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Version 2 June 2018 Rapid Tranquillisation Target Audience Who Should Read This Policy All Inpatient Staff
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Page 1: Rapid Tranquillisation - bcpft.nhs.uk

Version 2 June 2018

Rapid Tranquillisation

Target Audience

Who Should Read This Policy

All Inpatient Staff

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Rapid Tranquillisation Policy

Version 2.0 January 2019 2

Ref. Contents Page

Explanation of terms used in this policy 4

1.0 Introduction 5

1.1 Rapid Tranquillisation Definition 5

2.0 Purpose 5

3.0 Objectives 6

4.0 Principle and Practise of Rapid Tranquillisation 6

4.1 De-escalation Techniques 6

4.2 Choice of Intervention 6

4.3 Use of oral p.r.n medication 7

4.4 Rapid Tranquillisation and Physical Intervention 7

4.5 Rapid Tranquillisation and Seclusion 8

4.6 Care Planning/Reviews 8

4.7 Risk Assessment 9

4.8 Advance Statements 9

4.9 Legal Issues and the Mental Health Act (MHA) 9

4.10 Physical monitoring/review of history Before Rapid Tranquillisation 9

5.0 Rapid Tranquillisation 10

5.1 Medical Staff Availability 10

5.2 Medical Equipment 10

5.3 Rapid Tranquillisation treatment aims 10

5.4 Rapid Tranquillisation Prescribing 11

5.5 Choice of Medication in Rapid Tranquillisation 12

5.6 Algorithm 1: BCPFT Algorithm for Rapid Tranquillisation / oral p.r.n prescribing for Working Age Adults/Older Adults

13

5.7 Table 1: Rapid Tranquillisation / oral p.r.n notes for Working Age Adults

14

5.8 Table 2: Rapid Tranquillisation / oral p.r.n notes for Older Adults 16

5.9 General Prescribing Notes 18

5.10 Table 3: Drug information for oral p.r.n and IM Rapid Tranquillisation medication to be used with guideline

19

5.11 Prescribing in complex cases 20

5.12 Guidelines for the use of Zuclopenthixol Acetate injection (Clopixol Acuphase®)

21

5.13 Zuclopenthixol Acetate (Clopixol Acuphase®) Post-Administration Physical Observations Record Chart

23

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6.0 Risks and Complications associated with Rapid Tranquillisation 24

6.1 Circumstances for special care 24

6.2 Observations 24

6.3 Remedial Measures 25

6.4 Table 3: Managing the Complications and Side Effects of Medication 26

7.0 Algorithm 2: Rapid Tranquillisation of the Acutely Disturbed / Violent Patient - Adolescents Aged > 12 Years

27

7.1 Notes for prescribing Rapid Tranquillisation / oral p.r.n for adolescents

28

8.0 Documentation 28

9.0 Post Incident Support and Debrief 29

10.0 Procedures connected to this policy 29

11.0 Links to Relevant Legislation 29

11.1 Links to Relevant National Standards 30

11.2 Links to other Key Policies 30

12.0 Best Practice - Dissemination, Implementation and Monitoring of NICE Quality Standards and Guidance

31

13.0 References 31

14.0 Roles and Responsibilities for this policy 32

15.0 Training 33

16.0 Equality Impact Assessment 34

17.0 Data Protection Act and Freedom of Information Act 34

18.0 Monitoring policy’s effectiveness 35

Appendix

NEWS Observation Chart 37

Medical Emergency Flowchart 41

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Explanation of terms used in this policy Rapid Tranquillisation (RT) - NICE defines Rapid Tranquilisation (RT) as ‘use of medication by

the parenteral route (usually intramuscular) if oral medication is not possible or appropriate

and urgent sedation with medication is needed’. The aim of treatment is to use medication to calm or lightly sedate the patient and reduce the risk to themselves and/or others. The desired outcome is to

achieve an optimal reduction in agitation and aggression, thereby allowing a thorough psychiatric evaluation to take place.

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

QTc prolongation - QTc is a measurement obtained from an ECG. If this is above normal limits (440ms for men and 470ms for women) it may predict a risk factor for the ventricular arrhythmia Torsade de

Pointes, which is occasionally fatal (sudden cardiac death). Psychotropic agents such as haloperidol have been associated with QTc prolongation. Above 500ms there is strong evidence for increased risk of

arrhythmias. QTc prolongation may occur more frequently with higher doses, combinations of psychotropic medication, intravenous administration and in predisposed patients. Check Maudsley

guidelines for risk of QTc prolongation.

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

p.r.n (pro re nata) - when required. In this guideline, p.r.n. refers to the use of oral medication as part of a strategy to de-escalate or prevent situations that may lead to violence or aggression; it does not refer

to p.r.n. medication used on its own for Rapid Tranquillisation during an episode of violence or aggression

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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 or S136 suite 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 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. The aim of treatment is to use medication to calm or lightly sedate the patient and reduce the risk to themselves and/or others. The desired outcome is to achieve an optimal reduction in agitation and aggression, thereby allowing a thorough psychiatric evaluation to take place. This policy should be read in conjunction with the Prevention and Management of Violence and Aggression including NHS Sanctions Policy. 1.1 Rapid Tranquillisation Definition CQC guidance BG0401 and NICE guidance NG10 defines Rapid Tranquillisation (RT) as ‘use of medication by the parenteral route (usually intramuscular) if oral medication is not possible or appropriate and urgent sedation with medication is needed’. RT includes all medication administered whilst the patient is restrained to control behaviour. Administration of oral medication is not considered to be RT, however due to the potential agitated state, it is good practice to closely monitor the patient following administration of combinations of oral medication and repeated doses of oral medication given within the same episode to control behaviour. 2.0 Purpose

The purpose of this policy is to provide staff with clear direction in regard to the use of Rapid Tranquillisation (RT) when faced with incidents of acutely disturbed behaviour and extreme aggression.

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3.0 Objectives

To define and explain the use of Rapid Tranquillisation in inpatient settings or the S136 Suite.

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 (RT) is reflected upon and care plans reviewed appropriately.

4.0 Principles and Practice of Rapid Tranquillisation (RT)

In certain situations within psychiatric in-patient environments or the S136 suite, 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 de-escalation techniques, oral p.r.n medication, consideration of placement, physical interventions and seclusion. 4.1 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. Use a designated area or room to reduce emotional arousal or agitation and support the service user to become calm practised. Do not routinely use the seclusion room (if available) for this purpose because the service user may perceive this as threatening (NICE NG10 8.3.2.9).

