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Sept. 28 2010: Conference Presentation by Michael Stones The Canadian Network for the Prevention of Elder Abuse report that Statistics Canada 2001 Census shows that 9.2% of women and 4.9% of men aged 65 and over lived in health care institutions known as long-term care facilities. These include a wide range of institutions such as personal care homes, nursing homes, homes for the aged, and complex care facilities. One form of abuse within such institutions is systemic abuse, for which they offer an unspecific definition of ‘practices that take away a person's independence and dignity’. Related forms of abuse include over-medication and under-medication, and abuse by inappropriate use of physical and pharmacological restraints. At particular risk to these forms of abuse are people with dementia. ‘Dementia’ is a term used to describe a syndrome that may be caused by a number of illnesses in which there is progressive decline in multiple areas of function such as declines in memory, reasoning, communication skills and the ability to carry out daily activities. Alongside these declines, individuals may develop behavioral and psychological symptoms such as agitation, aggression, wandering, shouting, repeated questioning, sleep disturbance, depression and psychosis. These cause problems in themselves, which complicate care; they can occur at any stage of the illness.
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How many people with dementia are treated with antipsychotic medication? Censuses of the residential
and nursing home populations in Leicestershire in the UK indicated a stable prevalence of antipsychotic prescribing for cognitively impaired residents between 1990 (29.1%) and 1997 (30.7%). A more recent study in 12 nursing homes across 3 English cities (London, Newcastle and Oxford) found 48% of people with dementia to be on an antipsychotic. A recent report from IMS Health, a provider of pharmaceutical market information, suggested that 20.3% of prescriptions for the treatment of people with a recorded diagnosis of dementia included an antipsychotic drug, a proportion similar to those reported in Italy and Spain. However, these findings are likely underestimates because up to two-thirds of people with dementia do not have a formal diagnosis made and so it will not be on their notes. In Ontario, numbers and rates of older people with dementia who were prescribed antipsychotic drugs increased over the period 2000–07 – from 1.1% to 1.8% of the whole over-65-year-old population (roughly a quarter to a third of all people with dementia). Of the people with dementia receiving antipsychotic prescriptions, 41.8% were aged over 85 years and 70.5% were nursing home residents. Among residents of long-term care homes not receiving antipsychotic medication when admitted, nearly one-quarter received such medication within a year.
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Our research concurs with these findings, indicating that about one-quarter of residents of long-term care homes and patients in complex continuing care in Ontario receive antipsychotic medication. These people engaged in verbally or physically abusive behavior toward staff or other residents, or in socially inappropriate behavior, although they were not necessarily resistive of care or engaged in wandering. The evidence from Ontario suggests only a modest impact of the several pharmaceutical company and regulatory authority warnings regarding serious adverse events on prescribing antipsychotic medication.
What are these serious adverse effects? In October
2002 the manufacturer of risperidone notified Canadian healthcare professionals that in drug-sponsored clinical trials, risperidone users had been found to have a higher rate of cerebrovascular adverse events (CVAEs) relative to those receiving placebo. In 2003, the US Food and Drug Administration (FDA) and other authorities published warnings and required changes to the prescribing information for risperidone. In 2004 the European Medicines Agency (EMEA) also issued public advice about an increased risk of cerebrovascular adverse events and mortality in elderly patients with dementia receiving olanzapine. In March 2004, the UK Medicines and Healthcare products Regulatory Agency (MHRA) informed clinicians that risperidone and olanzapine should not be
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used to treat behavioral and psychological symptoms in dementia because of increased risk of strokes with both drugs. Similarly, in 2005 the US Food and Drug Administration (FDA) issued warnings for aripiprazole regarding the risk of cerebrovascular adverse events , including stroke, in elderly patients with dementia. In April 2005 the FDA informed health professionals of the results of an independent, pooled analysis of 17 randomised controlled trials reporting a 1.7 times increased risk of allcause mortality associated with atypical antipsychotic use compared with placebo. In November 2006, the National Institute for Health and Clinical Excellence in the UK recommended that: (1) People with dementia who develop such symptoms should be offered an assessment at an early opportunity to establish likely factors that may generate, aggravate or improve such behavior; (2) They should be offered a pharmacological intervention in the first instance only if they are severely distressed or there is an immediate risk of harm to the person or others; (3) They may offered treatment with an antipsychotic drug only after conditions have been met that include full discussion with the person with dementia and/or caregivers about the possible benefits and risks of treatment (in particular, cerebrovascular risk factors should be assessed and the possible increased risk of stroke/transient ischaemic attack and possible adverse effects on cognition discussed);
