Generics?

[liambob1]

So I am currently on my industrial placement as part of my pharmacy degree, here In Ireland the plan in the next few years is on the drug payments scheme, long term illness and government prescriptions, pharmacists will automatically dispense the cheaper Irish made generics in order to save the government money on these schemes, and if the customer wants to go with the brand name drug they have to pay the difference themselves. The company I am working for is already trying to switch people over to the generics to the change wont be too sudden however we are encountering a lot of resistance, particularly with older people. What are everybodies thoughts on this? Should people be entitled to have their brand name drugs on the schemes if they say they feel it works better, even if this effect is nothing but the placebo effect?

[CharonY]

One could try an outcome-based approach and see whether there is any potential improvement due to placebo (provided that the brand has higher effect). If the the outcome is sufficiently high, one could consider keeping them in.

[zapatos]

I think this is too complicated an issue to be decided by whether or not they are 'entitled'.

 

What is the impact of the law?

Are funds available?

If additional funds to pay for brand names is raised, will it impact other areas?

Who should make the determination? Doctors? Patients? Governments?

How much of a decrease in drug effectiveness is acceptable?

Is it worth listening to people bitch about it?

How does this affect the politics of those involved?

 

You probably need a method that is sustainable, effective, and delivers maximum benefit with an acceptable amount of downside. After you've done this, you can feel comfortable telling grandma that she just has to live with what she is given.

 

As an aside, my insurance plan insists on first prescribing generics, but then the doctor has the authority to use other brands if the effectiveness of the generic was not acceptable to him.

[Suxamethonium]

*I'm in Australia, so I don't know how much overlap there will be, but here goes..*

 

First and for most, education- Many older people probably don't want to change brands because they have set up some sort of method to identify when to take what. Generics have different packaging to the branded versions and can confuse the patient (particularly if they have both forms at the same time like if they've kept the older, branded medication then double dosing can occur). As such it may be beneficial to offer services that pre-dose which medicines they need to take (e.g. like a Webster-pak). Steps like the latter may also help with patient compliance.

 

Following on from the discussion above, it is also important to explain that generic companies have to prove the generic to be bioequivalent (i.e. the same API, have the same effects, mechanism of action, time of onset etc.) and make clear that it is the same quality drug (not like generic toilet paper which is substandard and scratchy lol). The idea behind generics is simply that the intellectual property is expired, so anyone can manufacture and distribute the drug- which leads to more competitive marketing as companies try to get a piece of the pie. The branded price will also drop by about 90%.

 

In Australia we have the Pharmaceutical Benefits Scheme (PBS) in which the patient pays up to about $35 of any PBS listed medication and the concession rate is $5.80. On some of these medications that are covered a brand fee applies (usually a $1-5 on the meds I've looked up) if the patient decides against a generic. (In reality the scheme is much more complex, but thats the gist/relevant parts of it). So if a patient wants a medication covered by the PBS, they will save a couple of bucks buying the generic. If the drug isn't on the PBS- they pay full price, so the generic saving is usually higher.

 

All in all, I feel that the emphasis should remain on the education side of things- and if people are still dead set on the branded version it's the governments choice whether or not to cover it, or partially cover it. I personally feel it lies outside the governments responsibility- however, as a future (hopefully industrial) pharmacist- I understand that covering the brands would be of interest to the originator company- as less people may change to generics.

 

I hope that was helpful. I'm only new to studying pharmacy, so I hope it makes sense. Also we are in the middle of PBS reform- so things may be changing.

[pantheory]

So I am currently on my industrial placement as part of my pharmacy degree, here In Ireland the plan in the next few years is on the drug payments scheme, long term illness and government prescriptions, pharmacists will automatically dispense the cheaper Irish made generics in order to save the government money on these schemes, and if the customer wants to go with the brand name drug they have to pay the difference themselves. The company I am working for is already trying to switch people over to the generics to the change wont be too sudden however we are encountering a lot of resistance, particularly with older people. What are everybodies thoughts on this? Should people be entitled to have their brand name drugs on the schemes if they say they feel it works better, even if this effect is nothing but the placebo effect?

Of course! If all the info is out there then I think we should let people pay more if in their opinion it works better. I don't think it is an open and shut case either that generics are always the same as branded products . Although the active ingredients may be the same, better processing methods may effect absorption rates, for instance, or inactive ingredients may work as a catalyst for bodily processing. Drug manufacturers that make such claims must show evidence for such claims or they can be sued for false advertising or otherwise stopped from false advertising by the FDA or its counter part in other countries.

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Edited April 10, 2012 by pantheory

[Suxamethonium]

Although the active ingredients may be the same, better processing methods may effect absorption rates, for instance, or inactive ingredients may work as a catalyst for bodily processing.

 

I noticed you mentioned FDA so I am not doubting your statement as I have very limited knowledge of the American system. However, I have been taught that in Australia a generic must be bioequivalent- meaning the same drug must reach the same concentration in the blood in the same amount of time as the branded version within strict variation guidelines. If it is not bioequivalent it cannot be provided as a generic substitution- even if it is based on the same drug.

 

For anyone interested in more detail, this article provides a good summary http://www.australia...azine/26/4/85/7 particularly under the 'bioequivalence' subheading.

Edited April 10, 2012 by Suxamethonium

[ewmon]

I'm not fully acquainted with EMA (Europe's agency that's similar to the US's FDA), but I'm assuming that, like the FDA, they qualify the generics to be the same medicines as the brands. I would say that a letter/announcement from the EMA would help calm concerns about generics. In fact, from what I know, they can run into counterfeit drugs (fakes) when dealing with the brands because there's more call for with them, and more profit to be had. The generics might actually be healthy because they're more likely to getting what they're supposed to be getting.

[pantheory]

I noticed you mentioned FDA so I am not doubting your statement as I have very limited knowledge of the American system. However, I have been taught that in Australia a generic must be bioequivalent- meaning the same drug must reach the same concentration in the blood in the same amount of time as the branded version within strict variation guidelines. If it is not bioequivalent it cannot be provided as a generic substitution- even if it is based on the same drug.

 

For anyone interested in more detail, this article provides a good summary http://www.australia...azine/26/4/85/7 particularly under the 'bioequivalence' subheading.

Only the active ingredients listed must be the same concerning FDA certification of a generic. Manufacturing methods are not normally listed in such patents. Even if the active ingredients are exactly the same, processing methods of manufacturing can alter the rate or percentage of absorption, which often differ amongst individual users. Inactive ingredients can also effect the absorption rate by decreasing sensitivity and side effects for some users, by being more palatable, easier to assimilate, being catalytic by improving the desired effects, acting as a buffer, etc. etc. By not listing an ingredient as being active and by giving it another stipulated function/ purpose, branded drugs can sometimes outperform their generic counter-parts for reasons unknown to all except the manufacturer who may not wish such disclosure.

 

After the patent runs out if generic testings do not yield similar results, the FDA can require further disclosure of the percentages of inactive ingredients as well as manufacturing methods. Such future disclosure possibilities is a condition of their patent. They do not, however, have do reveal manufacturing methods related to drug costs. If the manufacturer has a big winner, they often can figure out how to keep improving their product, maintaining a new patent, and thereby staying a step ahead of their generic competition.

 

The other side of the coin is that generic manufacturers could do the same, but rarely would risk the expenditures because their profits are usually a function of their costs and services rather than their company name being associated with "the best quality." Of course most claims of superiority by brand names are baseless with such claims as "after years of testing no other product works better" (since most generics would work the same )

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Edited April 13, 2012 by pantheory