychotropic Drug Directory 2012 eMC – SPC Haloperidol 5.5.04 Medicines Bulletin Number 3 Writing Prescriptions: Providing a Clear Record of Drug Therapy 30 Appendix 7 Guidance on the Preparation and Administration of Olanzapine (Zyprexa®) Intramuscular (IM) Injection Indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. For intramuscular use only. Do not administer intravenously or subcutaneously. Administration is a maximum of three consecutive days. The maximum dose in 24 hours is 20mg (including all formulations of olanzapine). The recommended initial dose is 10mg. A lower dose (5mg or 7.5mg) may be given, on the basis of individual clinical status (e.g. renal and/or hepatic impairment). A second injection, 5-10mg, may be administered 2 hours after the first injection. Not more than three injections should be given in any 24-hour period. Patients receiving olanzapine intramuscularly should be closely monitored for the first 4 hours following the injection for hypotension, bradyarrhythmia and hypoventilation. Intramuscular olanzapine and intramuscular lorazepam must not be administered within 1 hour of each other. If olanzapine IM is prescribed as part of rapid tranquillisation ALWAYS follow the Rapid Tranquillisation Policy, including patient monitoring parameters. The following shows the volume required for doses of olanzapine injection: Dose of olanzapine required 2.5mg 5mg 7.5mg 10mg Volume of olanzapine inj. 5mg in ml 0.5ml 1.0ml 1.5ml 2.0ml Reconstitution 1. Withdraw 2.1ml of water for injection into a sterile syringe. Inject into a vial of olanzapine. 2. Rotate the vial until the contents have completely dissolved, giving a yellow coloured solution. Inspected visually for particulate matter prior to administration. 3. The vial contains 11 mg olanzapine as a solution of 5mg/ml. 4. Discard the syringe and any unused solution in accordance with appropriate clinical procedures. 5. Use the solution immediately within 1 hour of reconstitution. 31 Appendix 8 Advice on the Preparation and Administration of Lorazepam (Ativan®) Intramuscular (IM) Injection IM lorazepam must only be administered diluted 1:1 with sodium chloride 0.9% or water for injection. IM Lorazepam must not be mixed with any diluents other than sodium chloride 0.9% or water for injection. Lorazepam injection is only manufactured as one strength: 4mg in 1ml. The following shows the volume required for doses of lorazepam injection 4mg in 1ml: Dose required 0.5mg 1mg 2mg 3mg 4mg Vol. of lorazepam = = = = = 0.125ml 0.25ml 0.50ml 0.75ml 1.00ml + + + + + Vol. of diluent 0.125ml 0.25ml 0.50ml 0.75ml 1.00ml Example: For a prescription of lorazepam 2mg IM Draw up 0.5ml of lorazepam 4mg in 1ml and 0.5ml of sodium chloride 0.9% or 0.5ml water for injection Always remember to mix lorazepam 1:1 with diluent If lorazepam IM is prescribed as part of rapid tranquillisation ALWAYS follow the Rapid Tranquillisation Policy, including patient monitoring parameters. Lorazepam injection MUST be stored in the FRIDGE 32 Appendix 9 Policy for the use of midazolam injection in rapid tranquillisation Introduction This policy outlines the use of intramuscular midazolam for rapid tranquillisation, or the treatment of agitation or aggression. This is only to be considered for action on receipt of a memorandum from either the Chief Pharmacist, the Deputy Chief Pharmacist or the Principal Pharmacist for Wakefield and Forensic. declaring an official shortage of lorazepam injection and authorising the use of intramuscular midazolam Midazolam is a benzodiazepine available as an intramuscular injection. It is not licensed for agitation, but has been investigated in a randomised trial. All formulations of midazolam were changed to controlled drug (schedule 3) status in 2008. Within the trust this means that it should be stored in the controlled drugs cupboard (midazolam does not need to be stored in a refrigerator) and all receipt and administration of midazolam must be recorded in the ward controlled drugs register. Prescribing and administering midazolam Where an intramuscular benzodiazepine is required, in the event of an official shortage of lorazepam, midazolam should be prescribed instead. The recommended dose in adults is 2.5mg (2.5ml), or 5mg (5ml) if judged to be clinically appropriate. A further dose may be given 30 minutes later if required. This may be titrated up to 5mg or 7.5mg according to response. The maximum cumulative dose should not exceed 15mg in 24 hours. In elderly patients the initial dose should be 1 to 2mg (1 to 2ml). In working age adults where renal, hepatic, respiratory or cardiac impairment is judged to be significant enough to compromise the patient’s well-being, this starting dose can