Formulary and Clinical Guideline Document Pharmacy Department Medicines Management Services

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1 Formulary and Clinical Guideline Document Pharmacy Department Medicines Management Services VIOLENCE, AGGRESSION OR SEVERE BEHAVIOURAL DISTURBANCE Introduction During an acute episode or illness, some service users can become behaviourally disturbed and may need help to calm down or reduce the risk of harm to self and others. The engagement of skilled health care staff who can listen and respond to the needs and anxieties of service users will help to alleviate personal distress. The Trust is committed to managing episodes of violence, aggression and severe behavioural disturbance in line within a No Force First framework, which utilises a graded approach to deescalate the situation, with the ultimate aim of eliminating the use of coercive interventions. Occasionally however when a service user is very agitated or displaying aggressive behaviour specific quick-acting drugs may prove useful to help quickly calm them. The use of medication in this process is called Rapid Tranquillisation (RT). Rapid Tranquillisation is a restrictive intervention and it should only be considered as an option if (i) de-escalation and other preventive strategies, including p.r.n. medication, have failed. (ii) and there is potential for harm to the service user or other people if no action is taken. (iii) There should also be continued attempts to de-escalation throughout a restrictive intervention. Differentiating between behaviour that would be in need of RT and that which is less challenging can be difficult. The medications used for the treatment of agitation may also be used for service users that are not exhibiting signs of violence and aggression. Prescribing and monitoring of medication for RT should follow Trust Policy SD11. As required (p.r.n.) medication for behavioural disturbance should not routinely be prescribed on admission but should be tailored to individual need and discussed with the service user. Clinicians may consider prescribing p.r.n. medication as part of a strategy to de-escalate or prevent situations that may lead to violence and aggression or as part of an advanced statement for defined situations. There should be clarity about the rationale and circumstances in which p.r.n. medication may be used. This should be documented this in the care plan and clinical notes. The maximum daily dose must be specified and it must not inadvertently exceed the maximum daily dose stated in the British National Formulary (BNF). Wherever possible p.r.n. medication should be reviewed 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. (NG10). Throughout the RT process, the service user should be fully informed of what is happening because their safety is the priority. The service user should be given an explanation of the medication used, its effects and why it is necessary. Following use of RT and within 72 hours, the service user should be offered a clear explanation of the decision to use RT and given an opportunity to discuss and document the experience. The use of Rapid Tranquillisation will be monitored routinely. All cases where Rapid Tranquillisation is administered must be reported on a trust incident form. 1 P a g e

2 Prescribing Advice Before implementing RT, the prescriber should ensure that: o Appropriate resuscitation provision is available. o The service user s notes have been checked for consent to treatment, advanced directives or any complicating factors, e.g. physical disorders, concomitant medication, substance misuse o The service user is not under the influence of drugs or alcohol. If significant problems are identified (e.g. serious cardiovascular or other physical health issues, pregnancy or clinically significant drug interactions), the duty doctor should contact the Consultant or Consultant on-call for advice. The appropriate dose of lorazepam, haloperidol, olanzapine, promethazine should be used. Consider procyclidine to prevent acute extrapyramidal side effects if haloperidol is used. The service user should always be offered these medications orally first. If parenteral administration is required, the intramuscular (IM) route of administration is preferred. Wherever possible, a single drug prescribed as a single dose, repeated if necessary, should be used before combination treatment taking into consideration: patient s preference or advance statements and decisions, pre-existing physical health problems, previous response to medication, potential for interactions and the total daily dose of medications prescribed and administered. If there is insufficient information to guide choice of IM medication for RT, or the patient has not taken antipsychotic medication before, intramuscular lorazepam may be preferred. If there is evidence of cardiovascular disease, including a prolonged QT interval, or no ECG has been carried out, avoid intramuscular haloperidol alone or in combination with intramuscular promethazine and use intramuscular lorazepam. Intramuscular haloperidol and promethazine in combination may be used for urgent rapid tranquillisation in adults if there are no contraindications. Allow sufficient time for clinical response between doses of medication for rapid tranquillisation. If the service user has not responded as well as expected (after a minimum of 30 minutes), a second dose may be prescribed within BNF limits by the duty doctor. If for any reason it is necessary to provide a dose exceeding the BNF limits the consultant (consultant on-call out of hours) should make this decision and must take sole responsibility. NB: Zuclopenthixol Acetate (Clopixol Acuphase) should not be used for rapid tranquillisation due to its long onset and duration of action. It should only be considered if a patient responds to other short acting parenteral antipsychotics and it is anticipated that they will require further frequent doses. It should not be given to antipsychotic naïve or actively struggling patients. It is best reserved for people who have had a previous good and timely response to zuclopenthixol acetate injection. A full incident review should follow any administration of Clopixol Acuphase. Violence, Aggression, Severe Behavioural Disturbance Next Review: Jan

