Generic Medicines

the_syco

A generic drug (generic drugs, short: generics) is a drug which is produced and distributed without patent protection. The generic drug may still have a patent on the formulation but not on the active ingredient.
A generic must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or bioequivalent to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are identical in dose, strength, route of administration, safety, efficacy, and intended use[1]. In most cases, generic products are available once the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.

Sounds excellent, doesn't it?


According to a Forfás study, commissioned by the Consumer Strategy Group (CSG) in 2004

In some EU countries, pharmacists may substitute a prescribed brand drug with a cheaper generic alternative. In Ireland, pharmacists are not allowed to provide substitutions.
In a study carried out for the Irish Medical Journal in 2003, expenditure on medicines under the Community Drug Schemes was €674.8 million in 2001, a 27% increase on the year 2000. In that year only 22% of GMS prescription items were dispensed generically and just 12% of DPS prescriptions were dispensed generically. Evidence suggests however that a further 18% of prescription items were dispensed as proprietary preparations when a generic
5 This scheme was introduced in 1993 and was due to expire in 2003. It was extended into 2004. 6 Generics may also be branded.
4
equivalent was available. The potential savings of substituting generic drugs for branded drugs in 11 of the top 30 drugs dispensed was identified at €5.65 million.

Now, with the cutting of a lot of pharmacies from the HSE, would it make sense for the pharmacies to

Display prices for branded and generic drugs in pharmacies at point of purchase.

The report says that Irish pharmaceutical prices are among the highest in Europe, which is no real surprise. What if the rules were changed, to allow pharmacists to provide generic substitution for branded drugs? Do you think this would make the drugs easier to afford?

=-=

In my opinion, the system the doctors use to prescribe drugs to people should be updated to include generic drugs. If they do the exact same thing, why not offer the cheaper drug? Sure, anyone getting them free may insist on the dearer option, but for those that must pay, offering the cheaper (cheap due to not paying a 60% markup for a brand name) drug may save people money, and enable them to properly do a treatment.

What are your thoughts on this?

/edit
Also, is there a list of generic brands available in Ireland? Couldn't find one, but may have been using the wrong terms in my search.

bleg

the_syco wrote: »

What are your thoughts on this?

Copy the French. If a generic equivalent is available it is dispensed, if not the patient pays the difference between the brand and generic products.

DrIndy

only certain drugs must be prescribed by brand due to different bioavailability - patients on Theophylline and Lithium should never change brands (are there any others?).

The rest can be generic.

I always make a point of prescribing generically at all times and always will - it is better to know the drug and how it works, not some random brand name.

RobFowl

Amazing how much coming off patent makes to the cost but also amazing how little difference there often is.
EG Fluconazole (diflucan) there are 6 generic versions and their cost prices are 6.21,6.38,6.41 6.45,.6.46 and 6.51 ! Not that long ago the cost price of diflucan was over 11 Euro

DrIndy

you can ascribe this to the manufacturing costs - but there is still considerable profit in generic version so long as you divvy out the market well with the competitors.

locum-motion

DrIndy wrote: »

only certain drugs must be prescribed by brand due to different bioavailability - patients on Theophylline and Lithium should never change brands (are there any others?).

Diltiazem and Verapamil are two more that spring immediately to mind. Also Nifedipine can be tricky, but usually OK if the form remains the same. ie. switching from Adalat Caps to Nifed Retard Tabs is problematic, but from Adalat Retard Tabs to Nifed Retard Tabs usu OK.

angeldelight

DrIndy wrote: »

only certain drugs must be prescribed by brand due to different bioavailability - patients on Theophylline and Lithium should never change brands (are there any others?).

The rest can be generic.

I always make a point of prescribing generically at all times and always will - it is better to know the drug and how it works, not some random brand name.

ciclosporin is another that springs to mind

The problem with generics in Ireland is that they are sometimes not that much cheaper than the generic as they are seen as "branded generics" so Clonmel etc all still visit Drs and we get scripts for Clonamox suspension or Pinaclav etc as the GPs are having these people telling them to prescribe their "generic".

greenwell

It is inncorrect scientifically to say one could not switch to a generic equivalent of a branded drug on bioavailability grounds.

A generic can only get a licence if it shows same bioavailability with the origionator (this is done in a Phase 1 trial setting) and thus ensure patient safety if there is an interchange between origional brand and generic.

