Rapid Tranquilisation Policy

Rapid Tranquilisation Policy Who Should Read This Policy Target Audience All Inpatient Staff Version 1.1 August 2015

Ref. Contents Page 1.0 Introduction 4 2.0 Purpose 4 3.0 Objectives 4 4.0 Process 4 4.1 Principle and Practise of Rapid Tranquilisation 4 4.2 Medical Staff Availability 7 4.3 Medical Equipment 7 4.4 Prescribing Guidelines 7 4.5 Risks and Complications Associated with Rapid Tranquilisation 18 4.6 Observations 18 4.7 Remedial Measures 19 4.8 Documentation 21 4.9 Post Incident Support and Review 21 5.0 Procedures connected to this policy 21 6.0 Links to Relevant Legislation 21 6.1 Links to Relevant National Standards 22 6.2 Links to Other Key Policies 22 6.3 References 23 7.0 Roles and Responsibilities for this policy 23 8.0 Training 25 9.0 Equality Impact Assessment 25 10.0 Data Protection Act and Freedom of Information Act 26 11.0 Monitoring policy s effectiveness 26 Appendices 1.0 NEWS Observation Chart 28 2.0 Medical Emergency Flowchart 32 Version 1.1 August 2015 2

Explanation of terms used in this policy Rapid Tranquillisation - use of medication to calm or lightly sedate the patient and reduce the risk to themselves and/or others. The aim is to achieve an optimal reduction in agitation and aggression, thereby allowing a thorough psychiatric evaluation to take place. Comprehension and response to spoken messages allowed throughout the intervention Violence - any incident where staff, patients or others are abused, threatened or assaulted in circumstances related to their work, involving an explicit or implicit challenge to their safety, wellbeing or health Aggression - this may be of a verbal nature or a physical act, whereby intentional behaviour leads to harm to the individual, to another person or to the damage of property Seclusion - supervised confinement of a patient in a room, which may be locked. Its sole aim is to contain severely disturbed behaviour that is likely to cause harm to others Calming - reduction of anxiety Advance Statements - preferred treatment choices expressed by the patient when well and are likely to be documented in care records. An advance statement is not legally binding Light Sedation - state of rest and reduction of psychological activity, but verbal contact is maintained QT intervals - specific period of time measured during an ECG, it represents the total period of electrical activity of the ventricles. The QT interval is dependent of the heart rate. If abnormally prolonged, there is a risk of developing ventricular arrhythmias. Many drugs such as haloperidol can prolong the QT interval. It is usually cited as QTc which is the QT corrected for heart rate. It is a useful indicator of torsade de pointes and of increased mortality. Normal limits are 440ms for men and 470ms for women Parenteral - administration of medicine usually via intramuscular route or, exceptionally, intravenous National Early Warning Scoring (NEWS) - single standardised early warning system which has been developed by the Royal College of Physicians and has been adopted nationally by the NHS to enable consistency across both acute and community hospital settings Version 1.1 August 2015 3

1.0 Introduction Black Country Partnership NHS Foundation Trust recognises that it is sometimes necessary to use pharmacological intervention to maintain the safety and physical health of some patients who are acutely unwell. It is accepted that certain situations may arise in psychiatric in-patient environments that can lead to potential or actual harm of the patient or those around them as a result of their extremely disturbed or challenging behaviour. This could arise due to psychotic or non-psychotic illness and may need to be brought rapidly under control with the appropriate use of medication in order to avoid prolonged use of physical interventions. Rapid tranquillisation can include both the use of oral and intramuscular benzodiazepines and Antipsychotic medication to calm or mildly sedate the agitated patient. Rapid tranquillisation is not a first line therapy for managing violence and aggression. The underlying condition does not necessarily predict response to rapid tranquillisation nor preclude rapid tranquillisation. Other approaches to manage imminent violence include de-escalation techniques, consideration of placement, physical interventions and seclusion but when used, management strategies to reduce the level of risk should be recorded in care plans. This policy should be read in conjunction with the Prevention and Management of Violence and Aggression including NHS Sanctions Policy. 2.0 Purpose The purpose of this policy is to provide staff with clear direction in regard to the use of rapid tranquillisation when faced with incidents of acutely disturbed behaviour and extreme aggression. 3.0 Objectives To define and explain the use of rapid tranquillisation in inpatient settings To provide a standardised approach to physical monitoring and nursing care before, during and following rapid tranquillisation To provide a framework for ensuring: The decision to use rapid tranquillisation is made with due consideration Rapid tranquillisation is used safely and effectively The use of rapid tranquillisation is reflected upon and care plans reviewed appropriately 4.0 Process 4.1 Principles and Practice of Rapid Tranquilisation In certain situations within psychiatric in-patient environments potential or actual harm of a patient or those around them can arise as a result of their extremely disturbed or challenging behaviour. Initial approaches to manage imminent violence can include deescalation techniques, consideration of placement, physical interventions and seclusion. Version 1.1 August 2015 4

4.1.1 De-escalation Techniques Maintain adequate distance Ensure environment is conducive to calmness (e.g. low stimulation levels, noise and other patients) Move to a safe place or seclude Explain intentions and be calm and self-assured Use non-threatening non-verbal communication Converse and try to develop therapeutic relationship throughout 4.1.2 Choice of Intervention Where de-escalation techniques have failed to calm a patient, it may be necessary to make use of additional interventions, such as physical intervention, rapid tranquilisation and seclusion to manage the incident. All such interventions should only be considered once de-escalation techniques have been tried and have not succeeded in calming the patient. The choice of intervention(s) will depend on a number of factors, but should be guided primarily by: Patient preference (if known) The clinical needs of, and risks to, the patient Obligations to other patients affected by the disturbed/ violent behaviour The protection of staff, patients and visitors The facilities available within the particular setting 4.1.3 Rapid Tranquillisation and Physical Intervention In certain situations, the multidisciplinary team may agree use of medication as the most appropriate method of managing extreme behaviour. Where this is likely to require the use of physical intervention in order to safely administer the medication - the force used to administer medication must be reasonable. Current physical intervention skills do not allow for the complete immobilisation of a patient. Movement will be generated by an agitated patient thus making it difficult to safely administer rapid tranquillisation. In order to reduce the injection risks staff should wait until movement is at a minimum and/or the patient is ready to cooperate with the injection. 4.1.4 Rapid Tranquillisation and Seclusion The combined use of seclusion and rapid tranquillisation should be avoided wherever possible, however, if seclusion is judged necessary to manage the serious risk of violence the following should be considered and the potential complications of rapid tranquillisation should be taken seriously: Continuous observation through the observation window by a delegated nurse Terminating seclusion once rapid tranquillisation has taken effect The patient s respiration and where possible all other vital signs should be monitored Once seclusion is instigated refer to Seclusion Policy for further guidance 4.1.5 Risk Assessment The decision to use rapid tranquillisation should be made after clinical assessment of need and risk to the patient and/or others. All patients should have a regular and comprehensive risk assessment to ensure the safety of the patient and the clinical environment. Risk assessments should be ongoing as risks may change according to circumstances. Version 1.1 August 2015 5

