After nearly dying from confusion, a pharmacist filled my prescription once again with a generic.

[bluesmail]

My doctor told me the pharmacists get paid more for pushing the generics over the brand. Why Not? Generics aren't under the same FDA laws as brands. I have noticed a difference in the generic over the brand name. In nearly every prescription drug I've been prescribed. :mad:

[northoftheborder]

1. Is this true, that generics are not under FDA regulation?

[MyrnaLoy]

3. No

it is not true. Also, generics are chemically identical to the name brand.

[PoliticAverse]

10. That isn't necessarily true...

Although they contain the same 'active ingredient' as the name brand they may
contain different 'inactive ingredients'.

Note from the FDA's page on generics: http://www.fda.gov/drugs/resourcesforyou/consumers/questionsanswers/ucm100100.htm

What standards do generic drugs have to meet?

Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards
as the innovator drug. To gain FDA approval, a generic drug must:

contain the same active ingredients as the innovator drug(inactive ingredients may vary)
...

[bananas]

13. "The FDA's use of the word identical is very much a legal interpretation, and is not literal."

"The FDA's use of the word identical is very much a legal interpretation, and is not literal." ...
"Bioequivalence, however, does not mean that generic drugs must be exactly the same (“pharmaceutical equivalent”) as their innovator product counterparts, as chemical differences may exist (different salt or ester – a “pharmaceutical alternative”)."

http://en.wikipedia.org/wiki/Generic_drug

<snip>

According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use.<3> The FDA's use of the word identical is very much a legal interpretation, and is not literal.

<snip>

Bioequivalence, however, does not mean that generic drugs must be exactly the same (“pharmaceutical equivalent”) as their innovator product counterparts, as chemical differences may exist (different salt or ester – a “pharmaceutical alternative”).

A physician survey in the US found that only 17% of prescribing physicians correctly identified the USFDA's standards for bioequivalency of generic drugs.<30> A latest development to address this issue enables interested doctors and consumers to check generic drug interactions and outcomes detail to the specific drug and drug company.<31>

The generic equivalent of name-brand warfarin has only been available under the trade name Coumadin in North America until recently. Warfarin (either under the trade name or the generic equivalent) has a narrow therapeutic window and requires frequent blood tests to make sure patients do not have a subtherapeutic or a toxic level. A study performed in the Canadian province of Ontario showed that replacing Coumadin with generic warfarin was safe.<32> In spite of the study, many physicians are not comfortable with their patients taking the branded generic equivalents.<33> In some countries (for example, Australia) where a drug is prescribed under more than one brand name, doctors may choose not to allow the pharmacist to substitute a different brand than prescribed unless the consumer requests a generic brand.<34>

<snip>

[PoliticAverse]

14. Note that the bioavilability of a generic equivalent can vary by as much as 20%....

from that of the name-brand drug:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm

[bananas]

11. Different manufacturing processes may cause differences in pharmacological action.

http://www.elmhurst.edu/~chm/vchembook/650drugs.html

In most cases, a drug bearing a generic name is equivalent to the same drug with a brand name. However, this equivalency is not always true. Although drugs are chemically equivalent, different manufacturing processes may cause differences in pharmacological action. Several differences may be crystal size or form, isomers, crystal hydration, purity-(type and number of impurities), vehicles, binders, coatings, dissolution rate, and storage stability.

[Commie Pinko Dirtbag]

2. ''Generics aren't under the same FDA laws as brands.''

Really? Sources?

In my experience, it's the opposite. Doctors get paid for pushing the brand over the generics.

Two molecules of substance X are the same.

[MyrnaLoy]

4. No one gets paid

for pushing generics, it's against the law. Has been for years.

[Commie Pinko Dirtbag]

5. Yup. I feel a strong smell of artificial grass. -nt

[hedgehog]

9. Here's the deal - the active ingredient may be the same, but the

inert ingredient may not be. Maybe for a given patient, the name brand dissolves in the stomach and the generic does not.

Another possibility: the name brand has tighter manufacturing control so each pill is +/- 0.001% of the stated dose, while the generic is =/- 1%.

