Antipsychotic drugs and dementia briefing paper

Introduction

Antipsychotic drug treatments are often prescribed to people with dementia as a ‘first resort’ in response to behaviours such as restlessness and aggression that nursing and care home staff find challenging. Whilst the use of antipsychotic treatments can be appropriate for people with dementia when symptoms are severe and alternative approaches have failed, there is wide spread inappropriate prescribing of the drugs. This has a detrimental effect on the individuals’ prescribed the drugs and a significant financial cost to the public purse.

Dementia is a complex, unpredictable and progressive long-term condition; people with dementia need high quality care that responds to their needs as the condition progresses. A person-centred approach that focuses on the needs of the individual and the adoption of alternative approaches to managing behaviour that challenges will reduce the inappropriate use of antipsychotic drugs.

Whilst research evidence has largely focused on the prescribing of antipsychotic drugs in care homes, it is important that the prescribing practice in hospitals and individuals homes is also regulated.

Alzheimer Scotland considers the inappropriate prescribing of antipsychotic drugs to be a serious clinical and human rights issue. We have written to the Minister for Public Health, Shona Robison, to outline the measures we consider need to be put in place at a national level by the Scottish Government. A summary of recommendations is provided at the end of this paper.

What are antipsychotic drugs?

Antipsychotics are a group of drugs developed to treat the psychotic symptoms associated with schizophrenia; they are also known as neuroleptics. First generation antipsychotics, known as typical or conventional drugs, were developed in the 1950s. The term used for second generation antipsychotic drugs is atypical.

Why and when are they prescribed to people with dementia?

They are often prescribed to people with dementia in response to behavioural and psychological symptoms. In line with good practice guidance, antipsychotic drugs in dementia should be reserved for severe aggression or psychotic symptoms where other approaches have failed, with treatment reviewed regularly. Despite this they are being used for people with mild behavioural symptoms, as a first resort, and prescribing is often continued for long periods of time .

Level of prescribing

There has been no audit of the scale of prescribing and estimates vary:

• Alzheimer’s Research Trust (2008/2007) suggested between 60% and 45% of people with dementia in nursing homes are prescribed antipsychotics as a treatment for behavioural symptoms such as aggression.
• Ballard (2008) estimated that between 100,000 to 150,000 people with dementia are prescribed antipsychotics in care facilities in the UK. This is equivalent to 39% to 59% of people with dementia living in care homes; this would mean between 9,750 and 14,750 people with dementia in care homes in Scotland are being prescribed antipsychotic drugs.
• Prentice (2002) found 46% of the 108 people with dementia in nursing homes in Perth and Kinross were regularly prescribed antipsychotic medication.
• McGraith AM & Jackson GA (1996) found a 24% prescribing rate in nursing homes in Glasgow (not dementia specific).

How much prescribing is inappropriate?

• In England the National Audit Office (2007) census of community mental health teams found that over a third used antipsychotic treatments regularly even in people with dementia whose symptoms were mild .
• There was a consensus from respondents to the All Party Parliamentary Group that over-prescribing of antipsychotic drugs is a significant problem. The outcome report suggest that as evidence shows the use of these drugs is only appropriate in very limited situations for people with dementia, the widespread use of treatments demonstrates that they are being inappropriately prescribed. They added that drugs are prescribed as a response to the behavioural and psychological symptoms of dementia, experienced as a result not only of the condition, but also as a result of a wider and more complex set of problems external to the individual’s control.
• Ballard (2008) estimated around 10% to 30% of prescribing is appropriate with at least 70% inappropriate. This would mean that between 6,825 and 10,325 people with dementia are being prescribed these drug treatments inappropriately in Scottish care homes.
• This builds on two earlier research studies in Scotland. Prentice (2002), found a lack of appropriate targeting of symptoms likely to respond to antipsychotic treatments. Whilst 39% of residents in care homes met their criteria for prescribing, more than 50% were on regular antipsychotic medication. In addition 25% of residents who would benefit from regular antipsychotic medication did not receive it.
• McGraith AM & Jackson GA (1996) applied American legislation to antipsychotic prescribing in nursing homes and found 88% had been prescribed for inappropriate reasons, mostly commonly for mild aggression and agitation, wandering, uncooperativeness and insomnia.

Effects of antipsychotic drugs

Negative effects of antipsychotic drugs include excessive sedation, dizziness and unsteadiness, which can lead to increased falls and injuries, body rigidity and tremors . Research evidence also shows an increased risk of stroke and premature death for people with dementia.

• The Committee on Safety of Medicines (2004) found there was clear evidence of an increased risk of stroke in elderly people with dementia who are treated with risperidone or olanzapine (atypical antipsychotic drugs). They considered the magnitude of the risk sufficient to outweigh likely benefits in the treatment of behavioural disturbances associated with dementia.
• Douglas et al (2008) found that all antipsychotic drugs were associated with an increased risk of stroke in all patients. People with dementia seemed to be at a higher risk of an associated stroke than people without dementia and use of antipsychotics should, when possible, be avoided in these patients.
• Ballard et al (2008) found that long term use of antipsychotic drugs was associated with a significant deterioration in the verbal fluency and cognitive function of people with Alzheimer’s disease. There was no benefit to people with mild behaviour symptoms and in those with more severe symptoms any possible benefit had to be balanced against adverse effects.
• Alzheimer’s Research Trust (2007) found that the drugs were linked with a significant increase in long-term mortality, with patients dying an average six months earlier. The USA Food and Drug Administration found that the use of atypical antipsychotics was associated with increased mortality in elderly patients with dementia.
• Schneider (2006) assessed the effectiveness of atypical antipsychotic drugs in 421 outpatients with Alzheimer’s disease and found adverse effects offset advantages for the treatment of psychosis, aggression or agitation.

