On June 15, 2005, Health Canada issued an advisory warning that elderly, demented patients prescribed second-generation antipsychotic medications had a 60 per cent greater risk of death than patients taking placebos. That figure was the result of reviewing 13 studies on the issue. Health Canada listed four drugs that could pose adverse risks for seniors:

• Risperidone (Risperdal)
• Quetiapine (Seroquel)
• Olanzapine (Zyprexa)
• Clozapine (Clozaril)

This warning came two months after a CBC News investigation called Prescribed to Death, which examined the over-use of drugs in the elderly. In its advisory, Health Canada requested that the drugs' manufacturers include a warning describing the risk in the safety information sheet for each drug, and that health care providers refrain from relying too much on the drugs to treat dementia.

But a CBC News investigation has discovered that despite the warning, doctors are prescribing more of the drugs to their patients suffering from dementia as a way to calm their behaviour.

David McKie of CBC's Investigative Unit spoke with Paula Rochon, a geriatrician and scientist at Toronto's Baycrest health centre and the University of Toronto. Baycrest is one of the world's premier academic health sciences centres focused on aging.

Rochon works in an environment where a lot of very frail elderly people take large numbers of medications and are very vulnerable to side effects. She's been researching the area of drug prescribing and the elderly for several years. Antipsychotics especially attracted her attention, Rochon says, because they constitute a drug class that is particularly likely to lead to side effects in older adults. She has also looked into whether health advisories have an effect on prescribing practices.

Here is an excerpt of the interview:

Paula Rochon

Antipsychotics are drug therapies that are used in the setting of dementia to manage difficult behaviours. So they're often used if people are very agitated, have aggressive behaviours, psychotic-type symptoms — things like that.

David McKie

And there's no doubt that when a doctor or someone is using these as an alternative, it's pretty serious, right? You're talking about serious behaviour here, aren't you?

Paula Rochon

These are difficult situations, very difficult situations for people to manage. Often they're the sorts of things you manage in nursing home settings. So it is a very big and real problem that people are facing.

David McKie

So this is not, then, to prescribe an antipsychotic, a situation that is entered into lightly? Or is it usually at the end of a lot of exasperation due to prolonged behavioural difficulties?

Paula Rochon

Well I think, I think it should be the latter. I think antipsychotics, sometimes they're a piece that you need to use immediately because situations are very difficult. Those would be sort of situations where the person may be in danger of causing harm to himself or to other people around them and it's a very acute situation where you need to do something. But usually the situation isn't that. Usually you have behavioural problems that are developing over time, and there's the opportunity to sit back and think about what the strategy should be. And antipsychotics should be one of the last things you should consider in one of those settings.

David McKie

OK, so let's take a look at the antipsychotics. Why would you use them in the elderly when you have presumably other alternatives, be they medical intervention or alternative things like behavioural modification techniques that one could adopt?

Paula Rochon

Well, I guess antipsychotics have been widely used and are being widely used because there are not other good drug options out there. But as you've correctly said, there's the strategy of looking after people with behavioural problems associated with dementia to start with non-pharmacologic approaches. So it needs to start with discussions that involve the caregivers, family members, nursing staff, the physicians, the pharmacists to figure out what are the problems that you're dealing with with an individual resident. What is it that's causing the agitation? What can you do to make that better? And often there are simple sorts of interventions that can be put into place that make the behaviours manageable. And you don't need to go to drug therapies. And so that would be sort of the desired approach that you'd want to take.

David McKie

But I guess that demands a lot of staff time at a time when, you know because you do work in the business, there are staff shortages. These are real issues where health-care providers don't have as much time as they would like to implement a lot of these strategies.

Paula Rochon

I think you're right, I think that's a real challenge. That these strategies do take time and they do take effort and they do take commitment. And the nursing home setting is very busy. But it's not all about staffing and numbers. It's about education and thinking about the approach and what you can do. And often finding things that for example family members and other people can do that could contribute and help with the process as well.

