Research led by Professor Clive Ballard

Our research showing that prescribing antipsychotics for people with dementia often do more harm than good informed a successful campaign to dramatically reduce prescription rates.

Our research showed that antipsychotic drugs prescribed to control behavioural and psychological symptoms in dementia (BPSD) were largely ineffective, caused serious physical side effects, increased the risk of stroke and premature death, and potentially made the symptoms of dementia worse. Our work informed a successful campaign to change prescribing practice, and between 2008 and 2011, there was a 52 per cent reduction in the number of prescriptions for antipsychotics for people with dementia in England.

The team, led by Professor Clive Ballard in our Wolfson Centre for Age-related Diseases, has since produced guidance for health professionals about how to support people with dementia when they become agitated or aggressive, experience delusions and hallucinations, or start to wander – without using medication. The majority of people who have dementia experience these behavioural and psychological symptoms (BPSD), particularly if they live in care homes.

‘Antipsychotics had been used since the late 1950s to sedate people experiencing BPSD’, says Professor Ballard, ‘but no one ever questioned whether they were doing any harm.’

He first discovered that antipsychotics might be detrimental to older people, when working in Newcastle on a study about how BPSD affects quality of life. ‘So we then started looking more systematically at how much these drugs benefit or harm people,’ he said.

After joining King’s in 2003 Professor Ballard and his team continued to investigate antipsychotic drugs. A number of trials showed that antipsychotics prescribed to control BPSD were largely ineffective, and did considerable harm, causing serious physical side effects, increasing the risk of stroke and premature death, and potentially making the symptoms of dementia worse.

These findings were considered by an All Party Parliamentary Group inquiry into the prescription of antipsychotic drugs to people with dementia living in care homes. Their 2008 report recommended that the National Dementia Strategy for England include an action plan to reduce the number of prescriptions for antipsychotics, and that care home staff should be trained to support people with BPSD without using medication. The 2009 Dementia Strategy contained a pledge from the government to do this.

A further report by Professor Sube Banerjee concluded that two-thirds of antipsychotic prescriptions for dementia were inappropriate. NICE now recommends not using medication to manage BPSD unless people are severely agitated.
In collaboration with researchers in Oxford and Newcastle, our research showed that the use of anti-psychotic in care homes could be reduced dramatically if staff were trained to support residents by working with them individually, encouraging hobbies, activities and interests suitable for their background and abilities, and helping them to form relationships with other people.

Developed with the support of the Alzheimer’s Society, the specialist training for staff in care homes is called FITS (Focused Intervention Training and Support). The charity funded a large national trial delivering FITS to staff working at 106 care homes, led by the University of Worcester, which showed a 30 per cent reduction in the use of antipsychotic medication, and that residents in homes with trained staff were more alert, active and communicative.

FITS is now one of several training schemes available for care home staff. ‘All have shown that a few sessions in the classroom won’t work: the key is to work alongside care home staff for six to nine months to embed changes in practice,’ says Professor Ballard.

References

• Ballard CG, et al. Management of agitation and aggression associated with Alzheimer disease. Nature Reviews Neuroscience, 2009; 5: 245-55
• Ballard C, et al. DART-AD investigators. The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial. Lancet Neurology, 2009; 8(2): 151-57
• Ballard C, et al. Investigators DART AD. A randomised, blinded, placebo-controlled trial in dementia patients continuing or stopping neuroleptics (the DART-AD trial). PLoS Med, 2008; 5(4): e76
• Fossey J et al. Effect of enhanced psychosocial care on antipsychotic use in nursing home residents with severe dementia: cluster randomised trial. BMJ, 2006; 332(7544): 756-61
• Ballard C, Howard H. Neuroleptic drugs in dementia: benefits and harm. Nat Rev Neurosci, 2006; 7(6): 492-500
• Ballard C et al. Quetiapine and rivastigmine and cognitive decline in Alzheimer’s disease: randomised double blind placebo controlled trial. BMJ 2005; 330(7496): 874