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Ethical exception reporting

When is it right to treat to target, and how do GPs judge when an individual is best served by being opted out? Dr Bill Beeby offers his advice.

The QOF has been running now for seven years. Hailed by most as a success, it has not been entirely without its critics, and one area of regular contention is exception reporting.

Opponents argue that since the upper thresholds for clinical indicators are never 100%, practices should be able to reach maximum points without ever excepting a patient. But proponents of exception reporting maintain that it allows GPs to consider an individual patient's personal circumstances. In deciding it is inappropriate to pursue an arbitrary target, because the patient is likely to derive little benefit and could even be harmed, we can show we are practising medicine rather than merely ticking boxes to gain rewards.

Advances in our understanding of disease and risk management may appear faster than the rules of the QOF can be changed. We must also accept not all patients will share our perspective on the pursuit of perfection, or tolerate side-effects with stoicism. For these and many other reasons, exception reporting is vital – and to keep it we need to use it wisely.

First, some dos and don'ts:

• Do record exceptions as you consider the decisions through the year.

• Do clearly document in the free text of the Read code exactly why the decision has been taken.

• Do have a practice policy on exempting patients from the QOF, however brief.

• Do expect to have to justify every decision one day.

• Don't leave it all to the last week in March, which looks like last-minute gaming.

• Don't forget even patients exempted for one reason can qualify for targets in other areas of the same domain.

• Don't delegate. True exemptions are going to be few in number, but are your responsibility.

Now let's air some of the dilemmas we face:

Cholesterol in the elderly

Aggressive management of LDL cholesterol in younger patients is demonstrably beneficial, but statistics and risk charts run out at about the age of 75, where the age limits were drawn in clinical trials. We can probably extrapolate beyond this age for a while with an assumption of continued benefit, but the question is for how long – and in which patients should we consider exception reporting?

Among people aged 70-80, and even beyond, we are likely to have a variety of patients, including many with pre-existing ischaemic heart disease and cardiovascular disease, who are otherwise healthy and active and in whom there will be no question of stopping their statin. However, some may appear to be less than optimally controlled. The QOF's 5.0 cholesterol target is based only on total cholesterol. There is no account taken of the HDL cholesterol value or the HDL/total ratio, or the percentage reduction. You either pass or fail, and if it's a fail, what do we do?

A patient who is compliant with treatment – not always a correct assumption – and has a cholesterol of 5.2, a reduction of 25%, an LDL of 1.5 and is treated because of their well-controlled type 2 diabetes might not have a lot to gain from a significant enhancement of their lipid-lowering therapy at any age.

As age progresses, the potential benefits of treatment may seem academic, and might not translate into any measurable clinical benefit for an individual. Since April, we have also had a conflicting target in the QOF with the introduction of quality and productivity targets in prescribing.

Many practices will have been encouraged to select one target measuring the percentage of low-cost statins for economic reasons, so increasing simvastatin to 80mg might be the only option to hit both targets. Yet we all know of the big risk of side-effects this could bring, and the increasing risks of polypharmacy in the elderly.

Our responses will be personal, but I would be strongly tempted to call time in someone over 90 and add the exemption code, and open to persuasion to do the same for someone over 80. Perhaps when we have a wider choice of generic statins, these decisions will be easier.

HbA1c control

Last year there was fierce debate over the safety of the QOF's 7.0% target for HbA1c, which resulted in a relaxation back to the previous target of 7.5%.

Unlike other targets in the QOF, we have a scaled response with the toughest targets having lower thresholds for maximum achievement.

The long-term benefits of better control are clear, though still statistical rather than directly relevant to individuals, so whether to intensify therapy or to consider exception reporting needs careful thought, particularly with trying to meet the stricter target.

There are lifestyle modifications that can help, but these are often challenging for patients to achieve, so the temptation will be to increase or add medication. But glitazones have been associated with adverse cardiac events, the long-term safety of newer treatments is far from guaranteed, and then there is the risk of hypoglycaemia, with awareness of this differing among patients. Exception reporting against the 7.5% target may be tempting, particularly because this does not stop patients counting for other targets as they are reached. But the current target for HbA1c control is realistic and achievable, so exception reporting will need to be used rarely.

Blood pressure in the elderly

I remember the rule of halves that was often quoted for blood pressures in primary care, and I strongly suspect our case-finding in the last seven years has laid this criticism to rest. Targets for measuring blood pressure across the population mean between 12-15% of our patients are labelled hypertensive and treated. We are meeting the targets well, but our patients are ageing and acquiring more conditions as they go, amassing increasing polypharmacy along the way.

I suspect I am not alone in seeing a few whose blood pressure becomes harder to control with increasing age, and in whom there is a decreasing tolerance to the side-effects of various medications as well as increasing interactions. Combine this with more symptomatic postural hypotension from decreasing mobility, the serious risk of falls in the elderly and the fact targets are likely to be toughened because of our success so far – and we have a problem.

At some point, the risk of harm from a fall and fractured hip climbs above the risk of stroke, cardiac events and renal damage from the raised blood pressure. The debate on this has yet to mature, but in the meantime I might just feel easier in recording some exemptions for individuals rather than push their treatment too far.

Lithium treatment

Here we have a good example of medicine moving ahead of the QOF. Targets for lithium monitoring only specify a levels check twice a year, yet current clinical standards already expect us to perform the checks every three months, as well as more frequent checks on other biochemistry.

Lithium has a narrow therapeutic margin and awful toxicity, so it is quite right that monitoring is strict – but the numbers in individual practices may be small, making targets easy to miss if just a few patients are adrift.

We only need to consider patients with levels just below the therapeutic range who are currently stable and have had similar lithium levels for a while. Would we want to suggest increasing medication to a patient with no clinical need (because their condition is stable), merely to meet an arbitrarily defined target for a therapeutic range?

We should offer our patients the choice of increasing medication or accepting that the lower level is beneficial to them, and their answer will determine if it is appropriate to enter an exemption code. Exception reporting would, of course, be against the target level alone, and not the continued monitoring.

Dr Bill Beeby is chair of the GPC's clinical and prescribing sub-committee and a GP in Middlesbrough.

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