Medicine and drug shortages.

palmcut

Eltroxin is scarce at present. I know a number of other drugs are also scarce. Are the HSE/IMB doing anything about this problem?

palmcut

There is a good article in today's Business Post about medicine shortages.
It appears some people that some of the shortages are being engineered by drug companies so that they can get more for their product if it becomes "Unlicensed".

There also seems to be some discussion on facebook. See Medicine-shortages. (I am unsure whether I am allowed to put such a reference here)

Delancey

Took me 4 visits to the Pharmacy before they had enough Tetralysall to fill my prescription :mad:.

LilMrsDahamsta

What I find amazing, particularly in relation to the eltroxin shortage, is that my local pharmacy only runs out of the 100mcgs; they still have 50s, so I end up paying nearly twice the price for the same quantity of active ingredient. Total rip off, though I acknowledge it may be the suppliers rather than the pharmacy creating the situation.

angeldelight

LilMrsDahamsta wrote: »

What I find amazing, particularly in relation to the eltroxin shortage, is that my local pharmacy only runs out of the 100mcgs; they still have 50s, so I end up paying nearly twice the price for the same quantity of active ingredient. Total rip off, though I acknowledge it may be the suppliers rather than the pharmacy creating the situation.

Trust me it's not the pharmacy. Currently Eltroxin 100s are back in stock, 50s and 25s have now gone short. There's an approved unlicensed pack of Levothyroxine 50mcg available now, but nothing for the 25s yet...

_AVALANCHE_

What are all these drugs used for?

angeldelight

_AVALANCHE_ wrote: »

What are all these drugs used for?

Eltroxin is used to treat hypothyroidism

bleg

LilMrsDahamsta wrote: »

What I find amazing, particularly in relation to the eltroxin shortage, is that my local pharmacy only runs out of the 100mcgs; they still have 50s, so I end up paying nearly twice the price for the same quantity of active ingredient. Total rip off, though I acknowledge it may be the suppliers rather than the pharmacy creating the situation.

Last time I worked full time in a pharmacy the 50s were short so, after consultation with the GP, I gave out half the quantity of 100s to be taken every second day.


Swings and roundabouts but there's nothing more frustrating than not being able to source meds for patients that need it.

mathepac

Tetralysal is a broad-spectrum antibiotic, hopefully prescribed to treat bacterial infections.

locum-motion

angeldelight wrote: »

Trust me it's not the pharmacy. Currently Eltroxin 100s are back in stock, 50s and 25s have now gone short. There's an approved unlicensed pack of Levothyroxine 50mcg available now, but nothing for the 25s yet...

Actually, Levothyroxine 25mcg became available from the wholesalers Dublin depots on Thursday and the provincial depots on Friday. I got a delivery ex-United Drug Limerick on Friday afternoon.

locum-motion

Mercury, the company that makes the Eltroxin brand of Levothyroxine, has a particularly bad record when it comes to drug shortages. Several of their products are currently short, and others have only patchy availability, to say the least. In recent months, the 100mcg, 50mcg and 25mcg have all gone short for several weeks at a time (to the poster who's blaming their pharmacy for this and implying that the pharmacy is doing it to gouge more money out of her: that's a very insulting accusation, and completely unfounded)

Mercury has a subsidiary called Forley Generics, who sell unbranded Levothyroxine tablets in the UK market, but not in Ireland.

In order to deal with the Eltroxin shortage, Mercury applied to the Irish Medicines Board for - and was granted - what is called a 'Batch Specific Variation' to their Product Authorisation for Eltroxin 50 and Eltroxin 25. In each case, essentially the IMB has given permission for stock from a specific batch of Forley's Levothyroxine to be sold in Ireland as if it were Eltroxin. This is the stock that Angeldelight and I mentioned above.

anotherlostie

Part of the issue here is the very small size of the Irish market, and the squeeze on pricing. A lot of older drugs don't generate much profit for the companies based on how much product is sold here - the regulations governing production are becoming more stringent, particularly environmental requirements, leading to companies having to change the way they make the products. Hormonal products have received a lot of attention in this area and the thyroid hormones fall in here. (This is speculation - I've no idea of the root cause of the shortage and more relates to why there's a more limited range of products on the Irish market compared to the UK).

These changes have to be approved by the regulators including the Irish Medicines Board and there's a cost associated with that. For the less expensive products, the cost of having the product on the market simply is not met by revenue.

Now people might say this is unethical, but why would any business continuously supply product at a loss? I've explained before that this is the reason why the 16p packs of Paracetamol from ASDA are unlikely ever to reach the Irish market.

The reason why the levothyroxine isn't on the market in Ireland is probably related to the size of the market, yet as soon as there's a medical need for it, the IMB are able to licence it through the back door. It's very hard to defend having to pay to have the product assessed in Ireland when it's already been done in the UK where there aren't even language issues to contend with in reviewing the mounds of documentation needed to get a drug's marketing authorization. If there was a reciprocal arrangement here, it would get around this but then the people who think there isn't enough governance of pharma would probably moan about that instead!

