12

Aug

We got a hotshot here

Posted by The *Angriest* Pharmacist as Drug Companies, Education, Hate Mail, Me being a dick, Pharmacy School, Stupid People, Update

So this guy flew off at the mouth in the comments on Circle of Spite by my former accomplice, Lil Laura. Here’s his comment and below that is my rebuttal.

Hey, I think it is important that patients be given the same brand that they have been taking. Its not the same, no matter what you learn in pharmachology school. Studies show that two brands of the same drug can vary as much as 20% in concentration. That is a big deal if your epilepsy dosage is a carefull balance of seizure control and side effects, or if you are taking psychiatric medications whereby flucutating concentrations can lead to mental instability. 20% can be a big deal and patients diserve reliabaility. Taking the same brand may at least lessen the likelyhood of dosage differences or drug release patterns in the case of XR formulations.

You’re right. The *can* differ as much as +/- 20% in AUC and +/- 3% concentration in the plasma per unit time. Here’s what *I* learned in pharmacy school — they don’t. The FDA has reported and actual indexed studies on PubMed (not your commoner WebMD bullshit) saying that most drugs vary in both of the above categories by minuscule amounts.

There are very few exceptions to the rule. For instance, Synthroid doses are measured in micrograms. When dealing with small doses like that, your 0.25% plus or minus could amount to a lot more (or less medicine). My second exception is an allergy to an excipient. Yes, I have taken the time to list out all excipients in a patient’s profile to figure out if an allergy can be attributed to them (or if there’s gelatin hanging around for the vegans). The final one is Comadin. With the weird every other day regimens and the time it takes to stabilize the patient. I don’t want to rock the INR-boat with that one. Just leave well-enough alone.

Are there any more *reasonable* examples?

Is there anyone out there that would be willing to delve into the pharmacokinetics studies on Pubmed and prove me right (or wrong)? I’m basing all my comment above on what I was told in Pharmacokinetics, Biopharmaceutics, Pharmaceutics, et al. I’d be willing to listen to CITED DISSENT, but I will not accept anecdotal bullshit. You come to me with a PubMed ID number or the Title and Author of a statistically and clinically significant randomized control trial — not with, “my 2nd cousin once removed was taking Allegra, then the druggist switched her to fexofenadine and she started sneezuhn and shit…Them generics and worth a lick.”


Dear UK patient,

Your beef is with the Dept of Health, not your local pharmacy. The DoH tell us to supply the cheapest version of a medicine available, unless prescribed by brand name by the doctor (and don’t bet on that continuing forever); assume we did and then pay us only for that.

RING THEM TO SHOUT, DON’T COME HERE AND DO IT. BTW, your taxes will have to go up (if you pay any in the first place…)

I’m guessing something similar applies to insurance in the US… may you should have paid higher premiums?

You will…

Let’s remember that the “brand” name also lives by the 90-110 percent rule. It is not just the big bad generics that may legally fluctuate, but also the expensive brands

I think patient choice is important, if they dont like it, even if the item is entirely the same, they wont take it, and many of them, especially the elderly, will not accept any explanation. My main gripe is that in my pharmacy we supply parrallel imports of brand names. The amount of times I have been told “i dont want this one, it makes me sick, i need the british one”. Firstly, if that is true and some people are made sick by the PI’s, why is NOBODY made sick by the british ones and demanding the italian ones for example. Secondly, most of these are made in the same factory, in the same county by the same damn company! so why wont people beleive me that it is just the packaging that is different, not the product? maybe its the ingredients of the pack that are making people sick? hmm, maybe i should start putting warnings on boxes not to be eaten?

Not to mention that the variance from mfg to mfg is no more than the variance of batch to batch from the same mfg.

But by God, if that generic Darvocet N-100 is white and not _pink_, you might as well flush it down the toilet because it doesn’t work. Woe unto the poor pharmacy intern who ordered the wrong NDC :-P

What has always annoyed me is the assumption that one bottle of brand name …I dunno, let’s say paxil …. will have the exact same pharmacokinetic parameters as the next bottle.

There are two pretty big problems with this assumption that Mr. Brand-Name-Only is completely unable to get his head around.

One is that the brand name manufacturer has perfect 100% lot to lot consistency when making the tablets in the first place. I’m not sure what the standards are but seeing as 100% is an impossible goal, there is an allowance for some variability.

