Milestone One Millionth Report to MHRA for Suspected Medicine Side Effects

Priscilla Lynch 

November 04, 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that it has received its one millionth ‘Yellow Card’ report since the scheme was first started over 50 years ago.

The scheme is the UK’s system for reporting suspected side effects to medicines and adverse events with medical devices run by the MHRA.

This major milestone coincides with the launch of the fifth annual #MedSafetyWeek (2-8 November), which highlights the value of the Yellow Card scheme to the nation’s health and the importance of reporting suspected side effects from medicines.

The MHRA has seen an increased rate of Yellow Card reports and would like to continue to encourage more reporting this #MedSafetyWeek.

MedSafetyWeek is a global campaign, with over 70 countries participating worldwide. This year, the theme is ‘every report counts’. The MHRA is calling upon patients and carers, as well as healthcare professionals and their organisations to report suspected side effects from medicines.

One recent positive change to medicines information for users involves a woman in the UK who helped identify a newly recognised side effect from a blood pressure medication. While pregnant, the patient noticed unusual side effects (burning nipple pain) when taking her medicine and reported it to the MHRA using the Yellow Card scheme. This led the MHRA to investigate and work with the manufacturers to improve the patient safety information, and the medicine now includes nipple pain as a possible side effect of Raynaud’s phenomenon.

Mick Foy, Head of Pharmacovigilance Strategy, MHRA Vigilance and Risk Management of Medicines Division, said: “Patient safety is our number one priority. We want this campaign to encourage everyone to report suspected side effects from medicines and make more people aware of our Yellow Card scheme. This important milestone shows that every report counts and contributes to improving the safety of medicines for all patients.”

This article originally appeared on Univadis, part of the Medscape Professional Network.

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