The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive Agency of the Department of Health and Social Care that acts on behalf of the Ministers to protect and promote public health and patient safety, by ensuring that medicines and medical devices meet appropriate standards of safety, quality and efficacy. The Yellow Card scheme run by the MHRA and is the UK system for collecting and monitoring information on safety concerns such as suspected side effects or adverse incidents involving medicines and medical devices. The scheme relies on voluntary reporting of suspected side effects or medical device incidents to be reported by health professionals and the public, including patients, carers and parents. Reporting helps others.
The purpose of the scheme is to provide an early warning that the safety of a medicine or a medical device may require further investigation. 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 issue and if necessary, take action to minimise risk and maximise benefit to the patients.
Reports can be made for all medicines including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies, all medical devices available on the UK market and reports of safety concerns associated with e-cigarette products . The MHRA is also able to investigate counterfeit or fake medicines or devices and if necessary, take action to protect public health.
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)
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 Cards 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 assesses the balance of risks and benefits of all medicines at the time of initial licensing and throughout their use in clinical practice. Where appropriate, the MHRA seeks advice from the independent Commission on Human Medicines (CHM). The MHRA takes action, whenever necessary, to ensure that medicines are used in a way that minimises risk, while maximising patient benefit.
- UK equivalent to the USA VAERS government system.
- Statistics Summary: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting