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    Old 10-05-2004, 10:40 AM   #1
    Streetcar
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    Question Generic VS Brand name

    I guess this question is probablly directed at Shoreline, Hello Dave ,

    I got into a discussion with my daughter-in-law who's a pharmacy tech about generic meds that lead me to do some online research regarding generic meds.

    I'm trying to prove my point about the -15% to +10% tolerance the FDA allows for generics and I guess I can't find the right location on the FDA's web site. All I could find was from the preface to the orange book and I'll quote.

    "Therapeutic Equivalents. Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.

    FDA classifies as therapeutically equivalent those products that meet the following general criteria: (1) they are approved as safe and effective; (2) they are pharmaceutical equivalents in that they (a) contain identical amounts of the same active drug ingredient in the same dosage form and route of administration, and (b) meet compendial or other applicable standards of strength, quality, purity, and identity; (3) they are bioequivalent in that (a) they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard; (4) they are adequately labeled; and (5) they are manufactured in compliance with Current Good Manufacturing Practice regulations. The concept of therapeutic equivalence, as used to develop the List, applies only to drug products containing the same active ingredient(s) and does not encompass a comparison of different therapeutic agents used for the same condition (e.g., propoxyphene hydrochloride vs. pentazocine hydrochloride for the treatment of pain). Any drug product in the List repackaged and/or distributed by other than the application holder is considered to be therapeutically equivalent to the application holder's drug product even if the application holder's drug product is single source or coded as non-equivalent (e.g., BN). Also, distributors or repackagers of an application holder's drug product are considered to have the same code as the application holder. Therapeutic equivalence determinations are not made for unapproved, off-label indications.

    FDA considers drug products to be therapeutically equivalent if they meet the criteria outlined above, even though they may differ in certain other characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration date/time and minor aspects of labeling (e.g., the presence of specific pharmacokinetic information) and storage conditions."

    I know that I can tell the diff between Roxicodone and M-Oxy of the same prescribed strength. Can anyone help with this? I don't want to end up with egg on my face, it wouldn't be the first time.

    Thanks and be comfortable.
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    Ken
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    Old 10-05-2004, 01:54 PM   #2
    Shoreline
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    Re: Generic VS Brand name

    Hey Streetcar, This such a common question, perhaps the best way to settle this with your daughter who with even a certified tech program has no clinical knowledge of how these meds work. Have her ask her pharmacist, If he had a heart or kidney transplant would he use generic immune suppressors or heart medications.

    Cardiologist flat out won't prescribe certain drugs in generic forms, due to the differences whatever they are, a transplant doc will not prescribe generic medication to prevent organ rejections.

    If the docs that treat these patient populations and prescribe these meds and read the journals and have been notified of the rejection and death rates from using generics Vs name brand won't prescribe them and the pharmacist knows that, why do they insist on the same BS we hear all the time..

    Poor quality control and allowable variances do make a difference, why do pharmacists, some docs and technicians believe generics are all the same when there are 6 different rating codes for a generic.

    I can't post names or links, But my brother has PhD's in microbiology and immunology, was the FDA liaison and quality control for the special blood products division for the company that made it's name with the invention of aspirin. He personally ran a GCMS on a methadose tab for me and it came back with less than 8.5 mgs of methadone.

    I don't want to insult your daughter or her education, I'm sure she's just trying to comfort you about medication and as every child is looking for their parent to be proud of what they are doing and their knowledge. The fact is, she's wrong. She hasn't taken the medications nor has had the training in chemistry to even explain what stereo chemistry is. Has she read a single medical journal? I hope she doesn't truly believ Oxycontin lasts 12 hours.

    The FDA guidelines are not a couple pages long posted on the Internet. It's thousands of pages of text that she has never seen. I have access to every .gov and .*** link that my brother has. Much more than the averrage bear can access and the allowable variations are there.

    Just think about mass producing a pill that contains say .125mgs of Requip, do she really think a computerized machine can mass produce on such a huge scale without some variations. Does she know what class of drugs Requip is in? But she's an expert on every generic manufacturer that makes the meeds we take. Very humorous. It's OK, I remember being young and wanting to share what I had learned. She needs to keep an open mind, learn from the patients that refuse to take specific generics, learn from docs that write for name only and ask the pharmacist why he would do that and continue her on the job training.

    She's discounting every patients experience and patient reporting is part of the entire medical process. Just because Methadone has a 20-30 hour half life, it doesn't mean you will absolutely get great results with BID dosing. Persoanlly I felt it wear off in 4-5 hours. That's also the standard dosing schedule for acute or hospice dosing. If it doesn't even reach half life untill 24 hours why the need to redose more frequently? Patients are wrong and docs are pharmacy techs are right? This is her chance to learn, not argue about something she has minmal training and experience with.

    Knowledge comes from experience prescribing, patient reporting and experience with the medication. Not something they teach at any Certified tech programs. They don't go page by page through the PDR. They learn how insurance is billed, proper security procedures, DEA rules and regulations. But it certainly doesn't prepair them to have a discussion with the FDA or the CFO of a major pharmacuetical company. How many Pharma companies has she talked too? How many pharma reps?

