Liothyronine Shortage: Confirmed

[helvella]

The other day several people reported problems concerning the supply of our only UK liothyronine tablets. The shortage of liothyronine (T3) in the UK has now been officially confirmed. See below most of the text of an email exchange between me and AMCO:

Subject: Mercury Pharma Liothyronine

Good evening,

I have seen rumours that supplies of MP 20mcg liothyronine are short.

Would you be good enough to let me know:

Is this true?

What is expected to happen - is this a very short term issue, or could it last months or longer?

What arrangements are being made to help those who might be unable to obtain their prescribed medicine?

Thank you

Which, a week later, received this reply:

Dear Sir,

Further to your query we regret to inform you we are out of stock on Liothyronine tablets.

There is delay in supply due to manufacturing problem .We are anticipating the Liothyronine tablets to be back in stock by end of April 2014.

Apologies for any inconvenience caused.

Regards

Shruti Shetty

Team Leader

Amdipharm Mercury (AMCo) Group

You may notice that the reply says nothing about any action or arrangements to help those unable to get their liothyronine.

I urge all those who might need any liothyronine (prescribed, in the UK) before the end of April to contact any or all of: their pharmacies, their GPs, MHRA, AMCO - and anyone else they see fit.

Rod

[Clutter]

Thanks for following that up, Rod.

[helvella]

Let us be careful of what we wish for.

What if AMCO/MP lose their licence but no-one else steps in to apply for one?

I don't pretend to be able to predict the consequences but it seems feasible that even fewer people will be prescribed liothyronine - even in the most severe cases such as myxoedema coma.

Rod

[shaws in reply to helvella]

Maybe GP's will consider the unlicenced T3 Cynomel (I think). They would have to do a different prescription on a named patient basis. I don't think my GP will but might if there's no supply.

It really is beyond a joke that within a few months, the same situation has occurred.

Thanks very much for enquiring and I see it took a week to reply to you, obviously taking their time in case they could get some.

[shaws in reply to shaws]

Rod who is in charge of ordering meds for the NHS as I would like to write to him/her about this T3 situation.

[helvella in reply to shaws]

I really don't know how it all works!

As I have understood so far, a company applies for and gets a licence for a product. They then make it available to their distributors. Pharmacies around the country order the product and dispense to patients.

A part of the NHS oversees acceptable pricing. For non-generic products, there are controls on prices.

So no single body orders products - it is every individual pharmacy (or group of pharmacies) doing their own ordering.

I suggest contacting the MHRA and asking them. Might not be the right people but they surely would know who you should contact?

mhra.gov.uk/

Also the NHSBSA:

nhsbsa.nhs.uk/Index.aspx

Some parts of the NHS will have no contact with patients.

Rod

[shaws]

An extract from MHRA re (in this case T3) unlicensed meds. This was dated May '13.

Provision for supply of an unlicensed product

A provision exists within UK medicines legislation for the importation and supply of an unlicensed medicine to meet the special needs of individual patients. An example of what would be considered a special need would be where there is an interruption of supply of a patient’s usual medicine, and there is no alternative UK licensed product which that patient could take instead. The use of an unlicensed medicine is on the direct personal responsibility of the prescriber, hence the prescriber needs to know from the pharmacist that an unlicensed medicine is to be supplied. It would then be the pharmacy's responsibility to obtain the product from an authorised supplier of unlicensed medicines.

If a pharmacy is having difficulty in locating an authorised supplier then we would advise that they consult the trade press where such suppliers advertise their services. Should any pharmacist still be unable to locate an importer then they can contact the MHRA imports section on 020 3080 6715.

[helvella in reply to shaws]

The MHRA's page about last year's liothyronine shortage is still available - here:

mhra.gov.uk/NewsCentre/What...

Rod

[Clutter]

Nothing on MHRA website about the shortage. I've tweeted the press office.

[Clutter]

I used a scattergun approach sending just under 100 tweets #Liothyronine linked to your post. I tweeted the Royal Colleges, GP and Endocrine trade press, British Pharma Soc, GPs, Nurses, Psychiatrists, managers, Online press, medical and MS journalists, MHRA press office, Andy Burnham and Jane Ellison and thyroid bloggers. I completely forgot about BTA & BTF. Must be cos they're so relevant

I've had over 40 favourites, retweets and replies.

Friday I shall try to devise a more structured strategy, starting with cabinet health chiefs and NHS Eng, Scot, Wales & NI I think, and hope that some Facebook fuss (to steal Mary's phrase) also follows.

[Marz in reply to Clutter]

Wow - wish I was a technobabe ! Well done you..... and keep up your good work ....

[Clutter in reply to Marz]

If I was techy I'm sure I'd have found a way to mass mail the tweets. It can be done, but I don't know how, so it was slow, naming recipient & c&p message to be sent.

[nightingale-56 in reply to Clutter]

You're a Star Clutter and I would echo Marz' words. Janet.

[HarryE in reply to Clutter]

Well done! Very impressive

[shaws in reply to Clutter]

Well done Clutter. You probably startled them all with your guns blazing. It must make them sit up and take notice.

