Brand vs. generic - need some info please

[ajh88]

I have always wondered what the "real" difference is between brand and generic (beyond the obvious stuff). I've been thinking about it more lately because over the weekend my father in law mentioned that he "can't" take generics - they make him sick to his stomach (he says). Then, earlier today on a completely unrelated forum, I see this post:

"I hesitated posting this but a dear friend is expecting her 3rd due to a generic OC. FWIW, an FYI -

Generics can be good but many are unaware of their huge window of efficacy error.

Generics are NOT always the same. In some RX categories, the patient / consumer needs to be VERY VERY careful.

By Federal Law (FDA) generics need ONLY fall between 80% - 125% of the active ingredients bioequivalency. Unlike BRANDed drugs that are REQUIRED to reach 100% in each and every tablet. Generics are not regulated the same way and there is a huge margin of potential error.
That means in terms of birth control, when using a generic you may be getting 100% of what is preventing pregancy -- OR you may be getting ONLY 80% of the active ingredients preventing pregnancy. Thats quite a risk!
Will 80% of the active ingredient(s) be enough to prevent pregnancy?
Having 20% less of some drugs may not make much difference (??!!) but when a life may be created, you would want the assurance of 100% covereage.
I don't know.... what price do you place on preventing pregancy?
http://en.wikipedia.org/wiki/Bioequivalence
(read towards the bottom under bioequivalence)
HTH."

I call BS on this and I looked it up on the FDA website (basically says that brand and generic have equivalent action and contain the same active ingredient). I believe bioequivalency studies are done prior to marketing a generic and the 80-125% acceptance criteria are for that specific study - NOT that there may only be 80% active ingredient in your generic med. I thought the accepted active ingredient ranges were 90-110% or 85-115% depending on the potencey/dose of medication (and I'm sure that 100% is not required anywhere, of anyone). And if a drug isn't efficacious at 85-115% range, it won't be approved (right?).

Anyway, just wondering what people think of the post (in red) and what do you tell people or discuss with them regarding brand name vs. generic drugs.

TIA!

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[bananaface]

I think you are smarter than this other person who has chosen Wikipedia as their reference tool.

 

[firefighter9015]

For a drug to be bioequivalent it must have the same activity. This is one reason why we are being trained to be pharmacist. To be able to call BS on uneducated interpations of information about drugs.

 

[Rumplestiltazepam]

I have always wondered what the "real" difference is between brand and generic (beyond the obvious stuff). I've been thinking about it more lately because over the weekend my father in law mentioned that he "can't" take generics - they make him sick to his stomach (he says). Then, earlier today on a completely unrelated forum, I see this post:

"I hesitated posting this but a dear friend is expecting her 3rd due to a generic OC. FWIW, an FYI -

Generics can be good but many are unaware of their huge window of efficacy error.

Generics are NOT always the same. In some RX categories, the patient / consumer needs to be VERY VERY careful.

By Federal Law (FDA) generics need ONLY fall between 80% - 125% of the active ingredients bioequivalency. Unlike BRANDed drugs that are REQUIRED to reach 100% in each and every tablet. Generics are not regulated the same way and there is a huge margin of potential error.
That means in terms of birth control, when using a generic you may be getting 100% of what is preventing pregancy -- OR you may be getting ONLY 80% of the active ingredients preventing pregnancy. Thats quite a risk!
Will 80% of the active ingredient(s) be enough to prevent pregnancy?
Having 20% less of some drugs may not make much difference (??!!) but when a life may be created, you would want the assurance of 100% covereage.
I don't know.... what price do you place on preventing pregancy?
http://en.wikipedia.org/wiki/Bioequivalence
(read towards the bottom under bioequivalence)
HTH."

I call BS on this and I looked it up on the FDA website (basically says that brand and generic have equivalent action and contain the same active ingredient). I believe bioequivalency studies are done prior to marketing a generic and the 80-125% acceptance criteria are for that specific study - NOT that there may only be 80% active ingredient in your generic med. I thought the accepted active ingredient ranges were 90-110% or 85-115% depending on the potencey/dose of medication (and I'm sure that 100% is not required anywhere, of anyone). And if a drug isn't efficacious at 85-115% range, it won't be approved (right?).

Anyway, just wondering what people think of the post (in red) and what do you tell people or discuss with them regarding brand name vs. generic drugs.

