Is it illegal to compound commercially available products?

trailerpark

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At a pharmacy I worked at they compound omeprazole 2mg/ml by mixing 24 capsules of the 20mg omeprazole capsules + 1 tsp baking soda, 240 mL water. I was told this is the only method Medicaid would pay for this disabled child who gets it twice a month. Another pharmacist then refused to make it saying it's illegal to compound because a commercially available product, First Omeprazole, is available. I'm really not sure. They have been compounding it twice a week for years (well before I ever worked there).

If it was illegal why would state Medicaid pay for it and not just approve a PA for FIRST? And FIRST also makes magic mouthwash and we compound that every now and then. I rarely compound in retail so not sure.
 

zelman

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At a pharmacy I worked at they compound omeprazole 2mg/ml by mixing 24 capsules of the 20mg omeprazole capsules + 1 tsp baking soda, 240 mL water. I was told this is the only method Medicaid would pay for this disabled child who gets it twice a month. Another pharmacist then refused to make it saying it's illegal to compound because a commercially available product, First Omeprazole, is available. I'm really not sure. They have been compounding it twice a week for years (well before I ever worked there).

If it was illegal why would state Medicaid pay for it and not just approve a PA for FIRST? And FIRST also makes magic mouthwash and we compound that every now and then. I rarely compound in retail so not sure.
It is illegal to compound commercially available formulations. FIRST products are not commercially available formulations. They are compounding kits.
 
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Old Timer

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Another pharmacist then refused to make it saying it's illegal to compound because a commercially available product, First Omeprazole, is available.
The other pharmacist suffers from a chronic disease rampant among my colleagues. THEY DON'T KNOW ****. They don't understand the law. As one of the most regulated professions I can't for the life of me understand why we make up regulations to follow that don't exist. As was pointed the First-Omeprazole is a compounding kit. It is not a commercially available product as the law envisions it. It does not have an NDA, it was not tested for safety and efficacy by the FDA as all other drugs are, it's just a compounding kit anyone who says it is not needs to put the spatula down, step away from the counter and go the F**K back to school.
 

PharmD500

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The other pharmacist suffers from a chronic disease rampant among my colleagues. THEY DON'T KNOW ****. They don't understand the law. As one of the most regulated professions I can't for the life of me understand why we make up regulations to follow that don't exist. As was pointed the First-Omeprazole is a compounding kit. It is not a commercially available product as the law envisions it. It does not have an NDA, it was not tested for safety and efficacy by the FDA as all other drugs are, it's just a compounding kit anyone who says it is not needs to put the spatula down, step away from the counter and go the F**K back to school.
It is a compounding kit, but it is a commercially available product. We are not supposed to compound commercially available products.

If FIRST products are available, then that's what the doctor needs to prescribe, instead of having you compound from scratch.
 

Old Timer

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It is a compounding kit, but it is a commercially available product. We are not supposed to compound commercially available products.

If FIRST products are available, then that's what the doctor needs to prescribe, instead of having you compound from scratch.
NO, NO, 1000 times NO. You DO NOT understand the law. Please read this. If after carefully reading this you still think First Omeprrazole is a Commercially Available DRUG Product then see my advise above as you would be considered too stupid to be allowed to practice.
 
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PharmD500

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NO, NO, 1000 times NO. You DO NOT understand the law. Please read this. If after carefully reading this you still think First Omeprrazole is a Commercially Available DRUG Product then see my advise above as you would be considered too stupid to be allowed to practice.
That document is too small to read on my phone. Where does it say what you are claiming?
 

giga

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That document is too small to read on my phone. Where does it say what you are claiming?
This document defines "commercially available drug product" and "essentially a copy of a commercially available drug product."

First-omeprazole is NOT a drug product. It is a compounding kit, which is not considered a drug product. It does not have an NDA. It has not gone through the FDA approval process as a drug product. It is not in the [email protected] database. It is simply a product that includes pre-measured amounts of the API and other ingredients that makes it easier to compound a drug that is not a commercially available drug product. There is no law that requires that you use First-omeprazole in order to compound omeprazole 2 mg/ml solution, which, again, is not a commercially available drug product.
 

