Dementia and antipsychotics: medication or management?

Dementia can trigger behaviours that are deeply depressing to loved ones. Aggression, agitation and even delusions and hallucinations. Antipsychotic medications are commonly prescribed. But they are now known to increase risk of mortality and stroke, with concerns that their use is excessive in under-resourced aged care settings. Management tool or good medical practice?

Natasha Mitchell probes. ABC - Radio National

Transcript

Natasha Mitchell: All in the Mind on ABC Radio National, Natasha Mitchell with a warm welcome to you. One thing we can be sure of is getting older, perhaps very old. So what sort of care do you expect when you can no longer make decisions for yourself -- decisions about the medication you're given, for example?

Worldwide there are 25 million people with dementia, some 200,000 Australians, and that's on the rise. This is a disease with behaviours that can be deeply distressing for loved ones. Aggression, agitation, even delusions and hallucinations. So antipsychotic medications are widely prescribed, despite growing evidence about the risks and concerns that their use is excessive in under-resourced nursing homes.

So, a management tool or good medical practice? That's today's show.

First let me share the experience of a second cousin of mine, let's call her Jane, with her 89-year-old mother, who has vascular dementia. Her mum's also had open heart surgery in the last few years and, as you'll hear ,the use of antipsychotics in dementia patients with a history of heart troubles is considered high risk, and should only be for extreme behavioural challenges. Jane wasn't told when her mother was put on antipsychotics during a recent stint in hospital, or why. And this is not an uncommon experience.

Jane: I mean the symptoms she exhibited as result of taking them, she had incredible diarrhoea, like totally uncontrollable, her room was a mess at her place. She looked as if she was almost dead, she was just sitting in a chair with her head bowed and a shade of grey, like she had deteriorated very rapidly. Anyway what was sorted out between these two doctors was that they would wean her off it over two weeks, which they did, and she immediately started to perk up again and become more normal.

Natasha Mitchell: What happened with the diarrhoea?

Jane: Well that stopped too; the only time if she has diarrhoea is because when I take 3 kilos of mandarins to her she eats them all in one day.

Natasha Mitchell: At any point, were you told that she was on an anti-psychotic medication?

Jane: Absolutely not, not a word. It was only because I happened to know what it was and see it on the bill I was paying. Normally the average person wouldn't have a clue what that was, and probably their family member would be dead, because I really felt like she was going to die pretty quickly.

Natasha Mitchell: What was your reaction to hearing and seeing that she was on an anti-psychotic medication?

Jane: I was furious. My first response was oh they have a tame doctor at this aged facility and he just prescribes any old drug that's going to keep them quiet so they are easy to manage. But that turned out not to be the case. And it wasn't her regular geriatrician, it was a geriatrician that just happened to be on duty because hers was away on a holiday.

Natasha Mitchell: Did you get an explanation for why she had been prescribed an antipsychotic medication?

Jane: No, because the conversation was a very polite one between the two doctors on the phone.

Natasha Mitchell: Do you get a sense that medications are being used as a management tool of some sort in the various care settings you've witnessed now?

Jane: Oh, absolutely, just keep them quiet and sitting there and not -- you know -- creating a fuss.

Henry Brodaty: Think about it another way, if we had a child in hospital and the child was being given medications or treated in various ways we, as a parent, would want to know what's happening, to be informed about it, asked to give consent. And it's the same way when we're responsible for a person who's older and unable to care for themselves or make those decisions. So it's incumbent on the family as well to take some initiative in this.

Lon Schneider: Forty to fifty per cent of our patients with dementia will develop delusions of a significant degree as an example. Thirty or forty per cent will develop aggression; in nursing homes the majority of patients have behavioural problems.

Daniel O'Connor: Some people with dementia, for example, will insist that their spouse is an impostor, they'll say this person may look and sound like my spouse but I know that they are not, this is a person masquerading as my spouse; their presence here frightens and alarms me; I want them to leave, if they don't leave I'll call the police. People can also have hallucinations, people with Lewy Body type dementia, for example, can have very vivid and sometimes extremely frightening visual hallucinations, perhaps people wanting to hurt or harm them in some way.

Natasha Mitchell: Daniel O'Connor is professor of old age psychiatry at Monash University and we'll hear more from him next week.

Lon Schneider: Unfortunately these problems are not easy to treat, they are hugely distressing, they very much affect quality of life of a patient and also care-givers, they often prevent patients from getting adequate care.

