The Yellow Card Scheme is well established as the way to report suspected side effects from medicines. However, the scheme has been extended to allow the reporting of all suspected problems or incidents with all healthcare products.
Yellow Card Scheme covers:
- side effects (also known as adverse drug reactions or ADRs) from prescribed medicines, as well as over the counter and herbal preparations
- medical device adverse incidents
- defective medicines (those that are not of an acceptable quality)
- counterfeit or fake medicines or medical devices
- safety concerns for e-cigarettes or their refill containers (e-liquids)
The Yellow Card Scheme is run by the Medicines and Healthcare Products Regulatory Agency (MHRA) which is part of the Department of Health. The MHRA is responsible for ensuring that medicines and medical devices work and are acceptably safe. Information gathered from the Yellow Card Scheme is assessed by medicine safety experts at the MHRA. If a new side effect or problem is identified, the frequency and seriousness is assessed and the treatment or device may have to carry additional warnings or, in rare cases, be withdrawn.
The Yellow Card Scheme is a way of monitoring side effects from medicines which were too rare to be found in clinical trials and which only become apparent when the medicine is being used by many more people. With medical devices, the Yellow Card Scheme could pick up a problem with the design, manufacture or maintenance of the device or that the instructions are unclear leading to errors in using the equipment.
It is important that you report any problems that you experience with a medicine or medical device. The Yellow Card Scheme allows anyone who is taking the drug, health professionals or carers to report their concerns.
Yellow Cards are available from pharmacies and GP surgeries or from the Yellow Card hotline by calling freephone 0800 731 6789 during business hours or email email@example.com. The Yellow Card form can also be downloaded, to print and complete from the Yellow Card website. Alternatively, you can call the Yellow Card hotline and make your report direct to their staff.