The Yellow Card Scheme is vital in helping the MHRA monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those that use them. 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 of May 2016, the MHRA is also collecting reports of safety concerns associated with e-cigarette products through the Yellow Card Scheme.
The Scheme collects information on suspected problems or incidents involving
- side effects (also known as adverse drug reactions or ADRs)
- 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)
It is important for people to report problems experienced with medicines or medical devices as these are used to identify issues which might not have been previously known about. The MHRA will review the product if necessary, and take action to minimise risk and maximise benefit to the patients. The MHRA is also able to investigate counterfeit or fake medicines or devices and if necessary take action to protect public health.
Side effects to a medicine, vaccine, herbal or complementary remedy
All medicines can cause side effects (commonly referred to as adverse drug reactions or ADRs by healthcare professionals).
Side effects reported on Yellow Card are evaluated, together with additional sources of information such as clinical trial data, medical literature or data from international medicines regulators, to identify previously unknown safety issues. These reports are assessed 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, the safety profile of the medicine in question is carefully looked at, as well as the side effects of other medicines used to treat the same condition. The MHRA takes action, whenever necessary, to ensure that medicines are used in a way that minimises risk, while maximising patient benefit.
See our animation below, developed as part of an EU wide social media campaign from the Strengthening Collaborations to Operate Pharmacovigilance in Europe (SCOPE) Joint Action project. It can also be viewed on MHRA’s YouTube channel here: https://youtu.be/3et5LdYLc8M.