dispensing contraindicated drugs? dose too high? unapproved age

[MARX22]

Hey guys!

I covered for a friend at his place the other day and noticed he's been dispensing contraindicated drugs (repaglinide and gemfibrozil). I know for gemfib and statins lexicomp says its CI but if you check the package insert, it doesn't list it as a CI... so I would still call the dr to warn them about the SE of the DDI but thats about it, and counsel the patient... as for actual things that are listed in the PI as contraindicated, like the repag and gemfib... I wouldnt feel comfortable dispensing. I asked 2 other friends and they said even if its CI, they call the dr and if the dr says to give it they do. I'm so confused, and surprised. Why would you dispense something when the package insert clearly warns against it? Other things I get theres gray areas but contraindications were always a "no no" in my head from school. I'm also concerned that if fellow rphs do this and you're at a store... if you try to call the md on a refill and try to switch it they might get nasty saying oh the other rph has been dispensing whats ur prob etc, or the patient will also argue. your thoughts?

How about if the dose is high? I got rx for ketotifen eye drops, 2 drops bid.. told the dr it should be 1 drop bid but he said dont argue with me just give it. It's topical so idk how concerned I should be but what do you guys do generally? I got montelukast 5 mg two tablets for a 7 year old.. 10 mg is the dose for 15 years and up... other rph kept filling.. i called the dr, no response. would you fill it even if the md "okays" it?... it isnt weight based so i dont get why they would give a higher dose. the parent said its because thats what works for the kid.. how do you go about it?

How about if a medication is for a kid and theres no fda approved dosing range for that age? Do you get the mds ok and still dispense as long as their age isnt listed as a contraindication? for example, clobetasol is approved for 12 and up.. its a topical so if the md ok it for a younger age, still give it? there are oral meds too for which theres no dosing for younger kids but doctors still prescribe it.. i cant think of any at the moment haha

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[BidingMyTime]

1) FDA said new pt shouldn't be started on repaglinide and gemfibrozil, but that pt's already on the combo could continue. As for gemfibrozil and statins, it's not recommended, but it's not absolutely contraindicated, and the combo is used fairly frequently. Very few drug combos are absolutely contraindicated, rather it's that they should only be used if the risks outweigh the benefits. If the patient has been on the combo, I wouldn't worry about it (unless it really were a true contraindication.) If it's a new RX, then I might call the doctor (depending on the pt's history), and counsel the patient.

2) 2 high of a dose, if there are going to be harmful side effects from 2 high of a dose, or clearly over the max recommended dose, then call the doctor. Otherwise, I wouldn't worry about it. With eye drops, realistically, most people are either squirting out a stream and thinking it's 1 eye drop, or they are missing their eye completely. Dosing is going to be individual for patients, if they are being started on a really low dose, maybe they have a history of being sensitive to drugs. If they are being started on a really high dose, maybe they had taken that drug in the past, and that was the dose that worked for them. Talking to the patient can get you a lot of answers as to why a particular dose may have been selected, if not, call the doctor.

3) few drugs are FDA approved for use in children, but they are often used in children anyway, because of a historical safety record. With the montelukast, the dr presumably tried the pt on the 5mg first, it didn't work or perhaps wasn't working well enough, so then he upped it to 10mg. Which now presumably works. As it's unlikely the pt is going to have adverse effects from a 10mg dose, as opposed to the 5mg dose, then yes, I would dispense it. Medicine is called "an art" for a reason. With the clobetasol, there is a concern with systemic absorption of corticosteroids in children, whether or not it should be used depends on what area of the body it's being used on, how large of an area, what other steroids or treatments has the patient tried. There are no clear-cut answers. Learning to apply the knowledge you gained in pharmacy school, to real world situations, is something that takes time and practice for most pharmacists to learn.

 

[owlegrad]

1) As for gemfibrozil and statins, it's not recommended, but it's not absolutely contraindicated, and the combo is used fairly frequently.

Where are you getting that info? Every time I have researched it I have seen that it is contraindicated and personally I have always refused to dispense them together, especially since adding a fibrate to a statin hasn't been shown to improve CV outcomes. How can we possibly say that the benefits outweigh the risks when there are no known benefits and the risks are serious and known?

 

[PharFromNormal]

Where are you getting that info? Every time I have researched it I have seen that it is contraindicated and personally I have always refused to dispense them together, especially since adding a fibrate to a statin hasn't been shown to improve CV outcomes. How can we possibly say that the benefits outweigh the risks when there are no known benefits and the risks are serious and known?