RobFowl

greenwell wrote: »

It is inncorrect scientifically to say one could not switch to a generic equivalent of a branded drug on bioavailability grounds.

A generic can only get a licence if it shows same bioavailability with the origionator (this is done in a Phase 1 trial setting) and thus ensure patient safety if there is an interchange between origional brand and generic.

Thats true for most but but not all drugs. Lithium is the obvious exception but there are others as weel

Kevster

As a person who's on medication daily for the rest of his life (and I'm only 26), I find this interesting, but I could have told you about it myself out of personal experience. Sometimes, my pharamcst doesn't have my medication from the usual manufacturer and then gives me one from a different one. Whenever this happens, I notice changes in how the medication works, and these can be sometimes mal-effects (even if the medication is in the same form - i.e. tablet, capsule, etc.).

greenwell

Kevster wrote: »

As a person who's on medication daily for the rest of his life (and I'm only 26), I find this interesting, but I could have told you about it myself out of personal experience. Sometimes, my pharamcst doesn't have my medication from the usual manufacturer and then gives me one from a different one. Whenever this happens, I notice changes in how the medication works, and these can be sometimes mal-effects (even if the medication is in the same form - i.e. tablet, capsule, etc.).

Well firstly your Pharmacist should not be giving you alternative medication unless cleared by your Doctor and you are made aware of this. Sometimes a generic product is provided in a different form say capsule not a tablet but the active ingredient is exactly the same otherwise it would not be licenced. If your Pharmacist gave you an alternative product from the same CLASS of drugs than it might differ from what you have been on previously. Again this would need to be cleared with your doctor

SomeDose

greenwell wrote: »

Well firstly your Pharmacist should not be giving you alternative medication unless cleared by your Doctor and you are made aware of this. Sometimes a generic product is provided in a different form say capsule not a tablet but the active ingredient is exactly the same otherwise it would not be licenced. If your Pharmacist gave you an alternative product from the same CLASS of drugs than it might differ from what you have been on previously. Again this would need to be cleared with your doctor

I think Kevster was talking about getting different generic brands of the same drug, which would've been prescribed generically to start with. In this case the pharmacist is free to interchange generics where appropriate. Giving a different product from the same drug class is a totally different kettle of fish (e.g. ramipril instead of lisinopril).

greenwell wrote: »

It is inncorrect scientifically to say one could not switch to a generic equivalent of a branded drug on bioavailability grounds.

A generic can only get a licence if it shows same bioavailability with the origionator (this is done in a Phase 1 trial setting) and thus ensure patient safety if there is an interchange between origional brand and generic.

A generic does not have to show identical bioavailability - it has to show bioequivalence i.e. the same pharmacological effect and efficacy (and safety too). Bioavailability is an important factor in this of course, and the majority of generics will have similar (and often identical) bioavailability to the original. Some of drugs mentioned previously do have different bioavailabilities amongst the generics which can be clinically relevant, although you may struggle to find significant amounts of definitive evidence to confirm this. This is especially true for those drugs with narrow therapeutic indices, such as Lithium and Theophylline. These differences are more important to acknowledge in primary care, whereas in hospital we can be a lot more cavalier with changing brands & formulations etc since we can keep an eye on the patient and monitor drug levels if necessary.

Also, remember that some brands of the same drug have different licensed indications e.g. Subutex is for opioid substitution whereas Temgesic is for pain relief (both are Buprenorphine 400mcg sublingual tablets).

Kevster

SomeDose wrote: »

I think Kevster was talking about getting different generic brands of the same drug, which would've been prescribed generically to start with. In this case the pharmacist is free to interchange generics where appropriate. Giving a different product from the same drug class is a totally different kettle of fish (e.g. ramipril instead of lisinopril)

Indeed, that's what I was referring to. If my pharmacist gave me an entirely different drug, I'd question him and consult my GP. The drug in question in this case is Olsalazine (Trade name: Dipentum), by the way.

greenwell

SomeDose wrote: »

I think Kevster was talking about getting different generic brands of the same drug, which would've been prescribed generically to start with. In this case the pharmacist is free to interchange generics where appropriate. Giving a different product from the same drug class is a totally different kettle of fish (e.g. ramipril instead of lisinopril).



