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 |
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.
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.
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.