Question about off label prescribing

Simon2015

I know Doctors in Ireland are allowed to prescribe drugs for conditions they were not intended for.

But are they allowed to do this whole sale or just in special cases ?

In Ireland hair loss clinics prescribe Proscar off label instead of Propecia to treat hair loss.

Proscar is the same drug as Propecia but at a higher dose.

Propecia is not even legal in Ireland.

It would seem to me that system is been abused by prescribing a drug off label on mass to get around the law.

palmcut

Doctors can prescribe unlicensed medicines. When doctors prescribe unlicensed medicines they take full responsibility for that drug and if anything happens to the patient, then the doctor is completely responsible and there is no liability on the drug manufacturer or drug supplier.
Prescribing licensed drugs for unlicensed use is the same and the doctor takes on full responsibility for that prescribing.

echo beach

Simon2015 wrote: »

Propecia is not even legal in Ireland.

It would seem to me that system is been abused by prescribing a drug off label on mass to get around the law.

Propecia is not licenced in Ireland but that doesn't mean it isn't legal. It is perfectly legal for a doctor to prescribe it, provided they do so in accordance with the law, as explained above by Palmcut. The doctor is obliged to tell you that the product isn't licenced, although because this is a complex and fast-changing area they may not always be aware of the exact licencing position of a particular drug.

The same applies to prescribing Proscar for an indication that isn't part of its product licence here.

Nobody is 'getting around' the law. They are acting within the law which recognises that not every drug will be licenced for a small market like Ireland. It is of course up to you if you want to take the drug, licenced or unlicensed, that you have been prescribed.

Simon2015

echo beach wrote: »

Propecia is not licenced in Ireland but that doesn't mean it isn't legal. It is perfectly legal for a doctor to prescribe it, provided they do so in accordance with the law, as explained above by Palmcut. The doctor is obliged to tell you that the product isn't licenced, although because this is a complex and fast-changing area they may not always be aware of the exact licencing position of a particular drug.

The same applies to prescribing Proscar for an indication that isn't part of its product licence here.

Nobody is 'getting around' the law. They are acting within the law which recognises that not every drug will be licenced for a small market like Ireland. It is of course up to you if you want to take the drug, licenced or unlicensed, that you have been prescribed.

There is reason Propecia is not licensed in Ireland.

One of Ireland's most respected Doctor's Andrew Rynne has called the drug a "dangerous toxic medication".

The drug is also banned in Russia and Belgium.

Propecia in its original form was never meant to be used as a cosmetic medication.

I find it very odd that Doctors in Ireland can get away with prescribing this drug for hair loss when its not licensed for that purpose.

It really is making a mockery of the law.

echo beach

Simon2015 wrote: »

There is reason Propecia is not licensed in Ireland.

One of Ireland's most respected Doctor's Andrew Rynne has called the drug a "dangerous toxic medication".

You don't know why Propecia is not licenced in Ireland. Has the company ever applied for a licence and been refused?

Every drug is a 'dangerous toxic medication' if it isn't used properly. Few drugs are as dangerous or toxic as paracetamol and you can buy it, legally, in every corner shop and petrol station.

If you feel that the doctors prescribing it are doing something unethical then you can report them to the Medical Council. There is certainly nothing illegal in prescribing it off-licence.

Simon2015

echo beach wrote: »

You don't know why Propecia is not licenced in Ireland. Has the company ever applied for a licence and been refused?

Every drug is a 'dangerous toxic medication' if it isn't used properly. Few drugs are as dangerous or toxic as paracetamol and you can buy it, legally, in every corner shop and petrol station.

If you feel that the doctors prescribing it are doing something unethical then you can report them to the Medical Council. There is certainly nothing illegal in prescribing it off-licence.

This cosmetic drug has caused at least 64 known suicides to date, I think its fair to say it is dangerous.

http://www.pfsfoundation.org/news/finasteride-induced-suicides-up-8-4-in-whos-vigibase/

It may not be illegal to prescribe it off label but I think the system is been abused.

Doctors are using a loophole to prescribe a banned drug which will probably never be officially licensed in Ireland due to all the new evidence that is coming out about the side effects of this drug.

echo beach

Simon2015 wrote: »

Doctors are using a loophole to prescribe a banned drug which will probably never be officially licensed in Ireland due to all the new evidence that is coming out about the side effects of this drug.

I'm not disagreeing with you about the drug itself or the potential dangers but it isn't accurate to say the drug is 'banned'. There is no ban. Prescribing off-licence isn't a loophole. It is a recognised and necessary part of medical practice.

All drugs, licenced or unlicensed, are dangerous. All drugs have side-effects. Look at the information on the HPRA website for licensed drugs. Many have pages and pages of potential side-effects, including suicidal tendencies and other life-threatening effects. Despite that they are still used when doctors and patients think they are the best, or the the least worst, option.

Simon2015

echo beach wrote: »

I'm not disagreeing with you about the drug itself or the potential dangers but it isn't accurate to say the drug is 'banned'. There is no ban. Prescribing off-licence isn't a loophole. It is a recognised and necessary part of medical practice.

All drugs, licenced or unlicensed, are dangerous. All drugs have side-effects. Look at the information on the HPRA website for licensed drugs. Many have pages and pages of potential side-effects, including suicidal tendencies and other life-threatening effects. Despite that they are still used when doctors and patients think they are the best, or the the least worst, option.

I don't buy your argument because hair loss is not a medical condition its a cosmetic one.

