Introducing the Yellow Card Scheme

Medicines are essential for so many of us, helping people to manage symptoms, to treat, and to prevent conditions. However, no medicine is perfect, and some may cause unwanted side effects for certain people. Many side effects are mild, but some can be serious and even life-threatening. Therefore, it’s everyone’s responsibility to report any side effects from medicines – regardless of whether you are a patient, carer or healthcare professional.

The more information that we have about a medicine, the safer that medicine is likely to be, and we can better predict how that medicine will react in different people more confidently. The Medicines and Healthcare products Regulatory Agency (MHRA) collects information about side effects (also referred to as adverse drug reactions) on Yellow Card reports. The scheme by which side effects are reported is called the Yellow Card Scheme. The MHRA uses these reports to review medicines. These reports help to identify previously unknown issues. If issues are found, the MHRA can then take action. If the side effects are very serious, this may lead to avoiding using that medicine in certain susceptible people, or dose adjustments can be advised and in very serious cases, the medicine may be withdrawn from the market.

Most people are unaware of the Yellow Card Scheme – let alone that patients and carers can report side effects of medicines, as well as healthcare professionals. Patient and carer reports are particularly valuable, since they provide important insights into how side effects affect quality of life and often provide a detailed timeline. It is important to remember you only have to report suspicion; you don’t have to be sure it was the medicine causing it. The MHRA will assess the reports and investigate suspicions. You should of course always speak to a healthcare professional involved in your care if you have any concerns about side effects of medicines that you are taking.

Reporting is quick and easy and can be done online, on paper or on the Yellow Card app (available through App Store and Google Play). Reports can be made for all medicines, including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies, and all medical devices available on the UK market. From the 20th May 2016, the MHRA is also collecting reports of safety concerns associated with e-cigarette products through the Yellow Card Scheme.

The Yellow Card Scheme collects information on suspected problems or incidents involving:

  1. Side effects (also known as adverse drug reactions, or ADRs);
  2. Medical device adverse incidents;
  3. Defective medicines (those that are not of an acceptable quality);
  4. Counterfeit or fake medicines/medical devices;
  5. Safety concerns for e-cigarettes or their refill containers (e-liquids).

If you experience, or have experienced a side effect and you want to make that medicine safer for other people, please report it!

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