The risks associated with rapid tranquillisation are to be explored by the team prior to the administration of medication to determine safety and appropriateness. Rapid tranquillisation is potentially hazardous and the risk of adverse effects is higher if the patient has taken illicit drugs or alcohol. 4.1.6 Advanced Statements Patients identified to be at risk of disturbed or violent behaviour should be given the opportunity to have their needs and wishes recorded in the form of an advanced directive and within a care plan. 4.1.7 Legal Issues and the Mental Health Act (MHA) (2007) If a patient refuses or lacks capacity to give valid consent to treatment for mental disorders they may be given treatment using reasonable force, in an emergency situation or where the treatment is deemed to be in their best interests. This applies to either informal or detained patients. 4.1.8 Physical Monitoring Before Rapid Tranquillisation In anticipation of the likelihood of prescribing medication for rapid tranquillisation, the prescribing doctor should: Ensure baseline measurements are taken and recorded i.e. blood pressure, temperature, pulse, respiration and weight Review the patient s clinical record with regard to his/her general medical history and consider the possibility of a physical examination Be aware of any previous drug sensitivity / allergies and communicate this information to all members of the MDT through normal communication channels Check for recent Electroencephalogram, blood and urine drug screen results, a previous history of severe extrapyramidal side effects, previous response to rapid tranquillisation or other methods of managing imminent violence Review current prescribed medication and recently administered medication, taking note of administrations of pro re nata (PRN) prescriptions 4.1.9 Rapid Tranquillisation Rapid tranquillisation is used in situations requiring the rapid control of agitation, aggression or excitement when other less coercive techniques of calming a patient, such as verbal de-escalation or intensive nursing techniques, have failed. It usually involves the administration of medication over a period of 30-60 minutes in order to produce a state of calm/light sedation. The medications used for rapid tranquillisation should ideally have a low level of side effects and rapid onset of action. For the purpose of this policy, rapid tranquillisation describes the use of medication to control severe mental and behavioural disturbance, including: Aggression associated with the mental illness of schizophrenia, mania and other psychiatric conditions Organic disorders, including dementia and delirium from a variety of causes Version 1.1 August 2015 6

4.2 Medical Staff Availability A doctor should be quickly available at all times to attend to an alert by ward staff when rapid tranquillisation is implemented. NICE Clinical Guideline on Violence and Aggression (NG10) recommends that a doctor should aim to be at the scene within 30 minutes. Medical support must be available in case of adverse reactions, over sedation or the need to administer Flumazenil (to reverse sedation, drowsiness). If rapid tranquillisation is to be considered out of hours the duty doctor should be contacted and requested to attend. 4.3 Medical Equipment The blue emergency bag should be available within 3 minutes in inpatient settings where rapid tranquillisation might be used. The bag should be maintained and checked weekly. 4.4 Prescribing Guidelines Where appropriate the patient may be offered oral medication, however if they are unable to accept this, or the decision is made that the situation is such that the quicker action of intramuscular injection(im) is required for safety reasons, then this should be undertaken. The use of IM medication must be reported externally and for this reason the use of IM medication must be reported via the Physical Intervention Monitoring Form. Care must be taken when giving IM injections particularly to highly aroused and/or violent individuals. The provision of adequate staff trained in approved care and responsibility techniques 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. Intravenous (IV) injection/infusion should only be given when you are dealing with a very hostile and disturbed patient and then only in discussion with a Consultant. The IV route of administration can lead to high concentrations of drug at the heart muscles and should always be avoided in older patients. Nursing staff working within the Trust are not trained to administer medication via the IV route and hence administration would need to be carried out by a doctor if necessary. 4.4.1 Choice of Medication Few fully randomised controlled trials of medication used in rapid tranquillisation have been conducted; those available show that Lorazepam IM, Haloperidol IM and Olanzapine IM are effective, but Lorazepam has fewer side effects. Hence the following have been deemed the most appropriate agents to use in rapid tranquillisation (NICE Clinical Guideline Violence and Aggression NG10). Their properties, the pharmacokinetics of each medicine and any cautions/notes are detailed in 4.4.2. Lorazepam oral and IM Haloperidol oral and IM Olanzapine IM Zuclopentixol Acetate IM specific circumstances only The use of two medicines of the same class for the purpose of rapid tranquillisation should not occur. Version 1.1 August 2015 7