I don’t think I ever dispense them together and if I do there’s certainly a lot of questions and certainly a call to the prescriber or prescribers. All that aside, it’s always been hard as a pharmacist to have a 100% always/never rule on clinical things like this. I relate it to gambling in a way...
Any game at the casino in the long run is statistically designed for you to lose. The House always wins... long term continually play will result in losing money. However, that doesn’t mean no one wins, or nobody is in the Black for their lifetime. It might be sheer luck that the proven and very regulated odds of the games didn’t exert a negative outcome, but they did experience the reward instead of realizing the risk. Just like I wouldn’t promote investing your finances into playing casinos as a good idea, I wouldn’t promote the idea of taking those two together. It’s hard for me to say no one will ever hit the jackpot on them both. The risk tolerance of other health care providers and pharmacists are their own, I just hope they know what the risks are and what if any the odds are in hitting the jackpot.

 

[imcallingcorp]

Hey guys!

I covered for a friend at his place the other day and noticed he's been dispensing contraindicated drugs (repaglinide and gemfibrozil). I know for gemfib and statins lexicomp says its CI but if you check the package insert, it doesn't list it as a CI... so I would still call the dr to warn them about the SE of the DDI but thats about it, and counsel the patient... as for actual things that are listed in the PI as contraindicated, like the repag and gemfib... I wouldnt feel comfortable dispensing. I asked 2 other friends and they said even if its CI, they call the dr and if the dr says to give it they do. I'm so confused, and surprised. Why would you dispense something when the package insert clearly warns against it? Other things I get theres gray areas but contraindications were always a "no no" in my head from school. I'm also concerned that if fellow rphs do this and you're at a store... if you try to call the md on a refill and try to switch it they might get nasty saying oh the other rph has been dispensing whats ur prob etc, or the patient will also argue. your thoughts?

How about if the dose is high? I got rx for ketotifen eye drops, 2 drops bid.. told the dr it should be 1 drop bid but he said dont argue with me just give it. It's topical so idk how concerned I should be but what do you guys do generally? I got montelukast 5 mg two tablets for a 7 year old.. 10 mg is the dose for 15 years and up... other rph kept filling.. i called the dr, no response. would you fill it even if the md "okays" it?... it isnt weight based so i dont get why they would give a higher dose. the parent said its because thats what works for the kid.. how do you go about it?

How about if a medication is for a kid and theres no fda approved dosing range for that age? Do you get the mds ok and still dispense as long as their age isnt listed as a contraindication? for example, clobetasol is approved for 12 and up.. its a topical so if the md ok it for a younger age, still give it? there are oral meds too for which theres no dosing for younger kids but doctors still prescribe it.. i cant think of any at the moment haha

So my most important advice is chill out and relax. Drug interactions and max dosages are there for you to consider but they are not themselves concrete definates meaning if I call and say Hey Dr.abc you wrote 2 drops ketotifen just wanna check you meant that usually 1 drop. Dr. abc says yea patient needs it . convo done. what are they gonna overdose from it. singulair same call you want it you got it. My take is I will call and verify and move on as long as can’t harm patient. The gemfibrozil example I ignore, they’ve clearly been on it and are fine.

 

[MARX22]

1) FDA said new pt shouldn't be started on repaglinide and gemfibrozil, but that pt's already on the combo could continue. As for gemfibrozil and statins, it's not recommended, but it's not absolutely contraindicated, and the combo is used fairly frequently. Very few drug combos are absolutely contraindicated, rather it's that they should only be used if the risks outweigh the benefits. If the patient has been on the combo, I wouldn't worry about it (unless it really were a true contraindication.) If it's a new RX, then I might call the doctor (depending on the pt's history), and counsel the patient.

2) 2 high of a dose, if there are going to be harmful side effects from 2 high of a dose, or clearly over the max recommended dose, then call the doctor. Otherwise, I wouldn't worry about it. With eye drops, realistically, most people are either squirting out a stream and thinking it's 1 eye drop, or they are missing their eye completely. Dosing is going to be individual for patients, if they are being started on a really low dose, maybe they have a history of being sensitive to drugs. If they are being started on a really high dose, maybe they had taken that drug in the past, and that was the dose that worked for them. Talking to the patient can get you a lot of answers as to why a particular dose may have been selected, if not, call the doctor.

3) few drugs are FDA approved for use in children, but they are often used in children anyway, because of a historical safety record. With the montelukast, the dr presumably tried the pt on the 5mg first, it didn't work or perhaps wasn't working well enough, so then he upped it to 10mg. Which now presumably works. As it's unlikely the pt is going to have adverse effects from a 10mg dose, as opposed to the 5mg dose, then yes, I would dispense it. Medicine is called "an art" for a reason. With the clobetasol, there is a concern with systemic absorption of corticosteroids in children, whether or not it should be used depends on what area of the body it's being used on, how large of an area, what other steroids or treatments has the patient tried. There are no clear-cut answers. Learning to apply the knowledge you gained in pharmacy school, to real world situations, is something that takes time and practice for most pharmacists to learn.