also be employed. This may be repeated after 30 minutes. The maximum cumulative dose should not exceed 7.5mg in 24 hours. Midazolam is available at a strength of 1mg /1ml in either a 2ml or 5ml injection. It does not require dilution before administration. Administration must be recorded in the controlled drug register. Wards must ensure they have access to flumazenil injection before administration. After administration patients must be monitored according to the requirements of the rapid tranquillisation policy, for four hours post dose. 33 Explanatory Notes Repeated episodes of supply failure of lorazepam injection mean that an alternative intramuscular (IM) benzodiazepine may be needed. Diazepam is inappropriate for use as an intramuscular injection, despite this route being listed in the British National Formulary (BNF) and manufacturer’s literature. Absorption following an IM injection is inconsistent, leading to unpredictable therapeutic effect. Midazolam is a benzodiazepine available as an intramuscular injection. It is indicated for sedation before or during diagnostic or therapeutic procedures; premedication before anaesthesia; induction of anaesthesia; and sedation in intensive care units. It has also been investigated in rapid tranquillisation in randomized trials (TREC, 2003) Doses used in these studies range from 2.5mg to 15mg, however higher doses led to a large proportion of patients being asleep within 20 minutes. The risk of respiratory depression with midazolam is thought to be greater than with lorazepam, so a more cautious approach to initial doses is reasonable. Absorption from intramuscular sites is rapid and complete, with peak plasma concentrations reached within thirty minutes. Onset of sedation and subsequent arousal has been reported to be quicker than lorazepam1. Elimination is also rapid, but repeated administration can lead to accumulation, and increased risk of adverse effects such as respiratory depression. Monitoring of the patient should continue for at least four hours after administration, using the monitoring chart in the rapid tranquillisation policy. Following IM administration patients may experience anterograde amnesia, with the patient not able to remember events which occurred when the product was at maximum effect. Midazolam products were reclassified as controlled drugs (schedule 3) on 1st January 2008. This means that it is subject to controlled drug procedures, and receipt and administration must be recorded in the controlled drug register. The National Patient Safety Agency produced a Rapid Response Report concerning risks of overdose caused by confusion between the different strengths of midazolam injection (NPSA, 2008). The only strength which should be used in the trust for rapid tranquilisation is the 1mg per ml preparation. 34 Appendix 10 Implementation Dissemination This policy will be implemented and disseminated throughout the organisation immediately following approval and will be published on the Trust Intranet site. A hard copy will be circulated to the in-patient areas. Staff will be alerted to changes to the policy through the Trust management briefing process. Associated Documentation: 1. The antipsychotic prescribing guidelines: Aripiprazole communication Haloperidol communication 2. Cardiopulmonary resuscitation policy. 3. Management of violence and aggression. Review The Drug and Therapeutics Sub Committee will review this policy 2 years after the implementation, although it may be fully or part reviewed on any occasion prior to this formal review in response to legislative changes or significant procedural changes in nursing, medical or pharmacy practice. The D&T will however continuously monitor its implementation and practice through an agreed programme of clinical audit as well as reviewing annual reports, incident reports and minutes. Compliance will be checked via the following audit parameter on each in-patient ward These will include: 1. Rapid Tranquillisation episode criteria and review pathway. 2. Rapid Tranquillisation – assessment and progress chart. 