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(4) Such treatment should time limited and regularly reviewed (every 3 months or according to clinical need). Our evidence from Ontario indicates that once administered antipsychotics, 80% of residents remain on that medication 9 months later. In November 2009, Professor Sube Banerjee reported to the Minister of State on the use of antipsychotic medication for people with dementia in the NHS in England. His conclusions included the following. (1) These drugs appear to be used too often in dementia and, at their likely level of use, potential benefits are most probably outweighed by their risks overall. This is a problem across the world, not one just restricted to the NHS. He is positive that, with action, we have the means with which to sort out this problem, quickly and safely. (2) It is clear that the overuse of these drugs reflects a cumulative failure over the years to develop an effective response to the challenges of dementia. (3) Using the best available information, he estimated that for every 1000 people with dementia and treated with a 12-week course of antipsychotic medication, less than a quarter will derive some benefit from the treatment.
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(4) Negative effects directly attributable to the use of antipsychotic medication include an additional 10 deaths per year, an additional18 cerebrovascular adverse events per year, around half of which may be severe, and an additional 60-100 individuals with gait disturbance on top of those that would be expected in this frail population. With the antipsychotic medication continued for two years, he estimated the number of additional deaths directly attributed to antipsychotic medication of up to 170 deaths within two years. (5) He estimated that it is reasonable to reduce the rate of use of antipsychotic medication to a third of its current level, and realistic to do so safely over a 36month period.∗
∗
The report is available on the Internet at:
.
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Table 1: Expectations of excess 1-year mortality based on a baseline rate of 25%, with 25% of residents on a 12-week course of antipsychotics
Use and # of Baseline Expected Effects of Cases Deaths Additional Deaths Antipsychotics Benefit No Benefit No Antipsychotics Total
50 200 750
12.5 50 187.5
.4 1.6 0
1000
250
2
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Table 2: Expectations from Banerjee (2009) for the excess numbers of cases per 1000 dementia patients that died after a 24month course of antipsychotics
Effects of # of Expected # Antipsychotics Cases of Additional Deaths
Benefit No Benefit Total
200 800 1000
34 136 170
Professor Banerjee offered 11 economically feasible recommendations for alternative treatment of behavioral and psychological symptoms in dementia to the use of antipsychotic medication. Some of these relate to the UK’s NHS but most have relevance to a Canadian context. Broadly, the recommendations revolve around education and implementation of a patient-centered approach – trying to make sense of and deal with the reasons why these symptoms arise – and how long-term care homes, physicians, mental health specialists and community organizations can combine and offer pooled solutions. Our research and that of others suggests that physical discomfort and distress are key elements in the origin of symptoms, a proposition with which Banerjee would probably agree. If people with dementia are neither
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uncomfortable nor distressed, they probably will not act out. What is worrisome in a Canadian context seems to me to be a cultural apathy toward the problem not just within the health care system but also in wider society. With a health care system perceived to be under some threat, who dares criticize or to re-label accepted practice as systemic abuse? What does the Alzheimer Society of Canada have to say? The head of its British counterpart, Neil Hunt, was certainly vocal about Professor Bagerjee’s report. “This, long awaited, landmark review is a welcome recognition of the scale of the issue and Alzheimer's Society's view that these drugs should only ever be used as a last resort, he said, “Today must mark a change in dementia care.” The British government also welcomed the report and accepted its conclusions. It said that the level of additional deaths due to antipsychotic use in people with dementia was “totally unacceptable”. The time is long since past when geriatrician Robert Butler railed against “pacification” by medication in the USA and was lauded for his efforts. The time is over, too, when people like me needed to carry out more background research. The time is now for people within our health
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care system or otherwise friendly to people with dementia to begin the process of effecting the required changes.