VA77

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If FIRST made a product that wasn't a kit and didn't have to be mixed then would it be exempt under the compounding rule?
 

PharmD500

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This document defines "commercially available drug product" and "essentially a copy of a commercially available drug product."

First-omeprazole is NOT a drug product. It is a compounding kit, which is not considered a drug product. It does not have an NDA. It has not gone through the FDA approval process as a drug product. It is not in the [email protected] database. It is simply a product that includes pre-measured amounts of the API and other ingredients that makes it easier to compound a drug that is not a commercially available drug product. There is no law that requires that you use First-omeprazole in order to compound omeprazole 2 mg/ml solution, which, again, is not a commercially available drug product.
Yeah, I just went to the manufacturer's site and read about their products. Their facilities are inspected by the FDA. Based on what I read, the FDA may be reviewing how the law affects compounding kits.

Also, if the whole purpose of the law was to prevent more tragic incidents involving compounding, it makes more sense to use the kits than to have random pharmacists opening capsules and using various recipes with varying levels of skill.
 

steveysmith54

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Yeah, I just went to the manufacturer's site and read about their products. Their facilities are inspected by the FDA. Based on what I read, the FDA may be reviewing how the law affects compounding kits.

Also, if the whole purpose of the law was to prevent more tragic incidents involving compounding, it makes more sense to use the kits than to have random pharmacists opening capsules and using various recipes with varying levels of skill.
It doesn't exactly take tremendous amount of skill and high IQ to pour liquid and mix it with some capsules. I'd say doctorate degree will suffice. I think nonsterile compounding errors rarely cause lethal adverse events, I'd worry a lot more about sterile compounding. I mean if you can't trust a pharmacy to make a simple comound, which is a practice that has been around longer than OLD TIMER, we may have a problem.
 

PharmD500

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It doesn't exactly take tremendous amount of skill and high IQ to pour liquid and mix it with some capsules. I'd say doctorate degree will suffice. I think nonsterile compounding errors rarely cause lethal adverse events, I'd worry a lot more about sterile compounding. I mean if you can't trust a pharmacy to make a simple comound, which is a practice that has been around longer than OLD TIMER, we may have a problem.
Right, but the kits make it more standardized and safer, and their facilities and processes are regulated and inspected by the FDA. They follow cGMP.
 

giga

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Right, but the kits make it more standardized and safer, and their facilities and processes are regulated and inspected by the FDA. They follow cGMP.
All facilities that manufacture APIs and other ingredients used for human consumption are inspected by the FDA and are required to follow cGMP. First-omeprazole simply provides pre-measured amounts in a nicely organized package. It's like brownie mix - the brownie mix is just as regulated as the flour, sugar, and cocoa powder you could mix individually by yourself, but the brownie mix is simply more convenient.

And yes, the line between when a compounding kit becomes a drug product is a little grey. At what point does brownie mix actually become a full-fledged brownie? (ETA: nonetheless, until the FDA figures that out, it is still not right to say that First-omeprazole is a drug product or that you have to use First-omeprazole in order to compound omeprazole)
 
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PharmD500

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All facilities that manufacture APIs and other ingredients used for human consumption are inspected by the FDA and are required to follow cGMP. First-omeprazole simply provides pre-measured amounts in a nicely organized package. It's like brownie mix - the brownie mix is just as regulated as the flour, sugar, and cocoa powder you could mix individually by yourself, but the brownie mix is simply more convenient.

And yes, the line between when a compounding kit becomes a drug product is a little grey. At what point does brownie mix actually become a full-fledged brownie?
But they are not the ones manufacturing the APIs. They're manufacturing the kits. Don't you think it's safer and more convenient to use their products than to have random pharmacists compounding them? Who knows if random pharmacists would use the right recipe, or clean their graduated cylinders and other compounding tools properly, or wear masks and not cough all over the compound, or have scales that are as accurate as what this manufacturer has, etc.
 

