Home Essential support Every report to the MHRA Yellow Card scheme helps improve the safety of medicines and medical devices for all

Every report to the MHRA Yellow Card scheme helps improve the safety of medicines and medical devices for all

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Launched today by the Medicines and Healthcare Products Regulatory Agency (MHRA), the seventh annual report #MedSafetyWeek runs until November 13 to encourage broad public engagement and improve patient safety by reporting suspected drug-associated side effects and adverse incidents involving medical devices.

This year’s campaign is a truly global effort and involves healthcare product regulators from no less than 82 countries. It focuses on the vital role played by every healthcare professional, patient and caregiver in reporting a suspected side effect or adverse incident, which in turn supports the safe use of medicines and medical devices.

All medicines can cause side effects and adverse events can occur when using medical devices. It is therefore important to have strong measures in place to continuously monitor their safety after clinical use. The purpose of safety monitoring is to obtain more information about known side effects and adverse events, to discover new ones and, above all, to make the use of medicines and medical devices as safe as possible. possible. Regulators operate systems to detect and analyze these adverse side effects and incidents and prevent harm to future patients.

It is important for everyone to report as soon as they suspect side effects and adverse events. This ensures that regulatory assessments are truly representative and can improve safety for as many people as possible.

The Yellow card scheme is the MHRA’s unique system for collecting suspected drug side effects and adverse incidents involving medical devices. These side effects and adverse events are then collated and quickly investigated by the MHRA. Since its inception in 1964, the program has identified many safety issues to the benefit of many, through individual reports from drug users across the country.

Anyone who reports suspected side effects and adverse events to Yellow card system website or appactively participates in identifying emerging national security issues, so that the MHRA can act where necessary and protect against harm.

Phil Tregunno, MHRA Deputy Director of Patient Safety Oversight, said:

Each report made by a patient, healthcare professional or carer plays a key role in understanding the risks of medicines and medical devices for clinical use and allowing rapid and targeted action to be taken to minimize harm and ensure that the benefit – the risk remains favourable.

Reporting suspected side effects and adverse incidents on the Yellow Card website is not just about the individual concerned, it helps to improve the safety of medicines and medical devices for all patients. By reporting, you are part of the solution – and you may be helping to protect the most vulnerable and at-risk groups from potential harm.

If you, your child or a patient in your care experience a suspected side effect or adverse incident related to a medicine or medical device, it is essential that you report it to us quickly. The sooner you report, the more likely we can step in and prevent others from having unfortunate, serious, upsetting, and sometimes fatal issues.

Minister of State for Health and Secondary Care, Will Quince, said:

Patient safety is at the heart of delivering the best care, and this government takes it extremely seriously. I am happy to support this campaign which will help to further improve the safety of medicines in the UK.

I urge everyone, from healthcare professionals to patients, to continue to report any adverse reactions involving drugs or medical devices through the yellow card system, so that potential incidents can be investigated. fast.

Anyone can report suspected side effects and adverse events to the Yellow Card program. Reports can be submitted in several ways:

Healthcare professionals and providers can also use local clinical systems to report, such as MiDatabank, SystmOne or VISION.

Reports related specifically to COVID-19, including suspected side effects caused by drugs, vaccines and medical devices and incidents while using coronavirus test kits should be made to coronavirus-yellowcard.mhra.gov.uk

Notes to Editors

  • National medicines regulators from 82 countries around the world and their stakeholders will take part in this international campaign led by the Uppsala Monitoring Center (UMC) – the World Health Organization (WHO) Collaborating Center for international drug monitoring. The campaign is supported by members of the International Coalition of Medicines Regulatory Authorities (ICMRA). The #MedSafetyWeek 2022 project team is made up of representatives from the following organizations working in collaboration: Medicines and Healthcare Products Regulatory Agency (UK) as co-lead, Medicines Regulatory Authority (Ireland), the Egyptian Section of the International Society of Pharmacovigilance (ISoP), and the Colombian Pharmacovigilance Association.
  • The Medicines and Healthcare Products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. The MHRA is an executive agency, sponsored by the Department of Health and Social Care.
  • Patients using the yellow card site should enter the relevant medicine, vaccine or medical device in the search bar and select “Start report” on the right side of the bar. The search bar also offers a drop-down menu to flag medicines, vaccines, medical devices, blood factors and immunoglobulin products, e-cigarettes, and herbal or homeopathic medicines that are not on the list from the MHRA, as well as the ability to send additional details of the suspected material(s) if the product type is unknown, so that the final report is accurate.
  • For adverse incidents associated with a medical device, healthcare professionals should report through the yellow card system or their local clinic reporting systems. Healthcare professionals in Northern Ireland and Scotland will be required to report adverse incidents involving medical devices through the Northern Ireland Adverse Incident Center (NIAIC) Where National Services Scotland.
  • Patients are advised to contact a healthcare professional if they have concerns about their health or the safety of any health product they receive.