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Yellow Card reporting during the COVID-19 pandemic

What adverse reactions should be reported for medicines and devices related to COVID-19 treatment?

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This article was correct at time of publishing (April 21). To keep up with the latest information please visit our COVID-19 hub

The Yellow Card scheme is the system used by the Medicines and Healthcare products Regulation Agency (MHRA) to record adverse events of medicines and medical devices in the UK. The Yellow Card website can also be used to report defective medicines, products that may be falsified and any safety concerns that may be associated with e-cigarettes or their refills. The Yellow Card scheme helps to ensure medicines and devices are acceptable and safe for use.(1)

Submitting a report to the Yellow Card Scheme can usually be made in various ways, either electronically or via post.

Electronic methods include:

  • online, through the Yellow Card website
  • using clinical IT systems, such as EMIS
  • through the free Yellow Card Scheme app.

Forms to report via post are available:

The MHRA has advised that other yellow card reports, for side effects to medicines, vaccines, herbal or homeopathic remedies, and adverse incidents to devices should be reported electronically during the pandemic, as MHRA staff have been working remotely.

If a yellow card was sent via post after 17th March 2020 and acknowledgement hasn’t been received then it is advisable to resubmit via an electronic method. The Yellow Card Scheme also has a free call line, 0800 731 6789, that is available Monday to Friday between 10am and 2pm for those unable to report online.(1)

Reporting during the COVID-19 pandemic

The MHRA has recently launched a new website, the Coronavirus Yellow Card reporting site. This site is for healthcare professionals, carers and patients to report any possible adverse events from medicines, future vaccines or any medical devices that are related to treatment for COVID-19.(1) Use of this dedicated site will allow the MHRA to quickly identify any safety signals that may be new or emerging, related to the management of COVID-19.(2)

There are currently no medicines authorised to treat COVID-19. Several treatments authorised for other diseases including severe respiratory illnesses, are being used in patients with COVID-19, as well as medicines and medical devices being used to treat the symptoms of coronavirus, provide supportive care or to suppress virus reproduction.(3)

As it is still unknown how COVID-19 interacts with these medicines and devices, it is important to report any adverse reactions to help inform decisions on the safe and effective use of medicines and medical devices as the pandemic evolves.(3)

What to report on the Coronavirus Yellow Card reporting site

The Coronavirus Yellow Card reporting site can be used to report any suspected adverse effects or incidents related to:

  • medicines being used for the treatment of COVID-19, including those that are currently being used off-label
    • reporting should be in line with trial protocol for medicines being used as part of a clinical trial program
  • medical devices being used for the management of COVID-19, including ventilators and respiratory support devices
  • diagnostic tests for COVID-19
  • medicines that patients may be taking long-term or for other pre-existing conditions where it may be thought they could influence the disease or potentially interact
  • personal protective equipment that is classed as a medical device and being used in the treatment of COVID-19.(2)

When reporting an adverse reaction, the following information should be included:

  • information on the patient
  • if COVID-19 infection has been confirmed with testing
  • medicine or device (including type and where it was sourced) causing side effects
  • any other medicines being taken (including over-the-counter and herbal medicines)
  • any co-morbidities.

The importance of reporting

The MHRA has advised that Yellow Card reporting for potential adverse effects has decreased during the pandemic, especially from healthcare professionals. It reminds healthcare professionals that the Yellow Card scheme continues to operate and that reporting is essential in order to understand the safety of existing medicines and medical devices that may be used to treat COVID-19, as well as identifying any new concerns that may arise.(2)

Further information

For further information about the Yellow Card Scheme, refer to the MHRA guidance: The Yellow Card scheme: guidance for healthcare professionals, patients and the public.

The Centre for Postgraduate Pharmacy Education (CPPE) has created an online, e-learning module for pharmacists on how to identify, report and prevent adverse drug reactions.

The MHRA has also published guidance about adverse drug reactions, including classification.

References
  1. Medicines and Healthcare products Regulatory Agency (2020) The Yellow Card scheme: guidance for healthcare professionals, patients and the public.
  2. Medicines and Healthcare products Regulatory Agency (2020) Yellow Card reporting site for healthcare products used in Coronavirus (COVID-19).
  3. Medicines and Healthcare products Regulatory Agency (2020) Yellow Card reporting site: About this service.
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