Psychotropic Medications in Dementia and Determining Chemical Restraint
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FACILITY RESOURCE Psychotropic Medications in Dementia and Determining Chemical Restraint DEFINITION AND LEGISLATION Difficulties in determining if a medication is chemical restraint Prescribers are asked to identify chemical restraints based on the reason for prescribing It can be difficult to establish if there is a or continuing and according to the definition of diagnosed mental disorder or physical illness/ chemical restraint in the Quality of Care Principles condition. Chemical restraint may also apply 2014 (current version available at https://www. outside the setting of dementia such as with a legislation.gov.au/Details/F2020C00096): diagnosis of Developmental Disability. Chemical restraint is a practice or intervention There are some ‘grey’ areas where it may be that is, or that involves, the use of medication or helpful for a psychiatrist/ geriatrician, sometimes a chemical substance for the primary purpose of together with a behaviour management clinician influencing a care recipient’s behaviour, but does (e.g. through Dementia Services Australia or in not include the use of medication prescribed for:the disability sector where there are specialist behaviour practitioners who assist with required (a) the treatment of, or to enable treatment of, Behaviour Support Plans), to collaborate with the the care recipient for: GP to assess the reason for use of a psychotropic (i) a diagnosed mental disorder; or medication and determine its continued benefit (ii) a physical illness; or as well as whether the use is a chemical restraint. (iii) a physical condition; or Individual circumstances may vary and where (b) end of life care for the care recipient there are multiple and complex conditions involved, specialist advice can also help minimise dose and length of treatment. If the reason for use is to manage a behaviour, the medication is likely to be considered chemical restraint. 1 Copyright © Meditrax 2021 “This material is copyright and the property of Meditrax the proprietor of the copyright. The material is loaned to the user on the condition that it is not copied in whole or part without the prior written consent of the owner of the copyright. When the purpose of the loan has expired, the material is to be returned to Meditrax.” Meditrax is a registered trademark of Manrex Pty Ltd t/as Meditrax.
Psychotropic management is similar whether or not the medication is All psychotropic medications used appropriately, chemical restraint including those that are chemical restraint, should contribute to achieving the best possible outcomes The appropriate management of ALL psychotropic for the resident. agents, whether or not they are chemical restraints, Documentation – monitoring and efficacy requires clear understanding and documentation of the following: Facility staff should document details of monitoring carried out in relation to the efficacy or not of • the diagnosis or reason (indication) for use a psychotropic agent and the occurrence of any • regular review of whether use remains required adverse effects – this is relevant for all psychotropics or if the dose could be reduced and forms part of the required documentation in the • the basis for continuation updated Quality of Care Principles 2014 from 1 July • the appropriate consent as per state/territory 2021 for chemical restraints. legislation. Best Practice Guidance for Psychotropics in In some cases, prescribers and facility staff are keen Behaviour Management to avoid identifying a medication as a chemical restraint. This may lead to longer than necessary According to Therapeutic Guidelines - Psychotropic treatment and inappropriate use. (March 2021): Note that where a medication is not flagged as a Behavioural and psychological symptoms of dementia chemical restraint, there should still be evidence are often temporary and can usually be prevented for the use, review and continuation which reflects and treated with nonpharmacological management. its role in the appropriate treatment of a diagnosed Communication abilities often decline as dementia mental illness, physical condition or physical illness. progresses, and changed or challenging behaviour is often caused by unmet needs unlikely to be helped Chemical restraint is not determined by ‘on label’ by drugs (eg need to toilet, distress from pain or or ‘off label’ use of a medication. For example loneliness, frustration). If behaviour is adequately the use of all antipsychotics for behaviours in assessed and its cause is promptly addressed, drugs dementia is deemed chemical restraint, despite that are unnecessary for most patients with dementia risperidone has a PBS-listing in BPSD with psychosis who experience symptoms of agitation, aggression and aggression, and others such as olanzapine, or psychosis. aripiprazole and quetiapine are also recommended in guidance information in specific circumstances of Australia’s Clinical Practice Guidelines and Principles aggression and psychotic symptoms. of Care for People with Dementia (2016) is based on the UK’s NICE guideline 2006 although the NICE While chemical restraint is best avoided where guideline has since been updated in June 2018, possible, it does have a role in reducing distress and provides similar recommendations to those in and the risk of harm for some residents, and use Therapeutic Guidelines – Psychotropic (March 2021). is allowed under the circumstances specified in updated Restrictive Practices legislation (Quality of Care Principles 2014). 2 Copyright © Meditrax 2021 “This material is copyright and the property of Meditrax the proprietor of the copyright. The material is loaned to the user on the condition that it is not copied in whole or part without the prior written consent of the owner of the copyright. When the purpose of the loan has expired, the material is to be returned to Meditrax.” Meditrax is a registered trademark of Manrex Pty Ltd t/as Meditrax.
