Chris Brewer, medicines information pharmacist for North Cumbria Acute Hospitals NHS Trust
Consider this community pharmacy scenario: as you hand out a prescription to a middle-aged man with a well-thumbed copy of Racing Post under his arm, he says:
“Excuse me, but instead of these tablets, do you think that you could give me the money?”
“The money; the sum that you will be reimbursed for them. It’s just under four quid, the doctor told me. I want to put it on a horse called Woscops in the 3.45 at Ayr, at odds of 42 to 1.”
Let us just imagine for a moment that you are willing to defraud the NHS, swayed by the man’s promise to put the winnings towards an elderly relative’s care home bills. If you were to open the till and hand over the Drug Tariff category M price then, obviously, the money could end up being wasted. In fact there is a 97.6 per cent chance that it will be. So would this be a sound investment for our public money?
Now let us imagine the man takes his tablets home. By extrapolating the results of the widely reported West of Scotland Coronary Prevention study (known as WOSCOPS),1 we could expect this man’s absolute risk of cardiovascular death or non-fatal myocardial infarction to fall by 2.4 per cent. So the money could end up being wasted. In fact there’s a 97.6 per cent chance that it will be. Would this be a sounder investment for our public money?
Given the high cost of hospital treatment for cardiovascular disease and the massive potential gain in quality-adjusted life years for each cardiovascular event prevented, the answer from the health establishment is an emphatic “yes”. Recent National Institute for Health and Clinical Excellence guidance2 reflects this pharmacoeconomic case for primary prevention of CVD with statins. NICE now recommends that individuals with a CVD risk over 20 per cent in the next 10 years should be treated with statins irrespective of their baseline cholesterol.
This is all well and good if you are the clinician responsible for the health of a sizeable population. However, from the perspective of an individual patient (who does not, after all, have responsibility for the health of any of the others), the question of whether to take the prescribed treatment becomes a little more philosophical.
Let us do as this man did, and look at the figures a little more closely. WOSCOPS concluded that primary prevention with pravastatin reduced the risk of cardiovascular death or non-fatal myocardial infarction by 31 per cent. That impressive 31 per cent figure is a relative risk reduction however, and sounds a lot better than the absolute risk reduction of 2.4 per cent. Dividing 100 by the percentage absolute risk reduction figure of 2.4 gives a number needed to treat (NNT) of 42, which is a language that our student of the turf understands. In his mind, it is a 42 to 1 shot that he is going to get any benefit at all. In fact, the recent NICE guidance cites a statin primary prevention study with an even higher NNT. In this, the largest such trial published so far, 95 patients would have to be treated with atorvastatin for three years to prevent one death due to coronary heart disease or non-fatal MI.
We might consider a person who backs a horse at these odds to be guilty of a little blind optimism. So are we instead expecting patients to take these lifelong treatments through a sense of public duty. To “do their bit” for the health of the nation, rather than to obtain a tangible benefit for themselves.
Looking at benefits and risks from the patient’s perspective can make non-compliant behaviour seem surprisingly rational. Maybe whenever a patient says to you “I don’t really like taking all these tablets”, they actually mean something quite different, which they are unwilling or unable to articulate. Those more scientifically minded might really mean “I am unconvinced that the likelihood of me personally receiving any benefit from this drug outweighs my inconvenience in taking it over a long period, combined with the risk of side effects”. Alternatively, the patient might be a pessimist: “I expect that the person down the road will be saved from a heart attack instead of me.”
However, patients on the whole do not articulate these thoughts to us or to their GPs and frequently take what they see as the path of least resistance. But this, of course, can lead to a tragic and entirely preventable waste of public money — in the form of an ever-growing statin stockpile at the back of the kitchen cupboard.
Crucially, this momentous piece of NICE guidance appears at a time when decisions to initiate a prescription-only medicine are increasingly moving away from the protected domain of medical practitioners. Primary prevention with statins will potentially now be offered to an extra 3.3 million individuals, and non-medical prescribers such as pharmacists will be responsible for much of this work. We need to realise that primary disease prevention is different from treating symptoms and demands a higher level of informed consent.
Underneath the headline statistics, there are some important caveats in the NICE guidance which must not be overlooked: “… the decision whether to initiate statin therapy should be made after an informed discussion between the responsible clinician and the individual about the risks and benefits of statin treatment, and taking into account additional factors such as comorbidities and life expectancy.”2
By hiding behind complex pharmaco-economic arguments — and failing to talk in a language the patient can understand — we risk the indiscriminate prescribing of a lifelong treatment to an extra 3.3 million people without proper consent. The practice of feeding quinolone antibiotics to intensively farmed chickens to improve meat yields is now discredited. Without informed consent, it could be argued that primary prevention of CVD with statins is little different.
1. West of Scotland Coronary Prevention Study. The effects of pravastatin on hospital admission in hypercholesterolemic middle-aged men. Journal of the American College of Cardiology 1999;33:909–15
2. National Institute for Health and Clinical Excellence. Cardiovascular disease — statins. Technology Appraisal 94. London: NICE; 2006.