4.4.2 Table 1- Rapid Tranquillisation Guidelines for Adults 1 Review the use of non-pharmacological strategies for managing an imminent risk of violence Review the patient s consent to treatment. Is it necessary to use section 62? Review the patient s clinical record for previous medical history and recent investigations Note total medication in last 24 hours and response Consider physical examination Consult with a more senior doctor at any stage if unsure Flumazenil must be available in case of Benzodiazepine-induced respiratory depression 2 Consider using ORAL medication. The options include: LORAZEPAM 1-2mg (May repeat after 45-60 minutes. Max. 4mg/24 hours) PROMETHAZINE 25-50mg (May repeat after 1-2 hours. Max. 100mg/24 hours) OLANZAPINE 10mg (May repeat after 4 hours. Max. 20mg/24 hours) HALOPERIDOL 5mg (best with Promethazine 25mg) (May repeat after 4 hours. Max. 20mg/24 hours) If the patient is prescribed a regular oral or depot Antipsychotic or has cardiovascular disease, consider using Lorazepam alone. Promethazine may be used as an alternative. If the patient is not already taking a regular oral or depot Antipsychotic, is Benzodiazepine tolerant, has respiratory disease or a doctor is not present out of hours, consider using an Antipsychotic alone. Avoid using Haloperidol in Antipsychotic naïve patients. The SPC for Haloperidol recommends avoiding concomitant Antipsychotics and having a pre-treatment ECG. Ensure Procyclidine is available for side-effects. Allow sufficient time for clinical response between doses. Alternatives consider: RISPERIDONE 1-2mg 3 No response or patient refuses oral consider using INTRAMUSCULAR medication. The options include: LORAZEPAM 1-2 mg (May repeat after 30-60 minutes. Max. 4mg/24 hours) If the patient is prescribed a regular oral or depot Antipsychotic or has cardiovascular disease, consider using Lorazepam alone. Version 1.1 August 2015 8

PROMETHAZINE 25-50mg (May repeat after 1-2 hours. Max. 100mg/24 hours) ARIPIPRAZOLE 5.25 9.75mg (Usual dose 9.75mg. May repeat after 2 hours. Max. 30mg/24 hours) HALOPERIDOL 5mg (May repeat after 30-60 minutes. Max.12mg/24 hours) Promethazine may be used as an alternative and is a useful option in a Benzodiazepine-tolerant patient. If the patient is not already taking a regular oral or depot Antipsychotic, is Benzodiazepine tolerant, has respiratory disease or a doctor is not present out of hours, consider using an Antipsychotic alone. Avoid using Haloperidol in Antipsychotic naïve patients. Haloperidol should be the last drug considered. The SPC recommends a pre-treatment ECG. The incidence of acute dystonia is high combine with IM Promethazine and ensure IM Procyclidine is available. Allow sufficient time for clinical response between doses. Transfer to oral route at earliest opportunity. 4 If unsuccessful seek advice from consultant psychiatrist on duty. Consider alternatives. 4.4.3 Rapid Tranquillisation Guidelines for Older People 1 Review the use of non-pharmacological strategies for managing an imminent risk of violence Review the patient s consent to treatment. Is it necessary to use section 62? Review the patient s clinical record for previous medical history and recent investigations Note total medication in last 24 hours and response Consider physical examination Consult with a more senior doctor at any stage if unsure Flumazenil must be available in case of Benzodiazepine-induced respiratory depression 2 ORAL medication should be first choice where possible 2.1 Patient with known diagnosis of schizophrenia, mania or other functional disease 2.2 Dementia with Lewy Bodies (DLB) present or cannot be excluded Refer to guidelines for younger adults but with reduced doses and longer times between doses. Consider half adult doses. Caution: renal or hepatic impairment, cardiovascular disease. Monitor B.P. Consider oral Lorazepam 0.5mg-1mg every 4 hours (Max. 2mg/24 hours). Version 1.1 August 2015 9

Must avoid Antipsychotic medication as it can cause sudden deterioration, side effects and even death. 2.3 Dementia other than DLB If the patient is established on a regular Antipsychotic or has cardiovascular disease, consider using Lorazepam alone. If the patient is Benzodiazepine tolerant or has respiratory disease or a doctor is not present out of hours, consider using an Antipsychotic alone. Caution Antipsychotic drugs are associated with an increased risk of mortality, stroke and transient ischaemic attack. 3 Rapid Tranquilisation Policy Consider oral Lorazepam 0.5mg-1mg every 4 hours (Max. 2mg/24 hours). Consider oral Haloperidol 0.5-5mg (Max.10mg/24 hours) or Quetiapine 25mg or Risperidone 0.25mg. (Avoid using haloperidol in Antipsychotic naïve patients. The SPC recommends avoiding concomitant Antipsychotics and having a pre-treatment ECG. Ensure Procyclidine is available for side-effects). Monitor status and continue oral. If no response or patient refuses oral medication seek advice from duty consultant psychiatrist. In cases of emergency consider using INTRAMUSCULAR medication. 3.1 Dementia with Lewy Bodies (DLB) present or cannot be excluded 3.2 Dementia other than DLB If the patient is established on a regular Antipsychotic or has cardiovascular disease, consider using Lorazepam alone. If the patient is Benzodiazepine tolerant or has respiratory disease or a doctor is not present out of hours, consider using an Antipsychotic alone. Caution Antipsychotic drugs are associated with an increased risk of mortality, stroke and transient ischaemic attack. 4 If unsuccessful seek advice from consultant psychiatrist on duty. Consider alternatives. Consider IM Lorazepam 0.5mg-1mg only (Max. 2mg/24 hours). Consider IM Lorazepam 0.5mg-1mg only (Max. 2mg/24 hours). Consider IM Haloperidol 0.5-2.5mg (Max. 6mg in 24 hours). (Avoid using Haloperidol in Antipsychotic naïve patients. SPC recommends pre-treatment ECG. Ensure Procyclidine is available for side-effects). Version 1.1 August 2015 10

4.4.4 Additional drug information to be used with guidelines Drug Route Onset of Action Time to Reach Maximum Concentration BNF Maximum Dose in 24 hours Aripiprazole IM NR 1-3 hrs. 30mg Haloperidol Oral 1-2 hrs. 4 hrs. 20mg Haloperidol IM NR 20 mins. 12mg Lorazepam Lorazepam Oral IM 20-30 mins. <20-30 mins. Midazolam* IM 15 mins. 30 mins. 15mg Other e.g. monitoring, licensing, administration IM effective dose range 5.25mg-15mg. A second injection may be administered 2 hrs. after the first injection. Maximum 3 injections in 24 hours. Caution in dementia ECG requirement Caution in dementia ECG requirement Caution in dementia 2hrs 4mg IV Flumazenil must be available NR 60-90 mins. 4mg IV Flumazenil must be available NR Only If no IM Lorazepam IV Flumazenil must be available Olanzapine Oral 1 hr. 5-8 hrs. 20mg Caution in dementia Low Promethazine* Oral NR 2-3 hrs. 100mg NR Promethazine* IM 1-2 hrs. NR 100mg NR Quetiapine Oral NR 1.5-1.8 hrs. Limited clinical experience 750/800mg (6 hours for XL) Caution in dementia Moderate Risperidone Oral NR 1-2 hrs. 16mg Caution in dementia Low Zuclopenthixol IM 2-8 hrs. 36 hrs. 150mg See separate guidelines NR ACETATE *Unlicensed indication. NR = Not Recorded QT rating Low High High NR Version 1.1 August 2015 11