From the Clinical Practice Guidelines and Principles of Care for People with Dementia: • Be aware that for people with dementia with Lewy bodies or Parkinson’s disease dementia, • At the time of diagnosis of dementia, and at antipsychotics can worsen the motor features of regular intervals subsequently, assessment the condition, and in some cases cause severe should be made for medical comorbidities and key antipsychotic sensitivity reactions. psychiatric features associated with dementia, including depression and psychosis, to ensure • Do not offer melatonin to manage insomnia in optimal management of coexisting conditions. people living with Alzheimer’s disease. • People with dementia who experience agitation • For people living with dementia who have should be offered a trial of selective serotonin sleep problems, consider a personalised reuptake inhibitor (SSRI) antidepressants (the multicomponent sleep management approach strongest evidence for effectiveness exists for that includes sleep hygiene education, exposure citalopram) if non-pharmacological treatments to daylight, exercise and personalised activities. are inappropriate or have failed. Review with evaluation of efficacy and consideration of de- Some of the relevant guidance information from prescribing should occur after two months. The Therapeutic Guidelines – Psychotropic is included need for adherence, time to onset of action and in the table below which contains examples and risk of withdrawal effects and possible side effects information about drug types and situations that should be explained at the start of treatment are or are not considered chemical restraint. Note that only psychotropic drug types that may be most • If a person with dementia is suspected to be commonly used as chemical restraints are included. in pain due to their distress or behaviour, as indicated by responses on an observational pain assessment tool, analgesic medication should NOTE be trialled using a stepped approach. The trial should be for a defined time period, particularly The information in the tables on if opioids are used. the following pages are not definitive and should be used as a guide only – the prescriber in each case should confirm Some further recommendations from the NICE reasons for continuing all psychotropics guideline, Dementia: assessment, management and which may be considered potential chemical support for people living with dementia and their restraints. Prescribers are suggested to carers: refer to available treatment guidance for psychotropic diagnoses/indications • Be aware that some commonly prescribed to ensure appropriate use, and medicines are associated with increased document reasons for treatment anticholinergic burden, and therefore cognitive decisions at each review. impairment. • Do not stop acetylcholinesterase (AChE) inhibitors in people with Alzheimer’s disease because of disease severity alone. 3 Copyright © Meditrax 2021 “This material is copyright and the property of Meditrax the proprietor of the copyright. The material is loaned to the user on the condition that it is not copied in whole or part without the prior written consent of the owner of the copyright. When the purpose of the loan has expired, the material is to be returned to Meditrax.” Meditrax is a registered trademark of Manrex Pty Ltd t/as Meditrax.
