What is a black triangle? Some tricky little sign that we have all forgotten from the Highway Code? No? Well, let's try an easier one - what is the yellow card (but not the one the referee waves after a dodgy tackle)?
A minority of people are likely to know the significance of these colour codes in relation to prescription medicines prescribed by GPs and yet they are important to us all. The yellow card is the form a doctor fills in and sends off to the medicines control agency if he is concerned that a patient has had a serious side-effect from a particular drug. The black triangle on the information sheet sent to doctors by the manufacturer tells them that the drug is less than two years old. Doctors are supposed to report all side-effects of black triangle drugs - not just the serious ones.
These are the nuts and bolts of what is known as pharmaco-vigilance in the UK, a system set up to prevent what happened with Thalidomide occurring again. Clinical trials do not show spot problems that may occur in a tiny minority of people, or what may happen to long-term users. Yellow cards and black triangles form a safety net which has alerted the authorities to unexpected harmful effects of licensed medicines and averted disasters.
A new drug should be under intense scrutiny. Look at Zyban, the new, black-triangle, anti-smoking drug. There have been 35 deaths among users so far. Each one is reported and investigated. The MCA and the manufacturers say that in each case, so far, there has been a separate underlying cause, such as lung disease caused by cigarettes or, in the case of the air stewardess who died, the combination of Zyban and anti-malarial drugs. Deaths are pretty well always reported, but not so some of the other side-effects of medicines. The Consumers Association points out that a staggering 6% of all hospital admissions are caused by adverse effects of drugs. Surely the detection system should have been prevented some of them?
In fact, there are major problems with the safety net. The Drug and Therapeutics Bulletin, a respected journal sent to all doctors, recently did a survey which found that a quarter of information sheets on new drugs sent to doctors by manufacturers did not carry the black triangle symbol. It also found that the information about the sort of side-effects on the liver that certain powerful drugs could cause was inadequate.
Doctors are busy. If Mrs Robinson arrives with a headache, they aren't going to fill in a yellow card if they don't see a black triangle, unless they happen to know the drug she is on is only 18 months old. The Bulletin thinks that patients could be put at risk and wants the MCA to act. But there are other, longstanding weaknesses. Doctors don't have to fill in a yellow form. It is voluntary. Some doctors fill in stacks, some hardly any - the average is less than one a year per doctor.
Then there is the patient. Things may be changing, but historically the British patient doesn't want to trouble the doctor, particularly with something minor and mildly embarrassing like diarrhoea. But it could be a warning sign of something serious. In an age of increasingly powerful new drugs, there are those who think the yellow card system just isn't good enough. The Consumers Association wants patients themselves to fill in yellow cards and post them off to the MCA. The idea was immediately slapped down by the Department of Health on behalf of the MCA. Health professionals are better placed to make appropriate judgments on potential side-effects was the response.
It is an answer that smacks of the patriarchal attitudes that modernisation of the NHS is supposed to be trying to oust and ill at odds with all we have been told by the politicians about a health service led by consumers. If the MCA has a better answer, perhaps it should tell us.
