New Pathway for Pharmacists?

[RxMTM]

I just read this article that deals with genetic testing and medicine:

http://blog.pharmacist.com/tmenighan/index.php/2010/05/11/the-personalized-medicine-revolution/

How do you think this will affect pharmacy?

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[StaviZFingerZ]

May issue of "Nature" has an excellent article by Lenzini dealing with pharmacogentic algorithm development and improved clincal outcomes of refined Warfarin Dosing when based on genotypic relevance on cytochrome P450 2C9 and sensitivity of VKORC1. Of course this approach allows for more accurate dosing of drugs.

Yet, there aren't that many drugs with diminshed therapeutic index or titration requirement where pharmacists can work full time providing a service for reimbursement.

Bottom line? Interesting stuff if you're interested in the stuff. But follow the rainbow to the end and you probably won't find the pot o' gold as promised by the little green guy.

 

[RxMTM]

May issue of "Nature" has an excellent article by Lenzini dealing with pharmacogentic algorithm development and improved clincal outcomes of refined Warfarin Dosing when based on genotypic relevance on cytochrome P450 2C9 and sensitivity of VKORC1. Of course this approach allows for more accurate dosing of drugs.

Yet, there aren't that many drugs with diminshed therapeutic index or titration requirement where pharmacists can work full time providing a service for reimbursement.

Bottom line? Interesting stuff if you're interested in the stuff. But follow the rainbow to the end and you probably won't find the pot o' gold as promised by the little green guy.

What are you smokin'?

 

[Praziquantel86]

May issue of "Nature" has an excellent article by Lenzini dealing with pharmacogentic algorithm development and improved clincal outcomes of refined Warfarin Dosing when based on genotypic relevance on cytochrome P450 2C9 and sensitivity of VKORC1. Of course this approach allows for more accurate dosing of drugs.

Yet, there aren't that many drugs with diminshed therapeutic index or titration requirement where pharmacists can work full time providing a service for reimbursement.

Bottom line? Interesting stuff if you're interested in the stuff. But follow the rainbow to the end and you probably won't find the pot o' gold as promised by the little green guy.

Have you read the original pharmacogenetic warfarin-dosing algorithm in NEJM? Clinically, it really didn't seem all that helpful (certainly not practical). Not to mention that dabigatran is going to push it out of use (and put a lot of pharmacists out of a job) relatively soon.

 

[type b pharmD]

May issue of "Nature" has an excellent article by Lenzini dealing with pharmacogentic algorithm development and improved clincal outcomes of refined Warfarin Dosing when based on genotypic relevance on cytochrome P450 2C9 and sensitivity of VKORC1. Of course this approach allows for more accurate dosing of drugs.

Yet, there aren't that many drugs with diminshed therapeutic index or titration requirement where pharmacists can work full time providing a service for reimbursement.

Bottom line? Interesting stuff if you're interested in the stuff. But follow the rainbow to the end and you probably won't find the pot o' gold as promised by the little green guy.

Do you think pharmacists will be heavily involved in giving injections of new protein based drugs in retail ??

 

[StaviZFingerZ]

Do you think pharmacists will be heavily involved in giving injections of new protein based drugs in retail ??

I hope not. I'd rather hire an LVN to do that. But let me mark up the drug and profit handsomely.

 

[StaviZFingerZ]

What are you smokin'?

I thought you wanted a serious response. Just to let you know 1 to 2% of my responses may be applicable to something..

 

[StaviZFingerZ]

Have you read the original pharmacogenetic warfarin-dosing algorithm in NEJM? Clinically, it really didn't seem all that helpful (certainly not practical). Not to mention that dabigatran is going to push it out of use (and put a lot of pharmacists out of a job) relatively soon.

Yes and yes..but the cost of dabigatran may be prohibitive.

 

[RxMTM]

I thought you wanted a serious response. Just to let you know 1 to 2% of my responses may be applicable to something..

I was quite surprised.

 

[Praziquantel86]

Yes and yes..but the cost of dabigatran may be prohibitive.

I think the safety profile would cancel out any cost issues...I can't see any insurances/hospitals not putting it on their formulary.

It's just too bad that Boehringer isn't a public company...

 

[pharmwannebe2]

I just read this article that deals with genetic testing and medicine:

http://blog.pharmacist.com/tmenighan/index.php/2010/05/11/the-personalized-medicine-revolution/

How do you think this will affect pharmacy?

ohhh i think that gene testing for meds is the future of all meds. I think pharmacists are going to be good at counseling on different medications a person can take instead if their genes interact with the drug. didn't they just black box clopidigrel because of genetic variations found in CYP2C19?

