Short use by on T3. My email to MHRA and their ... - Thyroid UK

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Short use by on T3. My email to MHRA and their response!

MacG profile image
MacG
10 Replies

I understand that the MHRA oversees good distribution practice. As such, I would like to report a problem with the supply and distribution of Mercury Pharma Liothyronine Sodium 20mcg tablets reaching patients with an appropriate “use by” margin. I will outline my experience over the last few months.

Example 1: On 18/7/17 I called at my pharmacy (a Lloyds pharmacy based in *****) to collect a prescription for 84 days-worth of Liothyronine tablets. The pharmacy were unable to supply me with my prescription as the tablets that they had “just been sent” from their suppliers were dated 10/8/17. Several days later I called back at the pharmacy and was given part of my prescription (tablets dated 4/10/17). I was due to start taking the tablets on 1/8/17, so the pharmacist said that they would try to source the remainder of my prescription with tablets with a use by after 4/10/17, as 84 days-worth of tablets (taken from 1/8/17) would take me beyond 4/10/17. For the next three weeks my pharmacy report to me that they were in contact with their suppliers, Alliance, sometimes ringing on a daily basis, and were still unable to source any Liothyronine tablets beyond 4/10/17. On 18/8/17 I myself rang Concordia and was told that the tablets dated 4/10/17 had now been “blocked” and that a new batch of tablets dated 25/1/18 had been released. I immediately relayed the details of my telephone conversation with Concordia to my pharmacist, yet still the problem persisted. My pharmacist reported to me that when they rang Alliance they were told that the 25/1/18 batch “weren’t showing on the system” so the operative at Alliance dealing with my pharmacist’s query would offer to “ring the warehouse” and call back. Despite daily phone calls, no return call was ever made from Alliance.

During this period of time I contacted Lyn Mynott (Head of the charity Thyroid UK) to report the problem, which to a greater or lesser extent has been an issue since I started taking Liothyronine in September 2014. Lyn contacted Concordia who released the following statement:

"Concordia endeavours and has invested significantly to provide a consistent supply of liothyronine to patients at all times. Due to the complexities associated with manufacturing the product, shelf-life can sometimes be impacted. Currently it is 12 months. Concordia presently sells liothyronine exclusively to Alliance Healthcare, who are the owners of Boots Pharmacy, and as such has no control over the remaining shelf life of product sitting in the supply chain outside of the Alliance/Boots network. We therefore recommend that patients concerned about shelf-life, collect their prescriptions directly from a Boots Pharmacy who are more likely to have the latest batches available."

The same day that I received Lyn’s email with Concordia’s statement (23/8/17) I did indeed ring a local Boots pharmacy. The pharmacist at Boots told me that they had no Liothyronine in stock but that they would ring their suppliers and get back to me. The pharmacist at Boots never got back to me. In the meantime, however, my own pharmacist has called to say that they had now been able to source the tablets dated 25/1/18, as a result of requesting to speak to someone more senior at Alliance.

As a result of the ongoing problems with the Liothyronine use by margin, I had already agreed several months ago with my pharmacist that rather than their system making an automatic order as soon as I pick up a prescription they would wait to order from the suppliers until I contacted them to say I had made the repeat prescription request from my GP (thereby cutting out the problem of the Liothyronine sitting on their shelves for 84 days or thereabouts before I was even ready to collect it). Yet still the problem persists.

Example 2: I requested a repeat prescription from my GP on 28/4/17. A few days later I called at the pharmacy to pick up my tablets and was given tablets that had a use by date of 10/8/17. When I saw the use by date I reminded my pharmacist of our agreement and was told, once again, that these tablets “had just come in”. Please note, that I trust what my pharmacist is telling me. Sometimes my pharmacist phones the supplier while I wait in the pharmacy. Furthermore, I approached another local pharmacy, as I hoped that they would be more successful in procuring tablets with a more appropriate use by margin. They too, however, reported that Liothyronine “comes in with a very short use by”.

I have tried my best to work my way around the use by issue since starting to take Liothryonine. Nevertheless, I have occasionally, and regretfully, found that if I am not absolutely meticulous about the timing of my prescription request, that I have to return some tablets to the pharmacy. Such waste (as I am very aware of the cost of Liothyronine tablets to the NHS) aggrieves me.

With regard to the statement above that Concordia released to Thyroid UK, my experience, despite a reported 12-month shelf life, is that Concordia are releasing tablets on a much shorter time frame.

