eFlow

W

Wheezie

New member
I posted about this on another thread but I hope someone might have a suggestion for me. My doc denied the eFlow saying it wasn't proven safe for use with tobra. Debbie warned me before she died that he would deny me (we have the same doc), so I even went armed with all of Amy's statistics. Here is my question: before Tobi, I mixed my own tobra much like I currently do for the colistin. Back then, it was safe to mix a special formulation of tobra for inhalation so why suddenly is this dangerous? My doc's concern is that the levels may become toxic - too high a concentration or delivered too fast or something????

Anybody have any suggestions for convincing him to change his mind? I can't just go to another doc; I'm restricted by insurance. Thanks.
 
W

Wheezie

New member
I posted about this on another thread but I hope someone might have a suggestion for me. My doc denied the eFlow saying it wasn't proven safe for use with tobra. Debbie warned me before she died that he would deny me (we have the same doc), so I even went armed with all of Amy's statistics. Here is my question: before Tobi, I mixed my own tobra much like I currently do for the colistin. Back then, it was safe to mix a special formulation of tobra for inhalation so why suddenly is this dangerous? My doc's concern is that the levels may become toxic - too high a concentration or delivered too fast or something????

Anybody have any suggestions for convincing him to change his mind? I can't just go to another doc; I'm restricted by insurance. Thanks.
 
W

Wheezie

New member
I posted about this on another thread but I hope someone might have a suggestion for me. My doc denied the eFlow saying it wasn't proven safe for use with tobra. Debbie warned me before she died that he would deny me (we have the same doc), so I even went armed with all of Amy's statistics. Here is my question: before Tobi, I mixed my own tobra much like I currently do for the colistin. Back then, it was safe to mix a special formulation of tobra for inhalation so why suddenly is this dangerous? My doc's concern is that the levels may become toxic - too high a concentration or delivered too fast or something????

Anybody have any suggestions for convincing him to change his mind? I can't just go to another doc; I'm restricted by insurance. Thanks.
 
W

Wheezie

New member
I posted about this on another thread but I hope someone might have a suggestion for me. My doc denied the eFlow saying it wasn't proven safe for use with tobra. Debbie warned me before she died that he would deny me (we have the same doc), so I even went armed with all of Amy's statistics. Here is my question: before Tobi, I mixed my own tobra much like I currently do for the colistin. Back then, it was safe to mix a special formulation of tobra for inhalation so why suddenly is this dangerous? My doc's concern is that the levels may become toxic - too high a concentration or delivered too fast or something????

Anybody have any suggestions for convincing him to change his mind? I can't just go to another doc; I'm restricted by insurance. Thanks.
 
W

Wheezie

New member
I posted about this on another thread but I hope someone might have a suggestion for me. My doc denied the eFlow saying it wasn't proven safe for use with tobra. Debbie warned me before she died that he would deny me (we have the same doc), so I even went armed with all of Amy's statistics. Here is my question: before Tobi, I mixed my own tobra much like I currently do for the colistin. Back then, it was safe to mix a special formulation of tobra for inhalation so why suddenly is this dangerous? My doc's concern is that the levels may become toxic - too high a concentration or delivered too fast or something????

Anybody have any suggestions for convincing him to change his mind? I can't just go to another doc; I'm restricted by insurance. Thanks.
 
E

Emily65Roses

New member
Other than going with Amy's studies, I don't have much for you. I know she said more than once that the eFlow was FDA approved... I can't find it anywhere, but I don't think she'd make it up. Maybe you have it in your compilation of "Amy files."

As for the TOBI, I honestly don't know because TOBI is one I have never tolerated well, and therefore, don't use.

There was the whole recent fiasco with the Colistin (they were sending pre-mixed, it killed a woman, you can't pre-mix it anymore)... but as soon as they discovered the pre-mixed wasn't safe, my doc told me to just mix it like I had been doing. He said as long as I used half of what was in the bottle (I put in 6 mls of saline, and take out only 3 of the saline/Colistin mix**), it was safe to put into the eFlow. I don't know if that's to give me a less concentrated dose or what, but maybe that's a possibility with the TOBI? Using a partial dose?