Examples of Common Psychotropic Medications and some uses which may be Chemical Restraint Examples of DRUG TYPE Chemical Comments and Diagnosis / Symptoms Restraint (reason for prescribing) ANTIPSYCHOTICS: Yes Target behaviours should be specified and evidenced in behaviour monitoring Dementia records. Behaviours BPSD Use is only recommended after (and with continued) non-pharmacological Developmental disability interventions which are inadequate alone. Aggression Agitation Therapeutic Guidelines – Psychotropic (March 2021): Psychotic symptoms (e.g. hallucinations, delusions) Antipsychotics are the drug class of choice for agitation, aggression or Anxiety/depression psychotic symptoms of Alzheimer disease and mixed Alzheimer disease and (symptoms rather than vascular dementia because they have the strongest evidence (although small) diagnosed disorders) of benefit. This modest efficacy must be balanced with a range of adverse effects, including further cognitive decline and an increased risk of death and cerebrovascular events. If the patient is at high risk of stroke (eg has poorly controlled vascular disease, atrial fibrillation or a history of stroke), avoid using an antipsychotic; undertake a benefit–harm analysis and if possible, seek expert advice. Patients who have dementia with Lewy bodies can experience severe sensitivity reactions and worsening of motor symptoms in response to antipsychotics. The drugs of choice for agitation, aggression or psychosis in these patients are rivastigmine or donepezil. There is insufficient evidence to guide antipsychotic therapy in dementia with Lewy bodies—use antipsychotic therapy with caution. If antipsychotic therapy is used, low-dose quetiapine is preferred because it may be less likely to cause the aforementioned adverse effects. Note that risperidone is PBS-listed for use in BPSD in Alzheimer’s disease where there are “psychotic symptoms and aggression” and where there is failure to respond to non-pharmacological management (+ other restrictions specified). ANTIPSYCHOTICS No People with mental health illness requiring antipsychotics have usually been Schizophrenia under the care of a psychiatrist and local mental health teams in the past and Bipolar disorder historical confirmation of the diagnosis and treatments utilised is suggested to Psychotic depression be sought to assist with ongoing management and review. End-of-life care (e.g. midazolam for agitation or Note however that the setting of mixed mental health diagnosis and haloperidol for nausea). behavioural issues may include chemical restraint if a stable dose of antipsychotic used to treat a diagnosed disorder is increased so as to also manage behavioural issues. e.g. schizophrenia well controlled with olanzapine but dosage increased or PRN added to treat behaviours associated with developmental delay or progressing dementia. 4 Copyright © Meditrax 2021 “This material is copyright and the property of Meditrax the proprietor of the copyright. The material is loaned to the user on the condition that it is not copied in whole or part without the prior written consent of the owner of the copyright. When the purpose of the loan has expired, the material is to be returned to Meditrax.” Meditrax is a registered trademark of Manrex Pty Ltd t/as Meditrax.
Examples of DRUG TYPE Chemical Comments and Diagnosis / Symptoms Restraint (reason for prescribing) ANTIDEPRESSANTS Yes Citalopram/escitalopram have some evidence of benefit in agitated/ Dementia aggressive behaviours in dementia (chemical restraint). Behaviours BPSD Therapeutic Guidelines – Psychotropic (March 2021): Developmental disability Aggression If an antipsychotic cannot be used or has been ineffective, a selective Agitation serotonin reuptake inhibitor (SSRI) antidepressant may be considered for agitation or aggression (not psychosis) of dementia.… Of all the SSRIs, citalopram has the strongest evidence for agitation and aggression of dementia—if it is used, monitor for adverse effects and review response to treatment at 2 to 3 months and consider stopping if effectiveness is limited. ANTIDEPRESSANTS No Therapeutic Guidelines – Psychotropic (March 2021): Major depression Generalised anxiety disor- Treat a patient with dementia who has major depression by optimising der (GAD) nonpharmacological interventions. Post traumatic distress There is a lack of evidence to support the use of antidepressants for major disorder (PTSD) depression in dementia—a Cochrane review found they had limited or no Obsessive-compulsive efficacy. Antidepressants are associated with adverse effects (eg dry mouth, disorder (OCD) dizziness, hyponatraemia) and increase the risk of falls and fractures in older Panic disorder people…... Neuropathic pain (e.g. du- Nevertheless, consider starting an antidepressant for major depression in loxetine, amitriptyline) dementia if the patient has: • mild to moderate major depression that does not respond to nonpharmacological therapies within 