For example, with regard to Example 2, I first telephoned Concordia on 21/6/17 to discuss the tablets I had been issued at the beginning of May with a use by of 10/8/17. On this occasion I was told that the tablets of 10/8/17 had now been “blocked” and that a batch with a use by of 4/10/17 had been released (no mention of any later batches). I did ask when the batch of 10/8/17 had been blocked but was told that this information wasn’t available. Still, however, 28 days later, these were the tablets that were sent to my pharmacist.

With regard to Example 1, the fact that my pharmacist was still struggling to source the 25/1/18 batch late into August would suggest that that particular batch had also only very recently been released.

Although Concordia say in their statement that they have “no control over the remaining shelf life of product sitting in the supply chain outside of the Alliance/Boots network” the fact that they seem to be releasing Liothyronine tablets with a shelf life WELL SHORT of twelve months, as the examples above suggest, IS causing problems in the supply chain. My impression is that Alliance are either very unresponsive or that they too are struggling to manage the short use by margin.

I am a hypothyroid patient with a DIO2 polymorphism inherited from both parents for whom Liothyronine has made a huge difference. I am concerned about the cost of the tablets and therefore the need to avoid waste. As a result of inappropriate use by margins I know that my pharmacist has had to send back Liothyronine tablets very close to or past their use by to the suppliers on more than one occasion. As I have explained, as a patient, I am also struggling to manage the situation.

I hope that the MHRA will be able to look into and resolve this problem.

Please do not hesitate to contact me if you require any further information. My details are as follows: *****

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MacG
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10 Replies
Hennerton profile image
Hennerton

I tried arguing this issue with the MHRA over a year ago. My problem was compounded by the fact that by the time I was close to a month of "use by", the product was definitely not of the correct strength and I was experiencing hypo symptoms. They acted in exactly the same way as in your reply, which leads me to assume they are working for the pharmaceutical companies and not for the patients. I have given up with them and but also raised this with my MP, including the astronomical price rise, all to no avail. It seems there is a conspiracy to fatten Big Pharma's profits and bankrupt the NHS. I suppose all will one day be revealed...

MacG profile image
MacG in reply toHennerton

Sorry to hear that you have experienced similar Hennerton. I took some trouble to make sure that I was sending my email to the correct dept/person at the MHRA and I have been staggered by the dismissive way in which my complaint was treated.

helvella profile image
helvellaAdministrator

On previous occasions when Mercury Pharma Liothyronine was not available, the MHRA made a statement about supplying other products. The sentence in their response "AI am unaware of any specific.." - WHY are they unaware! Goodness, the evidence is there. The rest of the response implies that these short-date issues should not normally occur. It is prima facie evidence of supply issues. Which the MHRA should know all about.

MacG profile image
MacG in reply tohelvella

Agree!

SlowDragon profile image
SlowDragonAdministrator

Perhaps with two new T3 licences issued the competition might knock some sense into them and reduce the price .........or am I just experiencing some very wishful thinking

My last batch use by date was 4/10/17 ......my last pill was due to be taken 2/10/17 ...therefore pharmacist insisted "it was fine"

At £280 for 28 tablets NHS is being ripped off, in more ways than one

MacG profile image
MacG in reply toSlowDragon

I am going to be very interested to see the outcome of the CMA investigation into Concordia.

Hennerton profile image
Hennerton in reply toSlowDragon

I expect they have done a deal with one another, or both are owned by the same conglomerate and they will never reduce the price. So much for market forces keeping prices low...

MacG profile image
MacG in reply toHennerton

Apparently there was a programme on BBC2 on Wednesday evening (7pm) called "Billion Dollar Deals and How They Changed Your World" which touched on the price-hiking with T3. Episode 1 was all about health. It's on my to-do list in the next few days to watch this on catch up.

Hennerton profile image
Hennerton in reply toMacG

Thank you. I watched it and was enraged. So will you be.

I had several conversations with Billy by email when he first published his findings and sent him my correspondence with Earl Howe in Parliament. Earl Howe told me that the reason it was so expensive was that it was difficult to make. Oh please! Oh and transport costs. Unbelievable.

There is no hope of ever getting to the truth.

Zephyrbear profile image
Zephyrbear

And yet, when I received my last batch of Greek Unipharma T3 (I guess I was one of the last lucky ones to get it before that source went belly-up) the expiry date was January 2020! So why can Unipharma manage such a long expiry date and yet Concordia can only manage a couple of months ahead? Could it be that they're blocking the August/October batches and re-labelling them for January 2018... Funny how, despite all these company name changes, that the labels on the pots are exactly the same as they were in 2013 when the PIL was last updated, showing the Marketing Authorisation Holder to be Mercury Pharma Group Ltd... Seems to me they may have been doing this for years now!

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