🟨 Making Yellow Card Reports 🟨

[helvella]

🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨

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.

🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨

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.

🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨

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...

🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨

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.

🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨🟨

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

[1tuppence]

Thank you helvella. It hadn't occurred to me to make a Yellow Card report until you suggested it recently, with regards to the differences I experienced in taking 5x 25mcg as against 100mcg+25mcg of the same brand.

[helvella Administrator Thyroid UK in reply to 1tuppence]

Not knowing, not occurring to you, is just one of those things. None of us knows things until we find out about them!

But, once we know, then it becomes pretty much a duty to report issues.

Thank you for doing so.

[LindaC in reply to helvella]

Sadly, in November 2022 I had great cataract surgery - post-op drops were never discussed with me at the months prior Assessment - I wasn't asked about any known drug reactions, only 'allergies'. I have an allergy to nickel, that's all. There is meant to be a distinction between 'ALLERGIES' and 'ADVERSE REACTION TO A DRUG' - but was neither asked nor informed of the drug to be given. Over the last couple of years, I've been 'sensitive' to steroid gel for eczema, so unable to use. Guess what? No mention that a steroid was to be given as eye drops. Six days after the one-month course, I contacted the provider because I was beginning to feel as I do with steroid gel [i.e. 'off' = vague/feeling washed out/plain awful] but was told there was no alternative. I had to just continue.

By week 2 - my inner ankles were bright red, BURNING, itching - severe pain/stabbing/tender/unable to touch + swelling veins with black splatters right down to toes, veins that I never had prior to this - pics taken are HORRIFIC - AND I just had to keep on using the very drug doing this to me - Maxidex [Dexamethasone]. Had I been told I would have emphatically refused. So, three months later there is no change. One earlobe became swollen to twice the size, cracks on my hands... that will do as a descriptor. Oh my!

[helvella Administrator Thyroid UK in reply to LindaC]

That is absolutely awful.

I so wish I knew anything that might help. (Of course I don't know anything.)

[LindaC in reply to helvella]

Thank you, hellvella - I'll refrain from posting the pics... scare too many off here! 😅😱 There is a 'Duty of Care' and should have been 'Informed Consent' - neither, apparently followed/applied!

[shaws Administrator in reply to LindaC]

I'm sorry you had problems with your cataract surgery and your experience sounds dreadful.

I had two cataract operations. One gave me no bother at all but the second was a problem.

Thankfully both eyes seem to be o.k. now.

I hope your problem has now resolved.

[LindaC in reply to shaws]

Thank you shaws. So pleased that you finally got there and now all is good. The surgery was fine and surgeon also - problem was the blinkered view towards using population statistics, that everyone can just be given the same steroid drops [which have a bolus effect and go right through the system 'as if' orally taking the drug Dexamethasone.

This has done me in - let alone ankles/legs ++ - I had to go to A&E last night with really HBP [mine is notoriously good/low] and I'm not sure where this will end. The protagonist is wriggling and patient blaming [what's new?] re them not telling me that a steroid was prescribed - I couldn't read it and told 'no alternative' without informing me and without asking 'Any reaction to steroids'? What a price to pay for lack of Informed Consent! PATIENT BEWARE. Now they won't do the other eye - no alternative - so the 'imbalance between eyes' is starting to affect [my existing vertigo!] What next!> Despite the pain etc I could still laugh, now this two weeks of elevated BP - culminating in last night - then just now, 180/113... I'm having to wait to see GP... I have an arrhythmia so rather disconcerting. THANK You for listening too. xox

[shaws Administrator in reply to LindaC]

I'm very sorry you are having such struggle after your op.

They should/could tell us beforehand of what to expect and we certainly don't want to be worse after an operation than before.

I also - a couple of months ago - had both cataracts in each eyes removed - with a few weeks space between the first and second. The first was perfect and the second was not but thankfully both eyes seem to have settled down now.

I hope your recovery will be soon.

I don't know if my drops were steriod or not.

[LindaC in reply to shaws]

Great to hear, shaws, that it's all working well now. Yes, I really need my second one done NOW. There is a Duty of Care to the patient, which includes gaining their Informed Consent on any treatment [surgery and drugs] prior to.

Thank you so much - I'm sure I'll survive this onslaught - we're tough, us hypothyroidees, had to be, haven't we. Best to you. xox

[shaws Administrator in reply to LindaC]

Yes, we have to be tough and going by some comments made by GP I told him he was wrong! He doesn't like me too much I should think but they have to be told they are wrong if it is going to affect our metabolism negatively.

[LindaC in reply to shaws]

Yes indeed, shaws! Sadly, many seem unable to accept that they do 'get things wrong' - what a silly way to behave from, supposedly, educated people! Unfathomable.

[shaws Administrator in reply to LindaC]

One of my GPs phoned to make a statement and I told him "I'm sorry you are wrong". He would not have liked me to make that statement but I had a long journey to be diagnosed as hypothyroid. You can click on my name and it should take you to my experience to be diagnosed as hypo.

[LindaC in reply to shaws]

Yes, I do likewise with them. It would be ludicrous not to say so. Thank you, I know some of your history and we both share the huge respect for Dr John Lowe. I'll go look again to refresh on your experiences. Take care and be well. xox

[Abimilne]

Reported to Yellow card. Thanks