The Irish Medicines Board and their rules regarding medicinal products

hatrickpatrick

This is basically a political discussion spun off from the 5 HTP thread which was moved here earlier.
Just wondering, who are the IMB accountable to? Who appoints them, how much power do they have to ban / restrict products to prescription only, etc? What kind of legislative basis do they operate under?

It seems to me (and I'm sure I'll open a can of worms here but regardless ) that their rules can be quite draconian. When I say draconian, I mean that in what might be considered typical Irish nanny state style, they seem to ban an awful lot of products which are widely available elsewhere, even just across the border in NI. I remember there was a big storm a few years ago about bodybuilding supplements which contained more than 100% RDA of vitamin B12, after which they took a bunch of massive name brands off Irish shelves - products by BSN (NO Xplode, Nitrix, Cellmass etc) and Universal (The entire Animal range, Stak 2, M-Stak, pump, test, flex and so on), and quite a few others. I remember an American friend looking at me aghast when I told him that tribulus terrestris, a herbal product which claims to be a mild testosterone booster, was actually illegal in Ireland (script only, but let's face it that means effectively illegal when it comes to bodybuilding and other "recreational" products).
I won't deny that I'm an avid user of Animal Pump for weightlifting sessions - for those who don't know, it's a pre-workout supplement which you take about 20 mins before heading to the gym, and it contains a large amount of L-Arginine and creatine (also caffeine but I remove that pill from my doses, it's optional) which basically allow you to train for longer than usual. I've been off it for two weeks since it's impossible to get here and I haven't had a chance to get it anywhere else, and the difference is genuinely noticeable in that I can't maintain my workout for the killer 2 hour sessions I usually go in for

Now I'm sure there are some who'll agree with all of those rulings, but I for one find it a little frustrating that Ireland seems to have this terminal nanny state issue in which so many things which are completely fine in most other jurisdictions (garden fireworks and head shops come irresistibly to mind) are banned here for relatively dubious reasons. If it's legal pretty much everywhere else in Europe, why the hell does Ireland have to be the one place where the government says "Nah, we'll decide whether this is good for you or not!"

Thoughts? Are the IMB accountable, are they reasonable, or are they another aspect of Irish government which wants far too much hands on control over citizens' personal lives?

nesf

The political question is whether we should be regulating. The specifics of regulation are very much a scientific/medical matter.


The question essentially boils down to whether an adult has to right to put what they want into their body and whether someone has the right to sell them this thing (the latter is normally where the issue lies).

Manach

I could be that this is one of the areas where the state has a natural competance. On the one hand the basic premise is that material aforementioned if in widespread use might have negative effects and cause widespread issues in the long term - for example thalidomide effecting the unborn. Another issue being the state's duty to enforce IP law under international conventions - ie if the products are unlicensed copies of patented drugs.
On the other, over-regulation does impose a financial burden which is paid for in the long wrong, as well as denying the patient's self-autonomy to choose.
So I'd tend to a more nuanced approroach to enforcement of products.

daveohdave

Are they subject to FOI I wonder? I'd be interested in knowing the reasoning behind some of their decisions -- St. John's Wort comes across as Nanny, for example (some people are too stupid to read the label, therefore everyone must be considered stupid), and why they think Dentinox teething gel shouldn't be allowed here is just mind-boggling, particularly when they allow chemists to sell snake oil like Teetha.

beggars_bush

A lot of conflicts of interest in pharmacies in terms of what they sell you.
Huge commission and mark up for promoting certain products.

Ocean Blue

I'm not referring specifically to any of the products mentioned above but often times people think the IMB are responsible for a lot more restrictions than they actually are.

In relation to head shops the government made psychoactive products illegal in Criminal Justice (Psychoactive Substances) Act 2010. The IBM don't have the power to add legislation to the statute book.

In relation to other products in a lot of cases we don't have the same range of products as the UK and Europe for commercial reasons. It's extremely expensive to go through the licensing process so a lot of companies don't see such an outlay as viable given our small population size.

weisses

Cheap St. John's worth was competing with big pharma selling anti depressants. Banning it from the shops made me loose any confidence in this quango . But this view is more suited in the CT forum.

Ocean Blue

weisses wrote: »

Cheap St. John's worth was competing with big pharma selling anti depressants. Banning it from the shops made me loose any confidence in this quango . But this view is more suited in the CT forum.

You're dead right. It is more suitable for the conspiracy theory forum. It is no longer available without prescription because depression is not an illness suitable for self-medicating, and because of significant interactions with other medications. There are multiple reports of accidental pregnancies due to it interacting with hormonal contraceptive pills.