3 Safety The RT process, including use of medication, carries risks which must be understood by the practitioners involved. Before prescribing medication for Rapid Tranquillisation the clinician should ensure that the prescription is proportionate to the risk and potential seriousness of harm and is the least restrictive option to meet the need. All staff who use rapid tranquillisation should be able to assess, monitor and manage the risks of the drugs used. Extra care should be taken when rapid tranquilisation is being considered in the following circumstances. o Where there is a known presence of congenital cardiac conductive abnormalities. o Where there is a known presence of certain disorders that may affect metabolism (e.g. hypothermia, hyperthermia, extreme physical exertion) o Where there is co-prescription of medications that can directly or indirectly lengthen QT intervals on ECG s. o Intoxication o Other antipsychotics o elderly or frail o restraint is being used Selecting the appropriate dose of the drug to be used is extremely important. Use the lowest effective dose. Avoid high doses and drug combinations; if used, document the risk assessment and rationale in the clinical notes. After administration of medication for RT, the doctor and nurse in charge should agree a care plan and necessary observations, in line Trust Policy SD11. Often it is difficult to do physical observations on agitated service users. The practitioner concerned will need to record and be clear why monitoring was not done and what steps were taken to ensure the service user has not deteriorated physically. After rapid tranquillisation, monitor side effects and vital signs until there are no further concerns about the service user s physical health status. Monitor more frequently if the BNF maximum dose has been exceeded or the service user appears to be over-sedated or intoxicated or has a pre-existing physical health problem or has experienced harm as a result of any restrictive intervention. Many of the medications given may take up to 2 hours to reach peak serum levels and this point should be considered in the care plan. In exceptional circumstances when the intravenous (IV) route is considered, the duty doctor must agree the use of IV medication with the consultant (consultant on-call out-of-hours). Lorazepam or haloperidol should be used as an intravenous preparation (do not mix in the same syringe). If IV haloperidol is used the duty doctor should also consider an anticholinergic drug to reduce the risk of dystonia and other extrapyramidal side effects. If complications arise, the duty doctor should seek advice from the consultant (consultant on call out of hour) and/or call 999. Violence, Aggression, Severe Behavioural Disturbance Next Review: Jan

4 Relevant NICE guidance NICE guideline NG10 - Violence and aggression: short-term management in mental health, and community settings ( ) NICE Pathway: Violence. Mersey Care NHS Trust Rapid Tranquillisation Policy Mersey Care NHS Foundation Trust Policy and Procedure for the use of Rapid Tranquillisation 18.pdf Violence, Aggression, Severe Behavioural Disturbance Next Review: Jan

5 Management of Violence, Aggression Or Severe Behavioural Disturbance First Line: Relative Cost Notes Oral agents Lorazepam (liquid) Haloperidol Olanzapine (Brand) ( ) ( ) Second Line: Relative Cost Notes IM injections Lorazepam Haloperidol Third Line: Relative Cost Notes IM Combinations Haloperidol + Promethazine Haloperidol + lorazepam - - Other: Relative Cost Notes IM olanzapine - (unlicensed use) Check care plan or advance statements or offer oral treatments. Prescribe minimum effective dose on the stat section of the medicines chart. Doses may be repeated within BNF recommended limits allow sufficient time between doses to assess response. Seek consultant advice and document the rationale for any exceptional use of high dose treatment. Antimuscarinics e.g. PRN procyclidine should be prescribed if haloperidol is to be used in case the service user develops dystonia and other extrapyramidal side effects. Use minimum effective dose as per BNF recommendations. Doses may be repeated within BNF recommended limits if there is a partial response allow sufficient time between doses. Prefer lorazepam if there is insufficient information to guide the choice of medication for RT, or if the service user has not taken antipsychotic medication before. Avoid IM haloperidol in cardiovascular disease, including QT interval prolongation, or when no ECG is available. Transfer to oral treatment at the earliest opportunity. Antimuscarinic agents (e.g. procyclidine) should be prescribed if haloperidol is used. Wherever possible, a single agent should be used at the minimum effective BNF dose rather than a combination. However, when rapid tranquillisation is urgently needed, combination treatment may be required. Consultant advice may be necessary for combination IM treatment. NICE guideline NG10 recommends that if there is no response to intramuscular lorazepam, consider intramuscular haloperidol combined with intramuscular promethazine. Do not mix in the same syringe. Avoid IM haloperidol in combination with promethazine in cardiovascular disease, including QT interval prolongation, or when no ECG is available. Procyclidine (antimuscarinic) should be prescribed to prevent dystonia and other extrapyramidal side effects. Use to be reserved to consultant advice only. NB: There must be a gap of at least one hour between administration of IM olanzapine and IM lorazepam; oral lorazepam should also be used with caution. Closely monitor for excessive sedation and cardiorespiratory depression. - Consultants only. Lorazepam or Haloperidol may be used only in exceptional circumstances and as a last resort. Monitor vital signs closely, e.g. respiratory depression, dystonia or cardiovascular compromise Intravenous (IV) injections Not Recommended Relative Cost Notes Zuclopenthixol acetate (Clopixol Acuphase) Zuclopenthixol acetate must not be used for rapid tranquillisation. It should only be considered by consultants only if a service user responds to other short acting parenteral antipsychotics and it is anticipated that they will require further frequent doses of IM antipsychotics. The BNF or SPC should be consulted for dosing. Violence, Aggression, Severe Behavioural Disturbance Next Review: Jan