Gerard Byrne: A small group of people with dementia do exhibit very severe behavioural disturbances including repetitive physical violence against the people who are looking after them or against other people with dementia in the residential care facility or perhaps at home. So quite serious problems which do need some form of intervention. In those situations most doctors and other medical personnel who are looking after these people agree that the use of, or restricted use of, anti-psychotic drugs is probably a reasonable thing. The question in my mind though is are these drugs being over-prescribed for behavioural or psychological problems for which there's very little evidence that they work?

The think to remember is that people with dementia are not stupid, but they do have brain failure and so they have a reduced capacity to understand what's going on around them, and they're more likely to resort to primal responses; and that's why we commonly see aggression or paranoia. And it's an easy solution to reach for antipsychotic medication, and I suppose until the funding model improves in residential age care and there's a greater understanding of the nature of dementia and how it's experienced by the people who have it, I suppose antipsychotic medication may well be used too often.

I'm not saying there isn't a place for it; there is, but it's probably being used too often.

Natasha Mitchell: Professor Gerard Byrne, head of psychiatry at the University of Queensland and he heads up The Older Persons Mental Health Service at the Royal Brisbane and Women's Hospital.

And before him three other world leaders in dementia care and research -- more from them later.

Neither the USA's federal drug watch dog the FDA, nor the UK's Committee on Safety of Medicines have approved the use of antipsychotic medication for behavioural problems in dementia; and the products carry warnings on their labels on the risk of doing so. Australia has approved one risperidone or trade name Risperdal but no others. But in reality they're being widely used off-label for dementia in all of these countries, that is, at the doctor's discretion.

One UK report suggests that 'more than 40% of people in residential care are taking antipsychotic drugs, often inappropriately and usually with little monitoring.' And a selective survey of Australian old age psychiatry units published last month in the Australasian Journal of Ageing reported on incidences of people with dementia on not just one, but two and even three different antipsychotic medications at once. Gerard Byrne.

Gerard Byrne: Antipsychotic drugs are widely prescribed, actually for a whole variety of different behaviours, some of which they are better at helping than others. The sort of common behaviours that you see in people with dementia, including apathy and depression, calling out or wandering behaviours, these behaviours are not responsive to antipsychotic medication as a general rule unless the person with dementia is being over-sedated by the medication.

Lon Schneider: These are medications that are not the most effective.

Natasha Mitchell: Lon Schneider is professor of psychiatry, neurology and gerontology at the University of Southern California. He also heads up the clinical program of the National Institutes of Health Alzheimer's Disease Research Centre and has led a number of key trials investigating the effectiveness of antipsychotics in dementia.

Lon Schneider: They're modestly effective if at all. They help some people to limited degrees. They do then become overused and are overused in many situations. So it's not the act of using the medication it's the failure to monitor, placing patients on medications for long periods of time even though it's not helping them or, alternatively, using doses of medication, not just antipsychotic medication, in order to sedate and make a patient easier to manage, at least over the short run.

Natasha Mitchell: Do delusions and hallucinations in dementia share the same basis or the same mechanism as in schizophrenia, for which antipsychotic medications are primarily approved for in Australia and the USA?

Lon Schneider: The short answer is we don't know.

Gerard Byrne: No they don't, the current view is that schizophrenia is a neuro-developmental disorder, as the brain develops in late adolescence and early adult life for the most part, whereas most cases of dementia are neuro-degenerative in the sense that some progressive disease process affects the ageing brains. So they are quite distinctive disease processes actually, but in some cases with similar symptoms. So because these drugs are being used to treat symptoms, not the underlying disease then the idea emerged that well they might be useful outside their core indication of schizophrenia. And so trials, clinical trials were conducted and they proved to be modestly effective in some people. And as a result of that the argument was put to the regulatory authorities around the world and succeeded in Australia for this particular drug, Risperdal.

Natasha Mitchell: Are anti psychotic medications in some cases being used as a quick fix management tool in some aged care settings in Australia, where the resources just really aren't there to deal with difficult behaviours? That's a concern that some people have -- is it a valid one?

Gerard Byrne: I think it may well be in some cases that antipsychotic drugs are being overused. However you have to bear in mind the very difficult situation that staff in residential aged care facilities in this country find themselves in. The funding model for residential aged care seems to be inadequate and the staff to patient ratios are not good, and so the level of personal care that's being provided in many homes is not, in my view, sufficient. This is a view that is held by quite a number of people, particularly family members of people who are residing in residential aged care facilities at the moment. So in that situation it's easy to resort to the use of potent pharmaceuticals, including antipsychotic drugs, in an attempt to control behaviour where perhaps less restrictive options might be possible if there were more staff and better trained staff and more appropriately designed facilities.