4.4.5 Notes 1. Previous medication taken by the patient must be considered and oral therapy should be first choice where possible. Care must be taken to ensure that high doses do not accidently occur through the use of PRN medication given in combination with regular medication. 2. Two drugs of the same class should not be used for rapid tranquillisation. 3. The BNF maximum doses include both oral and IM formulations. 4. Oral and intramuscular medications should be prescribed separately on the treatment chart. 5. Drugs should never be mixed in the same syringe prior to administration. 6. Haloperidol is not bioequivalent orally to IM. The maximum daily dose of Haloperidol is 20mg orally or 12mg by intramuscular injection. Maximum doses will need to be adjusted if a combination of both is used. The bioequivalence is approximately 10mg oral: 6mg IM. 7. A baseline ECG is recommended prior to treatment in all patients prescribed Haloperidol. If it has been refused or not taken for any other reason, this should be documented in the patient s notes clearly with the reasons why stated. 9. Elderly: in patients with dementia, Antipsychotic drugs are associated with a small increased risk of mortality, stroke and transient ischaemic attack. Olanzapine, Quetiapine and Aripiprazole are not approved for the treatment of dementiarelated psychosis and/or behavioural symptoms. Risperidone should only be used for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others. 10. If there is a shortage of Lorazepam IM see Midazolam guidelines section 6.8 Caution for intramuscular Lorazepam; check before use whether dilution is required (depends on the brand in stock). 11. Ensure Flumazenil injection (benzodiazepine antagonist) is available to reverse effects of Lorazepam or Midazolam. 12. Ensure Procyclidine is available to manage acute dystonic reactions or other extrapyramidal side-effects of Antipsychotic medication especially Haloperidol. 13. Risperidone and Olanzapine are available as orodispersible tablets. 14. There are specific risks with different classes of medication. Risks may be compounded if used in combination. Benzodiazepines: loss of consciousness, respiratory depression or arrest, cardiovascular collapse when receiving both Clozapine Version 1.1 August 2015 12

8. Despite the need for rapid and effective treatment, the use of two or more Antipsychotics (Antipsychotic polypharmacy) should be avoided on the basis of risk associated with QT prolongation. Other drugs may also affect the QT interval e.g. Citalopram, Escitalopram, Macrolide and Fluoroquinolone antibiotics, Amiodarone, Sotalol, Hydroxyzine. Contact pharmacy for further information. 15. Simultaneous administration of injectable Antipsychotics and parenteral Benzodiazepines may be associated with excessive sedation and cardiorespiratory depression. Patients should be monitored for excessive sedation and orthostatic hypotension. 16. It is recognised that clinicians may decide that the use of medication outside the Summary of Product Characteristics (SPCs) is occasionally justified, bearing in mind the overall risks. However, where the regulatory authorities or manufacturer issues a specific warning that this may result in an increased risk of fatality, the medication should only be used strictly in accordance with the current marketing authorisation. and Benzodiazepines. Antipsychotics: loss of consciousness, cardiovascular/respiratory complications and collapse, seizures, akathisia, dystonia, dyskinesia, neuroleptic malignant syndrome, excessive sedation. Antihistamines: excessive sedation, painful injection, additional antimuscarinic effects. 17. A resuscitation bag should be available within 3 minutes in healthcare settings where rapid tranquillisation might be used. The equipment should include an automatic external defibrillator, a bag valve mask, oxygen, cannulas, fluids, and suction and first-line resuscitation medications. These should be maintained and checked daily. 4.4.6 Antipsychotics After discussion with consultant: not for routine use in rapid tranquillisation. If a patient is on maximum dose of oral Antipsychotic, consider using above BNF maximum doses or alternative Antipsychotic for shortterm only. In certain circumstance, current BNF limits and the manufacturer s SPC may be knowingly exceeded. This decision should not be taken lightly or the risks underestimated. Record a risk-benefit analysis in the case notes and a rationale in the care plan. Undertake frequent and intensive monitoring of a calmed service user. Zuclopenthixol acetate injection (Clopixol Acuphase ). (See guidelines section 6.7). Caution in elderly. It is not recommended for rapid tranquillisation due to its significantly delayed onset and relatively long duration of action. Consider Promazine 25mg-50mg in the elderly. Version 1.1 August 2015 13

4.4.7 Benzodiazepines Consider Lorazepam: High dose. Use with caution and document in patients clinical notes reason for prescribing high dose. Undertake frequent and intensive monitoring. A doctor must be present to administer Flumazenil if needed. 4.4.8 Guidelines for the use of zuclopenthixol acetate injection (Clopixol Acuphase ) N.B. For use following approval from consultant only BNF Indications Dosage Frequency Route Onset, duration of action Other Short-term management of acute psychosis, mania or exacerbations of chronic psychoses. 50-150mg (1-3ml). Elderly: 50-100mg If necessary repeat after 2-3 days. One additional dose may be given 1-2 days after the first injection. Maximum cumulative dose 400mg per course and maximum 4 injections. Maximum duration of treatment 2 weeks. Not for long-term treatment. Deep intramuscular injection into the upper outer buttock or lateral thigh. Sedative effects usually begin to be seen after 2 hours after injection and peak after 12 hours. The effects can last for up to 72 hours. If resisting injection i.e. struggling, use appropriate MAPA techniques to decrease risk of injection into vein. If maintenance treatment is necessary change to an oral Antipsychotic 2-3 days after last injection or to a longer acting Antipsychotic depot injection given concomitantly with last injection of Zuclopenthixol Acetate. This should be considered only: When following consultant approval After an acutely psychotic patient has required repeated injections of short-acting Antipsychotic drugs such as Haloperidol, or sedative drugs such as Lorazepam In patients known to respond to it In physically violent patients for whom repeated attempts at injection would be dangerous for all parties It should be given only when enough time has elapsed to assess the full response to previously injected drugs. Allow 60 minutes after IM injection If cited in an advance directive Version 1.1 August 2015 14