If a person needs it, just get a prescription and a pharmacist will order it for you. It's not banned, it's just not licensed here but is still available on prescription.

weisses

Ocean Blue wrote: »

You're dead right. It is more suitable for the conspiracy theory forum. It is no longer available without prescription because depression is not an illness suitable for self-medicating

And you are dead right there ... We need big pharma to treat this

Ocean Blue wrote: »

If a person needs it, just get a prescription and a pharmacist will order it for you. It's not banned, it's just not licensed here but is still available on prescription.

I did not say it was banned all together, and we all know that when you get a prescription to treat depression your doctor will not advise you to get St Johns-worth specially when its advised to not use St. John’s wort to replace conventional care.

hatrickpatrick

nesf wrote: »

The political question is whether we should be regulating. The specifics of regulation are very much a scientific/medical matter.


The question essentially boils down to whether an adult has to right to put what they want into their body and whether someone has the right to sell them this thing (the latter is normally where the issue lies).

It's also a political question in terms of this authority which seems to have immense power over what can and can't be sold, and yet seems to operate on an entirely unaccountable / undemocratic basis.

hatrickpatrick

Ocean Blue wrote: »

I'm not referring specifically to any of the products mentioned above but often times people think the IMB are responsible for a lot more restrictions than they actually are.

In relation to head shops the government made psychoactive products illegal in Criminal Justice (Psychoactive Substances) Act 2010. The IBM don't have the power to add legislation to the statute book.

In relation to other products in a lot of cases we don't have the same range of products as the UK and Europe for commercial reasons. It's extremely expensive to go through the licensing process so a lot of companies don't see such an outlay as viable given our small population size.

I should have been clearer abotu head shops, I wasn't blaming the IMB, merely using them as an example of something which Ireland bans while other countries chill out and don't react so extremely to.

I can tell you for sure that the bodybuilding supplements I mentioned are specifically banned because of the IMB, and most of them are legal in the UK and US. Did you know that if you order supplements from bodybuilding.com (which itself has very strict rules regarding safe products and no steroids or prohormones, etc) and have them shipped here, the IMB are guaranteed to open the package?
I'm not necessarily saying it's wrong, I'm just looking for a debate about why Ireland seems to be so much more restrictive about so many things that other Western countries aren't. The amount of nanny state "ban everything" mentality here seems to be completely over the top.

Ocean Blue wrote: »

You're dead right. It is more suitable for the conspiracy theory forum. It is no longer available without prescription because depression is not an illness suitable for self-medicating, and because of significant interactions with other medications. There are multiple reports of accidental pregnancies due to it interacting with hormonal contraceptive pills.

If a person needs it, just get a prescription and a pharmacist will order it for you. It's not banned, it's just not licensed here but is still available on prescription.

What this still translates to is "we don't trust Irish people to read the label and take precautions". While seemingly most other Western countries do in fact trust their populations to make their own informed choices.

Lofty123

What this still translates to is "we don't trust Irish people to read the label and take precautions". While seemingly most other Western countries do in fact trust their populations to make their own informed choices.[/QUOTE]

This is the nub of the problem. I'm an adult and would like to make my own decisions based on what works for me!

I used to take Solpadene capsules for Arthritis flare-ups. I can no longer buy them without a prescription. I am aware that some people had issues with addiction, but must we all suffer because of a few weak-willed individuals?
:mad:

Dan_Solo

Appropriate dosing and duration and knowledge of side effects and interactions is well beyond a regular adult without specific training. That's why just being an adult doesn't qualify you to self-prescribe.

hatrickpatrick

Dan_Solo wrote: »

Appropriate dosing and duration and knowledge of side effects and interactions is well beyond a regular adult without specific training. That's why just being an adult doesn't qualify you to self-prescribe.

So what you mean is that, unlike almost every other Western nation, I can't be trusted to read the label on my Animal Pump which says "take one pack approximately half an hour before training, do not exceed the stated dose"? :rolleyes:

Dan_Solo

I don't know if YOU can be trusted. You seem clever enough so yeah, why not.
Now, how does that affect the fact that there are definitely large swathes of the public who can't or won't follow the most basic medicine regimen instructions?
I would certainly argue that ptescriptions are ridiculously expensive here, but that's more to do with overpaid doctors than anything. One you've shown you're any way clued in, repeat self-prescription should be allowed.

hatrickpatrick

Dan_Solo wrote: »

I don't know if YOU can be trusted. You seem clever enough so yeah, why not.
Now, how does that affect the fact that there are definitely large swathes of the public who can't or won't follow the most basic medicine regimen instructions?
I would certainly argue that ptescriptions are ridiculously expensive here, but that's more to do with overpaid doctors than anything. One you've shown you're any way clued in, repeat self-prescription should be allowed.