4 to 6 weeks • moderate major depression and has previously responded well to an antidepressant • severe major depression. BENZODIAZEPINES Yes Therapeutic Guidelines – Psychotropic (March 2021): Dementia Behaviours Avoid using benzodiazepines to treat agitation, aggression and psychosis of BPSD dementia—there is limited evidence of benefit and they are associated with Developmental disability serious adverse effects including cognitive decline, urinary incontinence, falls, Aggression hip fractures and dependence. Benzodiazepine use has also been associated Agitation with increased all-cause mortality. If an antipsychotic or an antidepressant Psychosis cannot be used, a benzodiazepine with a (comparatively) short half-life Nocturnal wandering or and no active metabolites (eg oxazepam) may be considered for agitation, disruptiveness aggression or psychosis of dementia for a maximum of 2 weeks—closely monitor the patient for adverse effects. People with dementia often have marked sleep fragmentation—they may doze during the day and experience sundowning (agitation and wandering) in the early evening or at night. Sleep problems can be behavioural and psychological symptoms of dementia.. 5 Copyright © Meditrax 2021 “This material is copyright and the property of Meditrax the proprietor of the copyright. The material is loaned to the user on the condition that it is not copied in whole or part without the prior written consent of the owner of the copyright. When the purpose of the loan has expired, the material is to be returned to Meditrax.” Meditrax is a registered trademark of Manrex Pty Ltd t/as Meditrax.
Examples of DRUG TYPE Chemical Comments and Diagnosis / Symptoms Restraint BENZODIAZEPINES No Therapeutic Guidelines – Psychotropic (March 2021: Generalised anxiety disor- der (GAD) Benzodiazepines are effective in reducing symptoms of generalised anxiety Post traumatic distress disorder. However, they should not be used as first-line pharmacotherapy disorder (PTSD) because of potential harms… If a benzodiazepine is used for an older person, Obsessive-compulsive lower doses may be needed…. Benzodiazepine use is usually restricted to disorder (OCD) acute crises and short-term initial therapy. In treatment resistance, they Panic attacks may be considered for maintenance therapy, ideally in consultation with a Panic disorder psychiatrist. Insomnia Avoid using drugs to treat insomnia in people with dementia—there is insufficient evidence to support their use. And for older people with insomnia: Avoid long-term hypnotic use—it is associated with daytime sedation, cognitive impairment, accidents, falls and hip fractures. Note that where used in the management of mixed diagnoses such as a history of GAD and current progressing dementia with behavioural issues, the use may be chemical restraint if commenced or dosage increased to treat escalating behaviours. Supporting documentation of the details of the symptoms prompting commencement or dosage increase is important, and the effect in the management of these should be reflected in the monitoring carried out and documented (e.g. whether effective or not and whether there are any adverse effects observed). ANTICONVULSANTS Yes Therapeutic Guidelines – Psychotropic (March 2021: Dementia Behaviours Do not use sodium valproate to treat agitation, aggression or psychosis of BPSD dementia. Limited evidence suggests it does not improve these symptoms Psychosis and is associated with a higher rate of adverse effects, some of which are Aggression serious—a Cochrane review concluded that further research on sodium Agitation valproate for agitation, aggression or psychosis of dementia may not be Mood stabilisation justified. ANTICONVULSANTS No Minimise doses due to the potential for adverse effects such as ataxia, Epilepsy confusion, weight gain. Neuropathic pain Bipolar disorder REFERENCES: (1) Quality of Care Principles 2014. https://www.legislation.gov.au/Details/F2020C00096 (2) Therapeutic Guidelines – Psychotropic in eTG complete. https://tgldcdp.tg.org.au/etgAccess (3) Guideline Adaptation Committee. Clinical Practice Guidelines and Principles of Care for People with Dementia. Sydney. Guideline Adaptation Committee; 2016. https://cdpc.sydney.edu.au/wp-content/uploads/2019/06/CDPC-Dementia-Guidelines_WEB.pdf (4) Dementia: assessment, management and support for people living with dementia and their carers. NICE guideline [NG97] Published: 20 June 2018. https://www.nice.org.uk/guidance/ng97/chapter/Recommendations#pharmacological-interventions-for-dementia 6 Copyright © Meditrax 2021 “This material is copyright and the property of Meditrax the proprietor of the copyright. The material is loaned to the user on the condition that it is not copied in whole or part without the prior written consent of the owner of the copyright. When the purpose of the loan has expired, the material is to be returned to Meditrax.” Meditrax is a registered trademark of Manrex Pty Ltd t/as Meditrax.