Clopixol Acuphase injection should never be administered: In an attempt to hasten the antipsychotic effect of other Antipsychotic Therapy For rapid tranquillisation (onset of effect is too slow) At the same time as other parenteral Antipsychotics or Benzodiazepines (may lead to over sedation which is difficult to reverse) As a test dose for zuclopenthixol Decanoate depot injection To a patient who is physically resistant (risk of intravasation and oil embolus) Clopixol Acuphase injection should never be used for, or in, the following: Patients who accept oral medication Patients who are Antipsychotic naïve; Patients who are sensitive to Extrapyramidal side effects (dystonia, laryngeal spasm, oculogyric crisis or previous neuroleptic malignant syndrome) Patients who are unconscious Patients who are pregnant Patients with convulsive disorders or Parkinson s disease Those with hepatic or renal impairment Those with cardiac disease Those with a depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), coma Those resisting injection i.e. struggling. Use appropriate physical intervention techniques to decrease risk of injection into vein Patients that are not detained under the Mental Health Act Caution: in patients who have recently received a dose of depot Antipsychotic which has not yet reached peak levels. Increases in the QT interval related to Antipsychotic treatment may be exacerbated by the co- administration of other drugs known to significantly increase the QT interval. NICE suggests that Clopixol Acuphase injection may be considered an option when: service user will be disturbed/violent over extended time period past history of good/timely response past history of repeated parenteral administration cited in an advance directive Never administer to those without previous Antipsychotic exposure. 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 patient has been reassessed by doctor. Version 1.1 August 2015 15

4.4.9 Guidelines for the administration of IM Midazolam in case of shortage of IM Lorazepam These guidelines should only be used when Lorazepam IM is unavailable, so IM Midazolam is the second drug of choice. NB: this is an unlicensed indication for Midazolam. It should only be used following consultant approval and the reason for use must be documented in the patient s notes. NB: IM Midazolam has not been used regularly within our clinical area before. Therefore, it is unknown quantity in regards to effect in patients. 4.4.10 Patient care Patients to be on high nursing observations for at least 4 hours after last dose Physical observations every 5-10 minutes for 1 hour then half-hourly until patient is ambulatory Monitor for excessive sedation, respiratory depression and hypotension Due to possible short term amnesia following administration of midazolam, observations should be done by staff of the same gender to take into consideration the safety, privacy and dignity of the patient at all times. Also, take into account individual patient risks and safety of staff Review/monitor continuously for 24 hours after last dose Patients to be reviewed by medical team after use of midazolam as per MAPA situation Summary: When IM Benzodiazepine use is being considered in the absence of IM Lorazepam, use IM Midazolam. Version 1.1 August 2015 16

4.4.11 Table 2- Comparison between Midazolam and Lorazepam Indication Properties of IM Midazolam Properties of IM Lorazepam Only to be used for rapid tranquillisation when IM Lorazepam is unavailable IV Flumazenil should always be available for use when administering IM Benzodiazepines Absorption after IM injection is rapid and complete Maximum plasma concentrations in 30 minutes. Absolute bioavailability is 90% Elimination half-life 1.5-2.5 hours. Excreted mainly renally Dose: 7.5mg, repeated once at 2 hourly intervals if required. Maximum 15mg/24 hours Elderly: 1-2mg, repeated at 2 hourly intervals if required. Maximum 5mg/24 hours. (Use with caution in: chronically ill, impaired renal/liver/cardiac function, chronic respiratory insufficiency) Controlled drug. Order via CD requisition book. Not stored in CD cupboard Administration: No dilution required Administer IM IM injection is readily and completely absorbed Maximum peak plasma concentrations in 60-90 minutes Elimination half-life 12-16 hours Dose: 1-2mg, repeated after 30-60 minutes if required, up to maximum 4mg/24 hours Elderly: 0.5-1mg, repeated after 4 hours if required, up to maximum 2mg/24 hours Stored in fridge Administration: Caution check whether dilution required, depends on brand in stock Administer IM Version 1.1 August 2015 17

4.5 Risks and Complications associated with Rapid Tranquillisation There are specific risks associated with the different classes of medications that are used in rapid tranquillisation. The specific properties of the individual drugs should be taken into consideration. When combinations are used, risks may be compounded. Staff need to be aware of the following: For Benzodiazepines: Loss of consciousness Respiratory depression or arrest Cardiovascular collapse (in patients receiving both Clozapine and Benzodiazepines) For Antipsychotics: Loss of consciousness Cardiovascular and respiratory complications and collapse Seizures Subjective experience of restlessness (akathisia) Acute muscular rigidity (dystonia) Involuntary movements (dyskinesia) Neuroleptic malignant syndrome (NMS) Excessive sedation 4.5.1 Circumstances for special care Extra care should be taken when implementing rapid tranquillisation in the following circumstances: The presence of congenital prolonged QTc syndromes The concurrent prescription or use of other medication that lengthens QTc 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 4.6 Observations After rapid tranquillisation is administered, the following should be monitored: Results of vital signs must be recorded on the NEWS Observation Chart (see appendix 1), nursing and medical notes Scheduled observation and engagement levels should be assessed by a doctor, with nursing staff, and the frequency of observations following rapid tranquillisation recorded in case notes. However it is recommended that Blood pressure, pulse, temperature, respiratory rate and level of consciousness should be monitored every 5-10 minutes for 1 hour after IM injections After the first hour continue to monitor every ½ hour for 4 hours or until the patient becomes ambulatory If the patient is asleep the use of pulse oximetry to continuously monitor oxygen saturation is recommended If the patient becomes unconscious or if there is an increase in NEWS score, care should be escalated following the clinical response table in Appendix 1. Refer to the Medical Emergency Flowchart (Appendix 2) Version 1.1 August 2015 18