    She's passing on info taught by her pharmacist that is paid a bonus if the generic scripts exceed the name brand scripts. Her information is wrong.
    Can she explain the difference between Oxycodone Hydrochloride,
    Oxycodone Terephthalate or Hydrocodone HCL and hydrocodone biotartrate.


    An even better way, In which she can see for herself. Have her pick up a name brand bottle of Tylox and compare it to the mellenckrodt version.

    She can also do it with name brand Percodan and generic percodan. They teach her it's the same so they will tell patients it's the same so the pharmacist makes his generic bonus and maintains an enoromous profit margin.

    I just ask my wife what the margin was to maintain their generic bonus, she managed for Rite aid, Eckerds and Revco for 7 years and unless the generic margin to name is 60% or higher they didn't get their bonus on generics which could reach up to $7500 per quater. It was my wifes job to gather that info for corporate headquaters, so off course they push generics, wouldn't you?
    Technician are not to dispense medical or pharmacological advice.

    I called the drug store the other day and ask if they had MS04 in 30 mg pills, she said what's that, what was after having talked to the pharmacist the day before and told she had plenty,The tech she said they didn't carry it. The pharmacy doesn't carry morphine?

    Same thing has happened with methadone, what's that ?. If your daughter has a degree in chemistry, microbiology, or pharmacology I would love to have a chat with her, But she's basicaly spewing the information fed to her by pharmacist to ensure their quarterly bonus.

    The talks I have with nurse practionieers are so rediculous it's amazing. Even docs and dentists really have minimal knowledge of pain management medications. 3 hours of their medical school is devoted to pain management, 3 HOURS A title does not instill knowledge.

    Unfortunately she will pick up the attitudes of the pharmacist she works with. If her pharmacist insist all CP patients are drug addicts , that's a larger and harder battle you have down the road. Nip it in the bud and tell her you will discuss your meds when she becomes a pharmacist, chemist or works for the manufacturer of the meds you take, or when she has actually taken a med you take and found it not inferrior.

    Tell her to ask her pharmacist about the transplant and cardaiac drugs, would he use them himself, and why not if they are all the same.

    Let her research. You won't end up with egg on your face. Nobody works with a 0 margin of error, even the FDA acknowldges this. If a doctor had to have a 100% on every board he took we would have no doctors, same with pharmacy and nursing boards, so what part of these exams did they get wrong and what does it mean to the patients they treat. Kinda scarry you may have a problem the doc, pharmacist or nurse has no knowledge off or is incorrect about. Not that they will admit it. But it sure makes you wonder. LOL
    Take care, Dave

    Last edited by Shoreline; 10-05-2004 at 03:37 PM.

     
    Old 10-06-2004, 10:27 AM   #3
    Streetcar
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    Re: Generic VS Brand name

    Thanks for taking the time to reply to this post Dave!

    The question really came up when I asked her why her pharmacist switched from Roxane to Mallinckrodt as a supplier of generic oxycodone which I had been using. So the matter of Generic bonus is not even a factor in the discussion (one generic vs. another Generic). I wouldn't want her to ask the pharmacist to switch back to Roxane just because Dad prefers them. I wouldn't want her or anyone else for that matter, to base their opinions on something that I tell them that I can't substantiate. I guess she'll learn (hopefully) some of that stuff as she becomes a pharmacist. She's been accepted to both UCSF school of pharmacy and UCONN school of pharmacy. As I previously said I can tell the difference between Generic and Name Brand on some of my scripts, so you don't have to convince me. Also my PM dr writes my Mscontin as "do not substitute" because there is a difference. He even got a little upset with me for asking why no generic substitution.

    I was simply looking to point her towards something a little more authoratative than my opinion.

    Anyway, Thanks again Dave, your time spent on the reply is inded greatly appreaciated.

    Be comfortable
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    Ken
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    Old 10-06-2004, 05:39 PM   #4
    Shoreline
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    Re: Generic VS Brand name

    Congrats for to your daughter , I'm sure your very prioud. She will learn in pharmacy school the rule sand regs of the FDA. It's just like some pharamcist refusing to do partials on C=-2, It is legal, just means they hve to follow up andleave their books opon untill it's complete which many are not comfortable with.

    You might want to expallin some of thepooor treatment PM patients receive from pahramcist and guide gher to a more comapsionate road.

    As far as deciding to carry one generic or another. Large chains have product line agreements, another reason why roxanne is harder to fnd is because Mallinckrost is gong to make sure they can fullfill their agreements with the higher paying retailers tbefore they supply the bulk meth to their competitors to create their tablests. Mallinckrost makes all the meth in the US, Including the meth used for Dolophine? Personally think Mallinkrodt slowed the flow of bulk meth to capture a huge portion of the reatail mth market which is booming now where it was pretty stagnent 6 years ago. But with the OxyC reported abuse it's become a preferred drug by many PM docs.

