A new online reporting site,
dedicated to reporting any suspected side effects from medicines,
future vaccines and incidents involving medical equipment
relating to COVID-19 treatment, has today been launched.
The tailored Yellow
Card COVID-19 reporting site makes it quicker and simpler for
healthcare professionals, patients and carers to report
side-effects or incidents.
The site has been developed as part of the Medicines
and Healthcare products Regulatory Agency’s (MHRA) work to
protect the public through enhanced COVID-19 vigilance and in
preparation for large-scale use of potential new or
repurposed medicines, medical
devices, diagnostic tests and future vaccines.
In our commitment to ensuring that the medicines and
medical devices that people use are safe, we will use
the COVID-19 Yellow Card reports to monitor the safety
of healthcare products being used in COVID-19 treatment. In doing
so there will be rapid identification of new or emerging
risks, which might not have been previously known about and will
take appropriate regulatory action, where
necessary.
Dr June Raine, MHRA Chief
Executive said:
“While our aim is to ensure that
potentially lifesaving COVID-19 treatments and medical equipment
reach patients as quickly as possible, patient safety is our
highest priority.
“I encourage healthcare professionals and patients to
use our new dedicated site to report problems with medical
equipment, including ventilators or testing kits, as well as any
suspected side effects
from medicines used to combat COVID-19.”
To make a report or find out more about the Yellow
Card COVID-19 reporting site please visit: coronavirus-yellowcard.mhra.gov.uk
Ends
Notes to Editor
• Medicines
and Healthcare products Regulatory Agency is responsible for
protecting and improving the health of millions of people every
day through the effective regulation of all medicines and medical
devices in the UK by ensuring they work and are acceptably safe.
All our work is underpinned by robust and fact-based judgements
to ensure that the benefits justify any risks.
•
The MHRA is a centre of the
Medicines and Healthcare products Regulatory Agency which also
includes the National Institute for
Biological Standards and
Control (NIBSC) and the Clinical Practice Research
Datalink (CPRD). MHRA is an executive agency of
the Department
of Health and Social Care.
•
There currently are no vaccines and no medicines authorised to
treat COVID-19 in the UK by the MHRA. However, several treatments
authorised for other diseases are being used in patients with
COVID-19.
• The Yellow Card scheme is
MHRA’s system of monitoring the safety of medicines and medical
devices in the UK and it acts as an early warning system to
identify new, and strengthen existing, safety information about
medicines, medical devices, falsified or
defective healthcare products, and e-cigarettes.
• The Yellow Card
COVID-19 reporting site is a separate platform dedicated to
COVID-19 related reports and linked to the main Yellow
Card scheme reporting site. Information provided by patients and
healthcare professionals through their COVID-19 Yellow
Card reports will be used alongside other scientific safety
information such as clinical trials, scientific literature, other
safety databases and studies to help MHRA to take action, if
necessary, to make changes to the warnings given to people taking
a medicine or review the way a medicine or a device is used to
maximise benefit and minimise the risk to the
patient.
•
Patients with confirmed or suspected COVID-19 should report
suspected side effects that they experience with any of the
medicines they are taking. This includes medicines to treat
COVID-19, as well as medicines taken by patients to manage
long-term, pre-existing conditions. It also includes medicines
that patients and healthcare professionals might be using
off-label to treat COVID-19.
•
Reporting categories for the COVID-19 Yellow Card
reporting site include medical devices such as
ventilators and respiratory support, testing kits, protective
personal equipment, and medicines used in COVID-19 treatment. For
full details on what can be reported go
to coronavirus-yellowcard.mhra.gov.uk
• The
COVID-19 Yellow Card reporting site
is not for reporting symptoms of COVID-19
and the MHRA cannot provide medical advice. People who need
medical advice or are worried about their health are encouraged
to speak to their doctor, pharmacist or to call NHS
111.
•
Falsified products, including fake testing
kits or counterfeit medicines can be reported using the main scheme which is also signposted
on the COVID-19 Yellow Card reporting site.