Explain intentions and be calm and self-assured.

Use non-threatening non-verbal communication.

Converse and try to develop therapeutic relationship throughout.

Use of sensory resources i.e. weighted blanket, games consoles. 4.2 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 oral p.r.n medication, physical intervention, Rapid Tranquillisation (RT) 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.

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4.3 Use of oral p.r.n medication When prescribing oral p.r.n. medication as part of a strategy to de-escalate or prevent situations that may lead to violence and aggression, consider the following;

p.r.n should be offered first line.

do not prescribe p.r.n. medication routinely or automatically on admission

tailor p.r.n. medication to individual need and include discussion with the service user if possible

ensure there is clarity about the rationale and circumstances in which p.r.n. medication may be used and that these are included in the care plan

ensure that the maximum daily dose is specified and does not inadvertently exceed the maximum daily dose stated in the British national formulary (BNF) when combined with the person’s standard dose or their dose for RT

only exceed the BNF maximum daily dose (including p.r.n dose, the standard dose and dose for rapid tranquillisation) if this is planned to achieve an agreed therapeutic goal, documented, and carried out under the direction of a senior doctor

ensure that the interval between p.r.n doses is specified.

The multidisciplinary team should review oral p.r.n medication at least once a week and, if p.r.n medication is to be continued, the rationale for its continuation should be included in the review. If p.r.n medication has not been used since the last review, consider stopping it.

If more than one medication is prescribed, the care plan should include the preferred order of administration of medicines and time interval between the medicines.

If two medications are intended to be given at the same time this should be clearly stated.

It should be noted that a single p.r.n antipsychotic dose does not have an antipsychotic action, as onset of its antipsychotic effect will require regular dosing over days and weeks.

When deciding which medication to use take into account any contra-indications, special warnings or precautions required. Also consider;

the service user's preferences or advance statements and decisions pre-existing physical health problems or pregnancy possible intoxication (alcohol or psychoactive drugs) previous response to these medications, including adverse effects potential for interactions with other medications total daily dose of medications prescribed and administered.

For full details of contra-indications, special warnings and precautions for all medicines can be found on http://www.medicines.org.uk/emc

4.4 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

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administer RT. 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. Consider RT or seclusion as alternatives to prolonged manual restraint (longer than 10 minutes) [NICE NG10 8.4.5.8]. 4.5 Rapid Tranquillisation and Seclusion The combined use of seclusion and RT 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 RT should be taken seriously;

Continuous observation through the observation window by a delegated nurse

Terminating seclusion once RT 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 4.6 Care Planning/Reviews Ensure that patients who might be subject to RT have an individual care plan. The multidisciplinary team should develop and document an individualised pharmacological strategy for using routine and p.r.n. medication to calm, relax, tranquillise or sedate service users who are at risk of violence and aggression as soon as possible after admission to the ward or S136 suite. Where possible care plans for the management of individual service users should be made in advance of the episode of acutely disturbed behaviour. These care plans should indicate:

At what stage medicines should be used

If more than one medicine is prescribed in what order they should be administered

At what stage medical involvement is required.

clarification of target symptoms

the likely timescale for response to medication The plans should be developed on the basis of past experience of the response of the service user to the medicines used and should include any advance statements agreed with the service user. The multidisciplinary team should review the pharmacological strategy and the use of medication at least once a week and more frequently if events are escalating and restrictive interventions are being planned or used. The review should be recorded and include:

the total daily dose of medication, prescribed and administered, including p.r.n medication

the number of and reason for any missed doses

therapeutic response

the emergence of unwanted effects. If RT is being used, a senior doctor should review all medication at least once a day.

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4.7 Risk Assessment The decision to use RT 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. The risks associated with RT are to be explored by the team prior to the administration of medication to determine safety and appropriateness. RT is potentially hazardous and the risk of adverse effects is higher if the patient has taken illicit drugs or alcohol. 4.8 Advance 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 advance directive and within a care plan. 4.9 Legal Issues and the Mental Health Act (MHA) If a patient refuses or lacks capacity to give valid consent to treatment, ensure there is appropriate legal authority in place prior for prescribing/administering RT e.g. if detained over 3 months, a section 62 or T3 is in place to cover prescribed medication. The enforced administration of medication by injection to an informal patient may necessitate use of the Mental Health Act. If treatment is to continue against the patient’s wishes then a MHA assessment must be undertaken to ensure continued administration is lawful. 4.10 Physical monitoring/review of history Before Rapid Tranquillisation (RT) In anticipation of the likelihood of prescribing medication for RT, the prescribing doctor should:

Ensure baseline measurements are taken and recorded i.e. blood pressure, temperature, pulse, respiration, weight

Review the patient’s clinical record with regard to his/her general medical history and consider the possibility of a physical examination

Previous response to RT or other methods of managing imminent violence

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 ECG, blood and urine drug screen results, a previous history of severe extrapyramidal side effects

Review current prescribed medication (including regular and p.r.n) and any recently administered depots/LAI’s. Also take note of recent administration of p.r.n medication

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5.0 Rapid Tranquillisation Rapid tranquillisation (RT) 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 and the patient is refusing oral p.r.n medication. RT involves the administration of parenteral medication in order to produce a state of calm/light sedation. The medications used for RT should ideally have a low level of side effects and rapid onset of action. For the purpose of this policy, RT describes the use of parenteral 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 from a variety of causes

5.1 Medical Staff Availability

A doctor should be quickly available at all times to attend to an alert by ward staff or S136 suite staff when RT 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 IV Flumazenil (to reverse sedation, drowsiness). If RT is to be considered out of hours the duty doctor should be contacted and requested to attend. 5.2 Medical Equipment

The blue emergency ILS bag should be available within 3 minutes in inpatient settings where RT might be used. The bag should be maintained and checked routinely. 5.3 Rapid Tranquillisation treatment aims

To reduce suffering for the patient: psychological or physical (through self-harm or accidents).

To reduce risk of harm to others by maintaining a safe environment.

To do no harm (by prescribing safe regimes and monitoring physical health).

