Report your own adverse effects

By Jean Robinson

AIMS Journal 2005, Vol 17, No 4

We have always been critical of the Yellow Card scheme. Only doctors were supposed to report adverse effects of drugs to the government body which regulated medical licensing by sending in a yellow card. The number who took the trouble to report was very small. I remember sitting in my doctor's surgery and insisting he filled in a yellow card, since a certain adverse effect only occurred when I took a particular pill, and I had experimented with long gaps in between doses.

If the damage was done because doctors had prescribed the wrong drug, or the wrong dose, they were naturally reluctant to report it.

When I was Chair of the Patients Association thirty years ago, I found that when patients (especially women) reported adverse effects of medication, they were not believed. Mood changes reported by women on oral contraceptives, for example, were dismissed, despite the fact that they were common and a large study run by the Royal College of General Practitioners had found that both depression and suicide were increased in women on the Pill.

We wanted patients to have the chance to report their own suspected adverse effects. (We prefer the word "adverse" effects to "side" effects because they are just as much effects as the beneficial results of taking a drug) I asked the regulatory agency to do this and was told that only doctors' reports would be reliable. Later, Beverley Beech and I tried to set up a consumer group called Drugwatch, which would collect such information direct from the public, but we failed through lack of money and support - and the internet did not exist then.

Now at last the MHRA (Medicines and Healthcare products Regulatory Agency) wants patients to report suspected adverse effects in themselves, their children, or those they care for. Details are available on the Yellow Card website: www.yellowcard.gov.uk and the MHRA website: www.MHRA.gov.uk Or you can obtain the leaflet from your doctor or pharmacist, or call yellow card on freephone 0808 100 3352. There is actually a translation service available for non-English speakers (Hurrah!). It comes with its own foldover envelope - and there's no need for a stamp.

On the yellow card website you can also check how many adverse effects of particular kinds have already been reported for a particular drug, and how many deaths have resulted.

Confidentiality

Although you are asked to give your name and address on the form, so that you can be contacted for further details if necessary, you can ask someone else to do this for you and put their name and address, so that you can be contacted via them if necessary. The form makes this clear. We are delighted at this, since we know for many people confidentiality is crucial, and they might otherwise be unwilling to send in reports.

Dangerous Devices Too

The MHRA collects information on safety and effectiveness of medical devices too, and you can report suspected problems to them by telephoning 020 7084 3080.

AIMS Comment

This opening up of channels of information from the public is long overdue. It should identify problems more quickly. Parents and midwives should make sure reports are sent in whenever they see a problem.