Time for action: the use of antipsychotics for
people with dementia
Sube Banerjee
Professor of Mental Heath and Ageing, The
Institute of Psychiatry, King’s College London
Aims
•
Published November 2009
1. Comprehensive review
– Negative effects
– Positive effects
2. Analysis of reasons for
current clinical behaviour
3. Formulate practical clinical
plan to deal with
problems found
Anti-psychotics
• Typical antipsychotics introduced in 1950s for
schizophrenia
• Atypical antipsychotics from 1980s
• Adverse effects
– over-sedation,
– hypotension,
– involuntary movements Parkinsonian symptoms (rigidity,
tremor and problems with walking)
– Cardiotoxicity
Antipsychotics in dementia
• Behavioural and Psychological Symptoms in Dementia
(BPSD)
– Common
– May be severe and complicated
•
•
•
•
•
agitation,
repetitive questioning,
depression,
aggression,
wandering and psychosis.
• Largely unlicensed or ‘off-label’;
• UK risperidone
– “short-term treatment (up to six weeks) of persistent aggression in
patients with moderate to severe Alzheimer’s dementia
unresponsive to non-pharmacological approaches and when there is
a risk of harm to self or others”.
Particular risks for people with dementia
• 2002 manufacturer risperidone
Canada
– higher rate of cerebrovascular
adverse events (CVAEs) relative
to those receiving placebo.
• 2003, US FDA
– published warnings
• 2004 the European Medicines
Agency (EMEA)
– public advice about an increased
risk of CVAEs and mortality in
people with dementia receiving
olanzapine.
• 2004, the UK Medicines and
Healthcare products Regulatory
Agency (MHRA)
– risperidone and olanzapine
should not be used to treat
BPSD because of increased risk
of strokes
• 2005 FDA
– warnings for aripiprazole
regarding the risk of CVAEs,
including stroke, in dementia
• 2005 FDA
– informed health
professionals 1.7 times
increased risk of all-cause
mortality
• 2006-8
– Same risk shared by all
antipsychotics
Extent of use
• Very poor data
• Residential and nursing home populations in Leicestershire
– 1990 (29.1%) and 1997 (30.7%)
• 3 English cities (London, Newcastle and Oxford)
– 168 (48%) of 348 people in nursing homes with dementia on an
antipsychotic.
• IMS Health (2009)
– 20.3% of people with a recorded diagnosis of dementia included an
antipsychotic
• USA 2004 National Nursing Home Survey,
– 24.8% of nursing home residents received antipsychotic medication; (23.5%
received atypical antipsychotics and 1.9% typical antipsychotic medication).
• Canadian province of Manitoba
– prevalence of antipsychotic use among those aged over 65 years increased
between 1996 and 2006 from 2.9% to 4.3% in men and from 4.1% to 6.0% in
women
New data and extrapolation
• NHS Information Centre for
Health and Social Care
completed analyses using the
IMS Disease Analyzer
• Practices from England, Wales,
Scotland and Northern Ireland a
representative UK sample by age
and sex.
• 1,098,627 patients 12-month
period from 1 April 2007 to 31
March 2008.
– 192,190 people (17.5%) over the
age of 65
– 10,255 (5.3%) received a
prescription for an
antipsychotic.
• Estimates for the report
– 25% people with dementia
receiving an antipsychotic
– 180,000 people with dementia
receiving an antipsychotic
– Includes people with dementia
at home as well as people in
care homes
Summary of risks and benefits at a population level of the use
of atypical antipsychotics for BPSD in people with dementia
• data suggest that treating 1,000 people with BPSD with an
atypical antipsychotic drug for around 12 weeks would result
in:
– an additional 91–200 patients with behaviour disturbance showing
clinically significant improvement
– an additional 10 deaths;
– an additional 18 CVAEs,
• around half of which may be severe;
– no additional falls or fractures; and
– an additional 58–94 patients with gait disturbance.
• For UK
– 1,800 deaths per year
– 1,620 severe CVAEs
Good practice clear – but very much the exception
rather than the rule
•
•
•
•
Antipsychotics should not be a firstline treatment except in
circumstances of extreme risk and
harm.
First line detailed assessment to
identify any treatable cause of the
BPSD (eg delirium, pain, depression
All treatable causes should be
treated with the correct specific
treatment (eg antibiotics for
infection or antidepressants for
depression).
