As we go to press, the count on NICE technology appraisals reaches the high seventies and the guidelines explosion has begun. Over 20 clinical practice guidelines have now been published, 20 more will be produced over the next 12 months and there are also about another 40 other guidelines in simultaneous development. NICE says that this is the 'largest guideline development programme of any healthcare system in the world'. It is not surprising therefore that the output of NICE this year is expected to be almost double that of 2003! But this mountain of guidance will surely place a huge and significant burden on the NHS.....

When NICE was set up way back in 1999, Chairman Prof. Sir Mike Rawlins said that NICE was not in the implementation business and it was not seen as part of NICE's role. Nevertheless, the Institute clearly has had a deep interest in the implementation of its guidance. So it was of great interest then that a significant theme of last December's annual NICE conference was this key issue around implementation. NICE currently has no 'formal' responsibility for this area but as evidence builds of lack of wholesale implementation, watch out this year as NICE appears set to get more involved.....

Certainly 2004 will mark a year of renewed focus on the implementation of NICE guidance and the Institute is now working closely with both Government and the NHS in order to identify best practice in implementation. The Institute reported back at the January Board meeting on the findings from its consultative workshops on implementing guidance that took place last November and the Institute is now developing a new implementation strategy, due out mid-April. This is likely to focus on a 'whole systems' approach locally. NICE will also take on board the findings from Prof. Trevor Sheldon's study (University of York) on the impact of NICE guidance. This two-year study looked at patterns and trends using a number of 'tracer' pieces of guidance for prescribing across both secondary and primary care.

At the NICE conference, Prof. Rawlins was clear as to the ways by which implementation could be made more successful. He said that the topics for appraisal and guidelines must be relevant to clinical practice; that the processes involved in developing NICE guidance should be robust and command broad confidence; that the guidance must be clear and unambiguous; that the guidance must be implementable and that it must be appropriately disseminated to those who need it and in a manner which is accessible at the time they need it. On topic selection, he was not sure that this was optimal as yet and that NICE had not really managed to engage the wider NHS in proposing topics nor had the NHS been forthcoming in suggesting topics for disinvestment.... On clarity, he said that this was an 'awkward' area in that on the one hand guidance must be comprehensive and yet on the other hand it must be accessible during the hurly-burly of surgeries, clinics and ward rounds. Probably, he said, they had so far erred on the side of comprehensiveness so new simpler formats are now being produced. On 'implementability', he said that this very much depended on the availability of appropriate financial and human resources, as well as the necessary infrastructure. And on dissemination, NICE is to change the way it disseminates guidance to meet the needs of each key audience. Said Prof. Rawlins, "Only if our guidance is implemented - and makes a real difference to patients - can we really claim to be successful. We will be doing everything we can to support the NHS in this key task, by producing answers that matter, in concise and accessible formats with practical advice on impact and implementation". He also said that NICE needs to know why its guidance might not be being adopted into routine clinical care as well as whether the uptake of its guidance was having any real effect on health....

And closing the NICE Conference, Lord Warner, Parliamentary Under Secretary of State for Health, and the minister responsible for NICE, had a lot to say about implementation. He said, "We now need to examine how effective we have been at implementing NICE guidance. For instance, have we been realistic about the speed at which NICE guidance can be implemented? Have we got the processes right whereby the NHS receives 'implementation-ready' guidance from NICE? Do we understand enough about what health bodies and clinicians do with the guidance when it arrives at the local level? How clear are the accountabilities for ensuring that action is taken on NICE guidance. Where does NICE guidance fit into national standards for the NHS to be produced under the Health and Social Care Act?" Lord Warner was also clearly concerned that the three-year funding notification wasn't working re the PCT planning and budgeting process, suggesting that some PCTs were not allocating enough local budgets for NICE implementation.

So what is the government planing to do? Well note particularly the following from Lord Warner: "We see a key role for the Commission for Healthcare Audit and Inspection to monitor the implementation of NICE guidance during the course of its reviews of NHS bodies and as part of seeing how bodies are meeting national standards. The Health and Social Care Act 2003 places CHAI under a duty to take the statement of standards, to be published in the New Year, into account when exercising its review and investigation functions...I am confident that CHAI will want to concern itself with the uptake and implementation of NICE guidance.....Ultimately this performance review process will reveal the places where NICE implementation is slow, with all the consequences that flow from falling below national standards.".... Well that seems pretty clear then - it is now up to Professor Sir Ian Kennedy, CHAI Chair, to fix it...... More teeth are-obviously-a-coming and non-implementation seems set to become an individual P45 performance indicator for Chief Executives and a loosing stars indicator for organisations. Watch out too as the Modernisation Agency gets more involved with stuff around 'compliance with evidence-based protocols.'....

Please note that CHIA will be for England only (unlike CHI) and that Wales will now have its own Healthcare Inspectorate and a Health Care Standards Board. And note too that in Scotland the Scottish Medicines Consortium's advice is to be made binding and that NHS Quality Improvement Scotland (NHSQIS) is set to 'absorb' SIGN this year....

So implementation has now finally been recognised as a key key challenge for both NICE and the NHS. Do please note then you avid 'NICE watchers' out there, all the documents due out shortly around implementation. But really there is nothing new here in all of this - the 'Hill of Resistance' model as regards the implementation of evidence-based medicine was produced by the DoH at least a decade ago. This is outlined in the accompanying diagram. As one can see, the barriers recognised at that time, as regards the uptake and the implementation of EBM, remain much the same as for the implementation of evidence based NICE guidance now!...

And finally, Lord Warner also said at the NICE conference, "In addition to the various pieces of work described, we also need to play into the discussion information on uptake from pharmaceutical companies...."..... Now this is an interesting one and a recognition perhaps at last that the Industry has some of the best data around on medicines uptake. I do wish that NICE would also think about 'formally' allowing companies to promote its guidance... Maybe Sir Ian can fix that too?.....

Article first pulished in PharmaTimes March 2004