What are the issues with the use of Antipsychotics in Dementia?1,2,3,4,8
l Elderly people with dementia are at risk of serious life-threatening side-effects when treated with antipsychotics.
o increased risk of stroke
o small increased risk of death
l In 2004 former UK CSM advised:-
o increased risk of stroke (approx. 3-fold) when risperidone or olanzapine used in elderly people with dementia
l In 2008 European Medicines agency and MHRA issued advice following assessment of observational data
o typical antipsychotics are also associated with increased mortality when used in elderly people with dementia
l Unless more evidence becomes available assume all antipsychotics (typical and atypical) carry risk
l Also need to consider risk of other side-effects such as extra-pyramidal symptoms, hypotension, weight gain, dysregulation of blood glucose levels
Assessment of Patient3,5,8 / If a person with dementia develops distressing non-cognitive symptoms or behaviour that challenges, do an early assessment to identify factors that may influence behaviour. Include:-
l Physical health
l Infections (especially UTI)
l Dehydration
l Depression
l Possible undetected pain or discomfort
l Side effects of medication - (including acetylcholinesterase inhibitors) Psychosis in Parkinson’s Disease
l Individual biography
l Psychosocial factors – against who is the aggression directed? Reason?
l Physical environment
l Behavioural and functional analysis in conjunction with carers and care workers
Individual Care Plans5,8 / l Is the behaviour primarily a problem for the person with dementia, or for their carers?
l Develop individual care plans, record in the notes and review regularly at a frequency agreed with carers and staff
l Involve carers in creating treatment plans
l Consider interventions tailored to person’s preferences, skills and abilities
Monitor response and adapt care plan as needed
Can Antipsychotics ever be considered?3,5,8,9 / l Antipsychotic drugs should not be used for mild-to-moderate non-cognitive symptoms in:
o Dementia with Lewy Bodies (DLB), because of the risk of severe adverse reactions
o Alzheimer’s disease, vascular dementia or mixed dementia, because of the increased risk of cerebrovascular adverse events and death
l Medication for non-cognitive symptoms or behaviour that challenges should only be considered as a first-line option if there is severe distress or an immediate risk of harm to the person with dementia or others
l People with DLB are at particular risk of severe ADRs with antipsychotics.
l Seek specialist advice either through the free medicines information helpline on 01924 327619 or by emailing before starting antipsychotic therapy in patients with DLB.
Before starting Antipsychotic treatment5,8,9 / l Discuss risks and benefits of treatment (with the patient and /or carers and document in the notes)
o Assess cerebrovascular risk factors and discuss possible increased risk of stroke/transient ischaemic attack and
o Possible adverse effects on cognition.
l Document clearly that non-pharmacological measures have failed.
l Identify, quantify and record target symptoms, so that changes can be regularly assessed and recorded.
l Changes in cognition should be regularly assessed and recorded; consider alternative medication if necessary.
l Consider co-morbid conditions, such as depression.
Which Antipsychotic?5,6,7,8,9 / l NICE recommends that the antipsychotic is chosen after an individual risk-benefit analysis.
l Both typical and atypical antipsychotics have been associated with increased morbidity and mortality.
l Risperidone▼ is the only antipsychotic licensed for:
o Short-term (up to 6 weeks’) treatment of persistent aggression in Alzheimer’s dementia unresponsive to non-pharmacological approaches and where there is a risk of harm to the patient or others
And when:
o The risks and benefits have been carefully balanced for every patient
o The increased mortality rate associated with antipsychotics in the elderly has been taken into account
o The risk of cerebrovascular events have been considered before treating with risperidone▼:
§ any patient who has a previous history of stroke or transient ischaemic attack
§ Other risk factors for cerebrovascular disease have been considered including hypertension, diabetes, smoking, and atrial fibrillation
l Use of other antipsychotics (including liquid specials) will be outside of licensed indications (See Grey list)
l Costs vary between antipsychotics:
o Haloperidol 500mcg x 60 = £2.36
o Risperidone▼ 500mcg x 60 = £2.85, 1mg x 60 = £1.66
o Quetiapine 25mg x 60 = £33.83 (Not recommended as on Grey List)
o Quetiapine 100, 150, 200mg strengths all flat priced at £113.10
All prices correct August 2011 - Drug Tariff
Reviewing patients with dementia on antipsychotics3,5
(Please refer to SWYPFT intranet site under the QIPP Antipsychotics in Dementia link8,9 for further advice on how to review patients) / l Treatment should be time-limited and regularly reviewed
l If treatment continued longer than short-term – should continue to be reviewed regularly (at least every 3 months)
l Review should include:-
o Assessment of target symptoms
§ i.e. is there any improvement?
o Assess for side-effects e.g.
§ Extra-pyramidal effects
§ Over-sedation
§ Effects on cognition
§ Anticholinergic effects
o Blood pressure and pulse, blood glucose, weight and central obesity should also be monitored
o Appropriate blood tests: e.g. U+Es, FBC, LFTs and Prolactin
o ECG if necessary
l In DLB, monitor for severe untoward reactions, particularly neuroleptic sensitivity reactions
Extreme agitation or aggression3,8 / l If oral drug treatment being considered for immediate management of violence, aggression, extreme agitation
o should be short term (no more than one week)
o use to calm person not sedate
l Options; in order of preference; low dose of:
o Oral lorazepam 0.5mg to 2mg daily or
o Oral haloperidol 0.5mg to 4mg daily
l Monitor response daily until patient stable
l If oral medication refused/ineffective or extreme agitation
o Obtain specialist advice urgently before making arrangements for admission
Principles of pharmacological control of violence, aggression and extreme agitation5,8 / l Conduct immediate management in a safe, low stimulation environment, away from others
l Use drugs to calm the person and reduce the risk of violence and harm, rather than to treat any underlying psychiatric condition
l Aim to reduce agitation or aggression without sedation
l Use the lowest effective dose for shortest possible time. Avoid high doses and drug combinations, especially in elderly or frail people
l Use drugs for control of behaviour with caution, particularly if the person has been restrained
l Offer people with dementia and their carers the opportunity to discuss their experiences, and explain the decision to use urgent sedation. Record in the notes
References
1. Professor Gordon Duff. Chairman Committee on Safety of Medicines. Atypical antipsychotic drugs and stroke. 9th March 2004.
2. CHM and MHRA. Drug Safety Update. Volume 2. Issue 5. December 2008.
3. Clinical Knowledge Summaries. Dementia.www.cks.nhs.uk. <Accessed August 2011
4. CHM and MHRA. Drug Safety Update. Volume 2. Issue 8. March 2009.
5. National Institute for Health and Clinical Excellence. Dementia: Supporting people with dementia and their carers in health and social care. Clinical Guideline 42. November 2006.
6. The use of antipsychotic medication for people with dementia: Time for Action. A report for the Minister of State for Care Services by Professor Sube Banerjee. November 2009 http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_108303
7. Summary of Product Characteristics. Risperdal Tablets, liquid and quicklet. Janssen-Cilag Ltd. http://www.medicines.org.uk/EMC/medicine/12818/SPC/Risperdal+Tablets,+Liquid+%26+Quicklet/ <Accessed August 2011
8. http://nww.swyt.nhs.uk/organisation/drugandtherapeutics/qipp.htm
9. www.choiceandmedication.org/swyp
Reducing Antipsychotic use in Dementia Flowchart