Case Scenarios – Chemical Restraint or not? The following scenarios are from Meditrax pharmacists conducting Residential Medication Management Reviews (RMMRs) and Psychotropic Medications Analysis (PMA) Audits. 1. (RMMR): “Mrs ‘Resident’ has significant dementia and previously received frequent PRN clonazepam. This was changed to lorazepam charted for PRN use in the afternoon due to anxiety and calling out. The drug has now been administered at 2pm on a regular basis although care charts do report that she still calls out intermittently. When asked, she does not know the reason for this behaviour. It may be prudent to review whether the regular use of lorazepam in the afternoon is contributing to sedation and possibly whether the dose could be slowly reduced. Increased sedation could increase the risk of aspiration.” Is the use of lorazepam in this scenario chemical restraint? Lorazepam is used to manage calling out behaviour, YES however facility documentation indicated it was not a chemical restraint as the resident also had a diagnosis of anxiety. 2. (RMMR): A resident prescribed quetiapine 25mg qid prn (no indication in charted order) was administered it without documentation of the reason or outcome, and the diagnosis or reason for prescribing was unclear despite thorough search of medical notes and other documents. The resident had recently been assessed by Dementia Support Australia for non-pharmacological management of behavioural issues. Is this chemical restraint? It could be an appropriate chemical restraint if there was evidence that use was a last YES resort (after use of other strategies), however this was clearly not the case according to the documentation available. 3. (PMA): A resident with developmental delay, osteoarthritis, chronic pain, and hypertension is quite restless at night banging on other residents’ doors and is prescribed mirtazapine 15mg nocte. Is this chemical restraint? YES Mirtazapine is likely prescribed to treat the agitated behaviour occurring at night. 7 Copyright © Meditrax 2021 “This material is copyright and the property of Meditrax the proprietor of the copyright. The material is loaned to the user on the condition that it is not copied in whole or part without the prior written consent of the owner of the copyright. When the purpose of the loan has expired, the material is to be returned to Meditrax.” Meditrax is a registered trademark of Manrex Pty Ltd t/as Meditrax.