The problem is exacerbated by non-compliance with Part 5 (Medical Treatment and Research) Adults with Incapacity (Scotland) Act by many medical practitioners both in the community and hospitals. Many doctors are failing to assess capacity to consent to treatment and develop treatment plans in consultation with family members and others closely involved with the person with dementia. Many nurse managers press GPs to prescribe antipsychotics to sedate residents whom staff find difficult to manage and lack knowledge of the legal position in relation to the treatment of people with dementia who are unable to give informed consent.

Cost of treatments

The average cost per daily defined dose (DDD) of antipsychotic drugs was £2.13 for 2006/07. The average cost of a single daily dose for a typical antipsychotic drug was £0.67 and £3.61 for an atypical. The average cost of a typical antipsychotic prescription was £8.47; an atypical antipsychotic prescription was £74.13 (9 times more expensive).

Applying the daily defined dose to the estimate of inappropriate prescribing above would mean that the cost of inappropriate prescribing was between £14,537 and £21,992 per day in Scotland, that is between £5million and £8million per year. The cost to the NHS of treating unnecessary side effects has not been calculated. A key question is how any savings achieved from reducing the use of these drugs be transferred to meet the costs of appropriate dementia care and treatment.

Limiting the use of antipsychotic drugs

Non pharmacological interventions and a focus on person centred care provide alternatives to the use of antipsychotic drug treatments for people with dementia in care homes.

The All Party Parliamentary Group on Dementia, Westminster identify a number of barriers to the use of other social and psychological approaches:

• the lack of dementia care training for care home staff, which results in staff not being able to support people with dementia who have mild behavioural symptoms;
• inadequate leadership in care homes;
• lack of support from external services (including inadequate monitoring and review of prescriptions) to develop individually tailored care plans.
• the exclusion of family and friends from decision-making. They recommend these alternatives should be put into practice in all care homes.

The NICE guideline recommends that people with dementia who display behaviour that is challenging should given an early assessment to establish likely factors that may generate, aggravate or improve such behaviour. Non pharmacological interventions should then be adopted unless the behaviour is severe.

Some care homes and hospitals have recognised the need for specialist dementia care training and adopted alternative strategies to good effect with prescribing of antipsychotic drugs reduced to a minimum, with a focus on dementia care training, a good knowledge of the individual, the provision of support from a ‘dementia specialist’ within the staff team, the creation of a dementia friendly environment, including the provision of a safe outside garden space.

Fossey et al (2006) evaluated the effect of enhanced psychosocial care on the prescribing of antipsychotics for nursing home residents with dementia. They found the promotion of person centred care and good practice in the management of people with dementia with behavioural symptoms provided an effective alternative to antipsychotic drugs.

Recommendations and guidance on prescribing

NHS Quality Improvement Scotland (December 2007) Standards for integrated care pathways for mental health recommends :

• Service users who develop behavioural or psychological dementia symptoms receive an intervention matched to their needs. Antipsychotic medication should be reserved for severe aggression or psychotic symptoms where other approaches have failed or would be inappropriate.

The SIGN guideline recommends:

• If necessary, conventional antipsychotics may be used with caution, given their side effect profile, to treat associated symptoms in dementia
• Atypical antipsychotics with reduced sedation and extrapyramidal side effects may be useful in practice, although the risk of serious adverse events such as stroke must be carefully evaluated.
• An individualised approach to managing agitation in people with dementia is required.
• Where antipsychotics are inappropriate cholinesterase inhibitors may be considered.
• In patients who are stable antipsychotic withdrawal should be considered.

NICE guideline recommends:

• People with Alzheimer’s disease, vascular dementia or mixed dementia with mild to moderate non cognitive symptoms should not be prescribed antipsychotic drugs because of the possible increased risk of cerebrovascular adverse events and death.
• People with Lewy body dementia with mild to moderate non cognitive symptoms should not be prescribed antipsychotic drugs because they are at particular risk of severe adverse reaction.
• People with severe non cognitive symptoms may be offered treatment with an antipsychotic drug after a number of conditions have been met; including time limited treatment and regular review.

Alzheimer Scotland recommends

• Protocols for the prescribing, monitoring and review of antipsychotic medication for people with dementia must be introduced.
• Improved education for GPs and other medical practitioners to be addressed in relation to both the behavioural and psychological symptoms of dementia and the operation of the Adults with Incapacity (Scotland) Act 2000.
• Mandatory dementia care training for nurse managers in care homes and on the risks and benefits of antipsychotics; all care staff should receive dementia care training which includes understanding person-centred care.
• A sub-set of national care standards for the care of people with dementia.
• Care homes must receive more support from external services, for example, the community mental health team, consultant in old age psychiatry.
• An audit of the prescription of antipsychotic drugs for people with dementia and clarity around which organisation would be best placed to conduct this.
• A cost-benefit analysis of prescribing antipsychotic drugs for people with dementia.

26 September 2008

References are available from Lindsay Kinnaird lkinnaird@alzscot.org or telephone 0131 243 1453