Pharmaceutical Journal Vol 263 No 7064 p489
September 25, 1999 The Conference

Keynote Address

Delivering the new quality

The role of pharmacists in implementing guidance produced by the National Institute for Clinical Excellence was discussed by Professor Sir Michael Rawlins (chairman, NICE) following his keynote address on September 15 which covered the work of the newly established institute

Michael Rawlins
Sir Michael Rawlins: pharmaceutical advisers to primary care groups will play an important part in getting guidelines from the National Institute for Clinical Excellence implemented

The Government had established the National Institute for Clinical Excellence as an attempt to tackle certain tensions and under-achievements of the current National Health Service, Sir Michael said.
There was an acknowledged under-achievement by the health care professionals involved in the NHS, he said. This was shown though unacceptable variations in clinical practice, poor uptake of effective treatments and continuing use of inappropriate or ineffective treatments, even when newer, better treatments had become available. The problem was a global one and not just confined to the NHS. In part it derived from a burgeoning knowledge base which made it impossible for professionals to keep up to date with all the latest developments. Attempted solutions to these problems had included mandatory care packages (introduced by some American health maintenance organisations), experiments with internal and external markets, clinical audit and evidence-based medicine.
The NICE would be undertaking formal appraisals of medicines and health technologies and developing clinical guidelines and referral protocols. Sir Michael said that the appraisal process was likely to be the highest profile part of its work, certainly in the short term, although he felt that any long-term changes which were made to the health of the nation as a result of the NICE would come from the introduction of the guidelines.

Product appraisal process

Products or procedures for NICE appraisal would be selected by the Department of Health and the National Assembly for Wales. Once selected, relevant manufacturers would be invited to submit a dossier of evidence for assessment by the NICE secretariat or its agents.
Once a provisional approval determination was decided upon, there would be a short consultation period with professional and patient organisations before a final decision was taken by the board of the NICE.
Pharmaceutical products selected for the first round of appraisals included interferon-beta, glutarimer (which was not yet marketed), proton pump inhibitors, taxanes and zanamivir (Relenza). Relenza was to be the subject of a fast-track assessment before this year's influenza season started.
Sir Michael highlighted the NICE partners council, which includes representatives of professional and patient groups and the pharmaceutical industry. He said that it would be one of the institute's strengths, giving advice on future activities and acting as a sounding board and a source of individual advice. The first meeting of the partners council had discussed what the proposed NICE patient guidelines might look like.

Questions and answers

During the question and answer session which followed his speech, Sir Michael said that for legal reasons there was virtually no relationship between the NICE and the Medicines Control Agency — which was a pity.
He went on to explain that products selected for appraisal by the NICE were recommended to Health Ministers by the Department of Health's managing clinical innovations group, which received intelligence from the National Prescribing Centre, the Department's horizon scanning centre and drug information pharmacists.
Asked if political and media pressure would influence the choice of products, he said that the NICE was a public body, part of the NHS, and "if there is public anxiety, then public reassurance may be necessary". However, he pointed out that the media did not produce scare stories on their own; they merely amplified the existing concerns of scientists and health care professionals.
When asked if health authorities would be able to afford to implement the NICE's advice, Sir Michael said that affordabililty would form part of the NICE's advice to ministers. However, he pointed out that not all of the NICE's decisions would be about new products and new spending — some would be about stopping older treatments or procedures, therefore there would be disinvestment. Health authorities would not be keen to hand this money back, he suggested.
He thought that in hospitals, the guidelines produced by the NICE would be adhered to "pretty rigidly".
In primary care the guidelines would be advisory. They could not be mandatory as they could not cover every eventuality, but those not complying with them would have to answer to their health authorities and to the Commission for Health Improvement (CHImp).
Sir Michael welcomed a suggestion from the audience that the NICE website (www.nice.org.uk) should contain a timetable of products under appraisal and estimated dates for publication.
When it came to putting the guidelines into practice, the NICE would be issuing guidance about its guidance. Several methods of dissemination would be used, but Sir Michael said that he saw pharmaceutical advisers within primary care groups playing an important role in the implementation of guidelines.
Above all, the NICE had to earn and retain a reputation for producing good, usable guidelines, in the way that the British Thoracic Society had done with its asthma management guidelines.