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
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.
A PRIMARY CARE
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
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
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 consultationNICE
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
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.
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.