The Assessment
The MHRA - Yellow Card scheme Assessment is a formative assessment to help prescribers understand the regulatory role of the Medicines and Healthcare products Regulatory Agency (MHRA) and its Yellow Card scheme.
The Assessment is a collaboration between BPS Assessment (BPSA) and the Medicines and Healthcare products Regulatory Agency (MHRA), and is delivered as a one-hour formative assessment, containing two modules:
- Module 1: ‘MHRA and the Yellow Card scheme’ - general knowledge questions about the role of the MHRA and the Yellow Card scheme; and
- Module 2: ‘Reporting Adverse Incidents’ – scenario-based case studies about adverse incidents and reporting routes.
Each question is presented in an easy-to-follow, question-and-answer format, with access to immediate question-by-question feedback and links to further reading and relevant guidelines.
The material has been written and reviewed by content specialists from the MHRA. It is aimed at all healthcare professionals wishing to improve their knowledge of the regulatory function of the agency and why reporting suspected safety concerns to the Yellow Card scheme is important for patient safety.
By the end of the Assessment, you will better understand the regulatory role of the MHRA, the importance of post-market surveillance activities in the real world, and the value of reporting any suspected safety concerns to the Yellow Card scheme.
The package is delivered using the same technology and layout as the UK Prescribing Safety Assessment, which is taken by over 7,000 medical students annually and assesses prescribing competencies among those graduating into the UK Foundation Programme.
Visit the MHRA: Yellow Card scheme Assessment page
About the Medicines and Healthcare products Regulatory Agency (MHRA)
The
MHRA is the regulator of 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.
Its responsibilities are to:
- ensure medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy (effectiveness)
- secure safe supply chain for medicines, medical devices and blood components
- promote international standardisation and harmonisation to assure the effectiveness and safety of biological medicines
- educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use
- enable innovation, and research and development that is beneficial to public health
- collaborate with partners in the UK and internationally to support our mission to enable the earliest access to safe medicines and medical devices and to protect public health
About the Yellow Card scheme
(Logo for the Yellow Card scheme)
The Yellow Card scheme is run by the MHRA and is the cornerstone of post-market surveillance of healthcare products in the UK. Through the Yellow Card scheme, the MHRA collects and monitors information on suspected safety concerns involving healthcare products, like side effects caused by a medicine, or adverse incidents involving medical devices.
Anyone can report to the Yellow Card scheme (including patients, parents and carer givers).
The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation. Data collected via the Yellow Card scheme can ensure that all healthcare products can continue to be used to benefit people by identifying new side effects or safety issues.
What to report
You can report safety issues around any healthcare product to the Yellow Card scheme. This can include side effects, defective products (not of an acceptable quality), and falsified or fake healthcare products.
‘Healthcare products’ include:
How to report
You can report suspected side effects electronically via:
In Scotland, healthcare professionals should report adverse incidents involving medical devices to NHS National Services Scotland online incident reporting system and their local incident recording system. If you are in England, Wales or NI please report any safety concerns with medical devices online using the Yellow Card website.
Further information and resources
The Yellow Card scheme website contains further information about the scheme:
• resources to help you encourage reporting
• campaign materials for MedSafetyWeek and World Patient Safety Day
• case studies demonstrating the impact of reporting to the Yellow Card scheme
• Interactive Drug Analysis Profiles (iDAPs) listing all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme
You can also view and sign up here for MHRA alerts, recalls and safety information.