<i>**I used to put 3 mls of liquid (saline and sterile water) into the Colistin and nebulize the whole thing. So my dosage is the same in mls from regular compressor to eFlow (3 mls and 3 mls)... but the Colistin itself is clearly more diluted in the eFlow instructions than it was when I had a regular neb. Maybe diluting it with more liquid makes it safer to use in the eFlow?</i>

Yeah, on this page, there are studies saying *fill in various CF med here* is safe or more efficient when used in the eFlow. I imagine you have this info already, but I thought I'd post it anyway.
<a target=_blank class=ftalternatingbarlinklarge href="http://blogs.cysticfibrosis.com/rss.cfm?catid=1977">eFlow info in Amy's blog</a>
 
E

Emily65Roses

New member
Other than going with Amy's studies, I don't have much for you. I know she said more than once that the eFlow was FDA approved... I can't find it anywhere, but I don't think she'd make it up. Maybe you have it in your compilation of "Amy files."

As for the TOBI, I honestly don't know because TOBI is one I have never tolerated well, and therefore, don't use.

There was the whole recent fiasco with the Colistin (they were sending pre-mixed, it killed a woman, you can't pre-mix it anymore)... but as soon as they discovered the pre-mixed wasn't safe, my doc told me to just mix it like I had been doing. He said as long as I used half of what was in the bottle (I put in 6 mls of saline, and take out only 3 of the saline/Colistin mix**), it was safe to put into the eFlow. I don't know if that's to give me a less concentrated dose or what, but maybe that's a possibility with the TOBI? Using a partial dose?

<i>**I used to put 3 mls of liquid (saline and sterile water) into the Colistin and nebulize the whole thing. So my dosage is the same in mls from regular compressor to eFlow (3 mls and 3 mls)... but the Colistin itself is clearly more diluted in the eFlow instructions than it was when I had a regular neb. Maybe diluting it with more liquid makes it safer to use in the eFlow?</i>

Yeah, on this page, there are studies saying *fill in various CF med here* is safe or more efficient when used in the eFlow. I imagine you have this info already, but I thought I'd post it anyway.
<a target=_blank class=ftalternatingbarlinklarge href="http://blogs.cysticfibrosis.com/rss.cfm?catid=1977">eFlow info in Amy's blog</a>
 
E

Emily65Roses

New member
Other than going with Amy's studies, I don't have much for you. I know she said more than once that the eFlow was FDA approved... I can't find it anywhere, but I don't think she'd make it up. Maybe you have it in your compilation of "Amy files."

As for the TOBI, I honestly don't know because TOBI is one I have never tolerated well, and therefore, don't use.

There was the whole recent fiasco with the Colistin (they were sending pre-mixed, it killed a woman, you can't pre-mix it anymore)... but as soon as they discovered the pre-mixed wasn't safe, my doc told me to just mix it like I had been doing. He said as long as I used half of what was in the bottle (I put in 6 mls of saline, and take out only 3 of the saline/Colistin mix**), it was safe to put into the eFlow. I don't know if that's to give me a less concentrated dose or what, but maybe that's a possibility with the TOBI? Using a partial dose?

<i>**I used to put 3 mls of liquid (saline and sterile water) into the Colistin and nebulize the whole thing. So my dosage is the same in mls from regular compressor to eFlow (3 mls and 3 mls)... but the Colistin itself is clearly more diluted in the eFlow instructions than it was when I had a regular neb. Maybe diluting it with more liquid makes it safer to use in the eFlow?</i>

Yeah, on this page, there are studies saying *fill in various CF med here* is safe or more efficient when used in the eFlow. I imagine you have this info already, but I thought I'd post it anyway.
<a target=_blank class=ftalternatingbarlinklarge href="http://blogs.cysticfibrosis.com/rss.cfm?catid=1977">eFlow info in Amy's blog</a>
 
E

Emily65Roses

New member
Other than going with Amy's studies, I don't have much for you. I know she said more than once that the eFlow was FDA approved... I can't find it anywhere, but I don't think she'd make it up. Maybe you have it in your compilation of "Amy files."

As for the TOBI, I honestly don't know because TOBI is one I have never tolerated well, and therefore, don't use.