TIA!

Your Father in law can't magically be allergic to all generics, that just doesn't makes any sense. There isn't some special ingredient in all generics. If I heard anyone in my family make that claim I would call them dumb straight out but that is my family...

 

[Knipps]

I think you are smarter than this other person who has chosen Wikipedia as their reference tool.

Totally. Wikipedia is the worst thing someone can quote when trying to prove a point.
To simply restate the point, you're the wiser to know better than the post in red

 

[Quiksilver]

I have always wondered what the "real" difference is between brand and generic (beyond the obvious stuff). I've been thinking about it more lately because over the weekend my father in law mentioned that he "can't" take generics - they make him sick to his stomach (he says). Then, earlier today on a completely unrelated forum, I see this post:

"I hesitated posting this but a dear friend is expecting her 3rd due to a generic OC. FWIW, an FYI -

Generics can be good but many are unaware of their huge window of efficacy error.

Generics are NOT always the same. In some RX categories, the patient / consumer needs to be VERY VERY careful.

By Federal Law (FDA) generics need ONLY fall between 80% - 125% of the active ingredients bioequivalency. Unlike BRANDed drugs that are REQUIRED to reach 100% in each and every tablet. Generics are not regulated the same way and there is a huge margin of potential error.
That means in terms of birth control, when using a generic you may be getting 100% of what is preventing pregancy -- OR you may be getting ONLY 80% of the active ingredients preventing pregnancy. Thats quite a risk!
Will 80% of the active ingredient(s) be enough to prevent pregnancy?
Having 20% less of some drugs may not make much difference (??!!) but when a life may be created, you would want the assurance of 100% covereage.
I don't know.... what price do you place on preventing pregancy?
http://en.wikipedia.org/wiki/Bioequivalence
(read towards the bottom under bioequivalence)
HTH."

I call BS on this and I looked it up on the FDA website (basically says that brand and generic have equivalent action and contain the same active ingredient). I believe bioequivalency studies are done prior to marketing a generic and the 80-125% acceptance criteria are for that specific study - NOT that there may only be 80% active ingredient in your generic med. I thought the accepted active ingredient ranges were 90-110% or 85-115% depending on the potencey/dose of medication (and I'm sure that 100% is not required anywhere, of anyone). And if a drug isn't efficacious at 85-115% range, it won't be approved (right?).

Anyway, just wondering what people think of the post (in red) and what do you tell people or discuss with them regarding brand name vs. generic drugs.

TIA!

brands don't necessarily have 100% of what they say either. Like generics, it falls into a range of acceptability in your product. Although generally generics have to meet a less stringent guidelines. But i think you already know that?

now the techs in my store say they are equivalent, and theres always some patient that says nay. NYS is wonderful in that by law if theres a generic that is AB rated, they get it, unless their is a DAW on it. I am not sure how other states are, but that, at least is my spring board. I will say " unfortunately, according to NYS law, if the doctor does not specifically write for brand name only, I cannot do a thing" I also talk about that like brands, generics have to be FDA approved, and most likely the brand version of the drug will be a more expensive copay, with possibly no benefit compared to the generic...

People don't want to hear about bioequivalence, pharmacology or the concepts of drug delivery design. Economics and law, thats all people care about. Its only after you tell them that they have a 50 dollar copay that they will actually put down their phone to listen to you

 

[b*rizzle]

I have always wondered what the "real" difference is between brand and generic (beyond the obvious stuff). I've been thinking about it more lately because over the weekend my father in law mentioned that he "can't" take generics - they make him sick to his stomach (he says). Then, earlier today on a completely unrelated forum, I see this post:

"I hesitated posting this but a dear friend is expecting her 3rd due to a generic OC. FWIW, an FYI -

Generics can be good but many are unaware of their huge window of efficacy error.

Generics are NOT always the same. In some RX categories, the patient / consumer needs to be VERY VERY careful.

