There appears to be confusion about the circumstances in which it is obligatory for GPs to follow NICE guidance. The quick answer is ‘never’. But the longer answer is worth understanding, particularly as GPs take on commissioning.
In some instances, NICE public health guidance applies to GPs, such as identifying people at high risk of type 2 diabetes. Occasionally our medical technologies programme assesses innovative devices that may help primary care. But two forms of NICE guidance are of special relevance to GPs: technology appraisals and clinical guidelines.
Technology appraisals are assessments of the clinical and cost effectiveness of either individual or groups of similar health technologies.
Many technology appraisals involve new pharmaceuticals used primarily in secondary care including new – and sometimes very expensive – drugs for late-stage malignant disease.
When NICE gives a ‘positive opinion’ about the use of a particular product there is a legal obligation on the NHS to make it available if the patient’s doctor feels it is clinically appropriate. There is no obligation on a doctor to prescribe it, but if they consider it to be in the patient’s best interest the NHS must provide it.
These arrangements were originally put in place in 2002 and were reinforced in 2009 by the NHS Constitution. The current Government has confirmed that the arrangements will remain in place when CCGs begin their work. My contacts with members of CCGs indicate their support for these arrangements.
If CCGs have to make their own decisions three problems immediately arise.
First, differences in availability of new medicines would occur, as would the resurgence of ‘postcode’ prescribing.
Second, there is every likelihood that patients would shop around trying to find a CCG to provide the product recommended.
And third, many GPs believe their relationship with patients would suffer. Patients and their families would suspect (albeit erroneously) that a CCG’s refusal to agree to the provision of a product would put money into the pockets of GPs.
Then there are clinical guidelines, which provide GPs and other clinical staff with guidance on the management of specific clinical conditions, for instance, for antenatal care, breast cancer and schizophrenia. These guidelines are very unusual in taking account of both cost effectiveness as well as clinical effectiveness.
NICE’s clinical guidelines are, in most instances, having a substantial influence on the quality of care.
There is no expectation, however, that all patients with a particular condition will be treated according to the provisions of NICE guidelines, for two reasons.
First, it is impossible to define an appropriate pathway of care for every encounter between a doctor and a patient. Some patients, for example, are intolerant of particular medicines even though – at a population level – they provide substantial benefit.
Thus although it is appropriate to prescribe aspirin to most patients after acute myocardial infarction, there will be some (such as those with active peptic ulceration or aspirin-induced asthma) for whom it is dangerous.
Second, the provision of care according to NICE guidelines may require infrastructure changes that take time to accomplish. NICE’s guideline on depression, for example, proposed much wider use of cognitive behavioural therapy (CBT) than was currently available. Substantial investment in clinical psychology has now put CBT within the reach of most patients who need it.
Clinical guidelines, though, play a major role defining the contents of the QOF, quality standards and the commissioning outcomes framework.
The construction of all three performance measures are critically underpinned by a NICE guideline.
The necessity for this is in part because of the need to ensure these metrics are supported by the best available evidence; and without an underpinning clinical guideline this would be impossible. But it is also because without an underpinning clinical guideline it would be unreasonable to expect NHS clinicians to achieve the required standards.
So NICE’s guidance is never clinically mandatory, but is accompanied by the following statement: ‘This guidance represents the views of NICE and was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgment. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient in consultation with the patient and/or guardian or carer.’ (And we mean it!)
Sir Michael Rawlins is chair of NICE