Tacrolimus generic

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icekitsune

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Hey All,
I just received a script for prograf for a patient that has had transplant probably for a couple of years. I'm assuming he was on prograf before. Never filled it in my pharmacy. I was wondering if there is an issue in changing diff manu in prograf. I thought I was told in school that you don't interchange manu. Maybe I remembered it wrong but any comments?

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There is no issue interchanging generic transplant medications. That is a myth. Fill with whatever generic you have.
 
You shouldn't interchange manufacturers with a narrow index drug such as tac. Its best to find out what manufacturer they've been taking and try and stick with the same one. If the patient has been taking brand prograf and wants to switch to generic tacrolimus the doctor should be informed of the switch and reorder tac levels be drawn and monitored more frequently. Studies have been out long enough to show there is only a slight variation between a/b rated generic tacrolimus and brand prograf but switching between products does increase the chance of adjustments in serum concentrations. If the patient is a few years out from transplant they're probably not having their levels drawn very frequently and should be informed to follow up with their md. Risk of graft rejection and transplant dysfunction is pretty low once patients are a few years out but if levels creep up patients can end up with various viral infections (cmv, bk virus, etc.). Always best to use your professional judgment.
 
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Legally, there is no problem with substituting (assuming the doctor didn't write DAW-1 and that your state doesn't have some strange law regarding substitutions.) Realistically, it can be problematic, because its a narrow therapeutic index drug. I would not do it without talking to the patient and the prescriber. However if cost is an issue.....well, switching is better than not taking nothing, I would do the switch, then talk to the patient about following up with his doctor (and then let his doctor know of the switch.)
 
You dispense the cheapest generic that you are able to get. If that means switching manufacturers every other month, so be it.
 
I am pretty surprised by the comments that you should try to find out what they were taking in that past, interview the patient/prescriber, and fil it with the same previous manufacturer. Who has time for that? Just fill whatever you have in stock.
 
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My pediatric preceptor was working on a research project on this with one of her transplant docs. The end result was that generic and brand weren't interchangeable. I wouldn't swap it without contacting the doc and patient first. This isn't just another statin.
 
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Unless there is a actual clinical study demonstrating non-bioequivelence (ie not a manufacturer white paper) and the FDA pulls the ab rating doctors and clinical pharmacists (who should know better) are just talking out their rear

Once again remember this fun fact. The same criteria/test that dictates brand generic BE is the same one that the FDA mandates a brand manufacture must use to demonstrate BE after formulation changes.
 
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There's some interesting literature out there on this topic.

From what I've seen, swapping out whatever generic you have on hand for NTI drugs, especially things like tacro, because it takes too long to ask a patient or physician what they took before might not be the best approach and could impact the patient negatively. Why take the risk?

Just call the physician.
 
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There's some interesting literature out there on this topic.

From what I've seen, swapping out whatever generic you have on hand for NTI drugs, especially things like tacro, because it takes too long to ask a patient or physician what they took before might not be the best approach and could impact the patient negatively. Why take the risk?

Just call the physician.

Then the law should be adjusted to reflect this. Until it is, I would be comfortable dispensing what I have in stock.

Either AB rating is enough or it isn't.
 
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Then the law should be adjusted to reflect this. Until it is, I would be comfortable dispensing what I have in stock.

Either AB rating is enough or it isn't.
Right? I mean, there's obviously zero chance for a negative outcome as long as we blindly follow a generic rule.
 
Just call the physician.

"Hello Dr. Smith, this is owlegrad calling about Mrs. Smith. Which brand tacrolimus has she been on? I would hate to substitute without your permission." <--Is a call you will never hear me make. ;)

Using the logic of "why take the risk", why do we ever switch manufacturers of any medication? Obviously once someone has had a particular manufacturer they should stay on that one forever.
 
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I asked a couple people about this today at the hospital and the response was that patients should not be switched back and forth between manufacturers because there have been significant changes in levels. Then I got a "what kind of pharmacist doesn't care about that?" response.

For NTI drugs I think it can definitely make a difference in some patient populations.

I'd say the FDA gives quite a lot of leeway.. 80-120% allowed variability?? That's a lot. It's also random generic 1 or 2 against brand, not generic 1 against generic 2.
 
I asked a couple people about this today at the hospital and the response was that patients should not be switched back and forth between manufacturers because there have been significant changes in levels.

Have fun tying to track down which manufacturer of every NTI drug your patients have been on. I assume your facility is ok ordering every manufacturer that all your patients have been on before being admitted? Don't want to risk changing brands once they have got started.

There is a reason we have the AB system. This is the reason. The whole "80%-120%" thing is the exact same standard that is applied to the branded version of the drug.
 
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Have fun tying to track down which manufacturer of every NTI drug your patients have been on. I assume your facility is ok ordering every manufacturer that all your patients have been on before being admitted? Don't want to risk changing brands once they have got started.

There is a reason we have the AB system. This is the reason. The whole "80%-120%" thing is the exact same standard that is applied to the branded version of the drug.

This. Patients in our facilities get what we have in stock. And that can change weekly because of our ordering and inventory practices. This is how pharmacy is practiced in the real world, by those of us who apparently don't care. LOL
 
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There are 7 possible manufacturers for tacrolimus. 10 for warfarin. I hope you got lots of shelf space! I would also like to say that the average physician has no idea which generic manufacturer their patient receives. They might know if they are on brand vs. generic, but knowing whether it's Amneal vs. Dr. Reddy's vs. Teva vs. Astellas? GTFO
 
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Right? I mean, there's obviously zero chance for a negative outcome as long as we blindly follow a generic rule.

Taking this to its logical conclusion, what's next? Not ever changing manufacturer on a beta blocker because there is not obviously zero chance for a negative outcome? The AB system has been set up for a reason. I am comfortable working within that system. If new rules need to be created for NTI drugs, then the term NTI should be strictly defined and new regulations should be implemented so that we have a framework to work within.

Using your logic, does a patient getting brand have to stay on the same lot of their NTI drug? Because the same tests used to compare lots of branded drugs are used to compare generics to brands.
 
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It's the switching back and forth repeatedly month to month as an outpatient that I think is the problem, not coming into the hospital for a few days.

Also, I thought this discussion was about transplant patients.
 
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It all boils down to generics at sloppy when they make their batches and brands are super strict /sarcasm
Yup. This is why the FDA forced that recall of all generic Tylenol in 2011 and you could only get the brand name for a year /sarcasm
 
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You shouldn't interchange manufacturers with a narrow index drug such as tac. Its best to find out what manufacturer they've been taking and try and stick with the same one. If the patient has been taking brand prograf and wants to switch to generic tacrolimus the doctor should be informed of the switch and reorder tac levels be drawn and monitored more frequently. Studies have been out long enough to show there is only a slight variation between a/b rated generic tacrolimus and brand prograf but switching between products does increase the chance of adjustments in serum concentrations. If the patient is a few years out from transplant they're probably not having their levels drawn very frequently and should be informed to follow up with their md. Risk of graft rejection and transplant dysfunction is pretty low once patients are a few years out but if levels creep up patients can end up with various viral infections (cmv, bk virus, etc.). Always best to use your professional judgment.

This is totally ridiculous and nonsense
 
Then the law should be adjusted to reflect this. Until it is, I would be comfortable dispensing what I have in stock.

Either AB rating is enough or it isn't.

See guys...this is someone who uses his head to think and not his book. Please don't practice pharmacy/medicine if you cannot think like this.
 
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