A generic does not have to show identical bioavailability - it has to show bioequivalence i.e. the same pharmacological effect and efficacy (and safety too). Bioavailability is an important factor in this of course, and the majority of generics will have similar (and often identical) bioavailability to the original. Some of drugs mentioned previously do have different bioavailabilities amongst the generics which can be clinically relevant, although you may struggle to find significant amounts of definitive evidence to confirm this. This is especially true for those drugs with narrow therapeutic indices, such as Lithium and Theophylline. These differences are more important to acknowledge in primary care, whereas in hospital we can be a lot more cavalier with changing brands & formulations etc since we can keep an eye on the patient and monitor drug levels if necessary.

Also, remember that some brands of the same drug have different licensed indications e.g. Subutex is for opioid substitution whereas Temgesic is for pain relief (both are Buprenorphine 400mcg sublingual tablets).

No this is incorrect you need to compute AUC's to show bioequivalence...I know i have filed these with MHRA and IMB...do we need to go into detail here...

generic drugs are same as origionator period, otherwise no licence

safety data is referenced to the origionator when filing for a licence

greenwell

Kevster wrote: »

Indeed, that's what I was referring to. If my pharmacist gave me an entirely different drug, I'd question him and consult my GP. The drug in question in this case is Olsalazine (Trade name: Dipentum), by the way.

one point it is illegal for a Pharmacist to substitute within generic brands without consulting your doctor
however if they have a "good deal" froma particular generic supplier say a 70% discount then they often give you this....but this is illegal

SomeDose

greenwell wrote: »

No this is incorrect you need to compute AUC's to show bioequivalence...I know i have filed these with MHRA and IMB...do we need to go into detail here...

generic drugs are same as origionator period, otherwise no licence

safety data is referenced to the origionator when filing for a licence

greenwell, if you have indeed been involved in filing generic licence applications then you will know that a generic does not have to show identical bioavailability to the original. I know all about AUCs and Cmax too. To prove bioequivalence, these pharmacokinetic values of the generic must be within 80-125% of those of the original i.e. have a 90% CI. If you can provide any regulatory documents from the IMB, MHRA, FDA or EMEA that says otherwise, I'd be interested to read it.

In practice, this means that most generics will have very similar or the same bioavailability to the brand, but by definition some will fall outside the CI. This is not usually clinically significant, but for certain drugs (like anti-epileptics with narrow therapeutic indices) there will be instances where such variations can manifest either as sub-therapeutic doses or toxicity. Hence why it is good clinical practice to maintain the patient on the same brand of drug.

greenwell wrote: »

one point it is illegal for a Pharmacist to substitute within generic brands without consulting your doctor
however if they have a "good deal" froma particular generic supplier say a 70% discount then they often give you this....but this is illegal

I think we've already established the issue here...if "Olsalazine capsules" was written on the prescription then the pharmacist is perfectly entitled to give the patient whatever olsalazine capsules they happen to have in stock (be it a brand or any generic).

Soapy Joe

Yes, as a pharmacist I will back up what SameDose is saying. If a prescription is written generically - as all doctors are encouraged to do (with the exception of Lithium/Nifed and a few others as mentioned above) - then the pharmacist can dispense any of a number of generics. Ireland has a very low rate of generic prescribing though.

I am also with SameDose on the otehr issue - bioequivalence has to be proved.

Odysseus

SomeDose wrote: »

Also, remember that some brands of the same drug have different licensed indications e.g. Subutex is for opioid substitution whereas Temgesic is for pain relief (both are Buprenorphine 400mcg sublingual tablets).

Out of interest are Temgesic still available in Ireland? I haven't heard of themi n years. The last time I looked a at Mimms apart form Subutex the only other buprenorphine products I seen where in patchs.

SomeDose

Odysseus wrote: »

Out of interest are Temgesic still available in Ireland? I haven't heard of themi n years. The last time I looked a at Mimms apart form Subutex the only other buprenorphine products I seen where in patchs.

Don't know to be honest, I work in the UK and they're still kicking about here.
We keep some in the hospital although they're seldom used now.

Soapy Joe

Temgesic are no longer licensed in Ireland. But they are still available in a patient named basis via the UK - that is for a specific patient if thought necessary. That said, I have not seen them for a few years now.