Analysis of behaviour
– is a problem primarily for the person
with dementia, or for their carers
•
•
•
Benign complementary approaches
may be used.
psychological approaches should be
used in the first instance.
Where medication considered, the
potential recipient should be as
involved as possible in the decision
In all cases relatives involved in
discussions about medication.
– information on positive and negative
effects of the medication
– contribute fully to the discussion.
– ultimately a ‘best interests’
decision.
•
•
atypicals rather than typicals
The medication should be used
– lowest possible effective dose,
– shortest possible time <12 weeks.
high rate of spontaneous recovery
– watchful waiting Up to half of all
cases may be self-limiting.
•
•
•
Once initiated, continuation should
be reviewed regularly
– at least monthly);
– at review, reduction or cessation of
the medication should be actively
considered.
Analysis of why
• Symptom of underlying system failure in health and
social care for people with dementia
• 1960s response to a 21st century challenge
• Why lack of response to clear warnings
– It is complicated
– System does not allow change
• Knowledge
• Attitudes
• Provision
• Need to treat the cause as well as the symptoms
Action
3. Provision
of specialist
input
1. Use quality
improvement
mechanisms
2. Improve
skills in
primary and
social care
1. Use of quality improvement mechanisms
R1: Making the use of antipsychotics in
dementia a clinical governance
priority
• across the NHS.
• Using existing clinical governance
structures
• Medical Directors (or equivalent)
– all primary care trusts,
– all mental health trusts and
– all acute trusts
•
•
Review their level of risk in this area
Ensure that systems and services are
put in place to ensure good practice
in the
– initiation,
– maintenance and
– cessation of these drugs
R2: National leadership for reducing the
level of prescription of antipsychotic
medication for people with
dementia
• Provided by the National Clinical
Director for Dementia,
• Work with local and national
services.
• Report on a six-monthly basis to the
Minister of State for Care Services on
progress against the
recommendations in this review.
1. Use of quality improvement mechanisms II
R3: National and local audit
• Developed by the National Clinical
Director for Dementia with national
and local clinical audit structures and
leads,
• Audit to generate data on the use of
antipsychotics for people with
dementia in each PCT in England.
• Baseline audit should be completed
as soon as possible
R4: Improving quality and decreasing
quantity of prescribing
• clear, realistic but ambitious goals to
be agreed for the reduction of the
use of antipsychotics for people with
dementia.
– To one third of current level in three
years
•
– agreed and published locally
– reviewed yearly at
– April-July 2010
•
•
Generating baseline data across
England.
Repeated one, two and three years
later to gauge progress.
Explicit goals for improvement in
their use where needed,
• primary care trust,
• regional and
• national level,
•
Information published yearly on
progress towards them at each level.
1. Use of quality improvement mechanisms III
R9: Inspection
• CQC to consider using as markers
of the quality of care provided by
care homes and PCTs
– rates of prescription of
antipsychotic medication for
people with dementia,
– adherence to good practice
guidelines,
– availability of skills in nonpharmacological management of
BPSD
– the establishment of care home
in-reach from specialist mental
health services
• These data available by analysis
of local audit data and
commissioning decisions.
2. Improving skills
R5: Further research
• including
– clinical and cost effectiveness of
non-pharmacological methods
– other pharmacological
approaches as an alternative to
antipsychotic
• The National Institute for Health
Research and the Medical
Research Council should work to
develop programmes of work in
this area.
R6: Developing skills for GPs and
others working in care homes
• The Royal Colleges of General
Practitioners, Psychiatrists,
Nursing and Physician
• Curriculum for the development
of appropriate skills for GPs and
others working in care homes
• Equip them for their role in the
management
– complexity,
– co-morbidity and
– severity of mental and physical
disorder in those now residing in
care homes.
• Part of CPD
2. Improving skills II
R7: Curriculum for the development
of skills for care home staff
• inc non-pharmacological
treatment of behavioural
disorder in dementia
• deployment of specific therapies
• Senior staff in care homes should
have these skills and the ability
to transfer them to other staff
members in care homes.
• An NVQ in dementia care should
be developed
3. Specialist input
R8: Each PCT to commission
specialist older people’s mental
health in-reach services
• Supporting primary care in its
work in care homes.