By Federal Law (FDA) generics need ONLY fall between 80% - 125% of the active ingredients bioequivalency. Unlike BRANDed drugs that are REQUIRED to reach 100% in each and every tablet. Generics are not regulated the same way and there is a huge margin of potential error.
That means in terms of birth control, when using a generic you may be getting 100% of what is preventing pregancy -- OR you may be getting ONLY 80% of the active ingredients preventing pregnancy. Thats quite a risk!
Will 80% of the active ingredient(s) be enough to prevent pregnancy?
Having 20% less of some drugs may not make much difference (??!!) but when a life may be created, you would want the assurance of 100% covereage.
I don't know.... what price do you place on preventing pregancy?
http://en.wikipedia.org/wiki/Bioequivalence
(read towards the bottom under bioequivalence)
HTH."

I call BS on this and I looked it up on the FDA website (basically says that brand and generic have equivalent action and contain the same active ingredient). I believe bioequivalency studies are done prior to marketing a generic and the 80-125% acceptance criteria are for that specific study - NOT that there may only be 80% active ingredient in your generic med. I thought the accepted active ingredient ranges were 90-110% or 85-115% depending on the potencey/dose of medication (and I'm sure that 100% is not required anywhere, of anyone). And if a drug isn't efficacious at 85-115% range, it won't be approved (right?).

Anyway, just wondering what people think of the post (in red) and what do you tell people or discuss with them regarding brand name vs. generic drugs.

TIA!

Also consider the following:

Generic drugs that are bioequivalent have to produce the same AUC as the brand name drug. Now ask yourself, could two tablets with the EXACT SAME amount of drug in them produce a different blood level?

Yes. Even if two different tablets have the exact same amount of drug in it, their bioavailability might be different as well (e.g. Lanoxin tabs/caps, generic digoxin). And for NTIs, I believe the generic has to be 95-105% of the brand.

This is what Firefighter already said, but I'll say it again: this is exactly why you will get paid 100k a year to "count pills" -- because you know the difference in what's in them and whether it's a big deal or not. Don't hesitate to call someone out on that.

 

[DuocSi2010]

It is possible that your father in law may be allergic or is unable to tolerate the inactive components in the generic product. But just like everyone has already mentioned, hydrocodone will give you the same constipation problem that Lortab will.

Although I have learned last semester in my administrative class that the oversea companies that make generics do not always follow the good compounding practice. The FDA isn't as strict with the oversea companies as they do with the drug companies in America. Hopefully that problem will be addressed and fixed soon.

In regards to the post you found, the reason that person is pregnant could be due to noncompliance or she's on a low dose OC.

 

[firefighter9015]

brands don't necessarily have 100% of what they say either. Like generics, it falls into a range of acceptability in your product. Although generally generics have to meet a less stringent guidelines. But i think you already know that?

now the techs in my store say they are equivalent, and theres always some patient that says nay. NYS is wonderful in that by law if theres a generic that is AB rated, they get it, unless their is a DAW on it. I am not sure how other states are, but that, at least is my spring board. I will say " unfortunately, according to NYS law, if the doctor does not specifically write for brand name only, I cannot do a thing" I also talk about that like brands, generics have to be FDA approved, and most likely the brand version of the drug will be a more expensive copay, with possibly no benefit compared to the generic...

People don't want to hear about bioequivalence, pharmacology or the concepts of drug delivery design. Economics and law, thats all people care about. Its only after you tell them that they have a 50 dollar copay that they will actually put down their phone to listen to you

The patient can request a DAW in Kentucky. I don't know if that is everywhere or not.

 

[genesis09]

In most pharmacies, if a patient asks for a brand, they will get it. It's not worth fighting it. A small number of people are allergic to dyes. However, I have never heard of anyone being allergic to things like methylcellulose.
A recent study was about the generic vs brand mindset. They gave placebo to patients, and for one group they told them it was an expensive brand drug, and for the other group, said it was a cheap generic drug. Generic placebo had significantly more side effects than brand placebo.

 

[Fenderplayer108]

A recent study was about the generic vs brand mindset. They gave placebo to patients, and for one group they told them it was an expensive brand drug, and for the other group, said it was a cheap generic drug. Generic placebo had significantly more side effects than brand placebo.

Interesting study. Do you have a article name? I would like to read it.

 

[genesis09]

I honestly don't remember the name. I just remember reading about it somewhere.

 

[mike36]

In most pharmacies, if a patient asks for a brand, they will get it. It's not worth fighting it. A small number of people are allergic to dyes. However, I have never heard of anyone being allergic to things like methylcellulose.
A recent study was about the generic vs brand mindset. They gave placebo to patients, and for one group they told them it was an expensive brand drug, and for the other group, said it was a cheap generic drug. Generic placebo had significantly more side effects than brand placebo.