[ET Awful]

12. As someone who works for an FDA regulated company and who has to comply

with FDA regulations on a daily basis, I can tell you with 100% certainty that your =/1% cite is complete hogwash.

Any company that produced a product with that large of a variance would end up first with getting a list of findings (known as a 483). After which, if the situation was not corrected, they would receive a Warning Letter and if still not corrected, would probably be held under a Consent Decree (which includes fines, halts in production, court actions, etc.).

A generic pharmaceutical is required by law to carry the exact dosage of the active ingredient. The manufacturing variance is NOT something that is permitted to vary from manufacturer to manufacturer.

[hedgehog]

16. I apologize for my numbers, but I think the principle of tighter control applies.

It's all a matter of how exact is exact. All manufacturers are required to be within a certain dose =/- range, but any manufacturer may choose to adhere to a tighter control.

[ET Awful]

18. You'd need a better understanding of the manufacturing process to understand how wrong you are.

If you're following cGMP (Current Good Manufacturing Process), your dose will be exactly the same as any other company who is correctly following cGMP.

I won't bother trying to educate you further.

[HuckleB]

30. It's not that simple.

Raises questions about whether some generic products are safe and effective when a narrow dose range separates patients from help and harm.

Read more: http://www.disabled-world.com/health/neurology/epilepsy/dosage.php#ixzz1RLwSh5FP


Raises questions about whether some generic products are safe and effective when a narrow dose range separates patients from help and harm.

Read more: http://www.disabled-world.com/health/neurology/epilepsy/dosage.php#ixzz1RLwSh5FP

[hedgehog]

6. In New York, the practice is to give the generic unless the

DAW (dispense as written) box is checked.

My pharmacist says most generics are OK for most people most of the time. He does have various customers who have found that some prescriptions need to be filled with the name brand.

[RC]

7. You are wrong

Generics must have the same active ingredients, in the same amounts.

Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.
http://www.medicinenet.com/script/main/art.asp?articlekey=46204

[bananas]

15. "The FDA's use of the word identical is very much a legal interpretation, and is not literal." ...

"The FDA's use of the word identical is very much a legal interpretation, and is not literal." ...
"Bioequivalence, however, does not mean that generic drugs must be exactly the same (“pharmaceutical equivalent”) as their innovator product counterparts, as chemical differences may exist (different salt or ester – a “pharmaceutical alternative”)."

http://en.wikipedia.org/wiki/Generic_drug

<snip>

According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use.<3> The FDA's use of the word identical is very much a legal interpretation, and is not literal.

<snip>

Bioequivalence, however, does not mean that generic drugs must be exactly the same (“pharmaceutical equivalent”) as their innovator product counterparts, as chemical differences may exist (different salt or ester – a “pharmaceutical alternative”).

A physician survey in the US found that only 17% of prescribing physicians correctly identified the USFDA's standards for bioequivalency of generic drugs.<30> A latest development to address this issue enables interested doctors and consumers to check generic drug interactions and outcomes detail to the specific drug and drug company.<31>

The generic equivalent of name-brand warfarin has only been available under the trade name Coumadin in North America until recently. Warfarin (either under the trade name or the generic equivalent) has a narrow therapeutic window and requires frequent blood tests to make sure patients do not have a subtherapeutic or a toxic level. A study performed in the Canadian province of Ontario showed that replacing Coumadin with generic warfarin was safe.<32> In spite of the study, many physicians are not comfortable with their patients taking the branded generic equivalents.<33> In some countries (for example, Australia) where a drug is prescribed under more than one brand name, doctors may choose not to allow the pharmacist to substitute a different brand than prescribed unless the consumer requests a generic brand.<34>

<snip>

[HuckleB]

28. However...

http://www.disabled-world.com/health/neurology/epilepsy/dosage.php

[HuckleB]

29. Generic Substitution for Psychotropic Drugs: Questions and Answers

http://www.cnsspectrums.com/aspx/articledetail.aspx?articleid=2335

[Incitatus]

8. pharmacists get paid more for pushing the generics over the brand.

Yes, I believe this because your insurance company would rather pay for generics. I thought they were exactly the same.