_AVALANCHE_

locum-motion wrote: »

(to the poster who's blaming their pharmacy for this and implying that the pharmacy is doing it to gouge more money out of her: that's a very insulting accusation)

It's not really.

I know a man on his third chemist in 3 years because they can't count to 28.

"Oh, sorrrrry about that":rolleyes:

Most people in business will screw ya if they think they'll get away with.

It must be because he's in his 60s.

palmcut

This facebook page may be useful.
http://www.facebook.com/#!/pages/Medicine-Shortages/453098518052347

locum-motion

_AVALANCHE_ wrote: »

It's not really.

I know a man on his third chemist in 3 years because they can't count to 28.

"Oh, sorrrrry about that":rolleyes:

Most people in business will screw ya if they think they'll get away with.

It must be because he's in his 60s.

Neither I nor the other poster said anything even remotely connected to what you're alleging here. This is a completely different situation.

You are not a pharmacist. So who are you to decide that what the other poster alleged is *not* insulting to pharmacists?

Delancey

anotherlostie wrote: »

The reason why the levothyroxine isn't on the market in Ireland is probably related to the size of the market, yet as soon as there's a medical need for it, the IMB are able to licence it through the back door. It's very hard to defend having to pay to have the product assessed in Ireland when it's already been done in the UK where there aren't even language issues to contend with in reviewing the mounds of documentation needed to get a drug's marketing authorization. If there was a reciprocal arrangement here, it would get around this but then the people who think there isn't enough governance of pharma would probably moan about that instead!

The poor IMB - they have to find some way of justifying their existence as an unnescessary QUANGO
If you go into a Boots in the UK you would see a range of own label medicines for a fraction of the price of the branded product ( talking about things like Beechams Lemsip vs. Boots own brand ) . Irish consumers are denied these cheaper products thanks to the IMB.

mathepac

Delancey wrote: »

The poor IMB - they have to find some way of justifying their existence as an unnescessary QUANGO
...

Not just an unnecessary QUANGO, they are funded by pharma companies and and only they can issue licences and make pricing decisions thus controlling the market and protecting their obscene margins.

RobFowl

mathepac wrote: »

Not just an unnecessary QUANGO, they are funded by pharma companies and and only they can issue licences and make pricing decisions thus controlling the market and protecting their obscene margins.

Not a group held in high regard I have to say....

LilMrsDahamsta

locum-motion wrote: »

(to the poster who's blaming their pharmacy for this and implying that the pharmacy is doing it to gouge more money out of her: that's a very insulting accusation)

Ah calm down! I said quite clearly that I acknowledged the fault in relation to the supply problem originates with the supplier, not the pharmacy. My issue is that as a consumer I am being forced to pay almost twice as much for the quantity of medication required (2 x 50mcg versus 1 x 100mcg; over €16, versus €9ish). Someone somewhere is making money from this. I have no idea if its the pharmacy or the supplier, or both. My point was simply that I am paying a lot more for what to me is the same thing.

opinion guy

locum-motion wrote: »

Mercury, the company that makes the Eltroxin brand of Levothyroxine, has a particularly bad record when it comes to drug shortages. Several of their products are currently short, and others have only patchy availability, to say the least. In recent months, the 100mcg, 50mcg and 25mcg have all gone short for several weeks at a time (to the poster who's blaming their pharmacy for this and implying that the pharmacy is doing it to gouge more money out of her: that's a very insulting accusation, and completely unfounded)

Mercury has a subsidiary called Forley Generics, who sell unbranded Levothyroxine tablets in the UK market, but not in Ireland.

In order to deal with the Eltroxin shortage, Mercury applied to the Irish Medicines Board for - and was granted - what is called a 'Batch Specific Variation' to their Product Authorisation for Eltroxin 50 and Eltroxin 25. In each case, essentially the IMB has given permission for stock from a specific batch of Forley's Levothyroxine to be sold in Ireland as if it were Eltroxin. This is the stock that Angeldelight and I mentioned above.

So wait - they are legally allowed sell their generic's for the price of branded drugs in Ireland through this mechanism ???

Farce.

anotherlostie

mathepac wrote: »

Not just an unnecessary QUANGO, they are funded by pharma companies and and only they can issue licences and make pricing decisions thus controlling the market and protecting their obscene margins.

I don't understand this. When you say 'only they can...' do you mean the IMB (they issue the licences certainly) and can you explain the role the IMB plays in making pricing decisions and protecting the margins of the pharma companies?

mathepac

posts above by locum-motion and opinion guy make that clear - apparently unbranded generic sold to end-users at the same price as branded drug. Has been discussed before in at least one other thread.

fearcruach

mathepac wrote: »

Not just an unnecessary QUANGO, they are funded by pharma companies and and only they can issue licences and make pricing decisions thus controlling the market and protecting their obscene margins.

