Select Committee on Health Appendices to the Minutes of Evidence


Memorandum by North Liverpool Primary Care Trust (NC 113)

  This response is made from the perspective of clinical and staff in primary care. The term prescriber will be used to encompass relevant health professionals such as GPs and nurses and the term adviser will refer to medical and pharmaceutical advisers. It focusses solely on guidance that applies to primary care.


  Prescribers are faced with ever increasing volumes of information on the effectiveness of medical interventions. They require this evidence to be evaluated by a credible authority, relevant to practice, and presented in a succinct manner. They also require guidance that reflects the reality of the health system and assists in the management of patient demand, rather than the creation of further demand.

  Advisors are required to develop policy and strategy to implement NICE guidance. Thus, in addition to the above, advisers need the evidence to be considered in context as a part of the total health system, rather than as a discrete document. Advisers also require either accurate financial projections, or clear indication on how financial estimations have been calculated.


Credible authority

  NICE is one of a number of organisations that issue clinical guidance. Unlike the MeReC Bulletin, the Drug and Therapeutics Bulletin and Clinical Evidence, NICE is widely viewed as pursuing a political agenda at the expense of the clinical credibility. This perception became apparent amongst prescribers and advisers after the rapid reversal of guidance on the use of zanamivir following thinly veiled threats from the Chief Executive of GlaxoWellcome.

Presentation of evidence

  There is a view that prescribers rarely read any document that runs to more than a single side of A4, and, in this respect, NICE guidance is succinct. However this means that important information for prescribers is either not included, or appears in a section of the document that is likely to be unread.

  NICE makes wide use of its website to publish both draft and final guidance. Many health professionals have indicated that the website is difficult to navigate and that material is difficult to find. The redesign of the website has not resulted in any appreciable improvement.

Evaluation of evidence

  It is becoming common practice not just to present, but also to grade the robustness of, evidence. Whilst the inherited guidance on MI prophylaxis, and guidance on pressure ulcers adopt this approach, other documents do not.

  NICE has made a number of recommendations that do not appear to reflect the available evidence. Examples include:

  The benefits of Cox 2 inhibitors noted as being less in patients who are also taking aspirin. This reflects trial data on rofecoxib, but no such data has been published with regard to celecoxib.

Relevance to practice

  Review dates of between 18 months and three years mean that in cases where potentially relevant information does not appear or where the guidance raises unanswered questions, the issue may not be resolved for a substantial period.

  Draft guidance is posted on the website for comments from stakeholders, with a four-week window for comment. In order to comment, prescribers and advisers must register as stakeholders, prospectively at the start of the development process, for each individual piece of guidance. Thus, whilst organisations and pressure groups have input into the process, prescribers and advisers who will be required to implement the guidance are effectively prevented from raising the issues noted in the previous paragraph.

Reflecting the reality of the health system

  Guidance on zanamivir indicates that it should be used for at-risk patients who present within 36 hours of onset of influenza like illness (ILI). Publication of this guidance has raised public awareness and created a large and inappropriate demand from patients with colds who are extremely difficult to refuse once they have entered a consulting room. In addition, triage of patients requires face to face consultation—NICE advises patients with ILI "not to visit your GP".

  In reality, patients who would truly benefit from the drug are often incapacitated by the illness and unable to access GPs and pharmacies.

  Guidance on COX 2 inhibitors suggests costings based partly upon a reduction in the use of gastroprotective agents. This is justified by a statement that there is no evidence of benefit from co-prescription of gastroprotective agents. A cardinal and often quoted rule in evidence based analysis is that absence of evidence is not evidence of absence. In light of the increasing numbers of cases of medicolegal litigation, many advisers find themselves unable to recommend that prescribers discontinue gastroprotection.

Guidance in the context of the health system

  NICE guidance effectively requires NHS organisations to allocate the appropriate resources. Whilst NICE is not required to consider the financial effect of the guidance, there is a danger that considering a large number of high cost, low volume, interventions in isolation will result in a transfer of resources away from drugs that benefit large numbers of patients. Forcing NHS organisations to satisfy accountability functions at the expense of population needs would contradict the apparent ethos of NICE to promote clinical excellence.

  Where a number of interventions are available, prescribers and advisers require an indication of relative effectiveness. Whilst it is appreciated that such evidence is not always available, this opens the Institute to charges that guidance is premature. The implementation and audit sections of each guidance document indicate that individual clinicians and health systems should audit practice to ensure compliance. However, this is not possible unless guidance is complete.

  Examples include:

  Pioglitazone and rosiglitazone are indicated as potential therapies in the treatment of type two diabetes. There is no indication of whether glitazones are more effective than, or preferable to, insulin.

  Guidance on the use of Proton Pump Inhibitors allows the choice between "step up" and "step down" therapy. The majority of PPI prescribing is at treatment dose. Review and step down treatment is uncommon and the resulting huge financial implications have effectively been justified by this failure to issue clear guidance.

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