• Commission as a new function
by PCTs
• Provided by specialist older
people’s mental health services
• Capacity to work routinely in all
care homes where there may be
people with dementia.
• May be aided by regular
pharmacist input into homes.
R11: Liaison for those in their own
homes
• Contact between specialist older
people’s mental health services and
GPs
• to plan how to address the issue of
people with dementia in their own
homes who are on antipsychotic
medication.
• Using practice and patient-level data
from the completed audits on the
use of these medications, they
should agree
– how best to review and manage
existing cases and
– how to ensure that future use
follows best practice in terms of
initiation, dose minimisation and
cessation.
3. Specialist input II
R10: Psychological therapies for
people with dementia and carers
• IAPT programme to ensure that
resources are made available for
the delivery of therapies to
people with dementia and their
carers.
• Information and support should
be available to carers to give
them the skills needed to deploy
elements of nonpharmacological care themselves
in the home
Final thoughts at publication
• Generation of a balanced report was attempted
• The use of these drugs in those with dementia has substantial clinical risk
attached
– Conservative estimate 1,800 extra deaths and a similar number of extra
serious adverse events such as stroke per year.
• Action is needed quickly
– Symptoms
– Causes
• Action plan
– simple,
– affordable,
– coherent
• Positive act in commissioning the review
• Positive act in accepting the report and its recommendations
• Now needs to be followed up by effective action
– Local
– Regional
– National
What happened next…
• Not a lot…
What makes things happen?
commissioning
Operating Framework 2008/9
‘dementia:
providing people with dementia and their carers the best life
possible is a growing challenge, and is one that is becoming
increasingly costly for the NHS. Research shows that early
intervention in cases of dementia is cost-effective and can
improve quality of life for people with dementia and their
families. The Department will shortly be publishing details of
the clinical and economic case for investing in services for
early identification and intervention in dementia, which
PCTs will want to consider when developing local services ’
Operating Framework 2008/9
‘dementia:
providing people with dementia and their carers the best life
possible is a growing challenge, and is one that is becoming
increasingly costly for the NHS. Research shows that early
intervention in cases of dementia is cost-effective and can
improve quality of life for people with dementia and their
families. The Department will shortly be publishing details of
the clinical and economic case for investing in services for
early identification and intervention in dementia, which
PCTs will want to consider when developing local services ’
Operating Framework 2009/10
60. There have been a number of important
62. The National Dementia Strategy will be
developments in the last year within the
a comprehensive framework aimed at
context of High Quality Care for All that
driving up standards of health and
will help PCTs determine how they develop
social care services to improve the
and implement their local plans. These
quality of life and quality of care for
cover the following areas:
people with dementia and their carers.
PCTs will want to work with local
authorities to consider how they could
• alcohol;
improve dementia services.
• dementia;
• end of life care;
3.30 Nationally, there is a range of tools to
• mental health;
assist PCTs and specialised
• military personnel, their dependants and
commissioning groups in delivering
their priorities as world class
veterans;
commissioners. These include, but are
• mixed-sex accommodation;
not limited to: the developing National
• people living in vulnerable circumstances;
Support teams (NST) for health
and
inequalities, tobacco, alcohol, infant
mortality, teenage pregnancy, sexual
• people with learning disabilities.
health, vaccinations and dementia…
Revision to the Operating Framework for the NHS in
England 2010/11
• One of only two new specific priorities
• 13. During the recent sign-off of SHAs plans, two areas stood
out as not being given sufficient emphasis. The first is
ensuring that military veterans receive appropriate
treatment… The second area is dementia. NHS organisations
should be working with partners on implementing the
National Dementia Strategy. People with dementia and their
families need information that helps them understand their
local services, and the level of quality and outcomes that
they can expect. PCTs and their partners should publish how
they are implementing the National Dementia Strategy to
increase local accountability for prioritisation.
Revision to the Operating Framework for the NHS in
England 2010/11
• One of only two new specific priorities
• 13. During the recent sign-off of SHAs plans, two areas stood
out as not being given sufficient emphasis. The first is
ensuring that military veterans receive appropriate
treatment… The second area is dementia. NHS organisations
should be working with partners on implementing the
National Dementia Strategy. People with dementia and their
families need information that helps them understand their
local services, and the level of quality and outcomes that
they can expect. PCTs and their partners should publish how
they are implementing the National Dementia Strategy to
increase local accountability for prioritisation.