PharmD500

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The point still holds. The manufacturer of the omeprazole capsules that a pharmacist breaks open to make the compounded drug also uses cGMP and is inspected by the FDA.
Right, but the pharmacist doesn't, and the pharmacy is not inspected by the FDA. That manufacturer is. It requires much more manipulation and steps to make it from capsules than to use the kit, therefore, increasing the risk for error.

Maybe we are talking about different things.

I'm trying to say it's safer to use the kits. Do you disagree?
 

giga

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But they are not the ones manufacturing the APIs. They're manufacturing the kits. Don't you think it's safer and more convenient to use their products than to have random pharmacists compounding them? Who knows if random pharmacists would use the right recipe, or clean their graduated cylinders and other compounding tools properly, or wear masks and not cough all over the compound, or have scales that are as accurate as what this manufacturer has, etc.
Right, but the pharmacist doesn't, and the pharmacy is not inspected by the FDA. That manufacturer is. It requires much more manipulation and steps to make it from capsules than to use the kit, therefore, increasing the risk for error.

Maybe we are talking about different things.

I'm trying to say it's safer to use the kits. Do you disagree?
If you are a pharmacist who can't be bothered to follow a recipe and keep your equipment clean, by all means, please use the First-omeprazole compounding kit. Is it safer? Maybe, that would be a fairly safe assumption. Does it really need to be safer, and does the supposed increased safety justify the increased cost? I don't know. The only thing I am arguing is that it is not illegal to not use the compounding kit, as the compounding kit is not technically considered a drug product.
 
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quickpic007

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Right, but the pharmacist doesn't, and the pharmacy is not inspected by the FDA. That manufacturer is. It requires much more manipulation and steps to make it from capsules than to use the kit, therefore, increasing the risk for error.

Maybe we are talking about different things.

I'm trying to say it's safer to use the kits. Do you disagree?
After practicing for 4 years I would hesitate to compound an omeprazole suspension from capsules. Quite frankly it has lawsuit written all over it, if there is a FIRST kit available.
On a new patient I'd pass for sure.
 

owlegrad

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Huh. I guess we should just refuse to compound anything since we use dirty equipment and sneeze all over the product. In this day in age do we even need to make custom products for individual patients?

Also how does the first kit prevent me from sneezing into the product? Or using any other poor technique while mixing?
 

zelman

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But they are not the ones manufacturing the APIs. They're manufacturing the kits. Don't you think it's safer and more convenient to use their products than to have random pharmacists compounding them? Who knows if random pharmacists would use the right recipe, or clean their graduated cylinders and other compounding tools properly, or wear masks and not cough all over the compound, or have scales that are as accurate as what this manufacturer has, etc.
If using the kits makes you feel comfortable compounding it, then no they aren't safer. They are just as dangerous as any other compounding method, but have given someone with an inability to accept a clear cut law a false sense of security. If you can't compound, you can't compound. Don't assume the kit is magic.
 
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zelman

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@giga Don't you work for the FDA? Maybe you can get them to count the kits as commercial drug products. Lol. I would be on board with that.
Will you pay the $2M for the NDA? And the additional millions of dollars for the studies required for approval?

Commercially available omeprazole capsules have prescribing information that includes: INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION, DOSAGE FORMS AND STRENGTHS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, DRUG INTERACTIONS, USE IN SPECIFIC POPULATIONS, OVERDOSAGE, DESCRIPTION, CLINICAL PHARMACOLOGY, NONCLINICAL TOXICOLOGY, CLINICAL STUDIES, REFERENCES, HOW SUPPLIED/STORAGE AND HANDLING, and PATIENT COUNSELING INFORMATION. You can't just print "LOL juzt read the prilosec OTC box. ROTFL" on a post-it and call it a day. There is a reason FIRST hasn't produced product intended for the end user and it's the cost of regulation.
 