So are you implying that the average Irish person is of far lesser intelligence than the average Brit, American, French, Spanish person etc? Or are you implying that the governments of these nations are being stupid and playing with fire by allowing their citizens to purchase products such as Animal Pump and St John's Wort in a health food store?

Animal Pump isn't something you'd get a prescription for anyway because its not medically necessary, it's simply an exercise aid. It's not the kind of thing one should have to go to the doctor about.

Dan_Solo

Yes, actually I do think those other countries should have at least some system in place to assess consumers of drugs and supplements with possible side effects or complications. Not a full prescription requirement, but somewhere in between.

daveohdave

Dan_Solo wrote: »

Now, how does that affect the fact that there are definitely large swathes of the public who can't or won't follow the most basic medicine regimen instructions?.

That's an interesting claim. Define "large swathes" please.

Manach

Dan_Solo wrote: »

.
Now, how does that affect the fact that there are definitely large swathes of the public who can't or won't follow the most basic medicine regimen instructions?

I'm neutral in this particular debate, but from a book I read recently (Age of Context), this has shown to be true from various medical studies and how this practice is responsible for billions lost in ineffective treatments. It occurs across all Western countries.

Dan_Solo

daveohdave wrote: »

That's an interesting claim. Define "large swathes" please.

You think there's a significant proportion of he general public with professional level pharmacy skills that they are hiding?
Most people don't know arse from elbow when it comes to medicine. Just look how many people still think antibiotics will cure a flu!

Dan_Solo

Manach wrote: »

I'm neutral in this particular debate, but from a book I read recently (Age of Context), this has shown to be true from various medical studies and how this practice is responsible for billions lost in ineffective treatments. It occurs across all Western countries.

Although you could make the case that most people are incapable of adhering to their prescripion schedule anyway so why bother stopping anybody else who wants to self-prescribe...

Lofty123

Dan_Solo wrote: »

Appropriate dosing and duration and knowledge of side effects and interactions is well beyond a regular adult without specific training. That's why just being an adult doesn't qualify you to self-prescribe.

I used to be able to buy this product at my local pharmacy, where the pharmacist is fully aware of any medical conditions I may have, and by default also knows what other meds I am taking. Nothing has changed, apart from the fact that I now will have to pay €50 to visit my GP for a prescription for a product that costs less than €5.

This product was freely available up until last year, and is still freely available in almost every other country in the world. Do we really need this degree of "protection" from ourselves?

hatrickpatrick

Dan_Solo wrote: »

Yes, actually I do think those other countries should have at least some system in place to assess consumers of drugs and supplements with possible side effects or complications. Not a full prescription requirement, but somewhere in between.

Well in America they have the FDA, which seems to be quite adequate while not banning anything beyond simply multivitamins from the shelves :rolleyes:

EDIT:

Dan_Solo wrote: »

You think there's a significant proportion of he general public with professional level pharmacy skills that they are hiding?
Most people don't know arse from elbow when it comes to medicine. Just look how many people still think antibiotics will cure a flu!

And part of the issue is what you define as "medicine". Most other countries define many things as supplements, while we decide to classify them as full blown medicines. That's part of the problem - it seems to be a knee jerk overreaction, like with so many things in Ireland.

Dan_Solo

hatrickpatrick wrote: »

Well in America they have the FDA, which seems to be quite adequate while not banning anything beyond simply multivitamins from the shelves :rolleyes:

Why do you automatically assume another country is doing things right just because they do it the way you prefer? It's not really an argument at all.

Ocean Blue

Lofty123 wrote: »

I used to be able to buy this product at my local pharmacy, where the pharmacist is fully aware of any medical conditions I may have, and by default also knows what other meds I am taking. Nothing has changed, apart from the fact that I now will have to pay €50 to visit my GP for a prescription for a product that costs less than €5.

This product was freely available up until last year, and is still freely available in almost every other country in the world. Do we really need this degree of "protection" from ourselves?

Solpadeine is not on prescription. Go to another pharmacy if you're having problems getting it.

Lofty123

Ocean Blue wrote: »

Solpadeine is not on prescription. Go to another pharmacy if you're having problems getting it.