Forget about BTF and BTA as they don't believe in using T3 anyway.

[Clutter in reply to shaws]

Dr. Mark Porter (R4 Inside Health) replied that drug shortages occur every week and that he's had two scrips (didn't specify Liothyronine) returned today. Hopefully pharmacies will be able to source abroad. Boots already supply Paddocks T3 from USA.

[Marz]

As a suspicious Grumpy Grandma - I can only think there is an alternative agenda at play - with the gradual conversion of certain parts of the NHS to private. I would think that mostly T3 is prescribed after a request from the patient - so perhaps that will be the difference. Have T4 on us - the NHS - or if you want/request T3 then you will have to buy it yourself....just a thought !

Would love to join the Facebook fuss - but am not a follower....

[nobodysdriving]

I've 'pinned this' Helvella

thanks

I am fully stocked to end of July this time thankfully!

[helvella in reply to nobodysdriving]

Have to admit, I was thinking of your liothyronine prescription as I posted...

[Clarebear in reply to helvella]

Ha ha

[Clutter in reply to helvella]

A couple of people have told me that Boots stock Paddocks T3, lactose free, from USA.

[helvella in reply to Clutter]

Certainly Paddock do lactose-free liothyronine.

The NHS Prescription Cost Analysis for England November 2013 has no mention of liothyronine tablets other than our well-known MP 20mcg - except Cytomel 5mcg and, oddly, Tertroxin 20mcg. So numbers of prescriptions must be minute. I am quite sure that Boots or any other pharmacy could get them in, possibly quite quickly, but I doubt they maintain their own stock unless it is for a specific patient. An official specials importer like Idis could well maintain a small stock - and that might look to a patient like Boots having them.

LIOTHYRONINE SODIUM tablet

[Paddock Laboratories, Inc.]

Each round, white Liothyronine Sodium Tablet, USP contains liothyronine sodium equivalent to liothyronine as follows: 5 mcg debossed 5 and 220; 25 mcg scored and debossed 25 and 222; 50 mcg scored and debossed 50 and 223. Inactive ingredients consist of calcium sulfate, microcrystalline cellulose, hypromellose, talc, and colloidal silicon dioxide.

dailymed.nlm.nih.gov/dailym...

Rod

[helvella]

I have now submitted a series of highly specific, targeted questions to AMCO with copies to MHRA & DH (and TUK).

The content is available to all of you here:

dl.dropboxusercontent.com/u...

(I have not included my brief covering email as a matter of my own privacy. It says very little.)

Rod

[Clutter in reply to helvella]

Lovely, Rod. I shall Tweet it widely tomorrow and Sunday so MPs, Health professionals & leaders and trade press have it for Mon am. I'll try to see my pharmacist on Monday and find out what his plans are.

[Jessiepup]

What a joke! Terrible that a drug company falls short like this - probably put all efforts into drug doctors demand more eg statins

[Neeta-K]

Let's hope you get somewhere Rod.

I called my pharmacy and they have 2 bottles that they will keep aside for me. Thanks for letting us all know.

[Clutter]

Last week's tweets of your opening post got 5,585 views. I've been very shocked to hear that drug shortages and suspension of supply are a weekly event, I had no idea!

Shannon Garrett RN (USA) advised that "manufacturers of thyroid hormone warn of future backorder issues" and "it is believed to be due to supply/demand issues, & new healthcare law changes".

I'm not sure if I've understood future backorder properly, but I think it means shortage of supply due to QC/compliance, supply and demand. I'd welcome clarification if that ain't the case.

I hope to tweet the email you sent to AMCo, MHRA & DH in a day or so.

[tdcco]

I am going off on a tangent here but the "QC/Compliance" part of Clutter's post rang some bells with me.

Is it possible that there has been a problem with quality of T3? I had my T3 raised from 10mg to 20mg in August last year. Now I had been caught up in the Eltroxin debacle and had changed to Mercury in the June of the same year. I was taking 100mg of Eltroxin and continued same dose with Mercury. However I have been under medicated and suffering my usual effects of this. I have raised my thyroxin to 125mg with no effect and am now on 150mg since January. I am not finding any changes in my symptoms.

I have been on T3 for 4 years with 100mg of Eltroxin very successfully until the supply ran out. My endo upped my T3 to help with my more severe symptoms, I have muscle problems which neurologists tell me is down to under medication of my thyroid. Since being on T3 I no longer am "ill", I do have some muscle weakness which cleared after a short time. I have noticed absolutely no change in increasing my T3 levels and again little change in increasing my thyroxin.

So could it be that there is a problem with T3 quality? I am heading back to my maximum thyroxin of 175mg, which is what I took before I was on T3. My endo has checked B12, Vit D, Cortisone levels and various other things with no results. My TSH and free T3 are both good for me but my free T4 is sitting at 15 which should be around 22-23 when I am symptom free.

Don't mean to hijack this post but wondered if others have had similar experiences. My endo has said that healthy thyroids fluctuate from time to time and that it will settle down, but I find it strange that I am in this position with increased doses.

Anyone else in this position?