02 November 2021

This year’s Meds Safety Week is on the importance of reporting suspected adverse reactions to vaccines.

Suspected drug reactions can be reported by anyone via the Yellow Card scheme. The Yellow Card Scheme is the UK system for collecting and monitoring information on suspected safety concerns or incidents involving medicines and medical devices. It is vital in determining if a response by one person is a one-off or if the symptoms/effects are experienced by a number of people which is a significant widespread effect needing investigation. 

How The Yellow Card Scheme Works
The Scheme is run by the Medicines and Healthcare Products Regulatory Agency (MHRA) and currently relies on voluntary reporting of suspected adverse drug reactions by health professionals and patients.

The purpose of the Scheme is to provide an early warning that the safety of a product may require further investigation. 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. Since 2016, the MHRA also collects 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)

 

Anyone Can Report a Concern
The campaign calls upon patients, parents, and carers, as well as healthcare professionals and their organisations, to report suspected adverse drug reactions to medicines. People are advised not to wait for someone else but rather to report their suspicions directly as soon as they can.