🟨 Making Yellow Card Reports 🟨

[helvella]

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In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) operates the Yellow Card scheme for reporting issues with medicines.

They have slightly different approaches to:

  🟡 Side Effects

  🟡 Defective medicines

  🟡 Counterfeit or fake medicines

All can be accessed by following this link:

yellowcard.mhra.gov.uk/

It vitally important that we report issues. Although we might wish that we could rely on medical staff (doctors, nurses, pharmacists, etc.) to make reports, the truth is they often do not. Often no-one has told them of the issues they are having. Even if you know they have made a report, your report will add to the information. You will explain it differently and might include different details.

I do not like the culture of blaming patients which seems to be far too common. But in this case, we can only blame ourselves if we do not file reports.

If in doubt, make a report. The MHRA must expect that some reports are inappropriate and will have mechanisms in place for handling them. It isn't your responsibility to make that decision. All that can reasonably be expected is that you make reports in good faith, taking care to be as accurate as you can.

Making a report is straightforward. Depending on the issue, you might be asked to photograph the medicine (or device) and upload them. Probably a good idea to take a set of photographs before you start the report.

Remember:

If you change makes and find the new one better, you might wish to report the previous make.

Retain all packaging (for example, card outer, blister packaging, Patient Information Leaflet) - even if you do not have any of the product left.

If you use some sort of daily pill dispenser, you might consider keeping any packaging for a while so it is available should you need it.

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Yellow Card Mobile App: You can now receive news updates from the MHRA and report side effects to medicines via the Yellow Card app. Please download it from the Apple App Store or Google Play Store. Key features of the app include the ability to create a ‘watch list’ of medications for which you can receive news and alerts from the MHRA. You can view numbers of Yellow Cards reported to the MHRA for medicines of interest and see previous Yellow Cards you have submitted through the app. At the moment account details are not synchronised between this website and the app, even if you use the same email and password!, so you need to create separate accounts.

The Apple app will run on iPhones, iPads and Macs which have Apple Silicon (M1 or later) processors.

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COVID-19 Issues

There is a special Covid-19 page which includes vaccines, diagnostic testing kits, a few specific medicines and several other things.

Coronavirus Yellow Card reporting site

coronavirus-yellowcard.mhra...

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Outside the UK

There are other routes outside the UK. For example the USA's FDA has a reporting mechanism.

How to Report Product Problems and Complaints to the FDA

fda.gov/consumers/consumer-...

The European Medicines Agency (EMA) handles reports for centrally licensed products - each EU country handles its own for nationally licensed products.

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[This is a re-post to increase visibility.]

[BB001]

Thank you, I didn't know there was an app and we could get alerts.

[helvella Administrator in reply to BB001]

You can go to this page and sign up to email alerts for a number of options:

gov.uk/drug-device-alerts/e...

I do not know if the app has its own built-in alerting mechanism - it looks like it might. Or if it just uses this email mechanism.

I am signed up for alerts and, when there is a medicine alert, I consider whether to post here.

If it is a thyroid medicine, I will always post.

If it is a medicine it seems likely many will be using, or if it is a particularly serious issue, I will post.

But lots are very minor issues like a detailed wording on a Patient Information Leaflet or similar.

But I am more than happy top know others are also looking and will post if I haven't. All too easy to miss an alert or be delayed.

[BB001 in reply to helvella]

Thank you!

[elwins]

already done a yellow card report for mannitol in Teva brand some time ago. But thanks for reminder.

[userotc]

Apparently the level of reporting may be as low as 5% according to Government(s), see youtu.be/brWU5QBfno0(Not working as expected?)