Thanks for that. Strangely though I have been refused it in at least 4 different pharmacies, where I was told it was now only available on prescription?

hatrickpatrick

Dan_Solo wrote: »

Why do you automatically assume another country is doing things right just because they do it the way you prefer? It's not really an argument at all.

It's not just "another country", its almost every other country in Europe, and the US. To justify a regime which is far more restrictive than the norm internationally, the burden IMO is on proponents.

RDM_83 again

Lofty123 wrote: »

Thanks for that. Strangely though I have been refused it in at least 4 different pharmacies, where I was told it was now only available on prescription?

I am not a 100% on this but I think the pharmacist has to satisfy themselves that you know how to take the stuff and are not abusing it.
I am not sure about this but there might be versions of solpadeine with higher Codine content that are script only.
Also if its about saving money it there is a 'generic' of solpadeine called maxrelief (or similar).

Dan_Solo wrote: »

Appropriate dosing and duration and knowledge of side effects and interactions is well beyond a regular adult without specific training. That's why just being an adult doesn't qualify you to self-prescribe.

They shouldn't just ban stuff though, a half way point would be to allow pharmacists to write scripts for certain products and restrict the sale to pharmacies. They will have a higher level of training than most medics anyway in relation to the actual risks and interactions.

hfallada

Lofty123 wrote: »

Thanks for that. Strangely though I have been refused it in at least 4 different pharmacies, where I was told it was now only available on prescription?

Im not trying to be smart or make a dig at you. But they might suspect you have a codeine addiction. A large amount of people are getting an addiction to codeine ( i have a friend whose mother is a bit fond of it). Pharmacies are not allowed to display it and have to ask you a set of BS questions before hand to check you dont have an addiction. Codeine is highly addictive and prescription only in most countries.

Lofty123

hfallada wrote: »

Im not trying to be smart or make a dig at you. But they might suspect you have a codeine addiction. A large amount of people are getting an addiction to codeine ( i have a friend whose mother is a bit fond of it). Pharmacies are not allowed to display it and have to ask you a set of BS questions before hand to check you dont have an addiction. Codeine is highly addictive and prescription only in most countries.

One wonders how the pharmacist can form an opinion based on said questions?

It's likely that if I did have a problem with addiction then I wouldn't answer them truthfully.

Also, one of the pharmacies involved is my local pharmacy, in a small rural town that has been my pharmacy for years.

Either it should be script only, or freely available. This is yet another example of an "Irish Solution"

TimeToShine

I got a letter from them a few days ago. I ordered some YHCL which apparently is a prescription drug over here. They asked me for all sorts of details such as credit card used and company name and gave me two weeks to respond.

Is the case closed if I give them the information? The fact that my money is gone is annoying enough. It seems very random as well, I know people who have ordered the same product from the same company and got it without issue.

daveohdave

Dan_Solo wrote: »

You think there's a significant proportion of he general public with professional level pharmacy skills that they are hiding?

You'd want to watch them goalposts pal, they jumped a whole pitch over to the right there!

You _specifically_ said that "there are definitely large swathes of the public who can't or won't follow the most basic medicine regimen instructions". Now it's "professional level pharmacy skills"? You wouldn't happen to be a chemist by any chance, eh?

oscarBravo

TimeToShine wrote: »

I ordered some YHCL which apparently is a prescription drug over here.

You bought a monoamine oxidase inhibitor by mail order...?

:eek:

TimeToShine

oscarBravo wrote: »

You bought a monoamine oxidase inhibitor by mail order...?

:eek:

Yes.

Any advice?

oscarBravo

TimeToShine wrote: »

Yes.

Any advice?

Yes: don't.

hfallada

Lofty123 wrote: »

[/B]

One wonders how the pharmacist can form an opinion based on said questions?

It's likely that if I did have a problem with addiction then I wouldn't answer them truthfully.

Also, one of the pharmacies involved is my local pharmacy, in a small rural town that has been my pharmacy for years.

Either it should be script only, or freely available. This is yet another example of an "Irish Solution"

Its not an Irish thing at all. In America, in states with Meth problems, they track your purchases of anti-histamines which is a main ingredient of Meth.Do you think they should make it free for all or script only in that case?

In the same way codeine is a highly addictive but an important pain killer. Do we try and prevent addiction or make it affordable for most people?

Dan_Solo

daveohdave wrote: »

You'd want to watch them goalposts pal, they jumped a whole pitch over to the right there!

You _specifically_ said that "there are definitely large swathes of the public who can't or won't follow the most basic medicine regimen instructions". Now it's "professional level pharmacy skills"? You wouldn't happen to be a chemist by any chance, eh?