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zelman

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Also, if the whole purpose of the law was to prevent more tragic incidents involving compounding, it makes more sense to use the kits than to have random pharmacists opening capsules and using various recipes with varying levels of skill.
If that was the purpose of the law, you might be trying to make a point. But it wasn't. Who do you think paid lobbyists to pay politicians to make the law? ISMP? No effing way. Pharmaceutical companies don't want competition, and they'll pay off anyone to avoid it (see "pay-to-delay" shenanigans for another example).
 

zelman

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If FIRST made a product that wasn't a kit and didn't have to be mixed then would it be exempt under the compounding rule?
Depends on what it was. If they made a bicycle, the rule wouldn't pertain to it. You would have to be much more specific to get a meaningful answer.
 

msweph

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Agree that you can continue to compound all "FIRST" products. They are compounding kits as stated by everyone above.

Sent from my Pixel using Tapatalk
 

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The stability and absorption with compounding with sodium bicarb and water is dubious and there is always the fact that those pellets refuse to dissolve. I would argue that this compound is ONLY for patients who can't take anything orally. If it's oral use a kit and if via tube AND a Medicaid patient then compound it.
 

RxVampire

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Maybe the meningitis incident has made all the recent graduates scared to compound anything period. Compounding almost the same product was actually on the compounding exam in NYS; basic competency stuff.

Likely just avoiding compounding due to company policy or a matter of time spent making and documenting
 

npage148

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All this belly aching over a kit and I remember when you could compound bactorban in nasal saline and gent in NS for nasal irrigation at a community pharmacy

I like he FIRST kits not because of liability (I trust my ability) but becaue I'm lazy.
 

Bubba98

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All this belly aching over a kit and I remember when you could compound bactorban in nasal saline and gent in NS for nasal irrigation at a community pharmacy
Your ability is still only a part of the equation. You still depend upon the recipe and the tools/environment provided by your employer

I like he FIRST kits not because of liability (I trust my ability) but becaue I'm lazy.
 

Old Timer

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The stability and absorption with compounding with sodium bicarb and water is dubious and there is always the fact that those pellets refuse to dissolve. I would argue that this compound is ONLY for patients who can't take anything orally. If it's oral use a kit and if via tube AND a Medicaid patient then compound it.
Really. This is as as silly a statement as the First Omeprazole is a drug. It dissolves fine if you know how to make it. There is stability data for 30 days under refrigeration.
 
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Bubba98

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Really. This is as as silly a statement as the First Omeprazole is a drug. It dissolves fine if you know how to make it. There is stability data for 30 days under refrigeration.
I found stability data at 14 days. And it doesn't dissolve fine, it's stubborn as heck. And you go ahead and give mom that salty chalky tasting mess and I'll give them something that tastes like chocolate.
 
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Old Timer

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You people are just nuts. In my long and storied career I have made:

Seconal Suppositories
Progesterone Vaginal Suppositories
Sodium Fluoride Oral Capsules
Cocaine Nose Drops
Belladonna and Calcium Oral Capsules (Pre H2 Blocker and Pre PPI)
Menthol/Camphor in Mineral Oil Nose Drops
Coal tar and Pine tar in various topical steroids
Various and Sundry liquid oral medications for Pets
Various and Sundry liquid oral medications for children (Spironolactone, Carvedilol, Bethanechol)
White Lotion

And probably many more that I have forgotten. Compounding is part of the skill set you are supposed to have as a pharmacist.
 
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Old Timer

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For all you folks who want the easy way to make Omeprazole:

Empty capsules into glass mortar
Pour enough NaHCO3 to wet and cover the granules
Let sit for 30-60 minutes (The NaHCO3 melts the coating of the pellets)
Grind the pellets
QS to appropriate amount.
 

Bubba98

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For all you folks who want the easy way to make Omeprazole:

Empty capsules into glass mortar
Pour enough NaHCO3 to wet and cover the granules
Let sit for 30-60 minutes (The NaHCO3 melts the coating of the pellets)
Grind the pellets
QS to appropriate amount.
Everyone has the recipe old timer it's in this thing called a computer. I think we are questioning the medical value of this particular compound in 2017.
 