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5.4 Rapid Tranquillisation Prescribing

RT as parenteral injection (usually IM) should only be considered when de-escalation techniques and oral p.r.n have been less effective or refused. The use of IM medication for RT must be reported externally and for this reason the use of IM medication must be reported via the Physical Intervention Monitoring Form and a Datix incident report completed. 5.4.1 The reason for prescribing should be documented in the clinical record, including the care plan. 5.4.2 Do not prescribe RT medication routinely or automatically on admission on the when required section of the drug chart. NICE guidance states that RT should initially only be prescribed as a single dose. Additional doses of RT should not be administered for the service user until the full effect of the first dose has been assessed and found to be physically tolerated. In exceptional circumstances, for example when the service user has a known relapse presentation requiring repeated episodes of RT, it may be prescribed with a specified number of doses for administration. Prescriptions for multiple doses of RT should be agreed by the multidisciplinary team or authorised by a Consultant Psychiatrist. 5.4.3 Only when RT continues to be required should it be prescribed on the ‘as required medicines’ section of the chart including indication, maximum dose, interval and maximum daily dose. This should be reviewed at least once weekly. 5.4.4 If more than one medication is prescribed, the care plan should include the preferred order of administration of medicines and time interval between the medicines. 5.4.5 When deciding which medication to use take into account any contra-indications, warning or precautions required.

the service user's preferences or advance statements and decisions

pre-existing physical health problems or pregnancy

possible intoxication (alcohol or psychoactive drugs) or delirium

previous response to these medications, including adverse effects

potential for interactions with other medications

the total daily dose of medications prescribed and administered. Full details of contra-indications, special warnings and precautions for all medicines can be found on http://www.medicines.org.uk/emc

5.4.6 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 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.

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5.5 Choice of Medication in Rapid Tranquillisation NICE NG10 states the following;

Use either IM lorazepam on its own or IM haloperidol combined with intramuscular promethazine (due to its antimuscarinic properties) for RT in adults.

If there is insufficient information to guide the choice of medication for RT, or the service user has not taken antipsychotic medication before, use IM lorazepam.

If there is evidence of cardiovascular disease, including a prolonged QTc, or no ECG has been carried out, avoid intramuscular haloperidol combined with IM promethazine and use IM lorazepam instead.

If there is a partial response to intramuscular lorazepam, consider a further dose.

If there is no response to intramuscular lorazepam, consider IM haloperidol combined with IM promethazine.

If there is a partial response to IM haloperidol combined with IM promethazine, consider a further dose. If there is no response to intramuscular haloperidol combined with intramuscular promethazine, consider intramuscular lorazepam if this hasn't been used already during this episode.

If intramuscular lorazepam has already been used, arrange an urgent team meeting to carry out a review and seek a second opinion if needed.

Alternatives which may be considered are;

Aripiprazole IM (alone or in combination with Lorazepam IM). Although not considered by NICE NG10 due to insufficient evidence, it is may be prescribed on inpatient wards if it is considered to be the safest and most appropriate treatment option for the service user.

Olanzapine IM alone. Not considered by NICE NG10 because the manufacturer of IM olanzapine has withdrawn the product from the UK market. As a result they were unable to make recommendations regarding its use. However, it remains a licensed product in the European Union (EU) and may be prescribed, if following a multidisciplinary review it is considered to be the most appropriate treatment option for a service user. IM olanzapine MUST NOT be co-administered with IM lorazepam, hypnotics (e.g. promethazine) or other antipsychotics. These medicines must not be given within 60 minutes of IM olanzapine (pre or post dose). This is due to the increased risk of respiratory depression, hypotension and bradycardia; on rare occasions fatalities have occurred.

The use of two medicines of the same class for the purpose of RT or p.r.n should not occur.

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5.6 Algorithm 1: BCPFT Algorithm for Rapid Tranquillisation / oral p.r.n prescribing for Working Age Adults/Older Adults

- Have access to procyclidine injection for acute dystonic

reactions and flumazenil for benzodiazepine induced

respiratory depression. - Have access to emergency resuscitation facilities

Consider de-escalation techniques

e.g. talking down, distractions, time out

Consider starting/increasing regular oral medication

Consider pharmacological management

Seek advice re: MHA status.

Is a section 62 required?

Try Oral Therapy ( p.r.n )

Patient refusing oral /

Rapid response required /

No response to oral

Try intramuscular injection ( RT )

WORKING AGE ADULTS Drug (oral)

Lorazepam 1 to 2mg

or Promethazine 25 to 50mg

(Where the use of benzodiazepines is inappropriate)

And/or another from the list below Olanzapine 5 to 10mg

Quetiapine 25 to 50mg

or

*Haloperidol 2 to 5mg and Promethazine 25-50mg

Use formulation most appropriate to patient

*Note ECG requirements

OLDER ADULTS Drug (oral)

Lorazepam 500microgams to 1 mg

And/or another from the list below

Risperidone 0.25mg to 1mg Quetiapine 25mg

Olanzapine 2.5 to 5mg

or

*Haloperidol 1 to 2.5mg and Promethazine 12.5-25mg

Use formulation most appropriate to patient

*Note ECG requirements

WORKING AGE ADULTS

Drug (IM)

Lorazepam 1-2 mg

or Promethazine 25-50mg

(Where the use of benzodiazepines is

inappropriate)

or

*Haloperidol 2 to 5mg and Promethazine 25-50mg

(if known to tolerate typical antipsychotics)

*Note ECG requirements

OLDER ADULTS

Drug (IM)

Lorazepam 500 micrograms to 1mg

or Aripiprazole 5.25-9.75mg

or

*Haloperidol 0.5 to 2.5mg and

Promethazine 12.5-25mg

(if known to tolerate typical antipsychotics)

*Note ECG requirements

Optimise regular psychotropic

medication

Restart or start oral medication

Review appropriateness of

continuing intramuscular

therapy

Monitor Patient

No response within 30 minutes

Review

Consider repeating IM Lorazepam (Adult Max 4 mg in 24 hours) and Haloperidol 5mg injections (caution – maximum adult Haloperidol dose is 20mg IM in 24 hours, avoid repeating Haloperidol in the elderly

above a total of 5mg IM without Consultant advice)

or any of the following

1) Aripiprazole usually 9.75mg IM [either alone or with IM Lorazepam](max dose 30mg in 24hrs by any route, however only IM used in RT,)

or

2) Olanzapine 5 to 10mg IM ALONE [not within 60 mins of IM Lorazepam](max dose 20mg in 24

hours by any route)

Complex case – refer to consultant /

seek advice from pharmacy

Never mix two drugs in the same syringe. Always dilute lorazepam injection before use

No response

Response

Response

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5.7 Table 1: Rapid Tranquillisation / oral p.r.n notes for Working Age 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 ORAL p.r.n medication.

LORAZEPAM oral 1-2mg

(May repeat after 45-60 minutes)

[Max. 4mg/24 hours]

PROMETHAZINE oral 25-50mg

(May repeat after 1-2 hours)

[Max. 100mg/24 hours]

OLANZAPINE oral 10mg

(May repeat after 4 hours.)