I don't see any incompatibility. Prescriptions should only be available from those with proper medical/pharmacy training. The fact the a lot of the public can't follow the instructions on the filled prescription is indeed a huge problem, but getting rid of the need for prescriptions entirely would hardly help matters, would it?

Lofty123

hfallada wrote: »

Its not an Irish thing at all. In America, in states with Meth problems, they track your purchases of anti-histamines which is a main ingredient of Meth.Do you think they should make it free for all or script only in that case?

In the same way codeine is a highly addictive but an important pain killer. Do we try and prevent addiction or make it affordable for most people?

Yes, one or the other, but not availability based on a pharmacist forming an opinion of me and my potential for addiction based on a few questions that I may or may not answer truthfully.

TimeToShine

oscarBravo wrote: »

Yes: don't.

Lesson learned... was wondering if you had advice in the meantime.

daveohdave

Dan_Solo wrote: »

I don't see any incompatibility.

Dear God. Goodbye.

RDM_83 again

hfallada wrote: »

Its not an Irish thing at all. In America, in states with Meth problems, they track your purchases of anti-histamines which is a main ingredient of Meth.Do you think they should make it free for all or script only in that case?

In the same way codeine is a highly addictive but an important pain killer. Do we try and prevent addiction or make it affordable for most people?

Actually someone with a bit more pharma knowledge may be able to clarify this but is the amount of codeine present in the semi regulated products like solpadiene actually high enough to have any therapeutic value.
There is a big issue anyway that even with having to get a prescription people just shop around for a doctor willing to prescribe more willingly

Dan_Solo

daveohdave wrote: »

Dear God. Goodbye.

We learned a lot from your concise yet comprehensive riposte. Do call again.

K-9

TimeToShine wrote: »

Yes.

Any advice?

oscarBravo wrote: »

Yes: don't.

TimeToShine wrote: »

Lesson learned... was wondering if you had advice in the meantime.

daveohdave wrote: »

Dear God. Goodbye.

Dan_Solo wrote: »

We learned a lot from your concise yet comprehensive riposte. Do call again.

Mod:

Seriously, cut out the one liners please.

weisses

weisses wrote: »

Cheap St. John's worth was competing with big pharma selling anti depressants. Banning it from the shops made me loose any confidence in this quango . But this view is more suited in the CT forum.

St. John's Wort going POM was a good initiative. Wish the UK had followed suit. Just because it is herbal does not mean it is safe. It interacts with a lot of other medication due to it's effect on cytochrome p450.

RDM_83 again

RDM_83 again wrote: »

Actually someone with a bit more pharma knowledge may be able to clarify this but is the amount of codeine present in the semi regulated products like solpadiene actually high enough to have any therapeutic value.
There is a big issue anyway that even with having to get a prescription people just shop around for a doctor willing to prescribe more willingly

Yeah. It is a theurapeutic dose. Solpadeine plus is 500mg paracetamol/8mg codeine. Licensed for short term pain relief (3 day). Can be addictive.

Maximum dose of 8 tablets in 24 hours but this is due moreso to overdosing of paracetamol rather than the codeine.

Bravobabe

Hi All,
I suffer from fairly regular sever headaches. Diagnosed recently with underactive thyroid, which could be a contributory factor and due to old injury surer from slipped discs in the upper & lower back. I don't really like taking too many tablets, but from time to time when needed I do find soluble Solpadeine very beneficial (It works for me). (Doctor does prescribe Define etc, but I only use them when I really really need them, can have them in the press for a year or more).
Over a year I would probable take about 30-40 doses or 3 - 4 boxes of 24 tablets.

I have two gripes
1 - The price increase in these tablets over the last 2 years (doubled approx.)
2 - Being quizzed by a shop assistant about why I using it and the dangers of it etc.

Sometimes, when you have a slipped disc or suffering from a severe headache, you may not be in the form for the mantra "have you tried these etc etc. I recently have a argument in a large Chemist chain. Basically "she" wouldn't sell me the Solpadeine but would sell me several boxes of nicotine replacement products. I don't know which is the most addictive?

My Doctor can give me a script for them, but that's more money

Fred Swanson

This post has been deleted.

Godge

hatrickpatrick wrote: »

Well in America they have the FDA, which seems to be quite adequate while not banning anything beyond simply multivitamins from the shelves :rolleyes:

http://247wallst.com/investing/2010/12/10/the-ten-worst-drug-recalls-in-the-history-of-the-fda/2/

yes, the FDA in America, the only regulator in the world equal to the Irish Central Bank of the early 2000s.