If the IMB wasn't reviewing licences of medication and deeming them fit for purpose with regards to Safety, Quality and Efficacy, who would? Anyone could supply the market with drugs that hadn't been proven for SQE.

Look at Thalidomide as an example of why loose to no regulation of the pharmaceutical industry is not a good idea.

The IMB is also responsible for inspecting all pharmaceutical manufacturing sites in Ireland which supply a large percentage of the worlds drugs. No country would accept Irish manufactured drugs (a huge percentage of our exports) if these plants weren't certified by the IMB.

So i'd hardly call them useless.

- I don't work for the IMB.

mathepac

fearcruach wrote: »

If the IMB wasn't reviewing licences of medication and deeming them fit for purpose with regards to Safety, Quality and Efficacy, who would? ...

A completely independent body that wasn't funded by pharmas and was free of the taint of marketing, promotion, availability decisions on licensed drugs and drug pricing. Why are our drugs amongst the most expensive in Europe? Why did Harney go head-to-head with them via the HSE to gain limited introduction of certain generics?

With regard to safety and licensing, does the IMB conduct in-depth drug-trials prior to the introduction of drugs in Ireland or does it rubber-stamp trial details from other jurisdictions as presented by manufacturers? Who "encouraged" pharmas to introduce PILs with drug packaging?

fearcruach

mathepac wrote: »

A completely independent body that wasn't funded by pharmas and was free of the taint of marketing, promotion, availability decisions on licensed drugs and drug pricing. Why are our drugs amongst the most expensive in Europe? Why did Harney go head-to-head with them via the HSE to gain limited introduction of certain generics?

With regard to safety and licensing, does the IMB conduct in-depth drug-trials prior to the introduction of drugs in Ireland or does it rubber-stamp trial details from other jurisdictions as presented by manufacturers? Who "encouraged" pharmas to introduce PILs with drug packaging?

Could you provide any evidence to support any of claims you have made about the IMB? They do not set pricing of medicine. That is the HSE. Two totally different bodies.

Some clinical trials are held in Ireland. Some are held elsewhere. It is not the responsibility of the regulator to hold these trials. How could they pay for them? They are extremely expensive to run. The burden of proof is on the company to show that the drug works and is safe. The IMB is an assessor of the data.

You say rubber stamp but I can assure it if far from that. They review all the data and if they are not satisfied with what they get then they will not hesitate rejecting the application or requesting additional data.

bleg

mathepac wrote: »

A completely independent body that wasn't funded by pharmas and was free of the taint of marketing, promotion, availability decisions on licensed drugs and drug pricing. Why are our drugs amongst the most expensive in Europe? Why did Harney go head-to-head with them via the HSE to gain limited introduction of certain generics?

With regard to safety and licensing, does the IMB conduct in-depth drug-trials prior to the introduction of drugs in Ireland or does it rubber-stamp trial details from other jurisdictions as presented by manufacturers? Who "encouraged" pharmas to introduce PILs with drug packaging?

Dude, stop digging. You have numerous fundamental flaws in your argument.

Delancey

fearcruach wrote: »

If the IMB wasn't reviewing licences of medication and deeming them fit for purpose with regards to Safety, Quality and Efficacy, who would? Anyone could supply the market with drugs that hadn't been proven for SQE.

Look at Thalidomide as an example of why loose to no regulation of the pharmaceutical industry is not a good idea.

The IMB is also responsible for inspecting all pharmaceutical manufacturing sites in Ireland which supply a large percentage of the worlds drugs. No country would accept Irish manufactured drugs (a huge percentage of our exports) if these plants weren't certified by the IMB.

So i'd hardly call them useless.

- I don't work for the IMB.

I agree that some level of regulation is required though I must question why if a drug is approved by , say , the FDA or the UK equivalent it must go though the approval process here as well ? Like I said , a variety of Boots own brand medicine is unavailable in Ireland as a result of this.

Motorist

Delancey wrote: »

I agree that some level of regulation is required though I must question why if a drug is approved by , say , the FDA or the UK equivalent it must go though the approval process here as well ? Like I said , a variety of Boots own brand medicine is unavailable in Ireland as a result of this.

Boots medication could be available here. They have obviously chosen for whatever reason not to apply for an Irish licence.

Mucco

My understanding is that pharmaceuticals for the EU market are scientifically assessed by the EMA in London, I'm not sure if they are tainted by pharma funding or not. I think it's interesting that generic penetration is low in Ireland, though Ireland is far from unique in this aspect.
I'm not sure what the Irish policies are, but generic entry can be encouraged by:
compulsory generic prescriptions like in the UK
or maybe allowing pharmacists to substitute a generic (they'd need an incentive)
pricing is not easy, but free pricing seems to work well in the States ( a very big market)
tendering is another option and has been shown to reduce prices by up to 90% in the Netherlands

As an aside, an in the FT yesterday mentioned that parallel trade can result in scarcity in low-price countries. This probably doesn't apply to Ireland, however.