Along with many other parts of the healthcare service, the Yellow Card system, and pharmacovigilance more generally, has faced significant challenges as a result of the pandemic. However, important opportunities have also arisen. The relatively rapid trialing and deployment of vaccines and newer therapeutic agents to prevent or treat SARS-CoV-2 infection, has refocused attention on the principle that the adverse effect profile of any new medicine is not fully elucidated at the time of granting marketing authorisation. The last two years have reminded everyone that healthcare professionals and the public have an invaluable role in providing early signals about less common but potentially serious reactions. These help to better inform prescribers, and those giving consent to treatment, about the balance of risks and benefits.
Throughout the course of the pandemic, around half a million Yellow Card reports of suspected adverse reactions were submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) for COVID-19 vaccines. These were made openly available as aggregated reports every two weeks and became a popular topic of public discourse. However, the conclusion that should be taken away is that a system, originally conceived in the 1960s, retains the capability of rapidly detecting, confirming, and beginning to quantify the extent of any new risks so that these can be weighed against the expected benefits. The latest MHRA update of research and analysis (3 November 2022)(1) uses reports to address some of the commonly expressed vaccine concerns regarding events such as miscarriage, anaphylaxis, Bell’s palsy, transverse myelitis, thromboembolic events, menstrual disorders, myocarditis and pericarditis, Guillain-Barré Syndrome and fatalities.
With what we all hope has been the passing of the worst of the pandemic, we now turn our attention to the future. Here in Scotland, Yellow Card Centre (YCC) Scotland, based at the Royal Infirmary of Edinburgh and co-funded by the MHRA and Scottish Government, is at the centre of pharmacovigilance efforts. Our role is to support adverse reaction reporting, raise awareness, promote pharmacovigilance, and provide educational events for professionals and public. Our latest Annual Report 2021/2022(2) shows that 94% Yellow Card reports were for suspected reactions to COVID-19 vaccines. However, if vaccines are excluded, we are pleased to report an 18% increase in Yellow Card reporting compared to the previous year, possibly indicating an increasing awareness of the importance of spontaneous reporting, which we hope will continue.
Notably, the end of 2022 marks an important milestone for YCC Scotland – 20 years since the Centre was established, largely through the efforts of Professor Nick Bateman, Professor Norman Lannigan and Dr Bill Scott (all based in Edinburgh at the time). In the intervening years, the Yellow Card scheme has undergone some important changes: it has expanded to include medical device incidents, suspected adverse reactions to defective or falsified (fake) medicines, and e-cigarettes; patients report suspected side effects alongside healthcare professionals; and paper reports have been largely replaced by electronic reports. Perhaps one of the most important ongoing developments in the next ten years will be the embedding of direct electronic Yellow Card reporting within a number of primary and secondary care electronic clinical systems. This is now working well in many parts of England and is hopefully going to become a reality in most areas of NHS Scotland shortly. In the meantime, we would encourage everyone to report any suspected serious adverse drug reactions via the online reporting system at https://yellowcard.mhra.gov.uk. Your reports do make a difference.
Professor Simon Maxwell
Medical Director, YCC Scotland
Reviewed by Louise Davies and Alexander Kiker, Lothian Medicines Information Service and YCC Scotland
References:
- MHRA. Coronavirus vaccine – summary of Yellow Card reporting. Available from https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting. Accessed 24th November 2022.
- Yellow Card Centre Scotland. YCC Scotland Annual Report 2021-22. Available from https://www.yccscotland.scot.nhs.uk/wp-content/uploads/2022/10/YCC-Scotland-Annual-Report-2021-22.pdf . Accessed 24th November 22.
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