There are growing concerns about the high level of use of psychotropic medications in the treatment of non-cognitive symptoms of dementia, particularly given the significant risks and side effects associated with the use of these medications.

 

What are non-cognitive symptoms of dementia?

Non-cognitive symptoms of dementia are symptoms related to mood, behaviour and psychosis. They may include:

• Mood disturbances;
• Personality changes;
• Agitation;
• Aggression;
• Pacing;
• Altered sexual behaviours;
• Changed sleep patterns;
• Appetite disturbances;
• Hallucinations; and
• Delusions (false beliefs).

Up to 90 per cent of people with dementia display non-cognitive symptoms. These can present as mild, moderate or severe. People with dementia experiencing these symptoms may be supported using non-pharmacological interventions and/or psychotropic medications. Non-pharmacological interventions are non-invasive interventions that do not involve medication and attempt to better manage complex needs. Some examples of non-pharmacological interventions include music therapy, physical exercise and cognitive stimulation therapy.

 

What is National Clinical Guideline No. 21?

National Clinical Guideline (NCG) No. 21, Appropriate prescribing of psychotropic medication for non-cognitive symptoms in people with dementia (available at hse.ie/eng/dementia-pathways > Dementia Resources for HSCPs > Implementation of National Clinical Guideline No. 21), was published in December 2019 by the Department of Health. It aims to guide the appropriate use of psychotropic medication for non-cognitive symptoms being experienced by people living with dementia. This Guideline is relevant to all doctors, nurses, pharmacists and health and social care professionals in Ireland who provide care to people with dementia. It applies to all settings that provide care for people living with dementia.

The recommendations and good practice points in the sister document, Non-cognitive symptoms of dementia: Guidance on non-pharmacological interventions for healthcare and social care practitioners, was published in 2019 by the HSE (available at dementia.ie > Research > Publications). This document provides detailed information and guidance on the use of non-pharmacological interventions for non-cognitive symptoms of dementia.

Table 1: Recommendations of National Clinical Guideline No. 21

No	Recommendation (Key recommendations are presented in bold)
1	Prior to considering any psychotropic medication in a person with dementia, a comprehensive assessment should be performed, by an appropriately trained healthcare professional.
2	Non-pharmacological interventions should be used initially to treat non-cognitive symptoms in a person with dementia, unless there is severe distress or an identifiable risk of harm to the person and/or others.
3	Antipsychotic medication should be used with caution and only in cases where there is aggression, agitation or psychosis that either causes an identifiable risk of harm to the person with dementia and/ or others or causes severe distress to the person.
4	People with Alzheimer’s disease, vascular dementia or mixed dementias with mild-to-moderate non-cognitive symptoms should NOT be prescribed antipsychotic medication due to the increased risk of cerebrovascular adverse events and death.
5	People with dementia with Lewy bodies and Parkinson’s disease dementia with mild to moderate non-cognitive symptoms should NOT be prescribed antipsychotic medication due to the increased risk of severe adverse reactions.
6	People with Alzheimer’s disease, vascular dementia, mixed dementias, dementia with Lewy bodies, or Parkinson’s disease dementia, with severe non-cognitive symptoms, causing severe distress, or an identifiable risk of harm to the person and/or others, may be offered antipsychotic medication, where appropriate.
7	A full discussion with the person and/or their relevant Decision Supporter about the benefits and risks, including the increased risk of stroke, transient ischemic attack and mortality, should occur before antipsychotic medication is commenced.
8	Atypical (second generation) antipsychotic medications are associated with fewer extrapyramidal effects and risks than typical (first-generation) antipsychotics, and therefore second generation medication should be used if antipsychotic therapy is necessary for the management of non-cognitive symptoms.
9	If a risk and benefit assessment favours the use of antipsychotic medication, treatment should be initiated at the lowest possible dose and titrated slowly, as tolerated, to the minimum effective dose.
10	If there is a positive response to treatment with antipsychotic medication, decision-making about possible tapering of the medication should occur within 3 months, accompanied by a discussion with the person with dementia and/or their relevant Decision Supporter.
11	If a person with dementia is taking an adequate therapeutic dose of antipsychotic medication without clear clinical benefit, the medication should be tapered and stopped; where possible after discussion with the person and/or their relevant Decision Supporter.
12	If antipsychotic treatment is being tapered, assessment of symptoms for re-emergence should occur regularly during tapering, and for a period after discontinuation of antipsychotic medication.
13	Acetylcholinesterase inhibitors are indicated for cognitive enhancement in people with mild to moderate Alzheimer’s disease but are NOT recommended solely for the treatment of non-cognitive symptoms in a person with Alzheimer’s disease.
14	Due to the particular risks with antipsychotics in people with Parkinson’s disease dementia and dementia with Lewy bodies, rivastigmine or donepezil may be considered for non-cognitive symptoms causing severe distress when non-pharmacological interventions have proved ineffective.
15	People with vascular dementia or frontotemporal dementia who develop non-cognitive symptoms should NOT be prescribed acetylcholinesterase inhibitors.
16	Memantine is indicated as a cognitive enhancer in people with moderate to severe Alzheimer’s disease, Parkinson’s disease dementia, and dementia with Lewy bodies, but it is NOT recommended to be prescribed solely for the treatment of non-cognitive symptoms in a person with dementia.
17	In people with mild to moderate dementia, and mild to moderate depression and/or anxiety, psychological treatments should be considered. Antidepressants may be considered to treat severe comorbid depressive episodes in people with dementia, or moderate depressive episodes that have not responded to psychological treatment.
18	Anticonvulsant medication is indicated for the treatment of seizures, bipolar disorder, or as an adjunctive therapy for pain, but is NOT recommended as a treatment for non-cognitive symptoms in a person with dementia.
19	Due to the very limited evidence to support the use of benzodiazepines in the management of non-cognitive symptoms in a person with dementia, and their significant adverse effects, they should be avoided for the treatment of non-cognitive symptoms, and usage strictly limited to the management of short-term severe anxiety episodes.
20	A personalised sleep management regimen may be considered for sleep disorders in a person with dementia.
21	Melatonin should NOT be used for sleep disorders in people with dementia.