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Old Timer

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Everyone has the recipe old timer it's in this thing called a computer. I think we are questioning the medical value of this particular compound in 2017.
No, people make it many ways and only you are questioning the medical value of this particular compound.
 

Niosh

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Just throwing my own crap into the water, our board of pharmacy has specifically answered this question and the short answer is a pharmacy is not required to use the kits.
Compounding Convenience Kits
By Sue Mears, MBA, RPh, Board Compliance Officer, and Laura Steffensmeier, Iowa Assistant Attorney General
Over the last few years, companies have been increasingly selling compounding “convenience kits” containing bulk drug ingredients that, when combined in accordance with the instructions, create a compounded drug product. Pharmacists have often posed two questions regarding these kits. First, if a convenience kit is commercially available, do they have to use it to compound the product? The answer is no; a pharmacy is not required to utilize a convenience kit to compound a drug product. A convenience kit is considered a bulk drug ingredient for human prescription compounding by FDA. Convenience kits, on their own, are not considered FDA-approved products (even though they may be labeled with a National Drug Code number), nor are they considered “finished pharmaceuticals.” A pharmacy is not required to utilize a convenience kit to compound a drug product for a patient. Second, does the pharmacist still need to complete and maintain a compounding record when making a compounded drug product using a convenience kit? The answer is yes; a pharmacy is still required to complete a compounding record when compounding a drug product using a convenience kit. Because the kit itself is not an FDA-approved product, following the kit’s instructions is not considered mixing or reconstituting per the manufacturer label, and is therefore not exempt from the definition of compounding and not exempt from the recordkeeping requirements applicable to all compounded drug products.
 
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I'm just going to chime in from the perspective of a PBM's view. Many state Medicaid plans utilize what is called the CMS Labeler File, which only allows NDC's which are rebatable by CMS to pay. The FIRST compounding kits are not on this list as rebatable for obvious reasons. If the plan chooses not to allow this exception and be reimbursed, then the only option for a member is to compound the prescription, which will then be covered.
I have been out of practice from real world pharmacy for a long time, but I would still agree that all of the FIRST products can still be compounded and not be penalized.
 
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quickpic007

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Huh. I guess we should just refuse to compound anything since we use dirty equipment and sneeze all over the product. In this day in age do we even need to make custom products for individual patients?

Also how does the first kit prevent me from sneezing into the product? Or using any other poor technique while mixing?
Man that would be awesome!
I mean if patients accuse of short narcotics, lost scripts, whats to stop them from saying "why did you use an outdated technique when the standard appears to be a simple kit? my child is now sick and I am calling corporate..."

Please retire.
Almost there!!! 1.3 Mil and I am out!!!
 

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Yeah, I just went to the manufacturer's site and read about their products. Their facilities are inspected by the FDA. Based on what I read, the FDA may be reviewing how the law affects compounding kits.

Also, if the whole purpose of the law was to prevent more tragic incidents involving compounding, it makes more sense to use the kits than to have random pharmacists opening capsules and using various recipes with varying levels of skill.
If you worked at my pharmacy I'd fire you. It is more profitable to compound.

#1 - The individual ingredients used in the compound are cheaper than purchasing a compounding kit from FIRST.
#2 - You get paid a compounding fee when billing for a compound. You're not gonna get paid a compounding fee for the FIRST compounding kit because then you can only bill for one NDC instead of two.
 

lord999

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This document defines "commercially available drug product" and "essentially a copy of a commercially available drug product."

First-omeprazole is NOT a drug product. It is a compounding kit, which is not considered a drug product. It does not have an NDA. It has not gone through the FDA approval process as a drug product. It is not in the [email protected] database. It is simply a product that includes pre-measured amounts of the API and other ingredients that makes it easier to compound a drug that is not a commercially available drug product. There is no law that requires that you use First-omeprazole in order to compound omeprazole 2 mg/ml solution, which, again, is not a commercially available drug product.
As you know, this is somewhat of a grey area within CDER to extend the regulations into compounding kits as pharmacists nowadays seem to need DTC instructions to compound anything. Larry S is arguing against it, because he doesn't think pharmacists are that dumb, but I kind of wonder if Greg P is right that Larry hasn't seen pharmacists as of late and Larry was trained in the era where you used Remington's as your textbook.