    If she's at a mom and pop, pharmacy, they use local Jobbers for their C-2 and it;'s just a matter of who can they get what they need from. If they use a local jobber "wholesaler" . The pharmacist may be able to order the Roxanne specifically for your hubby. The jobbers do try to complete orders with one brand, but if requested they could send the normal order in methadose and specifically ask for the Roxanne for your hubby, if the Jobber has any on his shelf.

    Pharmacy can be a great carrer, It however a pharnacist can also easlily become tainted by that one or two addd=icts that every pharmacy has to deal with. remind her not to let the actions of a few jade her thoughts of the truly needy patients. Whereveer you go, there willbe some abuse of the system and docs but the biggest shame would be to turn on the entire population of people using these meds and start eyeballing every customer. Remind her she can be a better pharmacist the more she knows about the patient.
    Take care, Dave

    I'll see what I can do to keep the egg off your face. But I've met several pharmacist that know about the problem with mallinckrodt but have no control over who their comapany makes aproduct line agreements with. I can't have my brother tear pages out of an FDA manual, but I have seen the specidfics on the net, I have just rocvered my system so many times in the last 6 years I have lost many sites and articles I once had book marked.

    Basic logic still tells me that if a transplant doc won't use a generic, there is a reason. There was a problem with a generic manufacturer of ativan a few years ago where psychosis and deaths occured by a company that followed fda guidlines.

    You would be surprised how many times management would tell my brother what process to use and wht not to use to ensure quality of products depending on where the batches were designated for use.

    If shipments were to be sent to 3rd world countries different standards were implimented by management. The folks that don't have degrees in Imunology but look at bottom line cost and bean counting decided what was a safe, not that the FDA allows it, But it won't be an american or german problem when people catch aids in africa from tainted blood products. Pretty sad but when you look at the history of the parent companmy I G Farben it's not surprising.

    Best wishes for your daughter to become a compasionate pharmacist who doesn't need to be right at the expense of others. I went without BT meds 2 days last week because a new pharmacist wouldn't fill 120 30mg Roxicodone without varifying it with my doc regardless of my 2 year history in her computer. 2 years of 120 30mg MSIR or 120 4mg Dilaudid, But this Roxi script had to be varified. Do you think anyone apologized for making nme suffer just because she could? A few days later the PIC "pharmacist n Charge" I normally deal with called and apologized for the other RpH because the Roxicodone was on hand because she specifically ordered it for me, because I told her I was switching BT meds. Go figure.
    Take care, Dave

     
    Old 10-07-2004, 09:59 AM   #5
    Streetcar
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    Re: Generic VS Brand name

    Hey Dave ,

    Don't waste any time about the egg on my face. At my age a little more or less egg on my face won't matter. I wonder though if egg on the face might be part of my high cholesteral problemm, Ha, Ha, Ha.

    My daughter will be very compassionate towards CP patients, having seen all the stuff I've been through and will most likely continue to go through.

    My heart really goes out to you and your wife and I'll keep the both ofyou in my prayers.

    Be comfortable!
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    Ken
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    Old 10-10-2004, 10:38 AM   #6
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    Re: Generic VS Brand name

    It took some digging but here it is.
    According to the Food and Drug Administration (FDA), a generic drug is identical or bioequivalent to its brand-name counterpart in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. The current FDA criterion for bioequivalence for both branded and generic drugs is a 0.8 to 1.2 confidence interval. Tighter confidence intervals would result in many branded and generic products not being bioequivalent to themselves.

    But are generic and branded drugs interchangeable in the case of narrow-therapeutic-ratio (NTR) drugs? These drugs (such as warfarin, quinidine, procainamide, theophylline, lithium, phenytoin, carbamazepine and valproic acid) are used in clinical situations where small variations in tissue levels might result in sub-therapeutic or toxic clinical outcomes. The FDA makes no distinctions between standard and NTR drugs when it comes to interchangeability. NTR drugs do require frequent adjustments and careful patient monitoring, regardless of whether a brand-name or generic product is being used. However, the FDA does not recommend that physicians perform additional testing when switching NTR drugs or any other drugs, whether from branded to generic, generic to branded, or generic to generic.4

    I was wrong too, the allowable confidence interval is -20 and +20% or
    .8 and 1.2 .
    .8X10mg =8mgs and considered bioequivalent
    Take care, Dave

    Last edited by Shoreline; 10-10-2004 at 10:43 AM.

     
    Old 10-12-2004, 10:19 PM   #7
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    Re: Generic VS Brand name

    Shore, are you saying that if I take 100 mgs, that it can vary from 80 mgs to 120 mgs?


    P.S. You read a lot. Have you read any studies on RSD causing irritability?... ;-)




    your grateful friend,
    PR

     
    Old 10-14-2004, 09:43 AM   #8
    Streetcar
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    Re: Generic VS Brand name

    Hey PR,

    The way I intrepret what Dave is saying, based on the original question I asked, is that from manufacturer to manufacturer there can legally be as much difference as you asked about. Not from dose to dose or from script to script.
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