Henry Brodaty: It's very difficult if you're a general practitioner and you're called by the nursing homes and told Mrs Smith is hitting all the other residents and is impossible, you have to prescribe something doctor. And the doctor doesn't have the expertise in managing behavioural disturbances. Often they'll go along with whatever the nursing staff require after checking that it's not contra-indicated and prescribe the medication.

Natasha Mitchell: : Old-age psychiatrist Professor Henry Brodaty and before him Professor Gerard Byrne. This is All in the Mind on ABC Radio National in National Mental Health Week, going global on Radio Australia, online and as podcast.

Antipsychotic drugs are commonly prescribed in dementia despite the risks and concerns that their use is excessive. Management tool or good medical practice? And sharing a story from my extended family, while in hospital with a nasty infection my second cousin's mother was prescribed antipsychotics, she has dementia, wasn't aggressive but had taken to wandering. At what point did you find out she'd been put on antipsychotics?

Jane: I didn't notice it originally, nobody tells you what they're on, it was only when I was paying the chemist's bill that I saw this Risperdal and I knew it was an antipsychotic, I'd known someone who had been on it at some point in their life and so the alarm bells started ringing. So I got on the web and downloaded information about it, which said it was not something to treat geriatric cases with, it could cause ultimately death etc. etc. So I got very upset, at this point she'd moved into an aged care facility and I asked them about this and they said, well it was not their local doctor that looks after their clients, it was actually diagnosed while she was in hospital. So I actually got a list of all her medication and went to her GP that she saw regularly before she had all these problems and she lived at home. And we went through the list of prescribed drugs and he took a couple off that he'd prescribed saying that he didn't think she needed them and he rang the doctor who had prescribed them at the hospital who then got back to him while I was still there and said oh no, he didn't feel she should be on it and it would be a good idea to take her off it.

Natasha Mitchell: Do you get the sense that a review of her medication -- in particular the antipsychotic -- would have happened had you not taken it up with her original doctor.

Jane: Nope, I got no feeling they were going to review; in fact, just recently, they've changed the medication again and we've had another trauma where she got quite agitated and has fell and broken her hip. And she's actually been -- one thing physically she's been quite mobile all the time -- so this was rather horrible and I have a feeling that the new medication is also having a bad impact. Two antidepressant Serepax and I can't remember the name of the other one unfortunately but apparently it's a strong antidepressive.

Lon Schneider: The Alzheimer's disease studies that we did looked at three of the most commonly used atypical antipsychotics, and initially compared them to a placebo in patients with Alzheimer's disease.

Natasha Mitchell: Professor Lon Schneider has led a number of key trials and research reviews on whether antipsychotic medication is suitable for people with dementia. One key study, a double blinded, randomised placebo controlled gold standard, focused on the newer or so-called atypical antipsychotics like Risperidone.

Lon Schneider: And the genesis of this, and the rationale was, they are being very widely used in patients with Alzheimer's disease yet the evidence base was rather skimpy. Out of that study we generally found the atypical antipsychotics that we looked at were not substantially and significantly more effective than a placebo. We also tended to find that the medications were associated with the diminishment in some symptoms but often not -- even though you could measurably see some improvements overall, the drugs were not terribly effective. Our conclusion from this study was the drugs should be used carefully and that we should be weighing benefits with the risks and assessing whether individual patients are benefiting. If they're not benefiting -- stop.

Natasha Mitchell: What are the common negative side effects for people who are put on antipsychotics if they have dementia?

Lon Schneider: The negative adverse events vary. For example, in our study some sedation, some of these medicines are associated with muscular stiffness or rigidity or postural instability; we saw increased confusion...

Natasha Mitchell: Which is unfortunate, isn't it, because we're dealing with a community of people who are already deeply confused as a result of their dementia?

Lon Schneider: Well it's quite unfortunate and we saw -- and others in other studies were able to observe -- that these medications are associated with a worsening of cognition, a small amount of worsening of cognition that's about the same magnitude as the improvement in cognition associated with the cognitive enhancing drugs for Alzheimer's disease such as Aricept. So in effect we saw the negative effect of that. Now to the degree that an individual, though, is affected by that really varies with the individual. So some individuals could have benefited from having their behaviour improved even at the expense of worsening cognition.