[Max. 20mg/24 hours)

HALOPERIDOL oral 5mg

(with Promethazine)

(May repeat after 4 hours.)

[Max. 20mg/24 hours]

QUETIAPINE oral 25-50MG

(may repeat after 4 hrs.)

[Max. 750-800mg/24hrs]

If the patient is prescribed a regular oral or depot antipsychotic or has

cardiovascular disease, consider using Lorazepam alone.

Consider using promethazine if the patient is benzodiazepine tolerant.

If not already taking a regular oral or depot/LAI antipsychotic, has respiratory

disease or a doctor is not present out of hours, consider using an antipsychotic

alone.

Avoid using Haloperidol in antipsychotic naïve patients or those with prolonged

QTc. The SPC for Haloperidol recommends avoiding concomitant antipsychotics

and having a pre-treatment ECG.

Haloperidol should be combined with promethazine to minimise EPSE as per

NICE NG10.

Ensure Procyclidine is available for extra pyramidal side-effects (EPSE).

Allow sufficient time for clinical response between doses.

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3 No response or patient refuses oral consider using INTRAMUSCULAR medication. The options for RT include:

LORAZEPAM IM 1-2 mg

(May repeat after 30-60 minutes.)

[Max. 4mg/24 hours]

PROMETHAZINE IM 25-50mg

(May repeat after 1-2 hours.)

[Max. 100mg/24 hours]

ARIPIPRAZOLE IM 5.25–9.75mg

Usual dose 9.75mg.

(May repeat after 2 hours.)

[Max. 30mg/24 hours]

HALOPERIDOL IM 2-5mg

(May repeat after 4-8 hours)

[Max.20mg/24 hours]

OLANZAPINE IM 5-10mg

(may repeat after 2 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 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.

Allow sufficient time for clinical response between doses. Transfer to oral route at

earliest opportunity.

Avoid using Haloperidol in Antipsychotic naïve patients. Maudsley suggests that

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 oral/IM Procyclidine is available.

Allow sufficient time for clinical response between doses. Transfer to oral route at

earliest opportunity.

IM olanzapine MUST NOT be co-administered with IM lorazepam, Promethazine

or other antipsychotics.

4 If unsuccessful seek advice from consultant psychiatrist on duty. Consider alternatives.

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5.8 Table 2: Rapid Tranquillisation / oral p.r.n notes for Older 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 ORAL p.r.n medication should be first choice where possible

2.1 Patient with known diagnosis of schizophrenia, mania or

other functional disease

Have longer times between doses.

Consider half adult doses. Caution: renal or hepatic

impairment, cardiovascular disease. Monitor B.P.

2.2 Dementia with Lewy Bodies (DLB) present or cannot be

excluded

Avoid Antipsychotic medication as it can cause sudden

deterioration, side effects and even death.

Consider oral Lorazepam 0.5mg-1mg every 4 hours

[Max. 2mg/24 hours].

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.

Consider oral Lorazepam 0.5mg-1mg every 4 hours [Max.

2mg/24 hours].

Consider oral Haloperidol 1-2.5mg [Max.5mg/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 EPSEs).

Promethazine in the elderly - caution should be exercised in

patients with a diagnosis of dementia.

Olanzapine – do not use in dementia.

3

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.

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3.1 Dementia with Lewy Bodies (DLB) present or cannot be

excluded

Consider IM Lorazepam 0.5mg-1mg only [Max. 2mg/24

hours.

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.

Consider IM Lorazepam 0.5mg-1mg only (Max. 2mg/24

hours).

Consider IM Haloperidol 0.5-2.5mg (Max. 5mg in 24 hours).

(Avoid using Haloperidol in Antipsychotic naïve patients.

SPC recommends pre-treatment ECG. Ensure Procyclidine is

available for side-effects).

Consider IM Aripiprazole 5.25-9.75mg [max 30mg in

24hrs]. May be used in combination with IM Lorazepam.

Promethazine in the elderly - caution should be exercised in

patients with a diagnosis of dementia.

Olanzapine – do not use in dementia.

4 If unsuccessful seek advice from consultant psychiatrist on duty. Consider alternatives.

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5.9 General Prescribing Notes

1. Previous medication taken by the patient must be considered. 2. Care must be taken to ensure that High dose prescribing does not inadvertently occur through the

use of p.r.n medication given in combination with regular medication. 3. Two drugs of the same class should not be used for RT. 4. The BNF maximum doses include both oral and IM formulations. 5. Oral and intramuscular medications should be prescribed separately on the treatment chart. 6. Drugs should never be mixed in the same syringe prior to administration. 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.

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 QTc prolongation. Other drugs may also affect the QT interval e.g. Citalopram, Escitalopram, Macrolide and Fluoroquinolone antibiotics, Amiodarone, Hydroxyzine. Contact pharmacy for further information.

9. Elderly: in patients with dementia, antipsychotic drugs are associated with a small increased risk of mortality, stroke and transient ischaemic attack. 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. Ensure Procyclidine is available to manage acute dystonic reactions or other extrapyramidal side-effects of antipsychotic medication especially Haloperidol.

11. Risperidone and Olanzapine are available as oro-dispersible tablets. 12. Benzodiazepines side effects: loss of consciousness, respiratory depression or arrest, risk

cardiovascular collapse when receiving both Clozapine and benzodiazepines. 13. Antipsychotics side effects: loss of consciousness, cardiovascular/respiratory complications and

collapse, seizures, akathisia, dystonia, dyskinesia, neuroleptic malignant syndrome, excessive sedation.

14. Antihistamines side effects: excessive sedation, painful injection, additional anti-muscarinic effects.

15. Simultaneous administration of injectable antipsychotics and parenteral Benzodiazepines may be associated with excessive sedation and cardio-respiratory depression. Patients should be monitored for excessive sedation and orthostatic hypotension.

16. 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.

17. 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 mortality, the medication should only be used strictly in accordance with the current marketing authorisation.

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5.10 Table 3: Drug information for oral p.r.n and IM Rapid Tranquillisation medication to be used with guideline

Drug

Route Onset of Action

Time to Reach Maximum Conc / Half life

BNF Maximum Dose in 24 hours

Other e.g. monitoring, licensing, administration

QT c rating

Aripiprazole IM NR Peak 1-3 hrs. t1/2 75 hrs

30mg May be repeated after 2 hrs. Half-life extends to 146 hrs in poor metabolisers of CYP2D6

Low

Haloperidol Oral 1-2 hrs. Peak 4 hrs. t1/2 20 hrs

20mg ECG requirement – QTc prolongation Note the change in maximum dose of IM haloperidol, as result of harmonisation by the

High

Haloperidol IM 20 mins Peak 60-90 mins. t1/2 20 hrs

20mg European Medicines Agency. See BNF. High

Lorazepam Oral 20-30 mins.