Thanks! I tried looking it up before i posted here and hadnt seen anything about the fda and that recommendation. I usually go by lexicomp but then i refer to the package insert

 

[MARX22]

Where are you getting that info? Every time I have researched it I have seen that it is contraindicated and personally I have always refused to dispense them together, especially since adding a fibrate to a statin hasn't been shown to improve CV outcomes. How can we possibly say that the benefits outweigh the risks when there are no known benefits and the risks are serious and known?

If you look at the package insert, it doesnt list it as a CI. Not sure why lexicomp does. It did that for fluoxetine and quetiapine (?) as well, then I called the dr and he said no it isnt CI... i checked the PI for both drugs and lo and behold it wasnt CI lol.

 

[MARX22]

I don’t think I ever dispense them together and if I do there’s certainly a lot of questions and certainly a call to the prescriber or prescribers. All that aside, it’s always been hard as a pharmacist to have a 100% always/never rule on clinical things like this. I relate it to gambling in a way...
Any game at the casino in the long run is statistically designed for you to lose. The House always wins... long term continually play will result in losing money. However, that doesn’t mean no one wins, or nobody is in the Black for their lifetime. It might be sheer luck that the proven and very regulated odds of the games didn’t exert a negative outcome, but they did experience the reward instead of realizing the risk. Just like I wouldn’t promote investing your finances into playing casinos as a good idea, I wouldn’t promote the idea of taking those two together. It’s hard for me to say no one will ever hit the jackpot on them both. The risk tolerance of other health care providers and pharmacists are their own, I just hope they know what the risks are and what if any the odds are in hitting the jackpot.

Nice answer. The package insert doesnt list them as contraindicated im not sure why drug interaction tools say its not allowed

 

[MARX22]

So my most important advice is chill out and relax. Drug interactions and max dosages are there for you to consider but they are not themselves concrete definates meaning if I call and say Hey Dr.abc you wrote 2 drops ketotifen just wanna check you meant that usually 1 drop. Dr. abc says yea patient needs it . convo done. what are they gonna overdose from it. singulair same call you want it you got it. My take is I will call and verify and move on as long as can’t harm patient. The gemfibrozil example I ignore, they’ve clearly been on it and are fine.

Thanks! I guess im jus always afraid of harm down the line and it tracing back to us

 

[BidingMyTime]

Where are you getting that info? Every time I have researched it I have seen that it is contraindicated and personally I have always refused to dispense them together, especially since adding a fibrate to a statin hasn't been shown to improve CV outcomes.

Personal experience. Doctors in my area, or maybe just 1 doctor, seem to think it works. If someone has sky-high cholesterol & triglycerides, out-of-control diabetes, refuses to follow dietary advice, can one fault a doctor for wanting to try something non-conventional. I'll say though, quite possibly the reason the doctor (or me) hasn't personally seen any adverse effects from this combo, is that the pt is probably non-compliant with both meds, just like they are all of their other meds.

 

[Sine Cura]

Prescribers can write for fenofibrate or fenofibric acid then as they don't present the PK liability of gemfibrozil, which hits hepatic OATP1B1 and renal OAT3


AHA Statement on Drug-Drug Interactions With Statins - American College of Cardiology

 

[CetiAlphaFive]

If you look at the package insert, it doesnt list it as a CI. Not sure why lexicomp does. It did that for fluoxetine and quetiapine (?) as well, then I called the dr and he said no it isnt CI... i checked the PI for both drugs and lo and behold it wasnt CI lol.

You do realize you can see the "detail" for why something is CI in whatever resource you're using, right?

 

[VA Hopeful Dr]

Where are you getting that info? Every time I have researched it I have seen that it is contraindicated and personally I have always refused to dispense them together, especially since adding a fibrate to a statin hasn't been shown to improve CV outcomes. How can we possibly say that the benefits outweigh the risks when there are no known benefits and the risks are serious and known?

I only ever use non-statins with very high triglycerides (so concern for pancreatitis) or in diabetics since triglyceride levels there do seem to have a CV impact.

 

[owlegrad]

The gemfibrozil example I ignore, they’ve clearly been on it and are fine.

LOL. Literally every interaction is fine until the patient experiences the adverse event. It's not like a single dose of both medications will automatically generate the adverse event immediately and therefor it will always be fine to give them together in the future, assuming the patient survives the first dose. What a bizarre 'logic'.