You can tell your pharmacist that you will do your business elsewhere if he doesn't give you want, but I think some insurance companies will only pay for generics in some cases, I'm not sure.

[blue neen]

17. Actually, there are some generics that pharmactists don't make any money on at all.

For instance, a grocery store chain in the Pittsburgh area offers certain generic antibiotics for free. This has the desired effect of bringing new customers into the grocery store where they are likely to spend more money than they would have on the cheap script.

Pharmacists don't really get paid more for "pushing" anything. It's the insurance companies that set the reimbursement rates.

If your doctor wants you to have a brand name medication rather than a generic, he/she can specify that on the prescription. You may have to fight your insurance company to get them to cover it, though.

[HuckleB]

19. Call me crazy, but this OP seems to be nothing but fictional flame bait.

:crazy:

[MyrnaLoy]

20. yup

it is

[gkhouston]

21. Agreed. I will say that I'm currently taking two generics that I prefer

to their name brand counterparts. One generic flat out works better and the other works as well but lacks some side effects the name brand drug has. Everybody's body chemistry is so individualized that you never truly know how a drug's going to work for you until you try it. One of the generics I'm on is a generic brand many patients dislike because they find it ineffective compared to the name brand, yet it works for me. Comically enough, there's a more expensive generic for this same drug which also works for me, but has side effects. It's the cheapest version of this drug which actually works "the best", to my surprise.

[bluesmail]

22. I take offense at that comment, since it was unintentional "flame baiting"

had to look it up for the meaning.

[HuckleB]

25. I don't buy it.

[Commie Pinko Dirtbag]

23. I can see a doctor spreading this bullshit to cover the fact that it's the other side that does it.

Incestuous relationship between Big Pharma and some easily-bribed doctors are well-known.

[HuckleB]

24. I don't see that as very likely.

[Commie Pinko Dirtbag]

26. Check this out:

http://www.google.com.br/search?q=big+pharma+paying+doctors&ie=utf-8&oe=utf-8&aq=t&rls=org.mozilla:en-US:official&client=firefox-a

Some results:
http://www2.nbc4i.com/news/2011/feb/07/10/monday-6-pm-how-much-big-pharma-paying-your-doctor-ar-385701/
http://www.healthiertalk.com/big-pharma-paying-docs-push-drugs-infographic
http://articles.philly.com/2011-04-01/business/29370673_1_clinical-research-pfizer-payments
http://www.propublica.org/article/lawsuits-say-pharma-illegally-paid-doctors-to-push-their-drugs/single

[HuckleB]

27. I love anecdotes.

If you think most docs do that, then you're living in a fantasy world.

https://www.harvardpilgrim.org/portal/page?_pageid=253,257694&_dad=portal&_schema=PORTAL

[Duer 157099]

31. OK here's a hypothetical

Let's say brand name drug X and generic drug X have the same active ingredient, in the same amounts.

But let's say that they differ in the composition/amount of some inactive ingredient. And let's say that this inactive ingredient is some sort of stabilizer or something, that might prolong shelf life or something.

Might this then result in a difference between brand X and the generic, if the drug is approaching it's shelf life?

Could happen, imho.

[Kennah]

32. I've had this problem with every mail order pharmacy I've used

Wife and I both take maintenance meds, and the doctor has been adamant that my wife not substitute for generic her Synthroid. However, for the 7 or 8 years we've been mail ordering drugs, it's a fight to prevent the pharmacy from substituting. They have outright lied to me at times.

"Your doctor didn't check the DAW (Dispense As Written) box."
"Yes, she did. Do you have the fax you received or a scanned image?"
"Of course we do. I can pull it right up on my computer."
"Good, because I have the prescription that we faxed right here in front of me."
pause
"Oh, I do see it."

I take generic Prilosec (omeprazole) and just recently I've switched to generic Asacol--from Canada, since you can't get it in the U.S.

However, not all generics are created equal. The People's Pharmacy, Joe and Terry Graedon, have written a bit about generics, and much of it is not encouraging.

http://www.peoplespharmacy.com/build/mt-search.cgi?blog_id=1&tag=Generic%20Drugs&limit=20

NTI drugs, like my wife's Synthroid, are a bad thing to gamble with generic.