Peak 2hrs t1/2 12 hrs

4mg Oral has similar onset of action to IM Risk of paradoxical disinhibition

NR

Lorazepam IM <20-30 mins.

Peak 60-90 mins. t1/2 12 hrs

4mg IV Flumazenil must be available NR

Clonazepam PO 20-60 mins

Peak 1-4 hrs t1/2 20-60 hrs

8mg Caution: high relative maximum BNF dose. Risk of accumulation, due to long half-life.

NR

Olanzapine Oral 1 hr. Peak 5-8 hrs. t1/2 31-52 hrs

20mg Do not use Olanzapine in Dementia Time to peak is longer.

Low

Olanzapine IM 15-30 mins

Peak 15-45 mins t1/2 31-52 hrs

20mg Do not use within 1 hr of IM Lorazepam IM results in peak 5x higher than oral dose.

Low

Promethazine Oral 20 mins Peak 2-3 hrs. t1/2 7-15 hrs

100mg Suitable for benzodiazepine tolerant pts. NR

Promethazine IM 20 mins Peak 2-3 hrs t1/2 7-15 hrs

100mg Can be combined with Haloperidol due to its anti-cholinergic properties.

NR

Quetiapine IR Oral NR Peak 1.5-1.8 hrs. t1/2 hrs 7-12 hrs

750/800mg Limited clinical experience Moderate

Risperidone Oral NR Peak 1-2 hrs.

16mg Limited clinical experience or trial data Low

Zuclopenthixol ACETATE

IM 2-8 hrs. Peak 12-36 hrs. Duration of action 48-72 hours

150mg See separate guidelines NR

NR=Not Recorded

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5.11 Prescribing in complex cases After discussion with consultant only: 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 short-term 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 5.12 on following page for further guidance] Caution in elderly. It is not recommended for RT due to its significantly delayed onset and relatively long duration of action. 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.

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5.12 Guidelines for the use of Zuclopenthixol Acetate injection (Clopixol Acuphase®) N.B. For use following approval from consultant only

BNF Indication

Short-term management of acute psychosis, mania or exacerbations of chronic psychoses.

Dosage 50-150mg (1-3ml). Elderly: 50-100mg

Frequency

If necessary repeat after 2-3 days. One additional dose may be given 1-2 days after the first injection. Maximum cumulative dose 400mg over 14 days. Maximum duration of treatment of 2 weeks. Not for long-term treatment.

Route Deep intramuscular injection into the upper outer buttock or lateral thigh. Injection volumes greater than 2ml should be distributed between 2 sites.

Onset, duration of action

Sedative effects usually begin to be seen between 2-8 hours after injection and peak between 12-36 hours. The effects can last for up to 72 hours.

Other

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.

Clopixol Acuphase® injection should be considered only;

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.

for patients known to respond to it.

in physically violent patients for who repeated attempts at injection would be dangerous for all parties.

be given only when enough time has elapsed to assess the full response to previously injected drugs. Allow at least 60 minutes after IM injection.

if cited in an advance directive. 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)

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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, illicit drugs, 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 should be exercised in patients who have recently received a dose of depot/LAI antipsychotic which has not yet reached peak levels. ECG monitoring is strongly recommended. Prolonged QTc related to antipsychotic treatment may also be exacerbated by the co- administration of other drugs known to significantly prolong QTc. NICE suggests that Clopixol Acuphase® injection may be considered an option when:

service user will be disturbed/violent over an 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 the doctor. Physical Monitoring Use Chart 1 overleaf to record physical monitoring following administration of zuclopenthixol acetate (Clopixol Acuphase®)

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5.13 Zuclopenthixol Acetate (Clopixol Acuphase®)

Post-Administration Physical Observations Record Chart

Name: Ward:

Date and time administered: Dose:

Time since

administration

Time

24hr

Level of

Alertness

(AVPU)

Respiratory

Rate

BP

Pulse

NEWS

Score

Signs of

EPSEs

(Yes/No)

Hydrated

(Yes/No)

Sign

Baseline

2 hours

4 hours

6 hours

8 hours

12 hours

16 hours

20 hours

24 hours

28 hours

32 hours

36 hours

40 hours

44 hours

48 hours

Codes: - Level of Alertness (AVPU)

A Alert: Eyes open with normal verbal response.

V Voice: Eyes closed but will open eyes on command, and with normal verbal response.

P Pain: Eyes closed, responds to painful stimuli (nail bed depression – finger or toe nail).

U Unresponsive: Does not respond to ANY of the above. Completely unconscious

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6.0 Risks and Complications associated with Rapid Tranquillisation 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. Staffs 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 6.1 Circumstances for special care Extra care should be taken when implementing RT 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

6.2 Observations After RT 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 RT recorded in case notes. However it is recommended that;

Side effects, blood pressure, pulse, temperature, respiratory rate, level of hydration and level of consciousness should be monitored every 15 minutes for 1 hour after IM injections

After the first hour continue to monitor every 30 minutes until the patient becomes ambulatory and there are no further concerns.

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)

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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

6.3 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, respiratory rate, level of consciousness, level of hydration and side effects.

Every 15 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 have respiration and level of consciousness recorded and refused documented for other vitals. Also be vigilant for signs/symptoms of pyrexia, hypotension, over sedation and general physical well-being.