The stability and absorption with compounding with sodium bicarb and water is dubious and there is always the fact that those pellets refuse to dissolve. I would argue that this compound is ONLY for patients who can't take anything orally. If it's oral use a kit and if via tube AND a Medicaid patient then compound it.
Is there a expectation that they should dissolve? They are not suppose to truly dissolve, it's a suspension, not a solution! As @oldtimer, you can and should levigate the particles for an easier particle reduction (levigation does make the eventual suspension much more uniform), but you are not going to create a solution from what you get, omeprazole is just not soluable enough. Um, are we as a forum really that inept with basic pharmaceutics?

Oral pharmacokinetics of omeprazole and lansoprazole after single and repeated doses as intact capsules or as suspensions in sodium bicarbonate

And

SAGE Journals: Your gateway to world-class journal research
 

Old Timer

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As you know, this is somewhat of a grey area within CDER to extend the regulations into compounding kits as pharmacists nowadays seem to need DTC instructions to compound anything. Larry S is arguing against it, because he doesn't think pharmacists are that dumb, but I kind of wonder if Greg P is right that Larry hasn't seen pharmacists as of late and Larry was trained in the era where you used Remington's as your textbook.



Is there a expectation that they should dissolve? They are not suppose to truly dissolve, it's a suspension, not a solution! As @oldtimer, you can and should levigate the particles for an easier particle reduction (levigation does make the eventual suspension much more uniform), but you are not going to create a solution from what you get, omeprazole is just not soluable enough. Um, are we as a forum really that inept with basic pharmaceutics?

Oral pharmacokinetics of omeprazole and lansoprazole after single and repeated doses as intact capsules or as suspensions in sodium bicarbonate

And

SAGE Journals: Your gateway to world-class journal research
Well explained. Better than I did. I was trained by pharmacists who graduated in the 50's and 60's so I was really trained to compound. I'm not afraid of it and I enjioy doing it, if I have the time. It seems to be a lost art. I've made a zillion different compounds over the years. My wife is sensitive to the side effects of antihistamines and decongestants. Back in the day I compounded Chlorpheniramine 1 mg and sudafed 15 mg capsules.

I guess there really is no training in school these days......
 

PharmD500

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It doesn't exactly take tremendous amount of skill and high IQ to pour liquid and mix it with some capsules. I'd say doctorate degree will suffice. I think nonsterile compounding errors rarely cause lethal adverse events, I'd worry a lot more about sterile compounding. I mean if you can't trust a pharmacy to make a simple comound, which is a practice that has been around longer than OLD TIMER, we may have a problem.
I fully trust myself in my compounding abilities, but knowing the quality of pharmacists out there, I do not trust random pharmacists to compound or even do something as simple as making sure a dose is appropriate.
 
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PharmD500

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Huh. I guess we should just refuse to compound anything since we use dirty equipment and sneeze all over the product. In this day in age do we even need to make custom products for individual patients?

Also how does the first kit prevent me from sneezing into the product? Or using any other poor technique while mixing?
Would you trust any random pharmacist in the whole US to compound things for you or your loved ones? I wouldn't. The kit makes it safer and more standardized, and the manufacturer's facilities are inspected by the FDA. I trust their kits more than a compound some random pharmacist made. It requires less steps and no measuring or calculating at the pharmacy. Even if all the pharmacists in the US were excellent, there would still be a bigger difference in quality between the compounds made by thousands of different pharmacists, than ones made using the kit.

We compound sterile and non-sterile medications all the time at the hospital. I still think the premix IVPBs and compounding kits make things safer. There's more oversight and quality control for the manufacturer than for a regular pharmacy.