Natasha Mitchell: Let's look at two other key risks of concern. There have been a number of trials trying to probe -- or certainly an analysis of existing trials -- trying to probe whether antipsychotics increase the risk of death in these patients, and also the risk of stroke. What's the picture there?

Lon Schneider: People started to notice, as we pooled the results, as we looked at the results through a technique called meta-analysis, there was an increased number of deaths in patients who received antipsychotic medicine compared to patients who received placebo. And it works out to something of the order of one to one-and-a-half per cent increase in risk for death over the course of 10 to 12 weeks. This was of concern to regulatory agencies and resulted in a warning on the labelling that this might occur. Unfortunately we don't know the mechanism.

Natasha Mitchell: Professor Lon Schneider. There's also evidence of an up to fourfold increase risk of cerebrovascular events, including stroke, in people with dementia on antipsychotics. Henry Brodaty, professor of aged care mental health at the University of NSW and Director of the Dementia Collaborative Research Centre, was part of a team which was the first to see this connection in a clinical study.

Henry Brodaty: There is a risk profile with antipsychotics, in fact our study was, I think, the first to draw attention to the increased rate of stroke in people on antipsychotics and that was a trial of Risperidone. It's since been shown that that risk is increased with all antipsychotics and may be even greater with the typical or more traditional antipsychotics like Haleperidol.

Natasha Mitchell: In both dementia and more widely, or just dementia?

Henry Brodaty: Well that's also another excellent question. The data had been shown for people with dementia, analyses from the drug companies looking at their data sets and people with schizophrenia -- even older people with schizophrenia -- they don't show the same increased mortality. In our sample the people who did have the stroke were people who had a number of vascular risk factors, they had high blood pressure, they had heart disease, they had rhythm problems with their heart, they had evidence of clogged up vessels elsewhere in their body; so they had a number of risk factors. But so did the people on placebo and they didn't get the strokes, so it's a real effect, but the mechanism for it is unknown. There are good data that the antipsychotics have a beneficial effect, particularly on aggression as a behavioural disturbance, somewhat on agitation, but not a great effect on other behavioural disturbances like people who are calling out, or screaming, or people who are wandering.

I think it's very clear, it shouldn't be the first line of treatment, it should only be used when other methods have failed, unless there's urgency or danger involved -- that when antipsychotics are prescribed that particular care needs to be taken with people who have cardiovascular risk factors: history of high blood pressure, history of stroke, history of heart attack, history of abnormal rhythms of the heart. So with those people it would be even more concerned. It's imperative to get informed consent before prescribing medication from the person responsible, usually the next of kin. Let the family know that there is a risk, there's also a risk of not treating somebody as there is a risk of treating somebody. And also the medication shouldn't be continued forever.

There was a study that came out this year called the DART AD trial which was a withdrawal study led by Clive Ballard in the UK, and what he showed is stopping medication had no ill effect on people who'd been on chronic neuroleptic or antipsychotic treatment for at least twelve months.

Natasha Mitchell: Yes in fact we're dealing with a population here who are often on many medications, they may have had a number of different treating doctors as they transition from home to hospital to residential care -- and certainly in a recent edition of the Australasian Journal of Ageing, a paper that you were involved in, it seems that some people were on to up to three antipsychotics, two or three antipsychotics - is that ever justified?

Henry Brodaty: No, poly pharmacy is something all doctors strive to avoid, using multiple psychotropics so drugs that act on the mind is not a good idea, it increases the risk of falls, it increases the risk of confusion.

Natasha Mitchell: I think also the reality is that family members -- so those who are responsible for the people with dementia -- don't always know what medications they're on and don't fully understand the consequences of those medications. I mean treating doctors don't fully understand the consequences of the medications, so that consent issue is a woolly one, isn't it?

Henry Brodaty: It is. We did a survey of three nursing homes in Sydney where we looked at how often the legal requirements had been satisfied for getting written informed consent from a family member and found that for only 6.5% of the residents in nursing homes was that complied with.

Natasha Mitchell: Professor Henry Brodaty director of the Dementia Collaborative Research Centre in Sydney. How would you consider that things could be done differently in your role as a daughter trying to navigate your mother's care and the regime of medications that she's on?