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 For further information regarding this please see the Management of Deteriorating Patient Policy 4.7 Remedial Measures Monitoring by nursing staff is necessary to ensure complications and side effects are recognised The NEWS observation chart is to be completed following rapid tranquillisation (appendix 1) Where possible, baseline measurements should be recorded After any parenteral drug administration, you should monitor: temperature; pulse; blood pressure and respiratory rate Every 5-10 minutes for 1 hour and then half hourly until patient is ambulatory. Record in notes. Patients who refuse to have their vital signs monitored or who remain too behaviourally disturbed to be approached should be observed for signs/symptoms of pyrexia, hypotension, over sedation and general physical wellbeing If the patient is asleep, the continuous use of pulse oximetry to measure oxygen saturation is desirable. A nurse should remain with the patient until ambulatory Seek urgent medical advice if the patient deteriorates or is unconscious ECG and haematological monitoring are also strongly recommended when parenteral Antipsychotics are given, especially when higher doses are used. Hypokalaemia, stress, and agitation place the patient at risk of cardiac arrhythmias. ECG monitoring is formally recommended for all patients receiving Haloperidol in any formulation Please refer to 4.7.1 below for more guidance Version 1.1 August 2015 19

4.7.1 Table 3 Managing the Complications and Side Effects of Medication Complication Symptom Acute Dystonia Fall in blood pressure Irregular or slow pulse Increased temperature Reduced respiratory rate Muscle spasms especially in the head and neck and can result in a forced sideways twisting of the neck. Laryngeal spasm, which leads to difficulty in swallowing and breathing. Oculogyric crisis is forced movement of the eyes usually upwards which the patient can t reverse (>30 mmhg orthostatic drop or <50 mmhg diastolic) characterised by light-headedness and dizziness Slow (<50/minute) or irregular pulse Neuroleptic Malignant Syndrome (NMS) include fever, rigidity, confusion, fluctuating consciousness, fluctuating blood pressure, and tachycardia (< 10/minute) or oxygen saturation (< 90%) (Respiratory depression) (Flumazenil side-effects patients may become agitated, anxious or fearful on awakening. Seizures may occur in regular benzodiazepine users) Management Procyclidine 5-10mgs IM immediately Repeat if necessary after 20 minutes Max 20 mg in 24 hours (If not severe oral may be given) Give oxygen, lay patient flat, raise legs, and ensure patient is not lying face down monitor blood pressure Refer to specialist medical care immediately Check creatinine kinase urgently Risk of NMS and perhaps arrhythmias monitor closely, cool patient, and refer to ITU if continued or any other signs of NMS Withhold Antipsychotics and seek urgent medical advic Seek urgent medical advice or MAU at the acute trust Give oxygen, raise legs and ensure patient is not lying face down If respiratory rate drops below 10/minute in a patient who has received Benzodiazepines, give Flumazenil (Stock in the emergency cupboard at Penn Hospital and the out of hours cupboard at Edward Street Hospital, Hallam Street Hospital and Heath Lane Hospital) 1. 200mcg I.V. over 15 seconds 2. If consciousness not resumed within 60 seconds give 100mcg 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 Do not use in patients with epilepsy on long term Benzodiazepines Dose should be carefully titrated in hepatic impairment If induced by other agent mechanical ventilation will be required Arrange transfer to ITU at Acute Hospital immediately Version 1.1 August 2015 20

4.8 Documentation Record any incident requiring rapid tranquillisation: Documenting all care or treatment given clearly in the patients records and DATIX NEWS observation chart is to be used to monitor vital signs Where an incident has required the use of a physical intervention, a physical intervention monitoring form should be completed Where an incident has required the use of seclusion, a seclusion monitoring form should be completed 4.9 Post Incident Support and Review Following the use of rapid tranquillisation, patients should be offered the opportunity to discuss their experiences to reduce the incidence and severity of trauma. The patient should be provided with a clear explanation of the decision to use rapid tranquillisation, the medication and its effects and a discussion of their experiences. The patient should also be offered the opportunity to write about their experience and be supported to do this. Where the patient would like the involvement of an independent body the nurse in-charge should ensure that advocacy services are contacted. A post-incident review should take place as soon as possible and at least within 72 hours of an incident ending. If possible, a person not directly involved in the incident should lead the review. This meeting should be used to ensure that the appropriate documentation has been completed and any issues relating to the use of rapid tranquillisation are discussed and lessons incorporated into practice. Staff and other patients who may have been involved should also be given the opportunity to discuss their experience. Prescriptions for rapid tranquillisation should be reviewed by the multidisciplinary team and, especially if used repeatedly, appropriate changes made to regularly prescribed medication. 5.0 Procedures connected to this Policy There are no procedures connected to this policy. 6.0 Links to Relevant Legislation Mental Health Act 1983 The Mental Health Act 1983 (which was substantially amended in 2007) is the law in England and Wales that allows people with a mental disorder to be admitted to hospital, detained and treated without their consent either for their own health and safety, or for the protection of other people. Mental Capacity Act 2005 Mental Capacity Act 2005, covering England and Wales, provides a statutory framework for people who lack capacity to make decisions for themselves, or who have capacity and want to make preparations for a time when they may lack capacity in the future. The Act sets out who can take decisions, in which situations, and how they should go about this. In addition - in some cases, people lack the capacity to consent to particular treatment or care that is recognised by others as being in their best interests, or which will protect them from harm. Where this care might involve depriving adults at risk of their liberty in either a hospital or a care home, extra safeguards have been Version 1.1 August 2015 21