If you would prefer a pharmacist who only passed the NAPLEX on the third try and makes mistakes doing calculations 50% of the time to make compounds for you, go for it. I'm not going to trust randoms. Give me the kit any day over a compound. In fact, I'd rather not even have them mix the kit. LOL. I'd rather do it myself. :p
 

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Can you explain it to me more slowly using simpler words? In addition to not being able to mix simple ingredients I also find following long posts difficult. :p
 

lord999

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Would you trust any random pharmacist in the whole US to compound things for you or your loved ones? I wouldn't. The kit makes it safer and more standardized, and the manufacturer's facilities are inspected by the FDA. I trust their kits more than a compound some random pharmacist made. It requires less steps and no measuring or calculating at the pharmacy. Even if all the pharmacists in the US were excellent, there would still be a bigger difference in quality between the compounds made by thousands of different pharmacists, than ones made using the kit.

We compound sterile and non-sterile medications all the time at the hospital. I still think the premix IVPBs and compounding kits make things safer. There's more oversight and quality control for the manufacturer than for a regular pharmacy.

If you would prefer a pharmacist who only passed the NAPLEX on the third try and makes mistakes doing calculations 50% of the time to make compounds for you, go for it. I'm not going to trust randoms. Give me the kit any day over a compound. In fact, I'd rather not even have them mix the kit. LOL. I'd rather do it myself. :p
I understand your point, and I think I would make it like this, which has a different implication than your wording.

I'm not opposed to using technology when it's available. The hell I'm going to use a Class III Torsion Balance when there's an arguably more accurate digital scale out that is very straightforward to use. Likewise, if someone gave me a kit to streamline my process when making omeprazole and it makes my life easier and faster with less errors, great, I'll use that too. I'm not going to avoid the use of technology even if it lowers the competency threshold, because why risk the matter if EZ is handed to you and cost isn't an object. If someone gave me the First kit, I'd use it as it makes my life easy. But I still would know why I was using the kit and know what steps the kit replaces in the same way that advanced IV technology makes life simple but you should still know how to inject stuff into bags.

The only reason that you don't bother learning an antecedent technology is if it is impossible at a practical level to actually use it. I don't think typewriters are a great idea to teach in pharmacy nowadays, because pharmacies in my area of the country no longer are required to maintain one, so learning a typewriter is not generally a productive use of time. You would expect though to make nonsterile, extemporaneous compounds at least every so often in general practice (and sterile compounds in hospital practice), so having some sense for the chemistry and pharmaceutics involved still is worth something. Unlike oldtimer's era, you don't necessarily memorize formulas like they did as the likelihood of direct preparation from scratch is not common anymore, but the background knowledge of why those formulations work still is a practice-relevant knowledge base.

I actually think pharmacists (in all generations) should be able to figure out the basic dosing preparation rules by themselves, and no, not at 50%, and I expect that either they know enough physical pharmacy to know the sort of problems around making something and what stability issues and being able to look it up properly. If this is a reasonably common thing to see in your practice, I would hope that you did the homework in finding out the most resource-effective personal way to get something done. But unlike the techs, I do expect pharmacists to know enough about the generalities of practice to know what they don't know or don't routinely practice that if confronted with a situation that is outside the norm, that they have reasonable judgment to still get the task done correctly. Pharmacists should know enough to know where to look, what factors to consider, and how to follow the instructions for making the preparation with the sort of professional instructions that are generally written including the FSAR (fiant secundum artem regulas) parts even if they don't know the method beforehand. That's the skillpart of our profession, the techs can do the grunt work but we ought to know what to do and why we do it.

But yes, in the same way that I don't trust every general surgeon to do a straightforward lance a boil, not every pharmacist has the competency to actually follow instructions on how to prepare medications. That's when they are suitable for have a pulse jobs like mail order.
 

owlegrad

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Lol. Just read what I wrote.
All kidding aside, I do take your point. But I also disagree with it. If I didn't trust a pharmacist to make an Omeprazole suspension from scratch I also wouldn't trust them to make it from the kit. The only value the kit has for me is convenience not safety.

You keep making a big deal about the FDA inspecting the facility where the kits are prepared but the FDA also inspects the facilities where the omeprazole capsules are prepared. In the end it's still being mixed in the pharmacy so I think that's a moot point.
 
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