If you look at the package insert, it doesnt list it as a CI. Not sure why lexicomp does. It did that for fluoxetine and quetiapine (?) as well, then I called the dr and he said no it isnt CI... i checked the PI for both drugs and lo and behold it wasnt CI lol.

Which PI are you looking at? I just looked at simvastatin and it is listed as a CI. I am not going to go through each statin but I bet it is listed for most or all of them. Or perhaps not all of them have the CYP3A4 interaction?

 

[CetiAlphaFive]

Good thread

 

[VA Hopeful Dr]

LOL. Literally every interaction is fine until the patient experiences the adverse event. It's not like a single dose of both medications will automatically generate the adverse event immediately and therefor it will always be fine to give them together in the future, assuming the patient survives the first dose. What a bizarre 'logic'.



Which PI are you looking at? I just looked at simvastatin and it is listed as a CI. I am not going to go through each statin but I bet it is listed for most or all of them. Or perhaps not all of them have the CYP3A4 interaction?

There is some variety in this. Pravachol and Crestor specifically are not metabolized as much at 3A4 compared to the other statins.

Now that Crestor is generic I use those 2 almost exclusively for that reason.

 

[imcallingcorp]

LOL. Literally every interaction is fine until the patient experiences the adverse event. It's not like a single dose of both medications will automatically generate the adverse event immediately and therefor it will always be fine to give them together in the future, assuming the patient survives the first dose. What a bizarre 'logic'.



Which PI are you looking at? I just looked at simvastatin and it is listed as a CI. I am not going to go through each statin but I bet it is listed for most or all of them. Or perhaps not all of them have the CYP3A4 interaction?

Hey doc your patient big DCK has been on these 2 meds for years, but you know its contraindicated Im just so worried. DR GO F Urself responds oh my god u are correct lets change therapy- happened never.

 

[owlegrad]

Hey doc your patient big DCK has been on these 2 meds for years, but you know its contraindicated Im just so worried. DR GO F Urself responds oh my god u are correct lets change therapy- happened never.

I haven’t had any issues getting this combo stopped. “Hey doc these two medications are dangerous together and have shown no benefit when given together in trials. Do you want me to stop the gemfibrazole?”.

What is your reason for not wanting one stopped? Loss of script count? Scared of angering the almighty doctor? I can think of no good reason for you to not care about a CI except complacency or timidity.

 

[CetiAlphaFive]

There is some variety in this. Pravachol and Crestor specifically are not metabolized as much at 3A4 compared to the other statins.
Now that Crestor is generic I use those 2 almost exclusively for that reason.

Don't forget Potatovistatin

 

[imcallingcorp]

y

I haven’t had any issues getting this combo stopped. “Hey doc these two medications are dangerous together and have shown no benefit when given together in trials. Do you want me to stop the gemfibrazole?”.

What is your reason for not wanting one stopped? Loss of script count? Scared of angering the almighty doctor? I can think of no good reason for you to not care about a CI except complacency or timidity.

yea bro I was paying for my ferrari with the gemfibrazole reimbursement lol. not all contraindications are that serious and if someone has not had issues for a long time then there is no issue. just cuz you practice your job 1 way does *not* mean that everything you do is correct or the only way it should be done. Smarten up

 

[CetiAlphaFive]

y


yea bro I was paying for my ferrari with the gemfibrazole reimbursement lol. not all contraindications are that serious and if someone has not had issues for a long time then there is no issue. just cuz you practice your job 1 way does *not* mean that everything you do is correct or the only way it should be done. Smarten up

.
Yeah Owle.

Just because you don't like exposing yourself to needless liability by way of exposing your patients to unnecessary risk doesn't mean that everyone else isn't an idiot

 

[imcallingcorp]

.
Yeah Owle.

Just because you don't like exposing yourself to needless liability by way of exposing your patients to unnecessary risk doesn't mean that everyone else isn't an idiot

you know i really would love to smack you in real life. not punch I don’t wanna hurt you just smack make you my btch. mwa

 

[wucool33]

y


yea bro I was paying for my ferrari with the gemfibrazole reimbursement lol. not all contraindications are that serious and if someone has not had issues for a long time then there is no issue. just cuz you practice your job 1 way does *not* mean that everything you do is correct or the only way it should be done. Smarten up

rhabdomyolysis is actually a pretty legit and scary concern. What do you mean it's not that serious? I hated working with rph like you that would just let every go... what's the difference between you and a tech at that point?

 

[OpeningIndependent]

Where are you getting that info? Every time I have researched it I have seen that it is contraindicated and personally I have always refused to dispense them together, especially since adding a fibrate to a statin hasn't been shown to improve CV outcomes. How can we possibly say that the benefits outweigh the risks when there are no known benefits and the risks are serious and known?