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 table 3 on the following page for more guidance

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6.4 Table 3: Managing the Complications and Side Effects of Medication

Complication Symptom Management

Acute Dystonia / EPSE

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

Procyclidine 5-10mgs IM immediately Repeat if necessary after 20 minutes Max 20 mg in 24 hours (If not severe oral may be given)

Fall in blood pressure

(>30 mmHg orthostatic drop or <50 mmHg diastolic) characterised by light-headedness and dizziness

Give oxygen, lay patient flat, raise legs, and ensure patient is not lying face down monitor blood pressure

Irregular or slow pulse

Slow (<50/minute) or irregular pulse Refer to specialist medical care immediately

Increased temperature

Neuroleptic Malignant Syndrome (NMS) include fever, rigidity, confusion, fluctuating consciousness, fluctuating blood pressure, and tachycardia

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 advice

Reduced respiratory rate

(< 10/minute) or oxygen saturation (< 90%) (Respiratory depression) (Flumazenil – to treat benzodiazepine induced respiratory depression – patients may become agitated, anxious or fearful on awakening. Seizures may occur in regular benzodiazepine users)

Seek urgent medical advice

Give oxygen, raise legs and ensure patient is not lying face down

Nurses in BCPFT are not IV trained, so Flumazenil will need to be administered by a doctor

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 pts 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

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7.0 Algorithm 2: Rapid Tranquillisation of the Acutely Disturbed / Violent Patient - Adolescents Aged > 12y Years

Developed in consultation with BCPFT CAMHS Consultants

Consider de-escalation techniques e.g. talking down, distractions, time out

Consult any Advance Decisions

Check Consent has been given

Try Oral Therapy (oral p.r.n)

Patient refusing oral / Rapid response required /

No response to oral

Try intramuscular injection (RT)

Oral p.r.n

Lorazepam 1 to 2mg

or Promethazine 12.5mg to 25mg

(Where the use of benzodiazepines is inappropriate)

And/or another from the list below Olanzapine 5mg

Risperidone 0.25mg to 1mg

* Haloperidol 1 to 5mg and Promethazine 12.5-25mg

(if known to tolerate typical antipsychotics)

Use formulation most appropriate to patient *Note ECG requirements

Rapid Tranquillisation (IM)

Drug (IM)

Lorazepam 500 micrograms to 1mg or

Promethazine 25-50mg

(Where the use of benzodiazepines is inappropriate)

/or * Haloperidol 1 to 5mg and Promethazine 12.5-25mg

(if known to tolerate typical antipsychotics, however avoid if antipsychotics are co-administered)

*Note ECG requirements

Monitor Patient

No response within 30 minutes

Review

ALLOW AT LEAST 30 MINUTES FOR I/M LORAZEPAM TO WORK.

If ineffective, repeat at same doses and allow a further 30 mins for effect.

Complex case – seek specialist advice from consultant for further options

Never mix two drugs in the same syringe. Always dilute lorazepam injection before use

No response

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7.1 Notes for prescribing Rapid Tranquillisation / oral p.r.n for adolescents

Evidence The best evidence for benefit over risk of harm is for IM lorazepam used alone and the

combination of IM haloperidol plus an IM promethazine. When IM haloperidol is combined with IM promethazine there is some suggestion that

risk of movement-related side effects may be reduced. In contrast, the combination of an IM benzodiazepine plus IM haloperidol does not

appear to be more effective than an IM lorazepam used alone. While IM haloperidol used alone is more effective than placebo, it clearly carries greater

risk of extrapyramidal and other side effects when compared with placebo or an IM lorazepam.

Choice depends on current treatment. If patient is established on antipsychotics, lorazepam may be used alone. If the patient uses ‘street drugs’ or already receives regular benzodiazepines, an

antipsychotic may be used alone.

Ensure procyclidine injection is available. Antipsychotics may cause acute dystonic reaction/EPSE.

Ensure flumazenil IV injection is available to reverse effects of lorazepam injection.

The maximum daily dose of haloperidol is either 10mg orally or 5mg by IM injection.

In adolescents, older than 12 years of age the recommended dose of promethazine 10-25mg (max 50mg/day).

There is a higher incidence of paradoxical disinhibition with benzodiazepines compared to adults.

Caution if using haloperidol if young person is unknown to services, or antipsychotic naive adolescent, as EPSE may be more common than in adults. Baseline ECG is strongly recommended.

In young people who are not Gillick competent, parents/carers should be informed of the situation and consent sought for such treatment. It is good practice to inform both the young person and their parents/carers. The use of many of these medicines in under 18 years is outside of their UK license and is therefore ‘off’ label prescribing. As such the prescriber responsibility and potential liability are increased. The young person and their patient/carer should be informed of the ‘off label’ use of medicines, and this should be documented in the patient’s notes. Refer to the trusts Unlicensed Medicines Policy.

8.0 Documentation Record any incident requiring rapid tranquillisation:

Documenting all care or treatment given clearly in the patients records and DATIX

Rapid tranquillisation physical 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

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9.0 Post Incident Support and Debrief Following the use of RT, a debrief should be completed soon afterwards. 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 RT, the medication and its effects and a discussion of their experiences. The patient’s care plan should acknowledge his/her preferences and wishes should they become behaviourally disturbed again. 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 staff debrief should take place immediately or as soon as possible and at least within 72 hours of an episode of RT. A person not directly involved in the incident (such as staff from a different ward) should ideally lead the debrief, which should include a minimum of a nurse and a doctor. This meeting should be used to ensure that the appropriate documentation has been completed and to identify and address physical harm to patients or staff, ongoing risks and the emotional impact on patients and staff, including witnesses, with issues relating to the use of RT discussed and lessons incorporated into practice. Prescriptions for RT should be reviewed by the multidisciplinary team and, especially if used repeatedly, with appropriate changes made to regularly prescribed medication.

10.0 Procedures connected to this Policy There are no procedures connected to this policy.

11.0 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 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. 11.1 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).

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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.

11.2 Links to other key policies

Management of the Deteriorating Patient Policy The purpose of this policy is to ensure that clinical staffs working within the 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 staffs 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.

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12.0 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.

13.0 References

Care Quality Commission Brief Guide BG040: Rapid Tranquillisation (by the parenteral route) in Mental Health March 2018

Patel M, Sethi F et al. Joint BAP NAPICU evidence-based consensus guidelines for the clinical management of acute disturbance: De-escalation and rapid tranquillisation. 2018. Journal of Psychopharmacology,1-40.

European Medicines Agency. 28th April 2017. Questions and answers on Haldol and associated names (haloperidol, oral solutions and injectable solution). Outcome of a procedure under Article 30 of Directive 2001/83/EC.

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)

Taylor D, Barnes T, Young A. The Maudsley Prescribing Guidelines in Psychiatry. 13th Edition. 2018. Wiley-Blackwell.

British National Formulary. Accessed via https://www.medicinescomplete.com on 1st Sept 2018.