The second assumption is that two random tablets will have degraded the same amount on their journey through time from manufacturing date to their expiry date. Once again I forget the exact tolerances allowed, but there is a fair bit of leeway there. A 20mg tablet is allowed to come from the factory containing a little bit more than 20mg of paroxetine and then by the time it reaches the expiry date will probably contain a little less than 20mg of med. Oh, what’s that Mr Brand-Name-Only, you thought pills came from a magical place where they are 100% fine the day they are made and then they just go poof into uselessness on their expiry date. Yeah, that’s right. Make sure you don’t park your magical pumpkin chariot in the handicap space.

So, anyways, to me I’ve always figured that you’re just as likely to experience a difference in drug delivery getting your prescription filled from a different bottle of the same brand as you are getting it filled with a certified generic equivalent.

The only medications I was ever taught it was important to maintain the patient on the same brands were anti-epileptics like Tegretol or Lamictal because the bioavailability of these can vary NOT the concentrations of the drugs. And seeing as how generics and brand are identical in all but packaging and appearance in a lot of cases I don’t see how you can be allergic to the generic but not the more expensive branded product….unless you can have an allergy to PACKAGING APPEARANCE!!!!!!!!! Fucking morons

The exicipients differ in every Brand to Generic switch. For instance Allegra 180mg by Sanofi-Aventis lists the following excipients:
Croscarmellose Sodium, Ferric Oxide, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene, Polyethylene Glycol, Povidone, Pregelatinized Starch, Silicon Dioxide, Titanium Dioxide

Fexofenadine 180mg by Dr. Reddy’s lists: Corn Starch, Croscarmellose Sodium, FD&C Red No. 40, Ferric Oxide, Hypromellose 2910, Magnesium Stearate, Mannitol, Polyethylene Glycol 400, Powdered , Silicon Dioxide (Colloidal), Titanium Dioxide

So, someone could be allergic to FD&C Red No. 40 and therefore be allergic to the generic and not the brand.

hi. just popped by. funny how people read what was published ages ago, and think that you’d automatically forget what you wrote…

thanks angriest jedi
i’m still around…. :)

ps to the cited asshole-I have epiliepsy. I know that usually consultants recommend that you stick to the brand…but then they listen to the brand reps, don’t they….
unless you can accurately predict the metabolism of a drug per individual person i think that the argument doesn’t hold water. i deal out what is allowed by the local nhs board, and if the patient doesn’t agree. they
can pay for it privately. Same rule applies for parallel imports-how do you know you aren’t being screwed there and a generic is put in the box instead? (what a loser).

Mary Augustine says August 13th, 2008 at 3:56 pm

Angriest,

Feel free to amend details PRN -longwinded. Here are 2 references omto issue of bioequivalence vs. tx of phenytoin (PHE) (and carbamazepine CBZ): Epilepsia, 35(3):65 & 660, 1994 Raven Press Ltd, NY, and Anderson GD, Pharmacokinetic, pharmacodynamic, and pharmacogenetic targeted tx of AEDs. Ther Drug Monit. 2008 Apr;30(2):173-80.

I’m sure other more recent substantial research studies published, but grabbed the 1st off internet mainly to relate recent anecdotewhen I filled in at sml mental hospl.

Here, in Mideast US can’t get enough psych MDs to see pts in State institutions, never mind staffing other facilities. Previous locum tenens MD was ~ 90 yrs old, -> aren’t many RPh in mental health either.

I’m checking orders for new admit. I recognize name of pt from 15 yrs ago when I worked hosp out-pt. This guy came in regularly in ER -> over to pharmacy (ruckus ensued). (One time he stopped me downtown as if he knew me. I figured I = goner if he recognized me. The asst tells me when he worked UPS, this guy answered his door buck naked for his daily pkgs.)

Anyway pt admitted - worsening psychosis on daily 900 mg Clozaril® and 400 mg PHE, plus fluoxetine, amantadine, etc. Whew! With regard to PHE & protein binding I recall he was kinda scrawny (unpredictable dietary intake). Starting dose of clozapine is 12.5 mg BID gradually upping daily to target 300-450 mg daily.) So, pt comes in from admit month ago on same doses of meds at disch.