I believe the old guidelines recommended them together, and a lot of doctors are old and got use to prescribing them together so they keep doing it.

 

[imcallingcorp]

rhabdomyolysis is actually a pretty legit and scary concern. What do you mean it's not that serious? I hated working with rph like you that would just let every go... what's the difference between you and a tech at that point?

Another genius of all geniuses. Maybe you and cetialpha can go on a date together and think of ways to save the world from contraindicated drug combos that patients have been on for years. I think you should make this your calling. Pick me up a coffee while your at it , you can also be my btch.

 

[imcallingcorp]

and on this note I am retiring from this useless forum again. I have concluded that pharmacy can NOT be saved. The vast majority of pharnacists are PuSSEes that spend their days worrying about the DEA, Board of Pharmacy, and lawsuits. There is no usefull posting or discussions on this forum , just a bunch of complaining and trolling and berating. So shot out to all my btches keep hooing and shot out to the haters just know that my new job is cozy real real cozy. Peace!

 

[VA Hopeful Dr]

Another genius of all geniuses. Maybe you and cetialpha can go on a date together and think of ways to save the world from contraindicated drug combos that patients have been on for years. I think you should make this your calling. Pick me up a coffee while your at it , you can also be my btch.

So you want to keep patients on a drug that doesn't improve outcomes and has a known serious risk?

Yeah, these other pharmacists are the problem...

 

[Sabril]

Insurance companies and PBMs should add more drugs to their list of bad drugs that at least require a PA. Gemfibrozil and some crappy statins need some good justification for prescribing. Less work for the lazy ones in us.

 

[CetiAlphaFive]

you know i really would love to smack you in real life. not punch I don’t wanna hurt you just smack make you my btch. mwa

The type of men who fantasize about that type of thing aren't the type who could.

Cheers, bud.

Enjoy your soy lattes, and taking your ball and going home yet again.

 

[Heroic Combo]

Given that gemfibrozil increases AUC of simvastatin acid by about 1.8 or 1.9 fold, I would be comfortable dispensing this combination when simvastatin is either at 10 or 20 mg and patient counseling. 40 mg simvastatin + gemfibrozil should carry about the same risk as simvastatin 80 mg by itself. In the case of the 40 mg dose, the patient can just be counseled with extra emphasis to report first signs of myopathy and I would be comfortable with this. Another study shows that overall occurrence of severe myopathy/rhabdo to be about 1/625 chances on this combination (factors in all simvastatin doses), and this is obviously dose dependent. The overall chances of this bad side effect at 10 and 20 mg would make this 1/625 chance be an even smaller chance.

 

[Sabril]

Given that gemfibrozil increases AUC of simvastatin acid by about 1.8 or 1.9 fold, I would be comfortable dispensing this combination when simvastatin is either at 10 or 20 mg and patient counseling. 40 mg simvastatin + gemfibrozil should carry about the same risk as simvastatin 80 mg by itself. In the case of the 40 mg dose, the patient can just be counseled with extra emphasis to report first signs of myopathy and I would be comfortable with this. Another study shows that overall occurrence of severe myopathy/rhabdo to be about 1/625 chances on this combination (factors in all simvastatin doses), and this is obviously dose dependent. The overall chances of this bad side effect at 10 and 20 mg would make this 1/625 chance be an even smaller chance.

interesting. do you know the frequency of rhabdo for rosuvastatin and atorvastatin in comparable fashion to simvastatin? I always think crestor has the lowest risk for rhabdo but never know the hard numbers behind it.

 

[Heroic Combo]

interesting. do you know the frequency of rhabdo for rosuvastatin and atorvastatin in comparable fashion to simvastatin? I always think crestor has the lowest risk for rhabdo but never know the hard numbers behind it.

I saw a study that showed 1.88 fold increase AUC with Crestor. But in theory rosuvastatin, pravastatin, and pitavastatin do not have 3A4 metabolism, which leads to less of an interaction. Therefore would be safer in combo with gemfib than other statins. I do know that Simvastatin has the highest incidence of rhabdo of all the statins. I would imagine atorvastatin to be similar or slightly less.

 

[MARX22]

You do realize you can see the "detail" for why something is CI in whatever resource you're using, right?

Yeah, I click the detail all the time. The reason I even bothered lookin at the PI was bc I called the dr to tell them the combo was CI, to which he said it isnt and to check the pi. After that I stopped relying on lexi as much. Still my go to resource, but PI to confirm if its a CI or not

 

[MARX22]

Where are you getting that info? Every time I have researched it I have seen that it is contraindicated and personally I have always refused to dispense them together, especially since adding a fibrate to a statin hasn't been shown to improve CV outcomes. How can we possibly say that the benefits outweigh the risks when there are no known benefits and the risks are serious and known?

