Monday, December 22, 2014

What is a GENERIC Drug?

A recent Twitter post by @PenguinCrystal in response to a blog post of mine stated "Generics aren't always equal," and that as a pharmacist, I should know that. See the original blog post HERE.

Basically my blog post recalls the story of a lady who brought back medication because it said "Endocet" on the label instead of "Oxycodone." The IRONY is that Endocet IS Oxycodone. Further irony occurs because in a lot of areas, the locals PREFER Endocet over the other generics. Finally, even more irony happens when I find out the patient is on Medicaid. Now I can't speak for all Medicaid patients, but the majority of mine are not overflowing in the IQ department, hence the blog post to begin with.

But as the tweet by @PenguinCrystal shows, there is a plethora of uneducated folks out there with a complete misunderstanding of generic medications. So just what is a generic medication? Below I have copied and pasted from the FDA website:

Generic Drugs: Questions and Answers

What are generic drugs?


A generic drug is identical -- or bioequivalent -- to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.

Are generic drugs as effective as brand-name drugs?


Yes. A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used.

FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs.

Not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. But, first, they must test the drug and the FDA must approve it.


Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less; therefore, generic drugs are usually less expensive than brand-name drugs. But, generic drug makers must show that their product performs in the same way as the brand-name drug.

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)
> Be identical in strength, dosage form, and route of administration
> Have the same use indications
> be bioequivalent
> Meet the same batch requirements for identity, strength, purity, and quality

> Be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products

Discussion

Are there some generics out there that are not bioidentical to the name brand? Possibly. If this happens it usually shows up pretty quickly and is usually a manufacturing issue of some kind. Any time there is a question about any drug in the marketplace there is an immediate recall. But the vast majority of generic medications meet or exceed the standards of the brand/trade name.

Do companies actively make less potent medications to cut costs? In the United States or most first world countries, no. But if you're buying a generic from some shady mail order company or an Internet pharmacy based in India? Watch out. That's a different circus and a different monkey.

Millions upon millions of drugs are dispensed every day in thousands of pharmacies. The vast majority of medications have generics made by a multitude of companies. Suppose they really were all in collusion with each other to make less potent medications... the sheer manpower alone to create and maintain such a widespread conspiracy to cover up everything would cost more than the "profit" made from such a conspiracy.

Further suppose generic medications really don't meet the same equivalency as their brand/trade counterparts... then where is the outcry from the brand companies? Why isn't Lipitor suing the generic manufacturers? Or more likely, why aren't they running ads on TV stating "all generics of Lipitor are not equivalent"? The reason WHY you don't see these ads is because they don't have a legal leg to stand on.

So in conclusion, if you're a patient, feel safe using your generic medication and enjoy the money you saved. Yes, it's that simple.

10 comments:

Anonymous said...

For the first 6 months after a generic is available, the first generic company that put in a patent had 6 months exclusive rights to only manufacturer that drug. It is usually a generic company that is owned by the brand company. Which is why we usually see two things. One, that the brand new generic is literally identical to the brand name drug (complete with identical markings, sometimes even displaying the brand name on the tablet), and two, prices for generics normally don't start to drop until after that six month period.

Anonymous said...

I'm one of those 'no, I need the brand name, please' people, but that's because generics that use dyes seem to use a different dye that causes me to have an allergic reaction. The drugs still work, but I'm covered in hives and my eyes swell shut, which kind of defeats the purpose, so I ask for brand.

Mundane Art said...

Hi Crazy,

I would like you to address the fact that the inactive ingredients are different in various generic and medications and thus there are legitimate occasions where one brand (be it original or generic) is medically necessary over another.

This will sound absurd, but I would get physically ill from Tri-Nessa (generic ortho tri cyclen) but be completely okay taking Tri-sprintec. We couldn't figure out why but the result was so clear. I didn't catch once that I got tri-nessa instead and took it once again, got physically ill. I didn't need brand, just a different generic.

Likewise, there are issues for people with food allergies that differ among generics. Dyes, fillers with gluten or fillers with dairy.

I also know someone that ended up in the ER after an allergic reaction to a generic inhaler. There was a different formulation in the propellant (not the medicine) that caused this near fatal trip.

I'm all for generics. I love the cost savings. But please don't paint everyone that has to request a specific brand as crazy or stupid.

Anonymous said...

Remember the good old days when pharmaceutical companies didn't advertise their products to the great unwashed masses? Nowadays, drugs are marketed like anything else and people automatically equate cost with quality; and as you noted, if you get your generic pharmaceuticals from Dr. Feelgood's Bargain Bazaar website, caveat emptor.