Its not necessary for Doctors to be prescribing dangerous unlicensed drugs for a cosmetic condition.

dermabrasion

90%of drugs prescribed in Paediatric intensive care are off-label and 99% of patients receive an off-label drug. Why? Its because the drugs were never tested this population or they are now off-patent and they there is no incentive for drug companies to do the rigorous studies required to license them. If they were to do the studies, it would take years, and they would not make their money back or the drugs would become so expensive to make them unaffordable for day-to-day care.
So, it is is investigator-initiated research that comes up with the data that helps doctors and pharmacists in this field. But, it is far from the benchmark of a license. That is reality and its not going to change anytime soon.

Ocean Blue

Simon2015 wrote: »

This cosmetic drug has caused at least 64 known suicides to date, I think its fair to say it is dangerous.

http://www.pfsfoundation.org/news/finasteride-induced-suicides-up-8-4-in-whos-vigibase/

It may not be illegal to prescribe it off label but I think the system is been abused.

Doctors are using a loophole to prescribe a banned drug which will probably never be officially licensed in Ireland due to all the new evidence that is coming out about the side effects of this drug.

Finasteride is not banned, it is licensed in Ireland as proscar and it's generics. It's the propecia brand which does not have a license. There's an important differentiation there.

Simon2015

Ocean Blue wrote: »

Finasteride is not banned, it is licensed in Ireland as proscar and it's generics. It's the propecia brand which does not have a license. There's an important differentiation there.

Propecia is banned in Ireland.

Ocean Blue

Simon2015 wrote: »

Propecia is banned in Ireland.

No it isn't.....it just doesn't have a license to be marketed here.

Simon2015

Ocean Blue wrote: »

No it isn't.....it just doesn't have a license to be marketed here.

It's illegal to sell the drug in Ireland.

echo beach

Simon2015 wrote: »

It's illegal to sell the drug in Ireland.

It is perfectly legal for a registered pharmacy to supply it, or any other unlicensed drug, against a properly written prescription.

Ocean Blue

Simon2015 wrote: »

It's illegal to sell the drug in Ireland.

You are embarrassing yourself now. The drug is finasteride - it's perfectly legal in Ireland. One brand of it is propecia - this product is not licensed but that doesn't mean it's illegal. It just doesn't have a license, like millions of other products in other countries that we don't have here.

A doctor is perfectly entitled to prescribe it once they accept responsibility for it's off label use, and a pharmacy is perfectly entitled to procure and dispense it according to the rules governing unlicensed use of medicines.

Simon2015

Ocean Blue wrote: »

You are embarrassing yourself now. The drug is finasteride - it's perfectly legal in Ireland. One brand of it is propecia - this product is not licensed but that doesn't mean it's illegal. It just doesn't have a license, like millions of other products in other countries that we don't have here.

A doctor is perfectly entitled to prescribe it once they accept responsibility for it's off label use, and a pharmacy is perfectly entitled to procure and dispense it according to the rules governing unlicensed use of medicines.

A doctor can only prescribe the off label version of the drug.

Proscar was never intended to be used for cosmetic purposes.

If this was all above board Finasteride would be licensed for hair loss in Ireland.

They are only able to prescribe it becasuse they are using a loophole in the law.

There is a reason you can't legally buy Propecia in Ireland.

Ocean Blue

Simon2015 wrote: »

A doctor can only prescribe the off label version of the drug.

Proscar was never intended to be used for cosmetic purposes.

If this was all above board Finasteride would be licensed for hair loss in Ireland.

They are only able to prescribe it becasuse they are using a loophole in the law.

There is a reason you can't legally buy Propecia in Ireland.

Really? Can you provide a determination from the HPRA that the manufacturers of Propecia applied for an Irish license and were refused?

Simon2015

Ocean Blue wrote: »

Really? Can you provide a determination from the HPRA that the manufacturers of Propecia applied for an Irish license and were refused?

Given that Propecia has been on the market for almost 20 years there must be a very good reason why they haven't legalised it in Ireland.

I suspect it's because of prominent Irish Doctors like Andrew Rynne who have called for the drug to banned here.

Also I'd like to point out that there is massive difference between the 5mg version of the drug that is used for legitimate medical purposes vs the 1mg version which is only used for cosmetic purposes.

Ocean Blue

Simon2015 wrote: »

Given that Propecia has been on the market for almost 20 years there must be a very good reason why they haven't legalised it in Ireland.

I suspect it's because of prominent Irish Doctors like Andrew Rynne who have called for the drug to banned here.

Also I'd like to point out that there is massive difference between the 5mg version of the drug that is used for legitimate medical purposes vs the 1mg version which is only used for cosmetic purposes.

The main reason that so many products aren't available in Ireland is commercial - the cost and bureaucracy involved in the licensing process isn't worth it for such a small country and the limited amount it would be prescribed.

palmcut

Simon2015 wrote: »

A doctor can only prescribe the off label version of the drug.

Proscar was never intended to be used for cosmetic purposes.

If this was all above board Finasteride would be licensed for hair loss in Ireland.

They are only able to prescribe it becasuse they are using a loophole in the law.

There is a reason you can't legally buy Propecia in Ireland.

As has been previously pointed out you can legally buy Propecia in Ireland.
A pharmacy can procure Propecia for you on foot of a valid legal prescription from your GP.
Propecia is an unlicensed medicine and is currently listed as being available from 4 suppliers in Ireland. There is no listed price given and the price is quoted as being available on application.
I have never dispensed Propecia in over 40 years of practice. However the product is available as an unlicensed medicine. This means that the prescribing doctor takes full responsibility for the product.
This product is not unique and there are several hundred unlicensed items available here.
The main reason for unlicensed is commercial. The volume of sales does not justify acquiring a licence in small markets.
(now if there was a European licensing agency that licensed products for all Europe without having each product licensed individually in each EU country...)

locum-motion

Folks, you're all wasting your time. Simon2015 has mad up his mind, and isn't going to be swayed by anything like 'logic' or 'reasoned argument'.