Jane: Well I think really, especially as I've got enduring power of medical attorney as well as enduring power of attorney, that any change or any medication should be discussed with me before it's administered. And if I don't know about it then I can discuss it with an uninterested party, someone not involved in the care who might know about that particular drug.

Natasha Mitchell: Are you personally convinced in your own practice as a psychiatrist by the evidence that antipsychotics are an appropriate way to respond to agitation -- or even delusional thinking in dementia.

Gerard Byrne: Well my view on this, Natasha, is that not all psychotic symptoms in people with dementia require treatment with antipsychotic medication. There's a reasonably high prevalence of hallucinations amongst people with no mental disorder or brain disease in the community. Many of us have heard a hallucination when we are in the shower where we hear our phone going, or we hear the doorbell, or we think our spouse has called out our name, only to get out of the shower and find the house is empty and there haven't been any phone calls, the spouse has long since left for work and there are lots of examples of that from every day life - that's just one example. In people with dementia they are really quite common and many of these hallucinations are friendly voices, or fleeting visual apparitions of someone they know or a friend or a relative visiting -- and don't cause the person any distress. My particular point of view is that if they don't cause distress then you really have to consider whether the risks associated with the use of antipsychotic drugs in this particular group of people is worth it. And in my view it's very important that before reaching for the prescription pad doctors need to think about what's going on in the environment of the person who's got dementia and has psychotic symptoms or agitated behaviour.

I mean the obvious thing is that there could be some inter-current medical problem; the person might have a bladder infection, or a chest infection, or a skin infection, or they might have some drug interaction going on, or they might be over-sedated with sleeping tablets or other sedative medications, or they might be getting some side effects from general medical medications that are prescribed. They might be in pain or discomfort and it might not be obvious to those around them that this is the case because some people with dementia will have a lot of difficulty articulating their pain or discomfort, so it's very important that these general medical problems and possible causes of pain and discomfort be considered before just jumping in with antipsychotic, or other types of psychotropic medication, for that matter.

The next class of issues in my mind is what's happening in the environment and what's happening in relation to the behaviour of the people looking after the person with dementia. I think when you look at some of the environments that people with dementia are cared for in, and you look at some of the behaviours of some of the people caring for them, then you can understand some of the behaviours of the person with dementia.

Natasha Mitchell: What do you mean by the environments that they're cared for in?

Gerard Byrne: Well some of the environments are less than ideal in the sense that they often do not have ready access to the outdoors, they don't necessarily have good lighting, are often noisy and have bad smells, the floor-space available for each person is often not adequate, opportunities for constructive activities and diversional activities and recreational activities is often poor. The staff through no fault of their own are often poorly trained, rushed off their feet -- and so the whole situation is really quite adverse for the person with dementia. And you have to remember that the person with dementia has a brain which isn't working properly, so they're trying to make sense of this sort of adverse environment and the odd behaviour of the people in the environment -- odd to them -- and they don't have a brain that's working well enough to sort of suss all of that out. If you put one of us without dementia into such an environment we wouldn't be very happy.

Natasha Mitchell: We'd walk out -- and people do.

Gerard Byrne: We'd walk out, and people do, that's right. And this idea that people with dementia should be quiet, not walking around and lying in their beds behaving themselves is ridiculous because none of the rest of us would put up with that.

Natasha Mitchell: Professor Gerard Byrne, director of The Older Persons Mental Health Service at the Royal Brisbane and Women's Hospital.

Jane: Because she really liked the other place, where she could go out the door and go for a walk down along a nice grassy walk with plants -- and she's a very keen gardener. Well she doesn't get that opportunity any more, they've got a little locked down garden but they don't allow them out there which to me I find extraordinary. So when I get these things about her being agitated and whatever, I think maybe she just wants to escape from this place. And the other day when I took her out, before she broke her hip, and we were leaving she went up to the desk and said thank you very much for having me to stay, I am going home now. Which was very sad for me because I then had to say, well we are actually just going out for lunch in the Botanical Gardens today.

Natasha Mitchell: The trials of supporting a mother with dementia. Next week a ground-breaking nursing home in Tasmania changing environments rather than medication to change difficult behaviours in dementia, and their approaches are outside the square. More details on our website of today's show and also the downloadable audio and a transcript along with the email address, as ever, and my blog for further info and discussion abc.net.au/rn/allinthemind.

Thanks to co-producer Kyla Brettle, studio engineer Carey Dell, I'm Natasha Mitchell, until next week take care.

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