Medicines Healthcare Products Regulatory Agency
What healthcare professionals can do to support MedSafetyWeek 7 to 13 November 2022
- follow the MHRA on its social media channels and show your support for this years MedSafetyWeek by retweeting, commenting, liking, and sharing material with your social media contacts using #MHRAyellowcard, #MedSafetyWeek, #ReportSideEffects, and #patientsafety
- dont delay in reporting suspected adverse drug reactions (side effects) to the Yellow Card scheme or via the Yellow Card app (download from the Apple App Store or Google Play Store) only a suspicion is needed to report a suspected reaction to us
- you can also use the Yellow Card scheme to report a suspected defective or fake medicine, adverse reactions to herbal or homeopathic medicines, and any problems with medical devices (including software, apps and artificial intelligence) and e-cigarettes including their refill containers (e-liquids)
- for suspected adverse reactions associated with COVID-19 vaccines and medicines, as well as suspected incidents with medical devices and test kits, report directly to the Coronavirus Yellow Card reporting site or use the Yellow Card app
- discuss with your patients:
- the importance of taking the right medicine, at the right time, in the right way, and at the right dose and of carefully following instructions for use of medical devices
- the importance of reading the Patient Information Leaflet that comes with a medicine or vaccine
- what to do if they experience problems with a healthcare product, such as contacting a healthcare professional and reporting to the Yellow Card scheme
- talk to your colleagues about being vigilant for suspected adverse reactions with medicines or vaccines, especially new, serious or rare reactions or those that may have a delayed onset, and the importance of reporting them to the Yellow Card scheme
About MedSafetyWeek
The annual MedSafetyWeek forms part of international efforts to raise awareness about the importance of reporting suspected adverse reactions to national medicines regulatory authorities, such as the MHRA. This year, regulators from 81 countries will take part.
The theme for 2022s campaign is how patients and healthcare professionals make safety work. More information on MedSafetyWeek is available on the Uppsala Monitoring Centres website.
This MedSafetyWeek, we ask that you report suspected adverse drug reactions to a medicine or vaccine directly to the Yellow Card scheme as soon as they arise. Do not wait or rely on someone else to report concerns. Only a suspicion is needed to submit a Yellow Card, so, if in doubt, please complete a report.
Adverse incidents associated with a medical device can be reported through the Yellow Card scheme and local reporting systems. Report incidents with any instrument or appliance (including software), used alone or in combination, which is intended by the manufacturer to be used for the diagnosis, prevention, treatment or alleviation of a medical condition. Potential problems with medical devices can also be reported.
In addition, Yellow Card reports can also be made for other healthcare products in the UK, such as blood factors and immunoglobulin products, herbal or homeopathic medicines, and e-cigarettes including their refill containers (e-liquids).
Safety monitoring systems protect public health
The Yellow Card scheme helps us to monitor the safety of healthcare products once they are on the market. Reporting to the scheme allows the MHRA to identify new adverse effects and gain more information about known adverse effects. By completing a Yellow Card report, you can help contribute to the safe use of healthcare products for patients and contribute to the safety information of a product and how it is used.
The Yellow Card scheme has helped to identify numerous safety issues, many of which were not previously linked to a particular healthcare product until Yellow Card reports were received by the MHRA. You can read some of our case studies where Yellow Card reports have contributed to patient safety.
There are some medicines for which it is very important that healthcare professionals, patients, and carers report all suspected adverse drug reactions to these products. The Commission on Human Medicines (CHM) and the MHRA intensively monitor the safety of all products with a Black Triangle symbol (?).
What to include on a Yellow Card?
We take every report seriously and encourage everyone to report any suspicions of adverse effects to medicines and other healthcare products. Further guidance is available on how to complete a report.
When submitting a Yellow Card, please provide as much information as possible, including product brand name, batch number (for vaccines and biological products), medical history, concomitant medications, treatment dates, onset timing, and duration.
Resources for healthcare professionals
More information and resources, such as accredited e-learning modules and materials to help raise awareness locally, are available on the Yellow Card website.
Healthcare professionals should also speak to their local Medication Safety Officer or Yellow Card Centre to help support the campaign locally and help raise awareness. You can also discuss with your local Medical Device Safety Officer (MDSO) how you can help support the reporting of adverse incidents with medical devices.
You should also encourage your colleagues to sign up to receive alerts for Drug Safety Update and other safety information from the MHRA about medicines and medical devices these messages are also available through the Yellow Card app (download from the Apple App Store or Google Play Store).
Article citation: Drug Safety Update volume 16, issue 3: October 2022: 1.