3. Training via training records. This will be carried out by the clinical governance sub-group of the D&T with each locality/area being subject to audit at least every two years. Appendix 11 - Equality Impact Assessment Tool 35 To be completed and attached to any policy document when submitted to the Executive Management Team for consideration and approval. Yes/No 1. Comments Does the policy/guidance affect one group less or more favourably than another on the basis of: Race Ethnic origins travellers) No (including gypsies and No Nationality No Gender No Culture No Religion or belief No Sexual orientation including lesbian, gay and bisexual people No Age Yes Older people may require lower doses of medication Disability - learning disabilities, physical disability, sensory impairment and mental health problems Yes People with physical disability may require different doses of medicines 2. Is there any evidence that some groups are affected differently? Yes Older people and people with a physical disability 3. If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable? Yes 4. Is the impact of the policy/guidance likely to be negative? NO 5. If so can the impact be avoided? N/A 6. What alternatives are there to achieving the policy/guidance without the impact? N/A 7. Can we reduce the impact by taking different N/A action? If you have identified a potential discriminatory impact of this policy, please refer it to the Director of Corporate Development or Head of Involvement and Inclusion together with any suggestions as to the action required to avoid/reduce this impact. For advice in respect of answering the above questions, please contact the Director of Corporate Development or Head of Involvement and Inclusion. 36 Appendix 12 - Checklist for the Review and Approval of Procedural Document To be completed and attached to any policy document when submitted to EMT for consideration and approval. Title of document being reviewed: 1. 2. 4. 5. Comments Title Is the title clear and unambiguous? Yes Is it clear whether the document is a guideline, policy, protocol or standard? Yes Rationale Are reasons for development of the document stated? 3. Yes/No/ Unsure Yes Development Process Is the method described in brief? Yes Are people involved in the development identified? Yes Do you feel a reasonable attempt has been made to ensure relevant expertise has been used? Yes Is there evidence of consultation with stakeholders and users? Yes Content Is the objective of the document clear? Yes Is the target population clear and unambiguous? Yes Are the intended outcomes described? Yes Are the statements clear and unambiguous? Yes Evidence Base Is the type of evidence to support the document identified explicitly? Yes Are key references cited? Yes Are the references cited in full? Yes Are supporting documents referenced? 6. Approval Does the document identify which committee/group will approve it? Yes If appropriate have the joint Human Resources/staff side committee (or equivalent) approved the document? 7. Dissemination and Implementation Is there an outline/plan to identify how this will be done? Yes Does the plan include the necessary training/support to ensure compliance? Yes 37 Title of document being reviewed: 8. 9. 10. 11. Yes/No/ Unsure Comments Document Control Does the document identify where it will be held? Yes Have archiving arrangements for superseded documents been addressed? No Process to Monitor Compliance and Effectiveness Are there measurable standards or KPIs to support the monitoring of compliance with and effectiveness of the document? Yes Is there a plan to review or audit compliance with the document? Yes Review Date Is the review date identified? Yes Is the frequency of review identified? If so is it acceptable? Yes Overall Responsibility for the Document Is it clear who will be responsible for implementation and review of the document? Lynn Haygarth, Chief Pharmacist 38 Appendix 13 TRAINING NEEDS 1. Medical staffing 1.1. All medical staff working within the Trust will be directed to the rapid tranquillisation guidance on the intranet at induction. 1.2. All medical staff are required to be trained on the use of rapid tranquillisation. Junior medical staff will be required to undertake training annually. Middle grade medical staff will be required to attend an update every 2 years. Consultant Psychiatrists will be required to attend an update every 2 years. 2. Nursing Staff 2.1. There will be a rapid tranquillisation policy on each in-patient area and a laminated copy of the algorithm in the clinic room. 2.2. Rapid tranquillisation will form part of the induction programme for the nursing staff, including locum and agency staff. 2.3. Band 5+ nursing staff who work in the areas defined below. 2.3.1. They will be required to attend training on rapid tranquillisation annually 2.3.2. Although rapid tranquillisation is only suitable to be carried out on in-patient areas it is important for staff working in crisis teams to be aware of the processes. 2.3.3. It is the responsibility of the BDUs and the ward manager to ensure staff are trained in the use of rapid tranquillisation. 3. Pharmacists 3.1. Rapid tranquillisation will form part of the induction programme for the pharmacists including locum and agency staff. 