Hey owlegrad... u say u refused to dispense the two together. How about if another rph okay’d the rx and now ur expected to refill.. what do u do then?

Here’s the link to gemfibrozil PI... nothing about statins being CI

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018422s048lbl.pdf



Simva PI on merck.com doesnt list gemfib under ci... its under warnings n precautions that it can have a higher risk but then in the table it shows it as CI... why wudnt it have been listed under the CI section?... then on accessfda pg 5 it says u can use the combo if benefit outweighs risk and do not exceed simva 10mg.. which means it isnt completely CI. Why the difference?! Which Pi do u follow?

Do rphs actually follow the recommendations of not exceeding such doses? Or like the simva amlodipine dose related ddi? It says avoid >20mg simva but i still see ppl dispensing >20 mg simva... are we supposed to take this as being a CI?

https://www.merck.com/product/usa/pi_circulars/z/zocor/zocor_pi.pdf


https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s078lbl.pdf

 

[cbrons]

Where are you getting that info? Every time I have researched it I have seen that it is contraindicated and personally I have always refused to dispense them together, especially since adding a fibrate to a statin hasn't been shown to improve CV outcomes. How can we possibly say that the benefits outweigh the risks when there are no known benefits and the risks are serious and known?

Fibrates aren't just used to improve CV outcomes. I use fibrates and statins together somewhat regularly for patients with pancreatitis-level hypertriglyceridemia (though I use fenofibrate and not gemfibrozil).

 

[PharFromNormal]

Hey owlegrad... u say u refused to dispense the two together. How about if another rph okay’d the rx and now ur expected to refill.. what do u do then?

Here’s the link to gemfibrozil PI... nothing about statins being CI

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018422s048lbl.pdf



Simva PI on merck.com doesnt list gemfib under ci... its under warnings n precautions that it can have a higher risk but then in the table it shows it as CI... why wudnt it have been listed under the CI section?... then on accessfda pg 5 it says u can use the combo if benefit outweighs risk and do not exceed simva 10mg.. which means it isnt completely CI. Why the difference?! Which Pi do u follow?

Do rphs actually follow the recommendations of not exceeding such doses? Or like the simva amlodipine dose related ddi? It says avoid >20mg simva but i still see ppl dispensing >20 mg simva... are we supposed to take this as being a CI?

https://www.merck.com/product/usa/pi_circulars/z/zocor/zocor_pi.pdf


https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s078lbl.pdf

I’m not sure why one pharmacist approving a previous fill means there’s any expectations on the next pharmacist to permit the fill of the refill... if a rph made an error on the original fill I sure as hell wouldn’t let the refill go out the door again if I caught the error... I’d prefer not be negligent myself in that situation... just because a pharmacist made a decision doesn’t mean you need to make the same one.

 

[Rockinacoustic]

Gemfibrozil is clearly listed as contraindicated in the Simvastatin package insert. Further, there are safer alternatives and indications beyond atherosclerotic disease as mentioned above.

I do not work outpatient and am spoiled with a full H&P, labs, and impressionable medical residents. However, trying to justify an unsafe drug combination because another pharmacist passed the buck is bad practice.

 

[VA Hopeful Dr]

Fibrates aren't just used to improve CV outcomes. I use fibrates and statins together somewhat regularly for patients with pancreatitis-level hypertriglyceridemia (though I use fenofibrate and not gemfibrozil).

My exact practice as well. I haven't used gemfibrozil since residency, you'll see if you haven't already that there are lots of doctors out there that don't keep up-to-date on the latest evidence (I don't mean to be condescending, but I couldn't remember where you were in terms of training. You're still a resident right?)

 

[MARX22]

Gemfibrozil is clearly listed as contraindicated in the Simvastatin package insert. Further, there are safer alternatives and indications beyond atherosclerotic disease as mentioned above.

I do not work outpatient and am spoiled with a full H&P, labs, and impressionable medical residents. However, trying to justify an unsafe drug combination because another pharmacist passed the buck is bad practice.

Definitely not trying to justify it... I was merely confused as to why the PI from merck and accessfda differed on gemfib and simva with one of them saying give it with no more than 10 mg simva and the other not listing it in CI but rather in a table later on. It would be better to switch to gemfib to fenofibrate or as someone else mentioned switch the statin to rosu. Still interacts with rosu but not as severely. Best bet is to switch to fenofib but if dr is adamant on keepin gemfib then i guess switch the statin.