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

BSMHFT Rapid Tranquillisation Policy V10 2017

Sussex Partnership NHS Foundation Trust The Rapid Tranquillization Policy. (including the use of oral PRN medication) 2016

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14.0 Roles and Responsibilities for this Policy

Title Role Responsibilities

Executive Director of

Nursing, AHPs and Governance

Executive Lead

- 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

Trust Board Strategic - Strategic overview and final responsibility for overseeing the use of rapid tranquillisation within inpatient areas across the

Trust

Executive Committee Accountable - 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

Quality & Safety Steering Group

Responsible - 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

Clinical Directors Lead

- 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

Group Quality &safety

steering groups Implementation

- 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

Medicines Management

Committee

Scrutiny and

Performance

- Monitor the frequency and any trends regarding the use of rapid tranquillisation and liaising with Group Quality & Safety

Steering Groups

Pharmacy Staff Monitor - Responsible for monitoring the safe and appropriate prescribing of medication

Group Directors and

Group Managers Operational Lead

- 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

Service Managers and

Ward Managers Operational

- 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

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Title Role Responsibilities

Nurses in Charge Operational - Responsible for safe administration of prescribed rapid tranquillisation medication and subsequent observations

- Report incidents associated with the use of rapid tranquillisation

Nursing Staff Adherence

- 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

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

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15.0 Training

16.0 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 [email protected]

17.0 Data Protection and Freedom of Information Data Protection Act provides controls for the way information is handled and to gives legal rights to individuals in relation to the use of their data. It sets out strict rules for people who use or store data about individuals and gives rights to those people whose data has been collected. The law applies to all personal data held including electronic and manual records. The Information Commissioner’s Office has powers to enforce the Data Protection Act and can do this through the use of compulsory audits, warrants, notices and monetary penalties which can be up to €20million or 4% of the Trusts annual turnover for serious breaches of the Data Protection Act. In addition to this the Information Commissioner can limit or stop data processing activities where there has been a serious breach of the Act and there remains a risk to the data.

What aspect(s) of this policy will

require staff training?

Which staff groups require this

training?

Is this training covered in the Trust’s Mandatory and Risk

Management Training Needs Analysis document?

If no, how will the training be delivered?

Who will deliver the training?

How often will staff require

training

Who will ensure and monitor that staff have

this training?

Rapid

Tranquillisation

All inpatient

qualified nurses and Healthcare

Support Workers in

MH and LD

Yes Learning and

Development Team

Annually Workforce Development

Group

Observation of

patients

Inpatient Nurses

and Healthcare Support

Workers

Yes Learning and

Development Team

3 yearly Workforce Development

Group

Medicines Management

Inpatient Nurses & Medical

staff

Yes Learning and Development Team

2 yearly Workforce Development Group

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The Freedom of Information Act provides public access to information held by public authorities. The main principle behind freedom of information legislation is that people have a right to know about the activities of public authorities; unless there is a good reason for them not to. The Freedom of Information Act applies to corporate data and personal data generally cannot be released under this Act. All staffs have a responsibility to ensure that they do not disclose information about the Trust’s activities; this includes information about service users in its care, staff members and corporate documentation 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. The Information Governance Team provides a central point for release of information under Data Protection and Freedom of Information following formal requests for information; any queries about the disclosure of information can be forwarded to the Information Governance Team. 18.0 Monitoring this policy is working in practice

What key elements will be monitored?

(measurable policy objectives)

Where described in

policy?

How will they be monitored?

(method + sample size)

Who will undertake this

monitoring?

How Frequently?

Group/Committee that will receive and

review results

Group/Committee to ensure actions are completed

Evidence this has happened

Rapid Tranquillisation is used in line with national guidance

and to meet our legal obligations

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

Quality & Safety Steering Group

Monthly Group Quality & Safety Steering

Groups

Group Quality & Safety Steering

Groups

Reports and minutes of the

meetings

Clinical Directors, Group Quality & Safety Steering

Groups, nursing and medical

staff are discharging their responsibilities for rapid

Tranquillisation

7.0 Roles and Responsibiliti

es for this

Policy

Monitoring of all incidents of rapid tranquillisation

Quality & Safety Steering Group

Monthly Group Quality & Safety Steering

Groups

Group Quality & Safety Steering

Groups

Minutes of meetings and

monitoring

templates

Group Annual Audit Programmes and the

implementation of action plans

Quality & Safety Steering Group

Annually

Group Quality & Safety Steering

Groups

Group Quality & Safety Steering

Groups

Minutes of meetings and

monitoring templates

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What key elements will be

monitored? (measurable policy objectives)

Where

described in policy?

How will they be

monitored? (method + sample size)

Who will

undertake this monitoring?

How

Frequently?

Group/Committee

that will receive and review results

Group/Committee to ensure

actions are completed

Evidence this

has happened

Prescribing guidelines for rapid Tranquillisation

4.4 Prescribing

Guidelines

All incidents of rapid tranquillisation must be

reported via Datix, the trust’s incident reporting

procedure

Group Pharmacist monitors the

medication used for Rapid

Tranquillisation on

a case by case basis within each

Group

Monthly Medicines Management

Committee

Medicines Management

Committee

Reports and minutes of the

meetings

How observations are recorded, including

timeframes when patients have received rapid

Tranquillisation

4.6 Observations

4.7 Remedial Measures

Appendix 1

NEWS Observation

Chart

A detailed review of practice will be audited

Quality & Safety Steering Group

Monthly Group Quality & Safety Steering

Group and Medicines Management

Committee

Quality & Safety Steering Group

Sign off of action

plans/minutes of meetings

Arrangements for monitoring

service users who have

received rapid tranquillisation

4.6

Observations

4.7 Remedial Measures

Appendix 1 NEWS

Observation

Chart

A detailed review of

practice will be audited

Quality & Safety

Steering Group

Monthly Group Quality &

Safety Steering

Group and Medicines Management

Committee

Quality & Safety

Steering Group

Sign off of

action plans/

minutes of meetings

How the organisation trains

staff, in line with the training needs analysis

8.0 Training Report on percentage of

staff trained in all mandatory topics

Workforce

Development Group

Quarterly Group Management

Boards for Group compliance and

Workforce

Development Group for Trust compliance

Group

Management Boards for Group

compliance and

Workforce Development

Group for Trust compliance

Reports and

minutes of the meetings

8.0 Training Reports on identified ward/

departmental compliance, where performance falls

below 95% compliance

Workforce

Development Group

Quarterly Group Management

Boards for Group compliance and

Workforce Development Group

for Trust compliance

Group

Management Boards

Reports and

minutes of the meetings

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Appendix 1 Based on the observation chart for the National Early Warning Score (NEWS)

Note: Where observations are Refused, record as ‘R’

RAPID TRANQUILLISATION PHYSICAL OBSERVATION CHART Patient name Ward Date of birth

DATE Time monitoring initiated: Time monitoring stopped: TIME(24 hour)