David McKie

And I guess we should also stress that although a lot of the writing that you've done from what I can see has focused on nursing homes, long term care facilities, etc., many seniors still live in their homes with some support from family and health-care providers, and they, too, are often prescribed antipsychotics as well, right?

Paula Rochon

That's correct. I mean, they're widely used in the setting of dementia, and so, as you say, many people with dementia are managed very successfully in a home environment, and often these drugs are used in that setting as well.

David McKie

Can you give us a scope of what percentage of seniors have some form of mental difficulty, mental problems including dementia?

Paula Rochon

Well, let's just talk about the nursing home environment. I would say that most of the people in nursing homes have some form of dementia, and within that nursing home environment somewhere like one-third of all nursing home residents are on an antipsychotic therapy.

David McKie

I don't know if you've done any research in this area, but there have been stories in the United States whereby some of the drug companies have been accused of actually targeting nursing homes for marketing these antipsychotic medications because of the profile that you've just mentioned.

Paula Rochon

Well, I think the nursing home population is a very vulnerable population, meaning by definition they are of advanced age. Most of them the average age is in the mid-80s. They have lots of medical problems, they're on a whole range of drug therapies, and they have dementia. And so it's a very fragile population, but this is the population where you may see problems associated with that dementia, behavioural problems, and so it is definitely a place where antipsychotics are being widely used.

David McKie

But is there any evidence that you've seen whereby there is a systematic attempt on the part of drug companies, for example, to market these products, to make sure they are given off-label in nursing homes, in long term care facilities because of the kinds of profile that you've just given us?

Paula Rochon

Well, I guess that's an interesting question and I don't know that we have sort of real evidence on that, but it is interesting that there's not a lot of studies that have actually looked at the benefit of these drugs for the management of difficult behaviours associated with dementia. There are very few studies, and it's interesting that those studies show that these drugs really have only modest benefit in terms of helping to manage these difficult behaviours. And in fact, some of the bigger studies to come out, or one of the big studies that came out, suggested that the risks associated with these therapies outweigh the benefit. So you're dealing with a group of drugs where it's not really clear that they're useful. Yet they're still being widely used.

David McKie

What kinds of explanations are there? Is it just convenience? Is it just habit on the part of doctors?

Paula Rochon

As you know, there have been warnings associated with these drugs, and they're fairly serious warnings. And you would think that would have an effect on prescribing. I don't believe it really has had an effect on prescribing practices. And part of the problem is that they don't think there's a good alternative. They don't really know what they should be doing. There's certainly not a clear drug option they can move to, and so in the absence of other sort of clear information in their perspective, they've continued on with what they know.

David McKie

And what they know is prescribing something that may or may not work?

Paula Rochon

That's right.

David McKie

It's interesting that you talked about the studies. There was a recent study, as you probably know, in the American Journal of Psychiatry, and the conclusion of that study is that the atypicals certainly do not work in people with Alzheimer's. So if they don't work, then the question is, Why are we paying for them? Now, in the States, as you know, the drugs are a little bit more expensive there than they are here, but the point that the study makes is that if you've got a class of drugs that don't work, that are dangerous, that this is something that policy makers should be looking at. Not necessarily Health Canada — apart from approving the drugs and issuing the odd warnings, really I guess that it can't do much. But certainly for the provinces that are responsible for putting these drugs on the formularies and so on, should this be something that policy makers at the federal and provincial levels should really be taking a look at now?

Paula Rochon

I think it is an important issue. I think the drugs are available through the provincial benefit system for providing drugs, and they're fairly expensive. I think it's something we need to start thinking — if they don't really work and they have side effects associated with them, maybe there's a better way to spend our resources and maybe there are mechanisms to do that which would involve educational interventions to help people to move from using those kinds of therapies to better options that might work.

David McKie

Can you see that happening? I've been looking at some of the dates of the articles that you've been involved with writing, and they go back a few years. None of this is a mystery to anyone anymore. Health Canada put out a warning on June 15, 2005. The FDA has had black-box warnings. There have been studies. This is out there, but yet these drugs are still on formularies and the prescribing patterns have not been altered one iota. So none of this seems to be having any effect on prescribing patterns.