The reason i mentioned other rphs was bc pts yell saying ive been on it for xyz years who are u to say I shouldnt take it, same with doctors. How do u guys respond? A lot of my friends just get an ok from the dr and dispense (although I always try to switch but sometimes drs are rude and just hang up... so im tempted to annotate and give)

Also, the dose limits of simvastatin and amlodipine and other combos... do u refuse to fill if it exceeds that maximum? Is that considered a contraindication when the PI says avoid simva >20 mg with amlod? The reason I ask is because things arent so black and white as one person mentioned about my question regarding montelukast 10mg for a child younger than 15, that they’d get an OK from the dr and discuss it with the pt/parent as well to counsel.

 

[CetiAlphaFive]

I got one changed today.
New Pt. Came in with Rx for Crestor 20 + Gem 600.

I called and got the story from the PA.
"He's been on gemfibrozil a long time, so that's OK. However, we keep having to change his statin because of leg pain!"

Ask if trig are still high after all this time
"240. We added it on to bring down his LDL"



Recommend D/Cing Gemfib, and initiating Zetia or at least changing the Gem to Tricor.
I explained the D/DI and why they've had tio change statins Q ~6 months.
They go with Tricor.

Easy

 

[Heroic Combo]

There is some variety in this. Pravachol and Crestor specifically are not metabolized as much at 3A4 compared to the other statins.

Now that Crestor is generic I use those 2 almost exclusively for that reason.

Definitely not trying to justify it... I was merely confused as to why the PI from merck and accessfda differed on gemfib and simva with one of them saying give it with no more than 10 mg simva and the other not listing it in CI but rather in a table later on. It would be better to switch to gemfib to fenofibrate or as someone else mentioned switch the statin to rosu. Still interacts with rosu but not as severely. Best bet is to switch to fenofib but if dr is adamant on keepin gemfib then i guess switch the statin.


The reason i mentioned other rphs was bc pts yell saying ive been on it for xyz years who are u to say I shouldnt take it, same with doctors. How do u guys respond? A lot of my friends just get an ok from the dr and dispense (although I always try to switch but sometimes drs are rude and just hang up... so im tempted to annotate and give)

Also, the dose limits of simvastatin and amlodipine and other combos... do u refuse to fill if it exceeds that maximum? Is that considered a contraindication when the PI says avoid simva >20 mg with amlod? The reason I ask is because things arent so black and white as one person mentioned about my question regarding montelukast 10mg for a child younger than 15, that they’d get an OK from the dr and discuss it with the pt/parent as well to counsel.

I saw a study where gemfib increased rosuvastatin AUC by 1.9x. and another study where gemfib increased simvastatin by 1.85x which is essentially the same.. If rosuvastatin in fact has less risk of rhabdo in general as a drug, maybe that explains the difference in the severity of interaction. It doesn't seem like the loss of the 3A4 component of the interaction is making much of a difference on drug concentrations.. so I am not sure if we can say the loss of 3A4 interaction is the reason for better outcomes compared with simvastatin for this reason. Maybe it is just the dynamics/other kinetics regarding the drug itself. Either way Simvastatin has the most risk for rhabdo in general.​

 

[owlegrad]

Definitely not trying to justify it... I was merely confused as to why the PI from merck and accessfda differed on gemfib and simva with one of them saying give it with no more than 10 mg simva and the other not listing it in CI but rather in a table later on. It would be better to switch to gemfib to fenofibrate or as someone else mentioned switch the statin to rosu. Still interacts with rosu but not as severely. Best bet is to switch to fenofib but if dr is adamant on keepin gemfib then i guess switch the statin.


The reason i mentioned other rphs was bc pts yell saying ive been on it for xyz years who are u to say I shouldnt take it, same with doctors. How do u guys respond? A lot of my friends just get an ok from the dr and dispense (although I always try to switch but sometimes drs are rude and just hang up... so im tempted to annotate and give)

Also, the dose limits of simvastatin and amlodipine and other combos... do u refuse to fill if it exceeds that maximum? Is that considered a contraindication when the PI says avoid simva >20 mg with amlod? The reason I ask is because things arent so black and white as one person mentioned about my question regarding montelukast 10mg for a child younger than 15, that they’d get an OK from the dr and discuss it with the pt/parent as well to counsel.

You have doctors hang up on you?! I don’t know what to you on that one. I would probably give the script back to the patient and let them know I can’t fill a script where the doctor won’t even discuss a medication related safety concern. Or if it is a refill like in your example I would just let the patient know I tried to reach the doctor but he hung up on me and I will not fill it under those conditions.