 

[StaviZFingerZ]

I was quite surprised.

I was practicing pharmacy when you were in diapers.

 

[StaviZFingerZ]

black box clopidigrel because of genetic variations found in CYP2C19?

No No No!!!! it's "Boxed Warning" now.

 

[WhiteCastlezzs]

Friend gave me 150 mg ampetamin salts. Is it safe taking before exam? Much aprecation with any reply. Pharmaicts always helpful to me.

 

[StaviZFingerZ]

I think the safety profile would cancel out any cost issues...I can't see any insurances/hospitals not putting it on their formulary.

It's just too bad that Boehringer isn't a public company...

mmmmmm.... I would question that. One way drug companies market their drug is by making a statement that their drug has a 74% less hemorrhagic stroke.. yet it was 0.38% vs. 0.12% rate... significant? You bet. Yet this was not a blinded study. I will have to take apart the study to see the validity. On the surface, it seems safter yet RE LY was a non blinded non inferiority study. And I'm not sure RE-COVER showed much that was impressive.. another non-inferiority study.

 

[Praziquantel86]

mmmmmm.... I would question that. One way drug companies market their drug is by making a statement that their drug has a 74% less hemorrhagic stroke.. yet it was 0.38% vs. 0.12% rate... significant? You bet. Yet this was not a blinded study. I will have to take apart the study to see the validity. On the surface, it seems safter yet it was a non blinded non inferiority study.

Well not necessarily direct costs of the safety profile (I haven't really looked at the safety study in depth either), but certainly the indirect costs of the warfarin monitoring, etc.

And still...2 hemorrhagic strokes prevented/1000 treated is going to be a huge amount of savings. You also have to take into account the clots that don't happen due to increased compliance, something you won't necessarily see during a clinical trial.

 

[StaviZFingerZ]

Well not necessarily direct costs of the safety profile (I haven't really looked at the safety study in depth either), but certainly the indirect costs of the warfarin monitoring, etc.

And still...2 hemorrhagic strokes prevented/1000 treated is going to be a huge amount of savings. You also have to take into account the clots that don't happen due to increased compliance, something you won't necessarily see during a clinical trial.

I agree and disagree. Do we know that the higher rate of hemorrhagic stroke was truly due to warfarin? We're not talking about 10% vs. 20%..

We're talking about 0.2% difference... 2 out of 1,000 patients.

 

[Praziquantel86]

I agree and disagree. Do we know that the higher rate of hemorrhagic stroke was truly due to warfarin? We're not talking about 10% vs. 20%..

We're talking about 0.2% difference... 2 out of 1,000 patients.

Not completely, no...placebo-control is impossible at this point for pretty much any condition that uses warfarin treatment. I guess you could do some sort of a case-control, but there's no way that could practically be done at the scale necessary to see a difference.

I will defer to you on this one though...you actually make these decisions, I just think about them.

I don't think a PharmEcon study determining the correct pricepoint would be too difficult to do though...

 

[StaviZFingerZ]

Not completely, no...placebo-control is impossible at this point for pretty much any condition that uses warfarin treatment. I guess you could do some sort of a case-control, but there's no way that could practically be done at the scale necessary to see a difference.

I will defer to you on this one though...you actually make these decisions, I just think about them.

I don't think a PharmEcon study determining the correct pricepoint would be too difficult to do though...

Nah... this will impact outpatient prescription business so PBM counterparts will have to sweat it out. What do I care...I worry about expensive drugs that are $100 to $10,000 per day... not $10 per day..when the hospital LOS is only 3.5 days. And generic enoxaparin will make up for it.

Look at the big picture. If a patient is stablized on it being admitted to the hospital, what right do I have to tell them they can't get it? So typically, I'm for keeping vital drugs on the formulary that's commonly used in community. It's drugs like Telavancin that's like $200 per day and not better than Vanco that I will fight to keep off the formulary.

 

[Silvermist]

Have you read the original pharmacogenetic warfarin-dosing algorithm in NEJM? Clinically, it really didn't seem all that helpful (certainly not practical). Not to mention that dabigatran is going to push it out of use (and put a lot of pharmacists out of a job) relatively soon.

Doesn't dabigatran slightly raise the risk of MI though?

 

[Praziquantel86]

Nah... this will impact outpatient prescription business so PBM counterparts will have to sweat it out. What do I care...I worry about expensive drugs that are $100 to $10,000 per day... not $10 per day..when the hospital LOS is only 3.5 days. And generic enoxaparin will make up for it.

