Primary care groups and trusts must be crystal clear on what action they will take when guidelines from the National Institute for Clinical Excellence arrive, says Alan Earl-Slater

The National Institute for Clinical Excellence has announced the drugs and medical devices it will be considering in its first work programme (see box, opposite page) 1. The evaluations are each expected to be completed within eight months. But what should healthcare professionals be doing in the meantime?

Let us start with what healthcare professionals should not be doing . They should not be carrying on with their usual business and waiting for NICE to report, because when NICE makes its recommendations action will be expected to follow.

Pressures to act will come from the Department of Health, health authorities, the Commission for Health Improvement and through clinical governance schemes.

NICE will also require changes to the details available in PRODIGY, the NHS's computerised prescribing decision support system.

There will also be noise from drug companies and technology suppliers, professional organisations, patient groups, opinion leaders and commentators. And there will be much interest from national and - more importantly - local media, hungry for news stories around the NICE recommendations.

If healthcare professionals do nothing they will be unprepared for these pressures.

Auditing activity

Each practice or trust should first hold a meeting to circulate the list of work that NICE is doing. Such information will alert practice and trust members to the fact that more promotional drives may be made in the run-up to and in the immediate aftermath of the NICE deliberations. The meeting should flag up the fact that more queries will arise about the products being assessed.

Next, find out how many patients in the PCG or trust are being treated in each area being looked at by NICE. Even if it is none, that is useful information. Find out what is being used to treat each patient with the same or similar problems.

Then identify the resources involved in treating each patient in each area under consideration. If the patient is being treated in hospital it is important to note this and work out the resources involved. If there are shared care agreements between the PCG and the hospital these should also be noted, along with the resources employed.

In some cases patients will be treated wholly in primary care.

The next task is to make two lists. List the amount of resources involved in each patient's treatment and list the number of patients under each NICE heading. This information can be further broken down to include patient characteristics such as age, gender, diagnosis, treatment, history and location.

Finally, circulate the details to members of the PCG and trust for correction and comment.

Using the data

Following the steps outlined above will provide information on who is getting what treatment, where, when, why and what resources are involved.2,3

The process will reveal what data is missing from the practice records, and how efficient the practice record system is. Finding gaps in the evidence base can result in useful discussion about where the gaps exist, why they exist, how important they are and how they can be filled.

This procedure will give a better understanding of current practice. It will put you in a reasonably good position when considering the implications of NICE, changing current practice, defending yourself to the board or with other health service providers, discussing the logistics of change and discussing care options with patients.

Defending decisions

It will also provide some defence when faced with enquiries from the Commission for Health Improvement, HA managers, the health action zone, the General Medical Council, and the media.

If you ignore NICE recommendations and guidance you could become involved in an investigation by the Commission for Health Improvement. If you have no bank of information to defend yourself you will not look good under investigation.

The information assembled through the above steps can also be used in legal defence. Following NICE guidelines will not insulate you from the law but, as Dr Peter Schutte of the Medical Defence Union explained in September:

'Doctors will not necessarily be found negligent if they do not follow NICE guidance.'

5Whether or not you follow NICE guidelines, do not ignore them: ignorance of them would be a very poor line of defence indeed.3,4,5

These steps provide each PCG and trust with a reasonable audit of their own current practice in each area being considered by NICE. You will be in a good position to consider the resource implications and logistics of NICE recommendations.

Beginning an audit now offers, among other things, an excellent opportunity to get to know your colleagues better in the new NHS. Each audit will provide information to help determine and then manage change. It will also help you prepare for any subsequent professional, legal or media enquiries.

Whatever NICE recommends, you need to know what is going on in your own unit. The twist in the tail is this: even if you do not do your own audits, NICE may be looking at what is happening in your PCG or trust to help it form a view of current practice.


1Press release. First work programme for the National Institute for Clinical Excellence .

NICE, 6 August 1999.

2 NHS Executive. National Institute for Clinical Excellence: initial work programme. HSC 1999/176. NICE, 6 August 1999.

3 Earl-Slater A. Dictionary of Health Economics . Oxfordshire: Radcliffe Medical Press,1999.

4 Earl-Slater A, Wilcox V. Audit: an exploration of two systems from outside the healthcare environment. J of Evaluation in Clinical Practice 1997; 3(4): 265274.

5 Press release. GPs will keep clinical independence under NICE says MDU . Medical Defence Union, 15 September 1999.

Key points

Trusts and PCGs should take action now to disseminate the list of topics being investigated by NICE.

Each organisation should carry out an audit to establish how many patients are being treated in the areas looked at by NICE and what their current treatments are.

Such information is essential to inform and defend treatment decisions, following guidance from NICE.

How NICE appraisals will work NICE is employing a standard strategy for each area under investigation. This involves the following steps:

identifying and examining medicines, devices and procedures that are likely to have a significant impact on the NHS;

examining current practice to identify unjustified variations in use or uncertainty about clinical or cost-effectiveness of the intervention;

collecting evidence and undertaking research to assess the clinical and cost-effectiveness of healthcare interventions;

considering the implications for clinical practice of the evidence on clinical and cost-effectiveness and producing guidelines for the NHS;

dissemination of the guidance and supporting audit methodologies;

implementation at local level, through clinical governance and other approaches;

monitoring the impact of advice, taking into account the views of patients and their representatives and any relevant new research findings.

The jury's out: the NICE agenda From autumn 1999 Advances in hearing aids.

Coronary artery stent developments.

Hip prostheses.

Inhaler systems for childhood asthma.

Beta interferon and glutarimer for multiple sclerosis.

Liquid-based cytology.

Proton pump inhibitors for treatment of dyspepsia.

Routine extraction of wisdom teeth.

Taxanes for ovarian and breast cancer.

From early 2000 Autologous cartilage transplantation .

COX-II inhibitors for rheumatoid arthritis.

Galantamine/prophentofylline for Alzheimer's disease.

Glitazones for type II diabetes.

Glycoprotein IIb/IIIa receptor inhibitors.

Implantable cardioverter defibrillators.

Laparoscopic surgery.

Orlistat/sibutramine for obesity.

Ribavarin/alpha interferon for hepatitis C.

Riluzole for motor neurone disease.

Ritalin for hyperactivity in childhood.

Wound care.