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Missed opportunities

A decades-old generic drug could be the key to helping more people with schizophrenia, argues David Kitchen

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Opinion

Not withstanding the current travails of the NHS, most areas of medicine today have well developed and successful models of treatment, support infrastructure and development strategies that are encouraging for the future.  Yet, our approach to serious mental illness, in particular schizophrenia, is neglectful by comparison.

To give some context, between 0.7 and 1 per cent of the UK adult population (approx. 500,000 people) are currently suffering with schizophrenia or a related disorder and, on average, their life expectancy is 15-20 years less than that of their peers who don’t have an serious mental illness diagnosis.

Within this group there is a spectrum of severity of presenting symptoms, from mildly disabling to completely debilitating.  Added to this, there is a wide variance in response to the many antipsychotic medications that we have available to prescribe.  A given treatment is usually taken for at least a 2-3 month trial period, to assess the clinical effect and tolerance.  If someone fails to respond sufficiently – or is unable to tolerate – two of these treatments, then there is little chance that subsequent options will achieve an improved outcome.  Hence, at this juncture they are considered to have a diagnosis of treatment resistant schizophrenia (TRS). Around 30 per cent of the schizophrenia population (approx. 150,000 people) have a diagnosis of TRS.

There is only one drug that is licensed for the treatment of TRS: the antipsychotic clozapine, which is regarded as the ‘gold standard’ treatment for these patients due to its superior efficacy. Clozapine, which has been available for several decades, has the advantage of being relatively inexpensive, in part because it is available as a generic medication.

Yet the disappointing reality is that of all the people with TRS, we barely treat a quarter of them with the only licensed treatment available for their condition. Why?

Clozapine is admittedly a complex drug to prescribe, primarily due to its significant side-effect profile. Indeed, shortly after it was first introduced, concerns regarding serious haematology side effects led to it being temporarily withdrawn from the market. It was only reintroduced once robust safeguards, involving monthly blood tests, had been established.  After many years, however, these measures have proved successful; the risk of clozapine-related blood disorders has been virtually eliminated. There are still lingering concerns regarding other side effects, principally related to cardiology and gastroenterology.  Again, though,  some services have been able to develop effective models to manage these issues, often relying on a similar shared care arrangements to those used in haematology.

These safety measures, however, bring their own problems. Many people working in mental health view trying to manage such a complex treatment in a patient group that is usually in need of a great deal of individual support, at least in the initial stages, as too challenging. However, once clozapine is established, most people receiving it benefit to such a significant degree that much of this support can be removed. The longer-term clinical risk can be managed effectively through monthly clinic check-ups and measures like regular assay monitoring to help improve compliance and reduce potential toxicity. Developing better integrated care models with other specialities within the NHS would help to alleviate many of the physical health risks for these patients.

Unfortunately, across the UK, many significantly stressed community mental health services are not in a position to offer this level of support.

The impact on the NHS and the community

This represents a significant missed opportunity. The safe and proper utilisation of clozapine for TRS offers us an opportunity to not only improve clinical outcomes but to simultaneously reduce costs for the health service, families, carers, and patients.

When we compare the ‘all care’ costs of an average TRS patient treated with clozapine against alternative treatments, the savings to the mental health trust alone are substantial.  The savings to society at large are potentially greater still: a sub-optimally treated person with schizophrenia is conservatively estimated to incur other costs of £100,000 a year.  This figure includes the demand on other primary and secondary health care, social services and police, as well as the difficulties for the patient, family and carers accessing opportunities to become more socially and economically active.

Direct public safety risks are also a factor.  Tragic treatment failures such as that which led to the attack in Nottingham last year are not only catastrophic to those directly involved but also have a significant impact on wider society. As a recent Panorama programme  highlighted, this was not an isolated case.  There are 60 similar homicide incidents each year committed by people under the care of mental health services in UK.

Developing opportunities

Most mental health trusts have recognised the need to develop better support around managing clozapine, and many have already developed specialist teams. Unfortunately, these teams mostly represent a relatively limited ambition when the full scale of the task is considered.

Indeed, most people who fulfil the criteria for a diagnosis of TRS haven’t even been recognised as such by their main mental health care provider. The initial task is to screen all people with schizophrenia to see if they have been prescribed more than 2 antipsychotics over time.  Due to the state of the IT systems most trusts have at their disposal, this is not as simple a task as it might seem, but it is not impossible.

Once identified, they should be referred back to their own consultant psychiatrist for an assessment to see whether clozapine treatment should be considered.  This is a professional judgement that needs to be respected.  Not all TRS patients are suitable for clozapine, and many clinical and social factors need to be taken into account.

If clozapine is thought to be appropriate, then the person could be referred to community clozapine team for initiation, or they could be initiated as an inpatient in a planned admission or even as a means of managing an emergency admission.  In any case, clinical mental health services should be looking for more proactive treatment opportunities rather than simply stabilising the patient and discharging them home again on the same suboptimal treatment which has already failed.

This Labour government has clearly stated that it wants to see the NHS reform the way it does business to achieve better outcomes for all. It has also indicated that mental health is a priority. Reforming our current management of schizophrenia should be included in this drive to change.

The author would like to thank Amanda Sanburg, a clinical pharmacist in Australia, for her support while writing this article.

 

Image credit: Stock Catalogue via Flickr

David Kitchen

David Kitchen is a senior clinical pharmacist with 35 years of experience, primarily in mental health (forensic and acute), neurology and neurosurgery.

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