introduced in law Deprivation of Liberty Safeguards, to protect their rights and ensure that the care or treatment they receive is in their best interests. 6.1 Links to Relevant National Standards Nice Guidelines Violence and Aggression NG10 (2015) This guideline has been developed to advise on the short-term management of violence and aggression in mental health, health and community settings in adults, children (aged 12 years or under) and young people (aged 13 to 17 years). This guideline updates and replaces NICE guideline CG25 (published February 2005). Nice Guidelines Psychosis and Schizophrenia CG178 (2014) This guideline has been developed to advise on the treatment and management of psychosis and schizophrenia in adults. The guideline recommendations have been developed by a multidisciplinary team of healthcare professionals, people with psychosis and schizophrenia, their carers and guideline methodologists after careful consideration of the best available evidence. It is intended that the guideline will be useful to clinicians and service commissioners in providing and planning high quality care for people with psychosis and schizophrenia while also emphasising the importance of the experience of care for people with psychosis and schizophrenia and their carers Nice Guidelines Bipolar Disorder CG185 (2014) This guideline, which updates the 2006 National Institute for Health and Care Excellence (NICE) guideline (NCCMH, 2006; NICE, 2006), has been developed to advise on the assessment and management of bipolar disorder in adults, children (aged under 13 years) and young people (aged 13 to 18 years) in primary and secondary care. It applies to people with bipolar I, bipolar II, mixed affective and rapid cycling disorders. Non-bipolar affective disorders are not covered because these are addressed by other guidelines. 6.2 Links to other key policy/s Management of the Deteriorating Patient Policy The purpose of this policy is to ensure that clinical staff working within the Black Country Partnership NHS Foundation Trust have a standardised approach to recognising changes in the patient s normal physiology and responding quickly by alerting experienced help. Prevention and Management of Violence and Aggression including NHS sanctions The purpose of this policy is to detail the Trust s strategy and legislative compliance in tackling violence and aggression against patients and staff. Seclusion Policy The purpose of this policy is to ensure that employees of the Trust have clear directions related to the use of seclusion. The policy will also ensure that staff work within the Mental Health Act 1983 Code of Practice. Clinical Observation Policy The purpose of this policy is to make clear the arrangements in place for the observation of patients and to provide direction and guidance to clinical staff in order to ensure safe levels of observation in clinical areas. Version 1.1 August 2015 22

Best Practice - Dissemination, Implementation and Monitoring of NICE Quality Standards and Guidance The purpose of these guidelines is to provide a clear process for responding effectively to the publication of NICE quality standards and national guidance, to ensure current practice reflects the best possible evidence and it is both clinically and cost effective. 6.3 References Mental Health Policy Implementation Guide: Developing Positive Practice to Support the Safe and Therapeutic Management of Aggression and Violence in Mental Health In-Patient Settings Department of Health (2004) British National Formulary (BNF) 69 (2015) Mental Health Act Manual, 8th edition. Jones R. (2003) Good Practice Guide for the management of Violence. Royal College of Psychiatrists. Maden & Ashead (2006) Mental Health Act (1983) Code of Practice (1999) Nice Guidelines Violence and Aggression: Short-Term Management in Mental health, Health and Community Settings NG10 (2015) Nice Guidelines Psychosis and Schizophrenia in Adults: Treatment and Management CG178 (2014) Nice Guidelines Bipolar Disorder: The Assessment and Management of Bipolar Disorder in Adults, Children and Young People in Primary and Secondary Care CG185 (2014) National Early Warning Score (2012) Royal College of Physicians 7.0 Roles and Responsibilities for this Policy Title Role Responsibilities Executive Director of Nursing, AHPs and Governance Trust Board Executive Lead Strategic - Ensure the Trust s management and use of rapid tranquillisation is discharged appropriately and has lead responsibility for the implementation of this policy - Ensure a systematic and consistent approach to the use of rapid tranquillisation within inpatient areas - Bring any serious concerns regarding the implementation of this policy to the attention of the Board - Strategic overview and final responsibility for overseeing the use of rapid tranquillisation within inpatient areas across the Trust Executive Committee Quality & Safety Steering Group Clinical Directors Accountable Responsible Lead - Responsible for ensuring that the use of rapid tranquillisation is managed efficiently and effectively in accordance with the Board s Assurance Framework and strategic priorities - Responsible for overseeing the implementation of a systematic and consistent approach to the use of rapid tranquillisation - Provide exception and progress reports to the Executive Committee - Responsible for the use of rapid tranquillisation within their Group - Lead discussions on the use of rapid tranquillisation at Group Quality & Safety Steering Group meetings - Oversee the completion of audits and subsequent action plans in respect of rapid tranquillisation - Provide updates on the use of rapid tranquillisation within their Group to the Quality & Safety Steering Group Version 1.1 August 2015 23

Title Role Responsibilities Group Quality &safety steering groups Medicines Management Committee Implementation Scrutiny and Performance - Responsible for monitoring the use of rapid tranquillisation within their Group - Ensure all incidents of rapid tranquillisation are reported via Datix, the trust s incident reporting procedure - Monitor use of rapid tranquillisation on a case by case basis within each Group - Report and discuss all incidents at monthly meetings of each Quality & Safety Steering Group - Receive results and recommendations of all related clinical audits - Responsible for monitoring action plans to implement changes to current practice until completion - Monitor the frequency and any trends regarding the use of rapid tranquillisation and liaising with Group Quality & Safety Steering Groups Pharmacy Staff Group Directors and Group Managers Service Managers and Ward Managers Nurses in Charge Nursing Staff Monitor Operational Lead Operational Operational Adherence - Responsible for monitoring the safe and appropriate prescribing of medication - Responsible for ensuring that all managers are aware of the policy and promote good practice - Provide support and guidance regarding resources to enable this policy to be implemented - Ensure nursing staff implement safe systems of work in accordance with the procedures referred to in the policy - Ensure they are familiar with this policy and be responsible for adhering to the procedures referred to - Ensure staff attend training applicable to their role and for implementing the guidance across their areas of responsibility - Ensure aggressive/violent patients have primary and secondary behavioural management plans in place - Ensure risk assessments of environmental health and safety factors that can reduce the likelihood of violence/aggression are carried out and plans are put in place to minimise them - Ensure all incidents of rapid tranquillisation are reported - Responsible for safe administration of prescribed rapid tranquillisation medication and subsequent observations - Report incidents associated with the use of rapid tranquillisation - Ensure they use de-escalation skills and promote the well-being and dignity of the patient at all times - Ensure they are familiar with the policy and be responsible for adhering to the procedures referred to within the policy - Ensure Advance Statements are considered and documented in CPA and Early Warning Signs care plans - Provide support and information to patients and carers regarding the application of guidelines implemented to address aggressive/violent incidents - Undertake risk assessments with patients where there is deemed a potential for aggressive/violent behaviour - Develop primary and secondary behavioural management plans - Attend training applicable to their role - Ensure they are aware of signs and symptoms of adverse reaction to medication to ensure patient safety is maintained - Any delegated observation task remains the responsibility of the delegating nurse Version 1.1 August 2015 24