Look at the big picture. If a patient is stablized on it being admitted to the hospital, what right do I have to tell them they can't get it? So typically, I'm for keeping vital drugs on the formulary that's commonly used in community. It's drugs like Telavancin that's like $200 per day and not better than Vanco that I will fight to keep off the formulary.

That's fair, I suppose...so along those lines, how's the reaction to the Angiomax patent extension so far?

 

[RxWildcat]

Doesn't dabigatran slightly raise the risk of MI though?

pre-pharm therapeutics

 

[Praziquantel86]

Doesn't dabigatran slightly raise the risk of MI though?

Well yes and no. The RE-LY trial had three arms: dose-adjusted warfarin, 110mg dabigatran BID and 150mg dabigatran BID. The risk of MI was statistically significantly higher in the high-dose dabigatran group (but overall, it was an incredibly tiny difference in an 18,000+ patient study). However, it's not clear whether that difference is due to dabigatran increasing the risk on its own, or if its because warfarin is itself better than dabigatran at preventing MIs.

When you look at the overall results though, its almost a moot point. The high-dose dabigatran group was much better than warfarin at preventing thromboembolic strokes in patients with A-fib, so the few additional MIs may come out in the wash, so to speak. The low-dose group of dabigatran was non-inferior (and non-superior) to warfarin for the same endpoint and also didn't have the increased risk of MI.

So, it comes down to a few things: Phase IV data from Europe/Canada might show whether the risk of MI is something that people actually have to worry about. Then, if it turns out it is something that people have to worry about, is that risk negated by the quality of life benefits, lower risk of stroke, lower risk of bleeding, etc. that can be provided by dabigatran. Finally, depending on what dose the FDA approves for use (if they do at all) it might be a moot point.

 

[Silvermist]

Well yes and no. The RE-LY trial had three arms: dose-adjusted warfarin, 110mg dabigatran BID and 150mg dabigatran BID. The risk of MI was statistically significantly higher in the high-dose dabigatran group (but overall, it was an incredibly tiny difference in an 18,000+ patient study). However, it's not clear whether that difference is due to dabigatran increasing the risk on its own, or if its because warfarin is itself better than dabigatran at preventing MIs.

When you look at the overall results though, its almost a moot point. The high-dose dabigatran group was much better than warfarin at preventing thromboembolic strokes in patients with A-fib, so the few additional MIs may come out in the wash, so to speak. The low-dose group of dabigatran was non-inferior (and non-superior) to warfarin for the same endpoint and also didn't have the increased risk of MI.

So, it comes down to a few things: Phase IV data from Europe/Canada might show whether the risk of MI is something that people actually have to worry about. Then, if it turns out it is something that people have to worry about, is that risk negated by the quality of life benefits, lower risk of stroke, lower risk of bleeding, etc. that can be provided by dabigatran. Finally, depending on what dose the FDA approves for use (if they do at all) it might be a moot point.

Cool, thanks for the insight!

 

[StaviZFingerZ]

Well yes and no. The RE-LY trial had three arms: dose-adjusted warfarin, 110mg dabigatran BID and 150mg dabigatran BID. The risk of MI was statistically significantly higher in the high-dose dabigatran group (but overall, it was an incredibly tiny difference in an 18,000+ patient study). However, it's not clear whether that difference is due to dabigatran increasing the risk on its own, or if its because warfarin is itself better than dabigatran at preventing MIs.

When you look at the overall results though, its almost a moot point. The high-dose dabigatran group was much better than warfarin at preventing thromboembolic strokes in patients with A-fib, so the few additional MIs may come out in the wash, so to speak. The low-dose group of dabigatran was non-inferior (and non-superior) to warfarin for the same endpoint and also didn't have the increased risk of MI.

So, it comes down to a few things: Phase IV data from Europe/Canada might show whether the risk of MI is something that people actually have to worry about. Then, if it turns out it is something that people have to worry about, is that risk negated by the quality of life benefits, lower risk of stroke, lower risk of bleeding, etc. that can be provided by dabigatran. Finally, depending on what dose the FDA approves for use (if they do at all) it might be a moot point.

you read some son?

 

[Praziquantel86]

you read some son?

Is that in the present or past tense?

But yup, I read the study a while back...reread the editorial yesterday.

 

[StaviZFingerZ]

present

 

[Praziquantel86]

Then yes, yes I do.