Yellow Card

[Pippah45]

Am I allowed to ask everyone who is not well on their Thyroid treatment to use the Yellow Card reporting system? It is my view that the statistics are not very accurate because people don't have the energy to complain - or perhaps the knowledge that they could be better?

[RedApple Administrator]

Pippah45, On this forum, we are always asking people to do this. We even have a pinned post about how to do it healthunlocked.com/thyroidu...

[Pippah45 in reply to RedApple]

Yes thank you RedApple as soon as I posted it all the links came up

[bantam12]

I believe the yellow card is for reporting "side effects and adverse incidents" not merely because the patient doesn't feel well on a medication.

[RedApple Administrator in reply to bantam12]

Yes true bantam, although it's not always going to be easy to distinguish between them. Wrong dose could result in patient and/or doctor mistaking symptoms for side effects. We've seen, for example, nausea claimed as a side effect which has later resolved with change of dose/brand.

[helvella Administrator in reply to bantam12]

Also defective medicines.

I suggest that a large number of members express concerns that they notice differences depending on make, or that appeared once started on levothyroxine, etc. The distinction between a clear side effect or adverse event and not feeling well is not easy to draw.

I'd tend to report rather than not, if I were in any doubt.

[Pippah45]

I have just come across this article about the stability of Levo - which might explain some anomalies people find.

pubmed.ncbi.nlm.nih.gov/343...

[jimh111]

Yellow card is for side effects or a drugs that have faults. e.g. a batch of levothyroxine that is less effective or effects that don't normally occur. Attempting to misuse the yellow card system will lead to unnecessary investigations and in the longer term dismissal of all complaints as a pattern sets in. This could make it uneconomic for some suppliers of levothyroxine (it is cheap) resulting in less choice.

It is likely that NDT has more side effects / quality issues and any tightening of regulations will reduce the supply of prescription NDT or at least drive up the price.

I would stick to honest reporting including stating when levothyroxine doesn't work. With accurate data we can investigate why levothyroxine doesn't work and find solutions. If the data is corrupted we will not be able to move forward.

[Delfim]

Since the newcprescribing guidelines have been produced in 2021 to ensure their is no constant changing of brands of Levothyroxine this should help to ensure that people get the brand that they feel is best for them . I agree it’s only essential to notify the yellow card system if you develop problems with certain brand of levothyroxine .

[helvella Administrator in reply to Delfim]

There is nothing in the MHRA's own guidance which says, or even implies, that you should only report if you develop issues with a certain brand.

If you start a medicine and get side effects, you most likely won't know if they are specific to a certain brand. You are unlikely to even have the opportunity to try another brand in order to find out. If you develop issues over time, with or without changes to brand, they should be reported.

The MHRA collect statistics on side effects and adverse drug reactions regardless anything else. On Patient Information Leaflets, they give an indication of how common issues have been. That is one reason it is important to report these issues.

Side effects to a medicine, vaccine, herbal or complementary remedy

All medicines can cause side effects (commonly referred to as adverse drug reactions or ADRs by healthcare professionals).

Side effects reported on Yellow Cards are evaluated, together with additional sources of information such as clinical trial data, medical literature or data from international medicines regulators, to identify previously unknown safety issues. These reports are assessed by a team of medicine safety experts made up of doctors, pharmacists and scientists who study the benefits and risks of medicines. If a new side effect is identified, the safety profile of the medicine in question is carefully looked at, as well as the side effects of other medicines used to treat the same condition. The MHRA assesses the balance of risks and benefits of all medicines at the time of initial licensing and throughout their use in clinical practice. Where appropriate, the MHRA seeks advice from the independent Commission on Human Medicines (CHM). The MHRA takes action, whenever necessary, to ensure that medicines are used in a way that minimises risk, while maximising patient benefit.

yellowcard.mhra.gov.uk/the-...

[jimh111 in reply to helvella]

Yes it's to report problems with medicines, I think Delfim comment about brands was just a simple mistake. The system isn't set up to report medicines that don't work, because the drug isn't effective or the doctor has misdiagnosed. It gets more complex. For example some patients get worse on levothyroxine, perhaps because it lowers TSH and reduces deiodinase. This isn't the fault of the drug, it's the fault of the doctor prescribing the wrong medicine.

We are not going to get this perfect. I think people should adopt an honest approach and not use the yellow card system to fight the liothyronine battle. There are plenty of reasons why liothyronine (or NDT) should be prescribed and we should focus on these.

[RhianR]

Excellent point & honestly never thought to do this. I will.

[sobs1962]

I tried using the yellow card reporting system, earlier this year when given metropolol to take but found it almost impossible and couldn't register my symptoms, so as far as I'm concerned, it's a waste of time.

[helvella Administrator in reply to sobs1962]

If we don't tell the MHRA, then our experiences simply cannot be taken into account.

For that reason, I'd still encourage using it.

Could someone, perhaps, help you do it?

[sobs1962 in reply to helvella]

Well, it occurs to me that the reason I struggled with it was because it caused extreme confusion and disorientation and all my GP practice had to say was, that my symptoms were not side effects of taking metropolol and it was more likely to be a virus and to get a covid test, which I did, was negative but don't think the receptionist I spoke to even passed on my concerns to either a doctor or a pharmacist and just told me that off her own back. Still very unhappy about it though.

[Pippah45]

I am afraid that doesn't surprise me but how annoying!

[SlowDragon Administrator]

gov.uk/drug-safety-update/l...

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. Associated symptoms were mostly consistent with hypothyroidism or hyperthyroidism, and included fatigue, headache, malaise, anxiety, palpitations, pruritus, nausea, myalgia, dizziness, arthralgia, feeling abnormal, alopecia, depression, abnormal weight gain, and insomnia.

Often symptoms are not due to the levothyroxine, but because simply not on high enough dose

Levothyroxine doesn’t top up failing thyroid, it replaces it

Important to increase dose levothyroxine slowly upwards in 25mcg steps until TSH is ALWAYS under 2

Most people when adequately treated will have TSH around or under one and Ft4 and Ft3 at least 50-60% through range

Essential to regularly retest vitamin D, folate, ferritin and B12 too

Levothyroxine needs optimal vitamin levels