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NICE wants more pharmacists involved with appraisals

The National Institute for Health and Clinical Excellence wants morepharmacists to get involved with its medicines appraisals process.During the 2009 joint conference of the Guild of Healthcare Pharmacistsand the United Kingdom Clinical Pharmacy Association, the rallying callcame from Sarah Garner, associate director for research and developmentat NICE, who believes pharmacists could be doing more to inform theinstitute’s work

By Gareth Malson, MRPharmS

The National Institute for Health and Clinical Excellence wants more pharmacists to get involved with its medicines appraisals process. During the 2009 joint conference of the Guild of Healthcare Pharmacists and the United Kingdom Clinical Pharmacy Association, the rallying call came from Sarah Garner, associate director for research and development at NICE, who believes pharmacists could be doing more to inform the institute’s work.

“Pharmacists are the experts in medicines. Many of the decisions that NICE makes are about medicines,” said Dr Garner. “We need the specialist knowledge pharmacists have about medicines use in practice to inform our decisions.”

She explained that much of NICE’s work involves determining whether a medicine’s clinical trials data remain applicable when the medicine is used in widespread clinical practice. “That’s where you come in,” Dr Garner told the audience, “to help us translate the efficacy data from clinical trials to what’s happening on the ground.”

She explained that every guideline or technology appraisal produced by NICE has its own section on the website (www.nice.org.uk) where all key documents, registered stakeholders and publication schedules are listed.

“Routinely, the Royal Pharmaceutical Society and the UKCPA are invited to participate,” confirmed Dr Garner, “but quite often we don’t have that engagement. I recognise that is often due to time … but I would like to see more representation from pharmacists.”

She told Clinical Pharmacist that, for guidance, pharmacists can contribute through registered stakeholders or nominate other stakeholders. For technology appraisals, they can also offer personal views for consideration by the appraisal committee.

The “Get involved” section of the NICE website offers the opportunity to sign up for newsletters, suggest topics for NICE to review or join guideline development groups, she added.

A tough job

Bill Dawson, member of the Royal Pharmaceutical Society’s science committee, highlighted the difficulties faced by NICE in conducting appraisals of new medicines. He believes the limited number of human and animal exposures to a medicine during clinical trials cannot always provide sufficient safety data.

“The regulator issues [marketing authorisation] on the basis of less than 8,000 mammalian exposures,” he pointed out. “A serious adverse event that occurs in, perhaps, one in 5,000 patients may not be seen during trials. But, it will cause the drug to be withdrawn within the first few years of use.”

He added: “NICE is pushed too hard to make an economic evaluation on the basis of 8,000 mammalian exposures. You need a population of a considerable number of thousands before you can see if it’s going to be commercially viable.”

Professor Dawson also highlighted the importance of postmarketing surveillance. He suggested that pharmacists could help communicate to the public the risks of rushing new medicines onto the market .

Citation: Clinical Pharmacist URI: 10965960

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