Table 2: Good Practice Points of National Clinical Guideline No. 21

1.      At all times, and throughout the dementia trajectory, an individualised and person-centred   approach should be promoted and practiced by all doctors, nurses, pharmacists, and health and social care professionals. 2.      The risk and benefits of pharmacological intervention using psychotropic medication should be discussed with the person, and/or their relevant Decision Supporter, in all cases where possible. 3.      Psychotropic medication that is commenced for non-cognitive symptoms in a person with dementia should be reviewed regularly to assess efficacy, adverse effects and continued need. 4.      If psychotropic medication is necessary for the management of non-cognitive symptoms, oral medication should be used initially. In the exceptional case where parenteral treatment is necessary, the intramuscular route is preferred to intravenous administration, and single agents are preferred to combination therapy. 5.      If rapid tranquilisation is needed, the attending doctors and nurses should be adequately trained and have access to adequate monitoring and resuscitation facilities, and should consult their local institutional policy.

6.      There is little evidence that antipsychotics are effective in the treatment of certain non-cognitive symptoms such as walking about, hoarding, fidgeting, inappropriate voiding, verbal aggression, screaming, sexual disinhibition and repetitive actions. Therefore, any use in the management of these symptoms needs to be particularly justified. 7.      Doctors, nurses, pharmacists and health and social care professionals are strongly advised to contact a specialist team with experience in treating people with Lewy body dementias for direct advice on a person with Parkinson’s disease dementia or dementia with Lewy bodies who has distressing psychosis. 8.      Doctors and nurses who prescribe antipsychotics should have written information available for the person with dementia and their family about possible side effects (e.g. falls, confusion, drowsiness), as well as easy to understand information about the risk of serious adverse events (stroke, death). 9.      In rare cases where a person with dementia has had two or more failed attempts of antipsychotic withdrawal and requires ongoing maintenance therapy with an antipsychotic, the person should be reviewed at the point of re-prescribing and at least 6 monthly thereafter.

10.   Apart from their role in the treatment of depression, antidepressants may have a role in the treatment of other severe non-cognitive symptoms in a person with dementia (such as agitation), where pharmacological treatment has been deemed necessary. If trialled for other non-cognitive symptoms, antidepressants should be used with caution, with close monitoring for side effects.

11.   There are no studies of z-drugs for sleep disorders in people with dementia. Due to their significant side effects, if z-drugs are considered, it should be for the shortest period possible (or as specified by medication license).