6 Drugs for Managing Violent, Aggressive or Acutely Disturbed Behaviour Drug Minimum effective dose Maximum dose per 24 hours Notes Lorazepam, oral 1 2 mg (elderly or frail - half of adult dose) 4 mg (any route) (elderly or frail half of adult dose) Peak serum levels reached 2 hours after dose. The elimination half-life is about 12 hours (range about 10 to 20 hours) Risk of sedation / respiratory depression/loss of consciousness Lorazepam, intramuscular 1-2mg (elderly or frail - half of adult dose) Lorazepam injection 4mg/ml must be diluted 1:1 with water for injection or normal saline. SEE TABLE OF DOSE CALCULATIONS 4mg (any route) (elderly or debilitated half adult dose) Absorption from the injection site is considerably slower if the intramuscular route is used and as rapid an effect may be obtained by oral administration of lorazepam tablets. Peak plasma concentrations occur approx minutes following IM administration. Risk of sedation/respiratory arrest/ loss of consciousness increased with CNS depressants e.g. alcohol/opiates/other sedative drugs; Risk of hypotension and cardiovascular collapse with clozapine The injection comes as 1ml of solution in a 2ml ampoule to aid dilution. Lorazepam 500micrograms 1mg 1.5mg 2mg 2.5mg 3mg 3.5mg 4mg Equivalent dose 4mg/ml (undiluted) 0.125ml 0.25ml 0.375ml 0.5ml 0.625ml 0.75ml 0.875ml 1ml Equivalent Volume Once diluted 1:1 0.25ml 0.5ml 0.75ml 1ml 1.25ml 1.5ml 1.75ml 2ml Haloperidol, oral Haloperidol, IM 5-10mg (elderly or debilitated - initially half adult dose) 2-5mg (elderly or debilitated - initially half adult dose) 20 mg (any route) Time to peak plasma concentrations 2-6 hours The mean elimination half-life is about 20 hours but varies from 10 to nearly 40 hours High incidence of extrapyramidal effects; risk of dystonic reactions increased in neuroleptic naïve and young people Caution in cardiac disease 12 mg* (* equivalent to 20mg oral; bioavailability from the oral route is about 60% of that from IM injection) Peak plasma concentrations similar to after oral but are reached within 20 minutes (range 15-60mins) Caution in cardiac disease. High incidence of extrapyramidal side effects (EPS); risk of dystonic reactions increased in neuroleptic naïve and young people. An antimuscarinic agent such as procyclidine IM should be immediately available in case of acute dystonia/epses. Violence, Aggression, Severe Behavioural Disturbance Next Review: Jan

7 Drugs for Managing Violent, Aggressive or Acutely Disturbed Behaviour Drug Olanzapine oral Minimum effective dose 5-10mg Maximum dose per 24 hours 20mg Notes Peak plasma concentrations occur within 5 to 8 hours. Orodispersible tablets preferable Approximate plasma half life is between hours; the mean half-life in healthy subjects varied on the basis of age and gender. The mean half life is prolonged in older people (65 and over), females and non-smokers Oral olanzapine and benzodiazepines should be used with caution due to risk of respiratory depression, hypotension or bradycardia. Olanzapine is not recommended for use in patients with dementia-related psychosis and/or behavioural disturbances because of an increase in mortality and the risk of cerebrovascular accident. Olanzapine IM (unlicensed use) 5-10mg by single injection (elderly 2.5mg or 5mg; renal or hepatic impairment 5mg) 20mg Peak plasma concentrations occur within minutes. Maximum 3 injections in 24 hours (minimum of 2 hours between 1 st and 2 nd injection); Maximum daily dose of 20mg (including oral) NB: The simultaneous injection of olanzapine IM with parenteral benzodiazepines is not recommended due to the potential for excessive sedation, cardiorespiratory depression and in very rare cases, death. If parenteral benzodiazepines are essential, administration should be a minimum of 1 hour after olanzapine IM administration. If parenteral benzodiazepine already given, IM olanzapine administration should only be considered after careful evaluation of clinical status. Use oral lorazepam with caution. Closely monitor for excessive sedation and cardiorespiratory depression. Violence, Aggression, Severe Behavioural Disturbance Next Review: Jan

