Actions for healthcare professionals:
- be vigilant for any potential safety issues associated with medicines and medical devices used in COVID-19 treatment
- use the new dedicated COVID-19 Yellow Card reporting site to report:
- all suspected side effects associated with any medicine used in patients with confirmed or suspected COVID-19, including medicines to manage long-term or pre-existing conditions, and unlicensed medicines or medicines used off-label
- medical devices incidents related to COVID-19
reporting of incidents in clinical trials should follow the trial protocol
for non-COVID related side effects from medicines please continue to report through the standard Yellow Card website, which can also be used for defective or falsified medicines and medical devices (including fake COVID-19 testing kits)
- any medical device incidents should be reported to Health Facilities Scotland in Scotland and to the Northern Ireland Adverse Incident centre in Northern Ireland
Launch of COVID-19 Yellow Card reporting site
The Yellow Card scheme is vital in helping the MHRA monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and users.
The MHRA has launched a dedicated COVID-19 Yellow Card reporting site for healthcare professionals, patients, and caregivers to report easily:
- suspected side effects associated with any medicine used in patients with confirmed or suspected COVID-19, including
- medicines to manage long-term or pre-existing conditions
- unlicensed medicines or medicines used off-label to treat COVID-19
- incidents involving medical devices used in relation to COVID-19, including adverse incidents with equipment, diagnostic testing kits and software/apps
In the future, the dedicated site will enable reporting of suspected side effects associated with new medicines or vaccines authorised to treat and prevent COVID-19.
Report at coronavirus-yellowcard.mhra.gov.uk
What should I report?
Medicines COVID-19 reporting
At present, there are no vaccines and no medicines authorised to prevent or treat COVID-19 in the UK. However, several treatments authorised for other diseases are being used in patients with COVID-19, particularly in clinical trials. If a patient is in a clinical trial, reporting of suspected adverse reactions should follow the trial protocol.
Any suspected side effect to a medicine used in the treatment of COVID-19 can be reported via the COVID-19 Yellow Card reporting site. This includes off-label or unlicensed medicines that healthcare professionals and patients might be using to treat COVID-19.
In addition, please report all suspected side effects associated with any of the medicines being administered to patients in which COVID-19 is suspected or confirmed. This includes any medicines taken by patients to manage long-term or pre-existing conditions. It is also important for any suspected side effects in children and adolescents with confirmed or suspected COVID-19 to be reported via the new site, as for adults.
When reporting, patients and healthcare professionals are encouraged to provide as much information as possible, including whether COVID-19 infection has been confirmed through testing.
Suspected adverse drug reactions for medicines that do not appear in the preselected drop-down list can be reported using the ‘Medicines’ option at the end of the list.
Medical devices COVID-19 reporting
This includes medical devices such as ventilators and respiratory support devices, testing kits, certain personal protective equipment that are classified as medical devices, and software/apps.
For medical devices, a description of the incident should be provided, including whether there was an associated injury.
Please note there are different ways for healthcare professionals to report a problem with a medical device in Scotland or Northern Ireland. For more information see here.
Reporting will enable the MHRA to rapidly identify new and emerging side effects and medical device issues associated with new or repurposed medicines and medical devices (including diagnostic tests) to combat COVID-19.
Understanding of the COVID-19 virus is limited, including possible interactions with medicines patients might be taking. By reporting suspected side effects of any medicines used in the context of COVID-19, healthcare professionals and patients can provide valuable evidence to inform decisions on the safe and effective use of medicines as the pandemic evolves.
What happens to my report?
Yellow Card reports submitted in relation to medicines or medical devices used in COVID-19 treatment are used alongside other scientific safety information such as clinical trials, scientific literature, other safety databases, and studies. The MHRA are closely monitoring any new or emerging safety signals in relation to medicines or medical devices used in or for patients with COVID-19. Where necessary, the MHRA can take appropriate regulatory action and communicate any associated risks.
Support for reporting Yellow Cards – please continue to report all adverse incidents for medicines and medical devices
We appreciate healthcare professionals are under pressure at this challenging time, but reporting remains essential both to understand the impact of COVID-19 on existing medicines and medical devices, and to identify new safety issues.
Non-COVID-19 related suspected side effects to medicines or concerns about medical devices (in England), defective or falsified products (including fake COVID-19 testing kits), and e-cigarettes should still be reported to the standard Yellow Card website. Please note, any medical device incidents should be reported to Health Facilities Scotland in Scotland and to the Northern Ireland Adverse Incident Centre in Northern Ireland.
During the pandemic, Yellow Card reporting for suspected side effects has decreased, especially from healthcare professionals. The Yellow Card scheme continues to operate as usual and safety concerns should still be reported to the MHRA. Further information on Yellow Card reporting or guidance for healthcare professionals during the pandemic please see our website.
Article citation: Drug Safety Update volume 13, issue 10: May 2020: 1.