Title Role Responsibilities Medical Staff Adherence - Adhere to the prescribing requirements identified in the guidelines and the actions to take in the event of an adverse drug reaction - Always refer to the most up to date British National Formulary (BNF) to check recommended drugs and dosage - Consider any advanced directives - Be available at the time of administration but no longer than 30 minutes after being requested - Be available to administer Flumazenil if needed - Be part of a multi-disciplinary team (MDT), ensuring risk assessments are conducted with the patient where there is a potential for aggressive/violent behaviour - Support the implementation and monitoring of this policy - Be aware of any previous adverse reactions to medication - Advise on the levels of scheduled observation and engagement levels required following rapid tranquillisation Practice Development Team - Responsible for collating monthly incidents of the use of rapid tranquillisation and feeding back to service leads 8.0 Training What aspect(s) of this policy will require staff training? Rapid Tranquilisation Observation of patients Which staff groups require this training? All inpatient qualified nurses and Healthcare Support Workers in MH and LD Inpatient Nurses and Healthcare Support Workers Is this training covered in the Trust s Mandatory and Risk Management Training Needs Analysis document? Yes Yes If no, how will the training be delivered? Who will deliver the training? Learning and Development Team Learning and Development Team How often will staff require training Annually Who will ensure and monitor that staff have this training? Workforce Development Group 3 yearly Workforce Development Group Medicines Management Inpatient Nurses & Medical staff Yes Learning and Development Team 2 yearly Workforce Development Group Version 1.1 August 2015 25

9.0 Equality Impact Assessment The following statement should always be included Black Country Partnership NHS Foundation Trust is committed to ensuring that the way we provide services and the way we recruit and treat staff reflects individual needs, promotes equality and does not discriminate unfairly against any particular individual or group. The Equality Impact Assessment for this policy has been completed and is readily available on the Intranet. If you require this in a different format e.g. larger print, Braille, different languages or audio tape, please contact the Equality & Diversity Team on Ext. 8067 or email EqualityImpact.assessment@bcpft.nhs.uk 10.0 Data Protection and Freedom of Information This statement reflects legal requirements incorporated within the Data Protection Act and Freedom of Information Act that apply to staff who work within the public sector. All staff have a responsibility to ensure that they do not disclose information about the Trust s activities in respect of service users in its care to unauthorised individuals. This responsibility applies whether you are currently employed or after your employment ends and in certain aspects of your personal life e.g. use of social networking sites etc. The Trust seeks to ensure a high level of transparency in all its business activities but reserves the right not to disclose information where relevant legislation applies. 11.0 Monitoring this policy is working in practice What key elements will be monitored? (measurable policy objectives) Rapid Tranquillisation is used in line with national guidance and to meet our legal obligations Clinical Directors, Group Quality & Safety Steering Groups, nursing and medical staff are discharging their responsibilities for rapid tranquilisation Where described in policy? How will they be monitored? (method + sample size) 4.0 Process New NICE or national guidance/legislation, reports of best practice or recommendations from an external agency in respect of rapid tranquillisation will be identified and implemented in accordance with the Trust s Best Practice NICE and Dealing with External Recommendations policies 7.0 Roles and Responsibiliti es for this Policy Monitoring of all incidents of rapid tranquillisation Who will undertake this monitoring? Quality & Safety Steering Group Quality & Safety Steering Group How Frequently? Monthly Monthly Group/Committee that will receive and review results Group Quality & Safety Steering Groups Group Quality & Safety Steering Groups Group/Committe e to ensure actions are completed Group Quality & Safety Steering Groups Group Quality & Safety Steering Groups Evidence this has happened Reports and minutes of the meetings Minutes of meetings and monitoring templates Version 1.1 August 2015 26

What key elements will be monitored? (measurable policy objectives) Where described in policy? How will they be monitored? (method + sample size) Group Annual Audit Programmes and the implementation of action plans Who will undertake this monitoring? Quality & Safety Steering Group How Frequently? Annually Group/Committee that will receive and review results Group Quality & Safety Steering Groups Group/Committe e to ensure actions are completed Group Quality & Safety Steering Groups Evidence this has happened Minutes of meetings and monitoring templates Prescribing guidelines for rapid tranquilisation How observations are recorded, including timeframes when patients have received rapid tranquilisation Arrangements for monitoring service users who have received rapid tranquillisation How the organisation trains staff, in line with the training needs analysis 4.4 Prescribing Guidelines 4.6 Observations 4.7 Remedial Measures Appendix 1 NEWS Observation Chart 4.6 Observations 4.7 Remedial Measures Appendix 1 NEWS Observation Chart All incidents of rapid tranquillisation must be reported via Datix, the trust s incident reporting procedure A detailed review of practice will be audited A detailed review of practice will be audited 8.0 Training Report on percentage of staff trained in all mandatory topics Group Pharmacist monitors the medication used for Rapid Tranquillisation on a case by case basis within each Group Quality & Safety Steering Group Quality & Safety Steering Group Workforce Development Group Monthly Monthly Monthly Quarterly Medicines Management Committee Group Quality & Safety Steering Group and Medicines Management Committee Group Quality & Safety Steering Group and Medicines Management Committee Group Management Boards for Group compliance and Workforce Development Group for Trust compliance Medicines Management Committee Quality & Safety Steering Group Quality & Safety Steering Group Group Management Boards for Group compliance and Workforce Development Group for Trust compliance Reports and minutes of the meetings Sign off of action plans/minutes of meetings Sign off of action plans/ minutes of meetings Reports and minutes of the meetings Version 1.1 August 2015 27

What key elements will be monitored? (measurable policy objectives) Where described in policy? How will they be monitored? (method + sample size) 8.0 Training Reports on identified ward/ departmental compliance, where performance falls below 95% compliance Who will undertake this monitoring? Workforce Development Group How Frequently? Quarterly Group/Committee that will receive and review results Group Management Boards for Group compliance and Workforce Development Group for Trust compliance Group/Committe e to ensure actions are completed Group Management Boards Evidence this has happened Reports and minutes of the meetings Version 1.1 August 2015 28

Appendix 1 Version 1.1 August 2015 29

Version 1.1 August 2015 30