The Yellow Card Scheme
The Yellow Card Scheme is vital in helping the MHRA monitor the safety of the medicines and vaccines that are on the market.
Before a medicine is granted a licence so that it can be made available in the United Kingdom, it must pass strict tests and checks to ensure that it is acceptably safe and effective. All effective medicines, however, can cause side effects (also known as adverse drug reactions), which can range from being minor to being very serious. For a medicine to be granted a licence, the expected benefits of the medicine must outweigh the possible risks of the medicine causing adverse effects in patients. Sometimes, it is difficult to tell whether a possible side effect is due to a medicine, or something else. Even if it is only a suspicion that a medicine or combination of medicines has caused a side effect, we ask patients and health professionals to send us a Yellow Card.
Yellow Card reports that we receive on suspected side effects are evaluated, together with additional sources of information such as clinical trial data, medical literature or data from international medicines regulators, in order to identify previously unidentified safety issues or side effects.
Information gathered from Yellow Card reports made by patients and health professionals is continually assessed at the MHRA by a team of medicine safety experts made up of doctors, pharmacists and scientists who study the benefits and risks of medicines. If a new side effect is identified, information is carefully considered in the context of the overall side effect profile for the medicine, and how the side effect profile compares with other medicines used to treat the same condition. The MHRA takes action, whenever necessary, to ensure that medicines are used in a way that minimizes risk, while maximizing patient benefit.
In assessing the safety of medicines, the MHRA is advised by the Commission on Human Medicines (CHM), which is the Governments independent scientific advisory body on medicines safety. The CHM is made up of experts from a range of health professionals and includes lay representatives.
Black Triangle medicines (▼)
Medicines that are being monitored particularly closely by regulatory authorities in the European Union (EU) are described as being under 'additional monitoring'. Medicines under additional monitoring will have Black Triangle displayed in their patient information leaflet and in the information for healthcare professionals called the summary of product characteristics, together with a short sentence:
▼ This medicinal product is subject to additional monitoring.
The accompanying advice will explain that the symbol means that the medicine is being monitored particularly closely and encourages reporting of suspected adverse drug reactions. A list of Black Triangle medicines is available at www.mhra.gov.uk/blacktriangle.
We ask that healthcare professionals and patients are especially vigilant in identifying and reporting suspected adverse drug reactions via the Yellow Card Scheme, particularly those associated with Black Triangle medicines.
Although the Black Triangle has been in place in the UK for many years to signify medicines that are subject to intensive monitoring, it will now be used in all EU Member States and the list has been agreed Europe-wide. For the first time in EU countries, the Black Triangle will start appearing in the package leaflets of the medicines concerned from the autumn of 2013. It will not appear on the outer packaging or labelling of medicines
Yellow Card data
Reports of suspected adverse drug reactions (ADRs) received in the UK by the MHRA through the Yellow Card Scheme are provided in lists for each medicine. These are known as drug analysis prints and can be accessed at Drug Analysis Prints.
A Yellow Card reports a suspicion of a side effect being due to a medicine. Therefore it is not possible to draw definite conclusions on the safety of a particular medicine from information received on Yellow Card reports alone, without referring to other scientific research.
More information on What happens to a Yellow Card, Looking for potential drug safety issues in Yellow Card data and the Impact of the Yellow Card Scheme are available on the MHRA website.