Case Scenarios – Chemical Restraint or not? 4. (PMA & RMMR): A resident was prescribed fluvoxamine 150mg daily and olanzapine 2.5mg nocte, for “treatment- resistant persistant depressive disorder, GAD, and obsessive and dependent personality traits” as per psychogeriatrician diagnoses, together with lorazepam 1mg daily prn “for severe agitation only” as per charted instruction and with diagnoses of “severe anxiety” per CMA and “GAD” per psychogeriatrician review. RMMR noted that the resident did not have dementia but was worried about developing it as she was often forgetful, noting this can be a symptom present due to depression/ anxiety and potentially exacerbated by the anticholinergic effects of olanzapine. RMMR also noted she “only requests the PRN lorazepam when she feels very anxious”. Are any, some or all of the psychotropics in this scenario chemical restraint? However the charted indication of ‘agitation’ for lorazepam should perhaps more accurately NO state ‘for severe anxiety’ instead, which is the intended and actual use of lorazepam. The resident has treatment-resistant depression and severe anxiety with generalised anxiety disorder diagnosed and the psychotropics she is prescribed are appropriate to treat her diagnosed mental illnesses. Olanzapine in this scenario was confirmed in RMMR to be “adjunct therapy for her treatment-resistant depression and anxiety disorder”. 5. (RMMR): A resident was prescribed PRN Endone ‘for agitation’ as per the charted order, and it had been given occasionally with documentation that the resident was agitated as the reason for administration. Is this chemical restraint? The use of the medication is for agitation which may have a number of potential causes, and YES although it may be a presentation of pain in some residents, there was not a relevant pain assessment or other documentation indicating that pain was the cause of the agitation. 6. (RMMR): A resident with paranoid schizophrenia is prescribed two antipsychotics; flupentixol injec- tion and olanzapine wafer, and phenytoin capsules with medical progress notes documenting in January 2021 the phenytoin was for agitation and anxiety, while an older progress note from 2018 stated for seizure. Are any, some or all of these medications chemical restraint? - If phenytoin is confirmed for seizures. The January progress note documentation may be an NO error, however it would be important to confirm there was a diagnosis of epilepsy or seziures as use of phenytoin for agitation/anxiety would be inappropriate and a chemical restraint in this setting. 8 Copyright © Meditrax 2021 “This material is copyright and the property of Meditrax the proprietor of the copyright. The material is loaned to the user on the condition that it is not copied in whole or part without the prior written consent of the owner of the copyright. When the purpose of the loan has expired, the material is to be returned to Meditrax.” Meditrax is a registered trademark of Manrex Pty Ltd t/as Meditrax.
Case Scenarios – Chemical Restraint or not? 7. (PMA): A resident was prescribed regular duloxetine for depression/anxiety and PRN diazepam for anxiety, and his diagnosis list and CMA also indicated he required long term treatment. Facility care plan documented both as chemical restraints. The resident was not cognitively impaired or lacking capacity and was noted to request PRN diazepam when he was feeling unable to cope with his anxiety symptoms. Is the duloxetine or PRN diazepam a chemical restraint? The resident has diagnosed depressive and anxiety disorders requiring continued treatment, NO and was aware of the availability of PRN diazepam for when his symptoms were exacerbated. Facility staff work with him to ensure he has non-pharmacological support as part of his management plan. 8. (RMMR): A resident has a diagnosis of schizophrenia noted on the facility Psychotropic Register for treatment with risperidone 0.5 mg twice daily. Is this chemical restraint? Schizophrenia is a diagnosed mental illness…..BUT POTENTIALLY YES in this case. The NO resident’s diagnosis of schizophrenia could not be confirmed in other documentation such as medical progress notes, Health Summary from the previous GP or other historical information. Nursing progress notes indicated the resident was experiencing hallucinations occasionally and there was a diagnosis of advancing dementia. The Care Manager and GP arranged for psychogeriatrician assessment to determine appropriate ongoing management and whether there was potentially late-onset schizophrenia. 9. (PMA): A resident with Alzheimer’s dementia was charted oxazepam for anxiety/agitation, and carbamazepine had also been commenced but a diagnosis not included on the facility Psychotropic Register. The Care Manager had thought the oxazepam was not a chemical restraint due to there being anxiety included in the charted indication for use, but was not clear why carbamazepine had been started. The following entry was located in recent medical progress notes: “Agitated at times and will not allow carer to assist him, increase oxazepam to 15 mg bd and add Tegretol 100 mg bd as mood stabiliser”. Is one or more of the psychotropics in this scenario chemical restraint? YES Both oxazepam and carbamazepine are being used in the management of agitation. 9 Copyright © Meditrax 2021 “This material is copyright and the property of Meditrax the proprietor of the copyright. The material is loaned to the user on the condition that it is not copied in whole or part without the prior written consent of the owner of the copyright. When the purpose of the loan has expired, the material is to be returned to Meditrax.” Meditrax is a registered trademark of Manrex Pty Ltd t/as Meditrax.
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