CO

NTI

NU

E TO

MO

NIT

OR

UN

TIL

AM

BU

LATO

RY

Observations (minutes) 0 15 30 45 60 90 120 150 180 210 240 270 300 NEWS

TEM

P ≥39 c 2

TEM

P

38.1-39. c 1 36.1 - 38 c 35.1 - 36 c 1

≤35 c 3

BLO

OD

PR

ESSU

RE

(SY

STO

LIC

)

≥220 3 3

BLO

OD

PR

ESSU

RE

(SY

STO

LIC

)

211-219 201-210 191-200 181-190 171-180 161-170 151-160 141-150 131-140 121-130 111-120 101-110 1 1 91-100 2 2 81-90 3 3 71-80 3 3 61-70 3 3 51-60 3 3 ≤50 3 3

PU

LSE

≥131 3

PU

LSE

121-130 2 111-120 2 101-110 1 91-100 1 81-90 71-80 61-70 51-60 41-50 1 ≤40 3

RESP RATE

≥ 25

3

RES

P R

ATE

21-24 2 12-20 9-11 1 ≤ 8 3

SpO2

≥96 94-95 1 92-93 2 ≤91 3

Inspired O2 % Oxygen Saturation Oxygen

Saturation Conscious Level = Alert Conscious Level V/P/U=3 V/P/U=3

Hydrated (Y/N) Hydrated TOTAL NEW SCORE TOTAL

NEWS Escalation plan Y / N / n/a Escalation plan Sign/Initials Sign/Initials

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The National Early Warning Score (NEWS) and Triggers

Scores

Clinical Risk

0

Low Aggregate 1 – 4

RED score*

(Individual parameter scoring 3)

Medium

Aggregate 5 – 6

Aggregate 7

or more

High

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Outline Clinical Response to NEWS Triggers

NEWS SCORE

FREQUENCY OF MONITORING

CLINICAL RESPONSE

0 Minimum 12 hourly Continue routine NEWS monitoring with every set of observations

Total:

1-4

Minimum 4-6 hourly

Inform registered nurse who must assess the patient

Registered nurse to decide if increased frequency of monitoring and / or escalation of clinical care is required

Total:

5 or more or

3 in one parameter

Increased frequency to a minimum

of 1 hourly

Registered nurse to urgently inform the medical team caring for the patient; (within 1hour)

Urgent assessment by a clinician with core competencies to assess acutely ill patients

Clinical care in an environment with monitoring facilities; Consider transfer to acute hospital

Total: 7

or more

Continuous monitoring of vital signs

Registered nurse to immediately inform the medical team caring for the patient – this should be at least at Specialist Registrar level;

A HIGH NEWS SCORE OF 7 OR MORE REQUIRES URGENT TRANSFER TO AN ACUTE HOSPITAL (9-999)

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CLINICAL PRACTICE STANDARDS: Rapid Tranquillisation (RT) Checklist

(Based on POMH audit)

Checklist Questions Yes No Sign Date Comments

Has oral medication been offered before administering IM medication for behavioural disturbance?

Has physical monitoring post RT been recorded adequately on the physical observation chart?

Has a debrief been completed promptly post RT? This as a minimum should include a nurse and a doctor and address physical harms to patients or staff, ongoing risks and the emotional impact on patients and staff, including witnesses.

Has the patient’s written care plan addressed the management of future episodes of disturbed behaviour. This should be completed within a week.

Has the patient’s care plan acknowledged his/her preferences and wishes should they become behaviourally disturbed again? This should be completed within a week

If Haloperidol has been used as part of RT, has a recent ECG been completed.

QTc =______ms Date of ECG:________

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Appendix 2

MEDICAL EMERGENCY

NURSE DISCOVERING EMERGENCY TO SHOUT FOR HELP/ACTIVATE

ALARM

BREATHING?

YES NO

GIVE 100% OXYGEN VIA NON RE-

BREATHE O₂ MASK. USING

ABCDE APPROACH RECORD OBSERVATIONS RECORD NEWS SCORE

1 MEMBER OF STAFF TO CALL 9-999 1 MEMBER OF STAFF TO COLLECT

EMERGENCY BAG AND SUCTION UNIT IMMEDIATELY

ILS TRAINED MEMBER OF

STAFF TO LEAD TEAM

ARRIVAL OF AMBULANCE

LEAD NURSE TO HANDOVER TO

AMBULANCE CREW

CALL

MEDICAL STAFF

TREATMENT GIVEN

AMBULANCE REQUIRED CALL 9-999

POST INCIDENT

CLEAN AREA, REPLENISH EMERGENCY BAG

COMPLETE DATIX AND MED EMERGENCY FORM

DEBRIEF STAFF (Resus Officer to attend debrief)

START 30 CHEST COMPRESSIONS FOLLOWED BY 2

RESCUE BREATHS

ASSESS RESPONSE, AIRWAY

AND BREATHING

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Policy Details Corporate Governance only

* For more information on the consultation process, implementation plan, equality impact

assessment, or archiving arrangements, please contact Corporate Governance

Review and Amendment History

Version Date Details of Change

V2.0 Jan 2019 Reviewed in light of CQC guidance BG040; Update to physical monitoring proforma

V1.1

Aug 2015 New policy format and minor amendments- maximum daily doses for Haloperidol (oral and IM) amended and National Early warning scoring system added

V1.0 Nov 2012 Alignment of policies following TCS

Title of Policy Rapid Tranquillisation Policy

Unique Identifier for this policy BCPFT-CB-POL-09

State if policy is New or Revised Revised

Previous Policy Title where applicable N/A

Policy Category Clinical, HR, H&S, Infection Control etc.

Challenging Behaviour Policy

Executive Director whose portfolio this policy comes under

Executive Director of Nursing, AHPs and Governance

Policy Lead/Author Job titles only

Deputy Chief Pharmacist / Chief Pharmacist

Committee/Group responsible for the approval of this policy

Medicines Management Committee

Month/year consultation process completed *

n/a

Month/year policy approved January 2019

Month/year policy ratified and issued March 2019

Next review date January 2022

Implementation Plan completed * Yes

Equality Impact Assessment completed * Yes

Previous version(s) archived * Yes

Disclosure status ‘B’ can be disclosed to patients and the public

Key Words for this policy

‘National Early Warning Score’, ‘NEWS’, ‘Lorazepam’, ‘Haloperidol’, ‘Olanzapine’, ‘Promethazine’, ‘Zuclopenthixol Acetate’, ‘Oral’, ‘IM’, ‘advance statement’, ‘seclusion’, ‘light sedation’