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, so you need to create separate accounts.
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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.
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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Written by
helvella
Administrator
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Thanks helvella for this information. I agree it’s vitally important to report side effects. I have just discovered that my intercranial hypertension and other health issues are being caused by Levothyroxine. All medics have told me that its not the case or that they have never come across this before but i know this is not true because when I stopped my meds all my symptoms disappeared. But of course they are only looking at reported issues.
For the 5-year period between 1 January 2015 and 31 December 2019, the MHRA received 335 Yellow Cards reporting one or more of the terms ‘product substitution issue’, ‘condition aggravated’ or ‘drug ineffective’ with levothyroxine. The majority of reports were received from patients rather than healthcare professionals, with 47 of the cases having a healthcare professional reporter.
We see many many members who have adverse reactions to changing brands….far more than 335 in 5 year period
Thank you. It is most important to report any side effects. We can’t rely on doctors for doing so because they usually dismiss any report! When I told my previous rheumatologist that I wanted to stop using methotrexate because I felt like I was being poisoned she was quite angry and told me this could not be the case because Methotrexate was well tolerated! Incredible!
Big thanks for that explanation Helvella. I've done my first MHRA report about a month ago for useless antihistamine creams, but despite asking them I was unclear about how to follow it up. My understanding right or wrong is it is vital sufficient of us report issues because MHRA unsurprisingly work on statistics of reports they receive. So even if "everybody knows something" (except the unfortunate in the dark) they will only take action if they receive enough reports. For simple stuff clinicians may be too busy to report. It is up to us to help our fellow patients.
Putting in reports is very definitely something we need to do.
I think a lot of people feel that their experience doesn't really matter to the MHRA. And, as one individual, that is likely true. But if everyone puts in reports, they do draw attention.
The other thing is that researchers sometimes refer back to numbers of reported side effects (or whatever) - even many years later.
I suspect levothyroxine side effects reported make it look almost perfect. Everyone, patients and professionals, even when they have known of them, have not reported their experiences.
Thanks Helvella. I have just bit the bullet and yellow carded a batch of mercury pharma t3 that was posted on here earlier. I’d blamed everything else for feeling rubbish and ft3 dropping like a stone but only just put 2 and 2 together. Where do we stand with this, do we just carry on with batch? Would company exchange if faults found? The potency seems to be diminished so I’ll up dose but that means I’ll run out eventually, can’t see gp prescribing more. My buffer is seriously depleted.
I think you could try talking to the pharmacy that supplied it. They might be able to help - make sure they are aware you are suggesting it is a defective medicine.
There are also similar sites for several other countries - such as the USA.
What is being reported
The MHRA is transparent in the data it receives via the Yellow Card scheme.
For suspected side effects being reported, the MHRA publishes this information in the form of interactive Drug Analysis Profiles (iDAPs) which can be accessed below. There is an iDAP for each licensed medicines by drug substance. Within an iDAP you can see all suspected side effects, known as suspected adverse drug reactions, that are reported to the MHRA.
You can access COVID-19 information received via the Yellow Card scheme here.
interactive Drug Analysis Profiles (iDAPs)
iDAPs enable you to interact with the data so you can understand more about the types of reactions that have been reported, and at a high level about who experienced the side effects.
Medicines are listed alphabetically by the name of the active ingredient, not by the brand name. To find the name of the active substance in your medicine, look at the patient information leaflet that was supplied with it. You can find patient information leaflets here.
Each iDAP contains complete data for all spontaneous side effects, known as suspected adverse drug reactions via the Yellow Card scheme from healthcare professionals and members of the public. They also include reports from pharmaceutical companies. Information regarding suspected adverse reactions to vaccines is not currently available via the iDAPs but is available upon request.
iDAPs provided on this website are regularly updated. Please be aware, however, that if you have reported a suspected adverse drug reaction it may not immediately appear on this website. There is a time lag of around one month from receipt of a report to it appearing in the iDAP.
When reviewing the data within an iDAP it is important to do so in the context of the essential guidance at the bottom of the report and before to ensure that you do not misinterpret the data.
Questions & comments
During their development iDAPs have been extensively tested with a variety of stakeholders, nevertheless if you have any questions or comments about how they should be used/ interpreted or if the substance you are interested in is not currently available, please do not hesitate to contact us.
Content on HealthUnlocked does not replace the relationship between you and doctors or other healthcare professionals nor the advice you receive from them.
Never delay seeking advice or dialling emergency services because of something that you have read on HealthUnlocked.
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