3.2. All pharmacists who work in mental health are required to be trained on the use of medicines in rapid tranquillisation. They will be required to attend training annually. 4. Records of training will be held on the Trusts Education and Training Management system. 39 Areas identified as requiring mandatory training in Rapid Tranquillisation Calderdale Beechdale Elmdale Ashdale Kirklees 8 Fox View Ward 19 Ward 18 Enfield Down Wakefield Chantry Horizon Centre Priory Trinity 1 Trinity 2 Sycamores Poplars Saville Park View House Castle Lodge Forensic Services Low Secure The Bretton Centre: Sandal, Thornhill, Ryburn and Almondbury Newhaven Medium Secure Appleton Bronte Chippendale Gaskell Hepworth Priestley Waterton Barnsley Melton Suite (PICU) Clark Ward (Female acute) Beamshaw (Male Acute) Willow (older adult) Intensive Home Based Treatment staff to be trained in all localities, this training is considered essential for this group. Oct 2011 40 Appendix 14 - Version Control Sheet This sheet should provide a history of previous versions of the policy and changes made Version Date Author Status Comment / changes 1 2002? Lynn Haygarth, Professor Curran, David Hargreaves, Professor Wattis, Nisreen Booya 2 August 2005 Updated by Lynn Haygarth and David Hargreaves Updated to include olanzapine IM injection 3 September 2008 Used principles in Bradford District Care Trust policy with consent. Updated by Lynn Haygarth Updated to include aripiprazole IM injection and requirement for ECG when prescribing haloperidol Format brought in line with trust requirements. 4 June 2010 Updated in line with new guidance Updated by Lynn Haygarth The introduction of a flow chart. Increase use of the forms for assessment and progress and the consideration of the process as a rapid tranquillisation pathway. Appendices have been introduced for the administration of the IM injectables. 5 Nov 2011 Updated to include practice in Barnsley. Updated by Mark Payne 5.1 December2 012 Updated to include Lorazepam IM by Paul Hardy Change in the therapeutic positioning of midazolam IM Addition of risperidone oral as treatment option Amended interval for post-intervention monitoring Reformatting of flow chart Lorazepam IM injection has recently become available again. To enable either Lorazepam IM or Midazolam IM to be used within the Trust. 5.2 January 2013 Updated to stand down midazolam memo by Lynn Haygarth Following D&T it was decided that lorazepam to be IM benzodiazepine of first choice and that midazolam 1mg/1ml injection to be removed from wards 5.3 September 2013 Updated The Richmond Agitation – Sedation Scale Paul Hardy Updated the Richmond Agitiation Sedation Scale for ease of use. 5.3.1 September 2014 Mark Payne Updated doses for haloperidol in line with changes to BNF / SPC 41 References SWYMHT Guidelines for Rapid Tranquillisation in adult acute psychiatric emergency Aug 2003 NICE Clinical Guideline 1: Schizophrenia. Core interventions in the treatment management of schizophrenia in primary and secondary care. National Institute of Clinical Excellence, December 2002. At www.nice.org.uk 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 2005. At www.nice.org.uk Bazire S Psychotropic Drug Directory. London: Lloyd-Rheinhold, 2012 TREC Collaborative Group Rapid Tranquillisation for agitated patients in emergency psychiatric rooms: a randomised trial of midazolam versus haloperidol plus promethazine British Journal of Psychiatry 2003; 327:708-13 McAllister-Williams RH, Ferrier IN. Rapid tranquillisation: time for a reappraisal of options for parenteral therapy. British Journal of Psychiatry 2002; 180:485-9. Alexander J et al Rapid Tranquillisation of violent or agitated patients in a psychiatric emergency setting British Journal of Psychiatry 2004; 185:63-9 Kapur S et al Evidence for onset of antipsychotic effects within the first 24 hours of treatment Am J Psychiatry (2005); 162:939-46 MacPherson R et al A growing evidence base for management guidelines Re-visiting…Guidelines for the management of acutely disturbed psychiatric patients Advances in Psychiatric Treatment (2005); 11:404-415 Davison S The management of violence in general psychiatry Advances in Psychiatric Treatment (2005); 11:362-370 Fenton M, Coutinho ESF & Campbell C Zuclopenthixol acetate in the treatment of acute schizophrenia and similar serious mental illnesses. The Cochrane Library, Issue 2, Chichester, UK: John Wiley & Sons, 2002. Taylor D, Paton C & Kapur S The Maudsley Prescribing Guidelines 11th Edition. London: Wiley-Blackwell, 2012 Pharmaceutical Press British National Formulary July 2014 (Accessed online, http://www.BNF.org) Summaries of Product Characteristics (SPC) (http://www.medicines.org.uk) SWYPFT Cardiopulmonary Resuscitation Policy (Director of Nursing) 2010 42