PHE & Michaelis Mentin kinetics are well described in school (i.e. sm dose change = possible big tx effect). Clozapine distribution sites include protein binding 97% (Prod Info Clozaril®, 2000; Fazaclo™, 2003) and RBCs, with extensive metabolism via extensive extrahepatic presystemic routes (Cheng et al, 1988; Prod Info Clozaril®, 2002p; Ayd, 1974b; Stock et al, 1977). Average hepatic extraction ratio is 0.2 (Cheng et al, 1988), and CYP-450 metabolism of parent compound to major metabolites desmethylclozapine (CYP1A2/ CYP3A4) and clozapine N-oxide (CYP3A4) (Eiermann et al, 1997; Jerling et al, 1997) & further metabolized to unstable toxic compound (hemopoietic precursors of myeloid/erythroid lineages) (Guitton et al, 1998; Gerson et al, 1994a). [Current edition of Micromedex]

Doc wants to up clozapine to 1 g/day; I’m concerned max daily clozapine dose is exceeded. PHE ia with clozapine noted = moderate effect, lowering clozapine (CYP450), PHE autoinduction, + ? albumin binding.

And, I’m thinking…if this pt was taking both brand name drugs—? prediction of psychosis control…or maybe ? consider other AED? But not CBZ (autoinduction). But, generic PHE & clozapine are significantly less costly than brand name. What’s the trade-off? 50 yrs ago he’d have been incarcerated in a mental ward costing State, at home on generics he’s getting worse… . Guess it doesn’t specifically speak to details of PHE equivalency of generics, but maybe suggests I should be grateful pt can afford meds. Or, maybe all the anecdote does is point to issues of minutiae to argue one way or the other.

Mary Augustine

I know some brands and generics vary in their excipients but i’ve had people claim that one generic makes them throw up but another generic doesn’t and when you check the excipients listed they are identical.
Most of the differences are in colourings added and binders and fillers and not the active itself so I was always taught the effectiveness shouldn’t vary with any sort of relevance, unless the bioavailability is adversely affected or highly variable as is reported with drugs like phenytoin.
I’ve had people tell me their temazepam doesn’t work as well because it didn’t come from a blister pack but a 500 tablet bottle…same generic company and everything. I’ve also come across the PI problem cos it’s “cheap and doesn’t work as well as the British version”. They don’t realise it was made in the UK shipped to Italy or wherever, repackaged, imported back to the UK, repackaged again and dispensed.

I have no problem with someone being allergic to a particular excipient. It’s when the patient comes to the counter and you ask their allergies and they declare “I’m allergic to all generics” that I’ve got issues.

While there are lot’s of times when the excipients are different from one brand to the other, there are times when there’s literally zero difference.

One of the drugs I’d always get reluctance on brand to generic switches was Percocet. The generic we used was made by the same company (bristol-myers squbb) with identical excipients and yet it still didn’t work as well for Mr Brand-Name-Only. Best bet is that it’s just a little harder to sell the generic across town.

Most of my experience with people who have a problem with a generic it’s because of complete ignorance, specific misinformation, or some ill-concieved desire to “get the most out of my drug plan that I can”. It’s the rare patient who comes in with a true allergy to F,D&C # 7 and would like me to work around that.

You can bet your ass that if a controlled drug wants brand name (like Vicodeen or Percocets) it is because people will recognize the brand name easier and pay for it. Some many generics are available, someone could sell you ibuprofen and tell you it is Vicoprofen. Gotsta make that skrilla…

we have our fair share of picky old people. i actually had one lady DEMAND that we order in the “round purple” zolpidem tartrate instead of the white oblong ones, because she couldn’t swallow the white ones. (mind you, they’re smaller than a tic-tac) since my owner is too soft, we complied. when she called in for a refill, we found that the mfr was out of her special purple pills. we put in a backorder request and she waited probably about 2 weeks for those stupid things. when she finally came in asking where it was, i told her that we still couldn’t get them, but we DID have the white ones she detested. she couldn’t remember ever telling me such a thing. when i pulled the bottle and showed her what the white pills looked like, she looked at me and said “well i’m sure i can swallow those.” agh!!!
the only other people who are ADAMANT about getting brand name are the oxycontin-seekers. oxycodone is the equivalent of dirt in their opinion. i’ve never met so many people who have an allergic reaction to generic oxycontin.
these are just 2 of the innumerable reasons why i hate when people try to tell me why they need brand/a specific generic brand.
i can understand if you actually DO have a reaction to the fillers in a generic, i myself had it happen with generic accutane many years ago. however, instead of DEMANDING that my pharmacy stock a ridiculously expensive drug, i simply asked my doctor to find something else for me. so, mr. brand name (have i seen you before in my pharmacy? you sound like some of my oxy patients), please remove your head from your rear asap.

No Drugs For You says August 15th, 2008 at 3:08 am

Most of my DAW2’s are those who had a bad reaction to a generic medication and decided not to mess with any generics. It’s silly, but since most of these people are rich and willing to pay the high copay what do I care. It’s the “same” medication, so from the pharmacist’s point of view, they are getting what they need.