8 Drugs for Managing Violent, Aggressive or Acutely Disturbed Behaviour Drug Minimum effective dose Maximum dose per 24 hours Notes Procyclidine oral 2.5mg-5mg Elderly preferably lower end of dose range Usual max. 30mg daily in 3 divided doses (60mg daily in exceptional circumstances) Elimination half-life after is approximately 12 hours. Antimuscarinic side effects (e.g. dry mouth, constipation, blurred vision, urinary retention) confusion can occur Procyclidine IM 5 to 10mg, repeated after 20 minutes if necessary. Elderly - a reduced dose may be required Daily maximum of 20mg Elderly - a reduced dosage may be required Useful for emergency treatment of acute dystonias and other extrapyramidal side effects Elimination half-life after is approximately 12 hours. Parenteral doses are usually effective within 5 to 10 minutes but may need 30 minutes to produce relief. Flumazenil IV 200 micrograms over 15 seconds then 100micrograms at 60 second intervals (usual dose micrograms) 1mg (1000 micrograms) For reversal of benzodiazepine-induce sedation or respiratory depression Across Mersey Care, only doctors may administer intravenous injections. Use small doses and administer slowly, by the IV route Flumazenil is short-acting so the sedative effects of benzodiazepines will re-emerge in a relatively short period of time following the administration of intravenous flumazenil; repeat doses may be necessary. May precipitate benzodiazepine withdrawal in dependent service users. Flumazenil can provoke serious adverse reactions when tricyclic antidepressants or other proconvulsants have been taken and in epilepsy. Flumazenil should not be used if the benzodiazepine has been taken with other substances. Violence, Aggression, Severe Behavioural Disturbance Next Review: Jan

9 Appendix 1: Haloperidol administration Oral & Intramuscular equivalent doses The maximum recommended daily dose for each route of administration is different because parenteral doses generally have a greater bioavailability than oral doses. The maximum dose of oral haloperidol in 24 hours is 20mg and of IM haloperidol is 12mg. Please use the conversion chart below, if a patient has received both haloperidol IM and oral in the last 24 hours, to calculate how much the patient has received in total already and how much they can still receive. APPROXIMATE EQUIVALENT DOSES (mg) Oral Haloperidol IM Haloperidol For example: Patient has been given 1 x 5mg haloperidol IM, followed 30 minutes later by 5mg orally, then 30 minutes later by another 5mg orally. Convert to all oral doses, i.e. 8.3mg + 5mg + 5mg = 18.3mg oral equivalent or Convert to all IM doses, i.e. 5mg + 3mg + 3mg = 11mg IM equivalent Use SEPARATE LINES on the prescription sheet for each route of administration. Violence, Aggression, Severe Behavioural Disturbance Next Review: Jan

10 References 1. Mersey Care NHS Trust Policy and Procedure for the use of Rapid Tranquillisation, SD NICE Clinical NG10. Violence and aggression: short-term management in mental health, health and community settings 3. NICE CG 178. Psychosis and schizophrenia in adults: treatment and management (2014) NICE CG 155. Psychosis and Schizophrenia in Children and Young People (2013) NICE CG 120. Psychosis with coexisting substance misuse (2011) NICE guidelines [CG185]. Bipolar disorder: the assessment and management of bipolar disorder in adults, children and young people in primary and secondary care. Published date: September Available at 7. NICE CG42. Dementia: supporting people with dementia and their carers in health and social care. Available from: 8. NICE ESUOM 28: Rapid tranquillisation in mental health settings: promethazine hydrochloride. March Taylor, Paton and Kapur. The Maudsley Prescribing Guidelines in Psychiatry, 12th Edition. 10. Bazire. Psychotropic Drug Directory Summaries of Product Characteristics Various - Available at: ebnf. Available online at: Violence, Aggression, Severe Behavioural Disturbance Next Review: Jan

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