Quality outcomes for people with dementia: building on the
work of the National Dementia Strategy (DH, 2010)
‘There are four priority areas for the Department of Health’s policy development work during 2010/11 to
support local delivery of the Strategy. These areas provide a real focus on activities that are likely to
have the greatest impact on improving quality outcomes for people with dementia and their carers. It
is important to emphasise however that the priorities are enablers for local delivery of the Strategy in
full, across all 17 objectives, as well as the work to implement the recommendations of the report in to
the over-prescribing of antipsychotic medicines to people with dementia.
The four priority areas are:
–
Good quality early diagnosis and intervention for all - Two thirds of people with dementia never receive a
diagnosis; the UK is in the bottom third of countries in Europe for diagnosis and treatment of people with
dementia; only a third of GPs feel they have adequate training in diagnosis of dementia.
–
Improved quality of care in general hospitals - 40% of people in hospital have dementia; the excess cost is
estimated to be £6m per annum in the average General Hospital; co-morbidity with general medical
conditions is high, people with dementia stay longer in hospital.
–
Living well with dementia in care homes - Two thirds of people in care homes have dementia; dependency is
increasing; over half are poorly occupied; behavioural disturbances are highly prevalent and are often treated
with antipsychotic drugs.
–
Reduced use of antipsychotic medication - There are an estimated 180,000 people with dementia on
antipsychotic drugs. In only about one third of these cases are the drugs having a beneficial effect and there
are 1800 excess deaths per year as a result of their prescription.’
Quality outcomes for people with dementia: building on the
work of the National Dementia Strategy (DH, 2010)
‘There are four priority areas for the Department of Health’s policy development work during 2010/11 to
support local delivery of the Strategy. These areas provide a real focus on activities that are likely to
have the greatest impact on improving quality outcomes for people with dementia and their carers. It
is important to emphasise however that the priorities are enablers for local delivery of the Strategy in
full, across all 17 objectives, as well as the work to implement the recommendations of the report in to
the over-prescribing of antipsychotic medicines to people with dementia.
The four priority areas are:
–
Good quality early diagnosis and intervention for all - Two thirds of people with dementia never receive a
diagnosis; the UK is in the bottom third of countries in Europe for diagnosis and treatment of people with
dementia; only a third of GPs feel they have adequate training in diagnosis of dementia.
–
Improved quality of care in general hospitals - 40% of people in hospital have dementia; the excess cost is
estimated to be £6m per annum in the average General Hospital; co-morbidity with general medical
conditions is high, people with dementia stay longer in hospital.
–
Living well with dementia in care homes - Two thirds of people in care homes have dementia; dependency is
increasing; over half are poorly occupied; behavioural disturbances are highly prevalent and are often treated
with antipsychotic drugs.
–
Reduced use of antipsychotic medication - There are an estimated 180,000 people with dementia on
antipsychotic drugs. In only about one third of these cases are the drugs having a beneficial effect and there
are 1800 excess deaths per year as a result of their prescription.’
DH commissioning packs (Landsley 2010)
Commissioning packs are tools to help commissioners improve the
quality of services for patients, through clearly defined outcomes
that help drive efficiency by reducing unwarranted variation in
services.
– Each pack contains a set of tailored guidance, templates, tools and information to assist
commissioners in commissioning healthcare services from existing providers, or for use in new
procurements.
– Integral to each pack is an evidence-based service specification which ensures that patients are
placed at the forefront of the service and are central to decisions about their care.
– The specification is non-mandatory and can be adapted to reflect local needs and once agreed with
the provider should inform part of a renegotiated contract or form the relevant section of the NHS
standard contract.
– By bringing together the clinical, financial and commercial aspects of commissioning in one place,
the packs simplify processes and minimise bureaucracy.
1. Cardiac rehabilitation – Oct 2010
2. Dementia – March 2011
3. Chronic obstructive pulmonary disease
What happens next…
• High likelihood of central
pressure for change
• Increasingly localised
decision-making/
commissioning
• What will be the effect of
cessation without support?
• Interesting times, but never
a better chance for possible
positive change
1. Use quality
improvement
mechanisms
3. Provision
of specialist
input
2. Improve
skills in
primary and
social care
Thank you and good luck!