Also, when you call the doctor do you give a recommendation or do you just state your concern and leave it at that? Years ago I had a pharmacist tell me that the phone calls go a lot better when you have a resolution in mind and in my personal experience I have found that to be the case. Even in the cases where the doctor doesn’t take my recommendation I think it goes smoother just having something in mind. Plus if they have a reason for the combo, like the VA doc above mentioned, they shouldn’t mind explaining it.

If all you are looking for is “MD Aware and states ok to give”, why even bother calling? You’re just wasting your time and theirs. Just notate and move on. The doctor already gave the ok to give when they wrote the script after all.

 

[owlegrad]

Fibrates aren't just used to improve CV outcomes. I use fibrates and statins together somewhat regularly for patients with pancreatitis-level hypertriglyceridemia (though I use fenofibrate and not gemfibrozil).

The fact that you have a reason for the combo AND already use the safer alternative puts you far outside the norm/discussion for this particular issue. 😉

 

[MARX22]

You have doctors hang up on you?! I don’t know what to you on that one. I would probably give the script back to the patient and let them know I can’t fill a script where the doctor won’t even discuss a medication related safety concern. Or if it is a refill like in your example I would just let the patient know I tried to reach the doctor but he hung up on me and I will not fill it under those conditions.

Also, when you call the doctor do you give a recommendation or do you just state your concern and leave it at that? Years ago I had a pharmacist tell me that the phone calls go a lot better when you have a resolution in mind and in my personal experience I have found that to be the case. Even in the cases where the doctor doesn’t take my recommendation I think it goes smoother just having something in mind. Plus if they have a reason for the combo, like the VA doc above mentioned, they shouldn’t mind explaining it.

If all you are looking for is “MD Aware and states ok to give”, why even bother calling? You’re just wasting your time and theirs. Just notate and move on. The doctor already gave the ok to give when they wrote the script after all.

I work for an independent, and the owners make a fuss if u refuse to fill something, that’s why I’m even more adamant on getting meds changed. I’m not just looking for an ok, my friends do that which I never really made much sense of. I call with an alternative in mind for such scenarios (abx, idk what indication so the dr decides themselves) and it usually goes well. Sometimes the dr explains the pt has been on it and hasn’t had issues, and that’s when idk if i should notate and fill or still refuse?

I only experienced one extremely rude doctor who hang up lol he jus said “fill it dont argue with me” and hung up

 

[siliso]

You’re not the doctor. I take responsibility for the medications I prescribe, you fill them accurately and conscientiously. That’s the deal. If you want to make sure I meant it, please do, but don’t deprive my patients of the medications I have decided in good faith they should take.

 

[johnpharm01]

You have to have backbone. To borrow a phrase from the military "walk your post from flank to flank and take no **** from any rank" Your license and the responsibility that comes with it is yours alone. Not the owners, not the techs, not the drs, not other rphs. How do you know when to act? If something is contraindicated (as defined by the pi) or beyond usual practice, contact the doctor perhaps there is a legitimate reason why (based on medical justification). I have been out of school for a while and it can be a challenge to keep up, so I study for the site I practice in learning what is usual and what is highly unusual. But still I have caught some bad rxs i.e. using ampules orally after breaking them and without using a filter needle. Hang in there.

 

[VA Hopeful Dr]

You’re not the doctor. I take responsibility for the medications I prescribe, you fill them accurately and conscientiously. That’s the deal. If you want to make sure I meant it, please do, but don’t deprive my patients of the medications I have decided in good faith they should take.

I'm hoping this is sarcasm...

 

[johnpharm01]

You’re not the doctor. I take responsibility for the medications I prescribe, you fill them accurately and conscientiously. That’s the deal. If you want to make sure I meant it, please do, but don’t deprive my patients of the medications I have decided in good faith they should take.

No problem just document in writing on the rx the specific clinical risk that we (pharmacists) would call on and that in your professional judgement the benefits outweigh the risks. If not I'll have to call. If the issue still doesn't get resolved and the risk is great, especially if its outside the scope of the thousands of rxs that we fill readily for numerous other drs for the same conditions, it will have to wait until it does.

 

[owlegrad]

You’re not the doctor. I take responsibility for the medications I prescribe, you fill them accurately and conscientiously. That’s the deal. If you want to make sure I meant it, please do, but don’t deprive my patients of the medications I have decided in good faith they should take.

Lol ok “doctor”.

 

[Sine Cura]

don’t deprive my patients of the medications I have decided in good faith they should take.

LOL@"good faith"

The problem is not necessarily you but prescribers who don't want to learn jack **** about how drugs work even when a pharmacist attempts to contact them or have "good faith" but ****ing ignorance