What really upset me are those DAW2’s that can all of the sudden tolerate the generics because the particular brand med they are taking go from $25 copay to $50 copay. I didn’t know that allergy can be dependent upon the copay amount. Perhaps pharmacy school should include that in their curriculum because I sure as hell didn’t learn that. I wonder if getting the brand make them somehow superior to those who are taking mere “generics.”

I work for a large chain; therefore I have the luxury of ordering every generic/brand the customer ask for. What they don’t know is sometimes I told them I need to order it when a bottle of 100-ct is sitting on the shelf (only if I determine that they still have a few pills left). If they have no problem making my life difficult, then I have no problem making them make another trip to pick up their med.

I consider myself lucky. Most of the time, not only are my customers ok with my stupid compnay switching generics every quarter (sometimes more often), many of them are willing to help me by taking the leftover of the old generic off my hands. These customers have and will always receive nothing but the best service from the entire pharmacy staff. Sorry, but we do not treat everyone the same. We treat them as they treat us. I believe that is the fair way to provide customer service (don’t tell my boss, she’ll have a heart attack).

“You’re damned if you do, your’re damned if you don’t”. You have to laugh at them. Appeased easily by brand-yet they would rather go to an outlet store to buy a knock-off gucci bag than spend hundreds on the real thing! Generics aren”t like the seconds that names sell for cheap because they could fall apart because of inferior quality-they undergo the same trials as their branded counterparts. I decided to ask a customer that when they were having a rant at me about the generic-was their dkny handbag a knock-off or the genuine thing? They took the generic and left……

To me, the worst offenders of all are the prescribers who put “Brand Name Medically Necessary” on prescriptions for drugs that do not have generic versions available.

I think that every time a pharmacist sees this, we should have to report it, and the prescriber should be fined or otherwise punished. It’s fraud folks, plain and simple.

I could say the same thing about prescribers writing “Brand Name Medically Necessary” when the patient has never taken the generic.

Pharmacist Eddie says August 23rd, 2008 at 11:01 pm

Didn’t Canada switch the entire country to generic warfarin per federal funded health care and pull it off without a hitch.

Didn’t brand Synthroid get pulled of the market due to stability issues a few years ago. None of the generics had any problems.

Who else has the generic Protonix that is the same company putting brand name in the bottles?

As others have said, the variance between brand and generic is about the same as the brand batch to batch.

pharmacyintern 2010 says August 28th, 2008 at 11:55 pm

I loved the patient that came into a store I was working at a couple of years ago with a script for vicodin. The patient started throwing a fit when he was checking out and paying for the script when he checked the pills and found out they were not brand and were not made by Watson. He was demanding we fill the script “properly” with either the brand vicodin or the watson generic. I guess they are worth more on the street that way. I guess I was right as I see he got busted for selling prescription drugs a couple of months later.

pharmacyintern 2010 says August 29th, 2008 at 12:00 am

I’ve seen some brands exist for meds that for the most part are not even available as brand in retail. A good example of this would be PFIZERPEN, but that’s a big bottle of IV penicillin for IV admixture or infusion use.

Eddie-
ha! i love that protonix! we had someone DEMAND brand name protonix. not only did we not have it stocked, but we were getting paid about $100 too few by the insurance. so we filled it with the generic. patient couldn’t tell the difference. neither could we when we first saw it.

I was actually looking for a scrip gc coupon and came across this posting, and speaking from experience, yes it can make a differance. Look at how people are so sensitive to drugs like paxil, effexor. People weening off often count beeds, or have to use the liquid form. The differance in active binding ingredient does matter.
http://www.msnbc.msn.com/id/21142869/
“Within the first two hours, 8 percent of the original Wellbutrin had dissolved, compared with 34 percent of the Teva product, according to Cooperman. By 16 hours, both drugs had released all the medicine.”
What if one generic brand your taking goes the full 20% in the (-) direction, then another generic manufacturer goes the full %20 in the (+) direction. That could actually be a 40% change for the patient, and that is huge. Unless you have experienced withdraw symptoms with antidepresents, you cant understand how imprtant this is to know. Patients could experience side effects from the differance, and a doc gives them another scrip to treat a problem, and that can be a chain effect. The result is a person could be loaded with scrips, when really the problem, shaking, crying spells, etc. could have been possibly fixed knowing manufacture differance.