Mary said...

I use several generics, but for my medication patch, I need brand only...it's the difference in the adhesives that causes the problem in some generics. The pharmacy can't predict which generic they will have si it's brand only or I get a major skin reaction. I suspect mant "brand only" people have similar intolerances to a non "active" ingredient.

Anonymous said...

I'm a big believer in saving money. I take generics when they're available for all of my meds but one: lithium. There's a huge difference between Lithobid and generic lithium. One is tolerable, the other produces horrible nausea. Only later did I find out that that reaction was common.

People are idiots, and behave badly about generics. But sometimes, there is a difference between brand and generic.

Anonymous said...

I also have to comment that my husband uses a brand only medication, as every generic he has tried (2 or 3 of them) have given him migraine headaches. I know that the active ingredients are identical, and I would love to save a little extra on the cost, but something in the inactive ingredients just doesn't sit well with his system.

Anonymous said...

on my maintenance meds that are not controlled, I can manage with some generics for it, Lamictal. I feel like Mylan Klonopin does nothing for the thunderstorms I take them for and Adderall XR from Actavis isn't quite the same but sometimes it is a matter of different durations or side effects as opposed to much else. I think the controlled medications are easier to tell right off because they have a rapid action. It does feel like that is how it works.

Anonymous said...

as awesome as this blog is, it's time to be truthful to patients about what's actually in (or NOT in) their generic meds. patients are NOT crazy. because it's only when someone has a severe reaction or notices that a certain generic is not working as it 'should', do patients start researching for themselves.
it's EXTREMELY aggravating and condescending when pharmacists and doctors want to pacify patients with BS about how all generics are all the same, and the patient is a PITA looneytoon.
many people DO have sensitivities and allergies to certain fillers, as whiney as that sounds. and although i'll admit it may take a little time for one's body to adjust to the difference in formulas when switched from one brand to another... BUT... it's absolutely TRUE that generics CAN, and DO, legally use UP to 20% LESS active ingredient in their formulas.
c'mon, RxMan, you know this it a fact. i have a bottle in my hand of generic Percocet, which i'll use as an example. this info is not hidden, it's right on the company's websites, fda.gov, nih.gov, etc.

Example: Rhodes Pharma makes a generic for Norco 10/325 (as well as other strengths). the label states 10mg*/325. note the asterisk. asterisks are there for a reason. the pills are manufactured by Purdue Pharma, and distributed by Rhodes... but yet Purdue has no such medication in its catalog, only Rhodes.

this is from: the Rhodes Oxy/Acetaminophen product info page on the FDA website.

you'll see that the 10mg* is actually 8.9637mg of oxycodone. you'll also see that ALL their Norco generics contain about 11% less active ingredient than what they claim to have. what they SHOULD have. and they are NOT the only brand doing this.
should someone file a complaint about this? we can't, because it's legal.

here's a closer pic of the label: Rhodes 10*/325 Oxy/Acetaminophen

so whether they be Medicaid patients or super-sensitive patients or whoever... generics are NOT all the same. and though i agree that more people may react from the differences in the FILLERS (as I am)... the STRENGTH is also INCONSISTENT from one generic to another, and oftentimes it can be enough for a body to notice (as I do)... especially by the honest, chronically ill people who are forced to rely on medication in order to function.

~ Rare Disease Sufferer

Crazy RxMan said...

The asterisk with the 10/325 is not printed on all labels for all generics of Percocet. This could be a local Board of Pharmacy labeling issue in the state where it is manufactured or redistributed.

The 8.9637mg of Oxycodone is what is delivered to your system after something called FIRST PASS METABOLISM (See https://en.wikipedia.org/wiki/First_pass_effect). Once a drug is absorbed in the gut, it first goes to the liver where approximately 11% of the active ingredient is eliminated. This is not "voodoo." It is known.

Have a look at the BRAND package insert for Percocet. This isn't a generic of Percocet. This is the actual brand. It lists the same asterisk and same delivered amount of drug:

http://www.endo.com/File%20Library/Products/Prescribing%20Information/PERCOCET_prescribing_information.html

It is true that some generics can have a difference in the amount of active ingredient before FIRST PASS METABOLISM. The 20% difference you speak of is incorrect. See:

http://www.pharmacytimes.com/contributor/steve-leuck-pharmd/2015/05/how-community-pharmacists-can-debunk-generic-medication-myths