I don't know if this is the same study, but our kinetics professor told us about a study where patients reported higher analgesic effect with brand placebo than with generic placebo. Of course, they were told that the brand cost more than the generic and that they were real drugs.

I'll email him to see if he remembers the source.

 

[SCCpharm]

From my bioequivalence class notes:

"The current FDA guidelines are that two formulations whose rate and extent of absorption differ by -20%/+25% or less are generally considered bioequivalent. "

Issues and Concerns regarding Bioequivalence:
6. Inadequate statistical criteria to evaluate bioequivalency
7. Bioequivalence does not always ensure therapeutic equivalence

From the Orange Book (http://www.fda.gov/cder/orange/obannual.pdf) :

Based on the opinions of FDA medical experts, a difference of greater than 20% for each of the above tests was determined to be significant, and therefore, undesirable for all drug products....The confidence interval for both pharmacokinetic parameters, AUC and Cmax, must be entirely within the 80% to 125% boundaries cited above. Because the mean of the study data lies in the center of the 90% confidence interval, the mean of the data is usually close to 100% (a test/reference ratio of 1).

 

[Pharmavixen]

In my experience, if someone insists on a brand-name opioid or benzodiazepine, they're probably re-selling them.

And if patients think they'll suffer an adverse reaction to a generic, they probably will.

 

[Priapism321]

I don't know if this is the same study, but our kinetics professor told us about a study where patients reported higher analgesic effect with brand placebo than with generic placebo. Of course, they were told that the brand cost more than the generic and that they were real drugs.

I'll email him to see if he remembers the source.

You both are referring to the same study. It was published in JAMA by a group from MIT; I believe it was March 5.

 

[Priapism321]

The patient can request a DAW in Kentucky. I don't know if that is everywhere or not.

They can request whatever they want at any time in most states....who cares? However, upon hearing the price of those brand name drugs that "work so good," is when they for the most part come back down to Earth, and take the "oh so inferior generic piece of **** drug."

 

[miketon907]

Here's an interesting blog article written by a pharmacologist about this issue.
http://scienceblogs.com/terrasig/2008/03/are_generic_drugs_inferior_to.php

 

[Farmercyst]

http://jama.ama-assn.org/cgi/content/full/299/9/1016
for those that have access through school or whatnot

 

[gaba101]

like the rest of the idiotic population, a non-life-threatening adverse drug event is NOT equivalent to a true allergy. Case in point: Red Man Syndrome is NOT a true allergy.

it's so hard to get stupid patients to understand that becoming constipated on your hydrocodone is NOT A FREAKIN ALLERGY!!!!!!!!!!!!!!!!! saves me typing all these drugs into their "allergy list"

 

[PharmDY]

if anyone's been paying attention to drug recalls.. recently Digitek has been pulled off the shelf (Class I) because the bioavailability of the active ingredients was apparently 200% than stated. now i bet digoxin sounds a whole lot better!

also, a lady came in with a huge rash because she demanded she wanted brand only Synthroid, which we've given her. not only did she suffer severe dermatitis to apparently some inactive ingredients in Synthroid, her copay also put a dent in her wallet (yea.. if i remembered correctly, Synthroid was off-formulary and she paid over $100 for #30). and the next time she came in demanding Sandoz's levothyroxine

here's my message: i believe there are some people who can have severe allergies with either an ingredient in a generic or a brand of a few particular drugs, but it's all in the head if someone gets offended by even being offered to use a generic or even the mention of the word (yes, this really happened!!!)

 

[RxWildcat]

Synthroid is a lot cheaper than that, usually $30 or less without insurance.

 

[All4MyDaughter]

Synthroid is a lot cheaper than that, usually $30 or less without insurance.

Yep, even at the highest strength (300 mcg) #30 tablets is only $33.20 (source = lexicomp).

 

[UBCmicrobi]

it's so hard to get stupid patients to understand that becoming constipated on your hydrocodone is NOT A FREAKIN ALLERGY!!!!!!!!!!!!!!!!! saves me typing all these drugs into their "allergy list"[/QUOTE]

Ha ha!!

 

[firefighter9015]

How are we supposed to get patients to understand what a true drug allergy is when other healthcare professionals do not even understand it?