That same difference applies to different batches from the same manufacturer — even of the name brand product. I don’t trust anything produced by a major news outlet. I could not imagine using this as a source for a reputable paper and therefore won’t allow it to hold any bearing on my website. MSN? Are you fucking kidding me? Let’s ask Fox News what they think — maybe the NoSpin Zone would like to blame Barack Obama for these inconsistencies.

when discussing the beeds, liquid form above, my point was how a small differance in medication does matter.

Yes, and I was explaining why your argument is stupid, easily refuted, and pointless since your reference was MSN…

Also in my opinion, I have said this for a few years, I believe not disclosing this is a legal problem. Pharmacies have signs “generic eaquivalent” and such with no (*). The signs should, with a note stating the FDA requirements. IMO this is deceptive advertisement.

You’re an idiot. In the 20’s pharmacies weren’t allowed to tell patients what was in the bottle or answer questions about it. People didn’t mind that either. What’s new?

If we listed the FDA requirements, we’d spend an hour explaining what AUC and Cp actually meant to patients with less than a HS equivalency. How much good would your little ‘rider’ do then? It’d add more pressure to pharmacists and technicians (who don’t even know what that shit means). It’s a waste of time and you’re a fool for thinking that is deceptive advertising. Should we begin explaining the indepth Mechanism of Action of every drug to patients? They deserve to know right? Otherwise it’s deceptive advertising — For High blood pressure is not the same as explaining the intricacies of Beta Blockade and why Atenolol is better than Propranolol in patients with asthma as well. Try explaining that one…otherwise, it’s false advertising…right?

Deceptive advertisement? Fuck that — you ever hear of Enzyte? I hear that it makes your special parts longer. That’s the beauty of it — pharmacists are there to explain these deceptions…within reason. Your suggestion is NOT within reason or close to sane.

A current civil lawsuit alleges Enzyte does not work as advertised.[1] Despite manufacturer claims that Enzyte will increase penis size, girth, firmness, and improve sexual performance, there exists no scientific evidence that Enzyte is capable of these claims. In fact, Enzyte has never been scientifically tested by the FDA, or other independent third party. [2] Accordingly, Enzyte is required by current US law to be marketed as an herbal supplement, and may not legally be called a drug. In keeping with FTC rulings, Enzyte is not allowed to claim these benefits in its advertising. However, as of August 2008, TV commercials for the product still use the phrase “natural male enhancement.”

your comparison is “NOT within reason or close to sane”.

What’s your point with this cut and paste? That you are the most retarded person browsing the internet? My comment was that pharmacists are there to make sense of all the vague and stupid advertising with knowledge of how drugs work and via reading journals and literature…not pasted in from Google. We all know that Enzyte’s bossman is going to prison. We know they got sued and their product doesn’t do a fucking thing. What’s your point? Mine was that if someone asked a pharmacist before buying this product, they’d save 20 bucks.

“Bioequivalence and therapeutic effectiveness are not necessarily the same,” wrote neuropsychiatrist Dr. Giuseppe Borgheini in a 2004 article published in the journal Clinical Therapy. Borgheini reviewed medical literature documenting differences in the effects of generic psychoactive drugs and their brand-name counterparts. In the case of three anti-seizure drugs – phenytoin, carabamazepine and valproic acid (marketed under the commercial names Cerebyx, Tegretol and Felbatol, respectively), studies found that generic formulations either failed to release the correct dose to patients’ bloodstreams or eventuated in higher rates of “breakthrough seizures.”

Once again, you fucking ignorant asshole — you didn’t list the source directly and this is one of the instances when you probably don’t switch from brand to generic…but, if you stabilize on a consistent brand, what the fuck is the difference? Dr. Giuseppe analyzed brand to generic, I bet he didn’t touch generic to generic….Please stop posting.

You can’t win.

The American Association of Clinical Endocrinologists, the Endocrine Society and the American Thyroid Association joined voices in 2004 to warn that patients with hypothyroidism could be harmed by switching among the many generics used to treat the condition. And physicians who care for organ transplant recipients have opposed generic substitution of immunosupressant drugs for their patients without a transplant specialist’s prior approval. Societies that represent these doctors have been active in seeking state laws that would limit such switches.

And those are two of the instances which approve of sticking with what you start with — brand name or generic….but, you’re still retarded for pasting something in here and not listing the source or URL. I even put those instances in the fucking post, twit!

We practice Evidence Based Medicine in America, and you are giving us Google Based Medicine…which, while convenient, is actually stupid and dangerous.

About the 20% thing. I dont think it is really +/-20% but a 20% range, so 90%-110% of the brand name. At least thats the way I understood it.

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