The Pharmaceutical Journal
Vol 269 No 7218 p494
5 October 2002

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British Pharmaceutical Conference 2002 summary

Hospital and community pharmacy: Modernising mental health services

How NICE guidelines are really decided

It was apparent from the first meeting that none of the people on the National Institute for Clinical Excellence appraisal committee responsible for making recommendations on the use of antipsychotics had any knowledge of the use of them DAVID TAYLOR, chief pharmacist, South London and Maudesley NHS trust, told the session. In his presentation, Dr Taylor, an advisor to the NICE appraisal committee, shared his experiences of working with NICE in the construction of its guidance on the use of newer (atypical) antipsychotic drugs for the treatment of schizophrenia.

All NICE decisions are influenced by standing appraisal statutory committees, stakeholder submissions, health technology assessment reports and external experts and advocates. The atypical antipsychotics appraisal committee was made up of 26 people, including doctors, nurses, economists, statisticians, managers and one pharmacist.

Stakeholder submissions

As might be expected, Dr Taylor said, in submissions from the manufacturers, each said that its drug was the best. However, there was a rather peculiar process where certain groups of people (including himself) were allowed to put forward their points of view twice, under different names, thus allowing them them two bites at the cherry. For example, manufacturers were able to make a submission as a conglomerate in addition to their individual submissions. Similarly, the stakeholder charities also combined to make an additional group submission through a group called Mental Health Charities in NICE.

Peer review

Just because a document says it has been peer reviewed by a particular expert, do not assume that the expert actually agreed with its content, is Dr Taylor's advice. In this case, the "peer reviewed" health technology assessment report was prepared by the NHS Centre for Reviews and Dissemination at York. However, as one of the reviewers, Dr Taylor's suggestions were completely ignored.

"For example", Dr Taylor said, "the review of efficacy suggested that it concluded that ziprasidone was the least effective atypical antipsychotic. However, the review of pharmacoeconomic evidence suggested that it concluded that ziprasidone was the most effective atypical antipsychotic. Now both of these could not possibly be true. I pointed this out to them and they took no notice."

How the guidance came about

In addition to scientific evidence, Dr Taylor gave some insight into other factors influencing the construction of the guidance, using various examples. As published, the guidance recommends that atypicals should be considered in the choice of first-line treatments. Originally, this said that atypicals should be first-line treatment. "However," said Dr Taylor, "somebody got in the word 'considered', which makes a good deal of difference."

Guidance on clozapine use defines treatment resistant schizophrenia as a lack of clinical improvement despite the use of at least two antipsychotics, "at least one of which should be an atypical". Dr Taylor said that the atypical requirement was not originally in the draft. However, he said, one of the manufacturers of atypicals suggested this should put it in, and this is one of the few manufacturers' appeals that was upheld.

Dr Taylor also recounted a situation where the charities, patients, and the experts had to try to drag the committee back from a position where all patients should be immediately be given clozapine on the basis that it is the most effective drug. He said that because the committee had no prior knowledge of the use of antipsychotics, when given the information, they formed a wholly different view from people who are rather tired of having information about antipsychotics thrown at them.

Who has the most influence?

Dr Taylor said that in contrast to a straw poll he had held with 200 psychiatrists a few weeks previously, where nearly all of them thought that the health technology assessment report would have the most influence on the outcome, in his opinion, the most important influence on the whole process and the outcomes came from a patient and a carer.

Talking about treatment options, Dr Taylor said that the fact that atypicals were suggested for patients experiencing unacceptable side effects as defined by patients, is radical, particularly in psychiatry.

"Secondly, it was the experts, and thirdly a long, long way back was the health technology assessment report, which was never presented and more or less ignored by the committee. What eventually came out was something that most people could agree with," Dr Taylor said.

What next for mental health?

Opening the session, CELIA FEETAM, chairman, United Kingdom Psychiatric Pharmacy Group, said that despite significant moves forward, mental health services are struggling against an overwhelming tide.

Ms Feetam wondered what had happened to the £700m promised by the Government in the National Service Framework published in December 2000. She welcomed the NICE guidelines for atypical antipsychotics (see above) but wondered whether the National Health Service could afford to follow them. Similarly, Ms Feetam asked whether the new guidelines on the treatment of schizophrenia would actually change anything.

It seems that development of mental health services is suffering from a bout of inertia. "The Royal Pharmaceutical Society's task force in mental health produced guidance for the treatment of patients with mental disorders. This was launched at the Conference two years ago. Not another word has been said or heard about it, so my question is, 'what next?'"

As for the reform of the Mental Health Act 1983 currently underway, "the consultation process as it stands now, suggests that the act has to be rewritten" she said.