How many people have heard of the Yellow Card, the Government’s way to gather information on side effects from medicines, medical devices, vaccines, vapes, and complimentary medicines?

We reckon not many, yet this system is relied on to track harm caused to patients.

So, if the public hasn’t’ heard of the Yellow Card to log side effects then maybe it’s doctors’ reports which provide this essential information.

Wrong.

It’s not mandatory for healthcare professionals to log Yellow Card reports – anything from allergic reactions to a painkiller to bad reactions to a contraceptive coil, anti-depressants increasing suicidal thoughts or pain and infections from a surgical mesh implant.

So if the Medicines and Healthcare products Regulatory Agency (MHRA) relies on reports from the general public who are mostly in the dark – and Drs voluntary logging, then surely this means lots of evidence on complications is missed?

Yes. It does.

And, because the Yellow Card is a voluntary system, with each report taking up to 30 minutes to complete, busy doctors don’t log them all.

The pelvic mesh scandal revealed that two thirds of mesh complications weren’t logged to the Yellow Card system, resulting in surgeons who continued to implant women for two decades before anybody realised the scale of harm.

“and will be expanded to include medical devices in due course.” – does that mean this year, next year or never? https://t.co/7OhcKicW0V

— Carl Heneghan (@carlheneghan) June 6, 2023

What does a voluntary Yellow Card system mean for patient safety?

It means thousands of cases of harm and side effects are missed. Every. Single. Year. They go into a black hole.

The result is treatments with terrible side effects going unnoticed for months, years or even decades.

In the case of the epilepsy drug, sodium valproate, it meant nobody realised the scale of harm caused if women continued to take it during pregnancy, as it can cause birth defects and developmental disorders.

Sling The Mesh has campaigned for some time to make the Yellow Card mandatory for clinicians to report – but our plea falls on deaf ears.

Who oversees and regulates the Yellow Card information?

How is information tracked? Are there early warning triggers of harm? Who do these concerns go to? Most importantly, can the information be made publicly available?

Some medicine and vaccine harm information is on a public database, but for medical devices, like mesh, the information is not publicly available. Further probing by ourselves reveals that the Yellow Card public data “will be expanded to include medical devices in due course.” But what does in due course mean? This year? Next year? Never?

MP Emma Hardy, co-chair of the All-Party Parliamentary Group on Surgical Mesh asked three questions recently on regulation and oversight of the MHRA.

Questions include, how does the MHRA publicise the Yellow Card system to a public mostly ignorant of what it is. Patient campaign groups have asked for years for the MHRA to print flyers to go into all prescription bags from chemists, so people realise what the Yellow Card is and how to report. Our pleas fall on deaf ears.

The government replies to MP Emma Hardy’s questions, from 5 June 2023, can be seen below

QUESTION ONE

To ask the Secretary of State for Health and Social Care, which body has responsibility for analysing data collected by the Adverse Events Yellow Card system; and what assessment has he made of the potential merits of collating this data on a publicly accessible database.

Answer:

The Medicines and Healthcare products Regulatory Agency (MHRA) collects and analyses the data received through the Yellow Card Scheme, and publishes data on medicines and COVID-19 vaccines in a searchable database on the Yellow Card website for transparency purposes.

As outlined in the Yellow Card Privacy Policy, the MHRA has responsibilities under both the UK General Data Protection Regulation and the Data Protection Act 2018 to protect confidential data and personal data pertaining to individuals. The content and format of the data is currently being enhanced in line with patient and healthcare professional feedback and will be expanded to include medical devices in due course. The data provided will continue to be aligned to the MHRA’s legal responsibilities to data subjects.

QUESTION TWO 

To ask the Secretary of State for Health and Social Care, what assessment he has made of the (a) level and (b) adequacy of data collected by (i) mandatory and (ii) voluntary reporting of adverse clinical events by health professionals before the introduction of the Yellow Card reporting system in England compared to that now collected via the Yellow Card system.

Answer:

The Medicines and Healthcare products Regulatory Agency (MHRA) has reviewed other international mandatory and non-mandatory reporting systems for healthcare professionals and found limited evidence that making reporting mandatory increases the ability to detect safety signals. Very few international mandatory reporting systems have a better reporting rate or a more successful system for detecting safety signals than the United Kingdom.

In both medicines and devices legislation there are requirements for manufacturers to report, but there is no legal obligation for healthcare organisations. However, there are professional body standards and guidelines that make reporting a gold standard for healthcare professionals. The MHRA continues to work with partners across the healthcare system to promote and encourage use of the Yellow Card scheme to help detect safety issues.

The MHRA has reviewed global approaches to mandatory reporting in other regulatory systems and continues to consider the approach in the UK as we work to improve reporting capability and functionality through systems.

QUESTION THREE 

To ask the Secretary of State for Health and Social Care, what assessment he has made of the level of awareness of (a) health professionals and (b) the general public of the Adverse Events Yellow Card System; and what steps is he taking to increase awareness of that system among those groups.

Answer:

The Medicines and Healthcare products Regulatory Agency (MHRA) recognises the importance of both public and healthcare professional understanding of, and access to the MHRA Yellow Card scheme, so that they can promptly report any concerns they have about the safety of healthcare products. The MHRA monitors the number of reports it receives from members of the public and healthcare professionals and strives to keep improving understanding and awareness of the reporting system. The MHRA continually works to encourage reporting of any safety concerns to the Yellow Card scheme and help improve the safe use of medicines and medical devices for everyone.

A sharp increase in reporting, mainly from patients, has been seen due to better awareness of the scheme following significant communications activity at the start of the COVID-19 vaccination campaign.

---

• If you or a friend or family member have been harmed by a healthcare treatment please log it to the MHRA Yellow Card system Report Guide | Making medicines and medical devices safer (mhra.gov.uk)