Paula Rochon

Well, I think this is the sort of situation where, it's difficult because the nursing home population is, as we've said, a vulnerable group. You know, they're old, they're frail, they have lots of medical problems. They can't really speak for themselves in terms of what's right or what's wrong. They're not in a position to do that, especially when they have problems like dementia. So it's important for their family members, caregivers and staff around them who are working in these situations to help continue to bring the issue forward and come up with better solutions. And I think right now one of the reasons why people are continuing to prescribe is that they don't have a sense of what another option would look like. And I think we are spending, through our funding, a lot of money on these therapies right now. We could maybe be reallocating that in other ways that could be beneficial, even though it's difficult. I think that's where the discussion has to go, and that's what we have to start doing.

David McKie

Can one conclude that if you put out an advisory warning people and two years later, if you take a look at the number of prescriptions written and the fact that the majority of these scripts for the atypicals described in that advisory are for low doses, which would indicate that they're being prescribed off-label among seniors, can we conclude from that that the advisory from Health Canada on June 15,2005, did not work?

Paula Rochon

I don't think it did work. I think people accept that, and I think to make an advisory like that work, you need to couple it with some clear guidance from professional organizations to say, What should we be doing instead?, and give people some guidance. I think physicians right now are feeling they don't know what else they can do, and so that's what they're sticking with. But, if you could give them some better advice and do it in some way that's had buy-in from some different organizations, then that, in addition to the warnings, might be a useful strategy.

David McKie

So how could that warning back in June 15, 2005, have been worded or put together in a way that would have carried more meaning?

Paula Rochon

Well, I think the warning was fairly clear, but I think some of the responsibility also goes with other groups that could support those warnings. So other professional societies, professional groups, who are working with this population should really be coming together and coming up with information that could really be used to help give guidance to people working in this setting. And it's not only about just starting the therapies. It's also about re-looking at people on the therapies who maybe don't need to still be on the therapies.

David McKie

So, and I'm not asking you to scoop yourself, but you are coming out with a journal article that takes a look at Health Canada advisories? And I think that one of the conclusions that you will reach is that they don't work?

Paula Rochon

Well, I think that from a lot of the studies that we've done, the data that's out there in terms of prescribing patterns after the Health Canada warnings, we can see that these drugs are still being very widely used, that's quite clear.

David McKie

Without scooping yourself, in general terms, what are some of the conclusions that you've reached after having studied these advisories about why they don't seem to be working?

Paula Rochon

Well when we discuss this issue, and we discuss it a lot amongst our research group — which includes psychiatrists, geriatricians, internists and other professionals working with this population — we all wonder why they haven't had more impact. Because, clearly, they are strong warnings. The kinds of things they're talking about are things that are serious problems and things that are outcomes that you definitely don't want to be happening.

David McKie

Such as?

Paula Rochon

Well, such as death. That was what one of the warnings was about. Another was about linking it to problems like stroke. In addition to that, we all know that in clinical practice these drugs are associated with problems like Parkinsonism, problems with difficulty walking, with falls, problems which can lead to hip fractures — a big problem in this population — sedation, which can lead to problems like pneumonia. So these are very, very serious problems.

David McKie

When you looked at advisories, did you look at a number of advisories with regards to antipsychotics or just in general or what exactly?

Paula Rochon

I think the question that we're interested in looking at is the one that you're interested in as well, I think, which is how can you make advisories which you think are important, better. And part of it isn't necessarily about the warning itself, but maybe it's about some of the other things that need to happen to complement that warning. So I think what we're looking at, and what we can see from a lot of different kinds of information, [is] that the warnings themselves, in the absence of other kinds of information that would help clinicians and professionals working in this group, don't have the effect that they should. And we need to think about how to strengthen them, which would involve other strategies that could complement the warnings.

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