How is NCG no. 21 being implemented?

An Implementation Programme for NCG No. 21 commenced in 2022, and is ongoing. The key objectives of the Implementation Programme are to:

1. Raise awareness of the risks of psychotropic medications for people with dementia, and raise awareness of NCG No. 21 as a key resource to guide clinical decision-making;
2. Develop and rollout education programmes including an eLearning programme of education and local education events across the country in a variety of settings;
3. Develop an audit tool and manual to assess compliance with NCG No. 21, and provide training on use of this audit tool; and
4. Undertake a comprehensive evaluation of the implementation of NCG no. 21 to assess the reach of the education and training programme.

What are the key messages for community pharmacists?

National Clinical Guideline no. 21 provides an important point of reference to guide clinical decision making in relation to the appropriate prescribing of psychotropic medications for non-cognitive symptoms of dementia.

There is a lack of evidence for the benefits of psychotropic medications for non-cognitive symptoms of dementia and they should be reserved for severe symptoms.

Psychosocial interventions should be started before any pharmacological treatment is recommended. This may include social activities, activities that involve exercise, enjoyable activities and problem-solving, or specialised psychosocial interventions.

Adverse effects of psychotropics often outweigh the benefits of pharmacological treatment. Given the higher risks of adverse effects and drug-drug interactions in people with dementia receiving psychotropics, monitoring of symptoms is important.

As required (PRN) psychotropic medications are often used to manage episodes of responsive behaviour, however without review, this may lead to long term use. ‘As required’ prescriptions should be monitored and duration of use clarified.

There are a range of resources available for pharmacists, including an eLearning programme of education, to improve prescribing practices in relation to psychotropic medications, and to enhance the provision of care to people with dementia.

 

Resources 

A range of resources to complement NCG No. 21 and the guidance document on non-pharmacological interventions have been developed by the Implementation Programme team. These will be valuable to all staff who provide care to people with dementia, particularly staff involved in the prescribing of psychotropic medications.

The resources listed in this box can be accessed on the Implementation Programme webpage, which is available at hse.ie/eng/dementia-pathways > Dementia Resources for HSCPs > Implementation of National Clinical Guideline No. 21.

National Clinical Guideline No. 21: Read National Clinical Guideline No. 21 for detailed information on the appropriate prescribing of psychotropic medication for non-cognitive symptoms in people with dementia. Design note: (available at 43428_0ab63bed4afb4f388b99801882e04652.pdf)

Algorithm to guide appropriate prescribing of psychotropic medication for non-cognitive symptoms in people with dementia: This algorithm to guide appropriate prescribing of psychotropic medication for non-cognitive symptoms in a person with dementia is to be used in conjunction with NCG no. 21.

Non-Cognitive Symptoms of Dementia: This guidance document on non-pharmacological interventions for non-cognitive symptoms of dementia is a sister document to NCG no. 21.

Support module: A HSeLanD module, Support pathways for people with non-cognitive symptoms of dementia, has been developed. This 30 minute module will help you to determine the best person-centred supports for a person with non-cognitive symptoms of dementia. It will also help you to recognise the risks of unnecessarily prescribing a psychotropic medication.

Prescriber information leaflet: A prescriber information leaflet has been developed for prescribers of psychotropic medication. This summarises the recommendations and good practice points of NCG no. 21, provides additional information on comprehensive assessment, and links to relevant resources.

Document to support comprehensive assessment: This document to support comprehensive assessment of the person with dementia experiencing non-cognitive symptoms, answers a number of frequently asked questions in relation to comprehensive assessment.

Plain English Guide: Prescribing Psychotropic Medication for Non-cognitive Symptoms for People with Dementia: This Plain English information guide for people with dementia and their family carers provides information on prescribing psychotropic medication for non-cognitive symptoms for people with dementia.

Easy to Read Guide: Prescribing Psychotropic Medication for Non-cognitive Symptoms for People with Dementia: This Easy Read information guide for people with dementia and their family carers provides information on prescribing psychotropic medication for non-cognitive symptoms for people with dementia.

 

Where can I get more information?

As outlined in the ‘Resources’ box and throughout this article, there is a range of further information available at hse.ie/eng/dementia-pathways > Dementia Resources for HSCPs > Implementation of National Clinical Guideline No. 21.