There was the whole recent fiasco with the Colistin (they were sending pre-mixed, it killed a woman, you can't pre-mix it anymore)... but as soon as they discovered the pre-mixed wasn't safe, my doc told me to just mix it like I had been doing. He said as long as I used half of what was in the bottle (I put in 6 mls of saline, and take out only 3 of the saline/Colistin mix**), it was safe to put into the eFlow. I don't know if that's to give me a less concentrated dose or what, but maybe that's a possibility with the TOBI? Using a partial dose?

<i>**I used to put 3 mls of liquid (saline and sterile water) into the Colistin and nebulize the whole thing. So my dosage is the same in mls from regular compressor to eFlow (3 mls and 3 mls)... but the Colistin itself is clearly more diluted in the eFlow instructions than it was when I had a regular neb. Maybe diluting it with more liquid makes it safer to use in the eFlow?</i>

Yeah, on this page, there are studies saying *fill in various CF med here* is safe or more efficient when used in the eFlow. I imagine you have this info already, but I thought I'd post it anyway.
<a target=_blank class=ftalternatingbarlinklarge href="http://blogs.cysticfibrosis.com/rss.cfm?catid=1977">eFlow info in Amy's blog</a>
 
E

Emily65Roses

New member
Other than going with Amy's studies, I don't have much for you. I know she said more than once that the eFlow was FDA approved... I can't find it anywhere, but I don't think she'd make it up. Maybe you have it in your compilation of "Amy files."

As for the TOBI, I honestly don't know because TOBI is one I have never tolerated well, and therefore, don't use.

There was the whole recent fiasco with the Colistin (they were sending pre-mixed, it killed a woman, you can't pre-mix it anymore)... but as soon as they discovered the pre-mixed wasn't safe, my doc told me to just mix it like I had been doing. He said as long as I used half of what was in the bottle (I put in 6 mls of saline, and take out only 3 of the saline/Colistin mix**), it was safe to put into the eFlow. I don't know if that's to give me a less concentrated dose or what, but maybe that's a possibility with the TOBI? Using a partial dose?

<i>**I used to put 3 mls of liquid (saline and sterile water) into the Colistin and nebulize the whole thing. So my dosage is the same in mls from regular compressor to eFlow (3 mls and 3 mls)... but the Colistin itself is clearly more diluted in the eFlow instructions than it was when I had a regular neb. Maybe diluting it with more liquid makes it safer to use in the eFlow?</i>

Yeah, on this page, there are studies saying *fill in various CF med here* is safe or more efficient when used in the eFlow. I imagine you have this info already, but I thought I'd post it anyway.
<a target=_blank class=ftalternatingbarlinklarge href="http://blogs.cysticfibrosis.com/rss.cfm?catid=1977">eFlow info in Amy's blog</a>
 
I

Imogene

Administrator
I met with the president of PARI e-FLOW last April.

He told me the e-Flow device is in clinical trials with the new Gilead drug and is due to be approved by the FDA in 2008.

It is my understanding that the e-Flow device has to be approved by the FDA for each drug it is used with through a clinical trial.

This is a long process.


Please check this information with your CF center or with your CF doctor.

Jeanne
 
I

Imogene

Administrator
I met with the president of PARI e-FLOW last April.

He told me the e-Flow device is in clinical trials with the new Gilead drug and is due to be approved by the FDA in 2008.

It is my understanding that the e-Flow device has to be approved by the FDA for each drug it is used with through a clinical trial.

This is a long process.


Please check this information with your CF center or with your CF doctor.

Jeanne
 
I

Imogene

Administrator
I met with the president of PARI e-FLOW last April.

He told me the e-Flow device is in clinical trials with the new Gilead drug and is due to be approved by the FDA in 2008.

It is my understanding that the e-Flow device has to be approved by the FDA for each drug it is used with through a clinical trial.

This is a long process.


Please check this information with your CF center or with your CF doctor.

Jeanne
 
I

Imogene

Administrator
I met with the president of PARI e-FLOW last April.

He told me the e-Flow device is in clinical trials with the new Gilead drug and is due to be approved by the FDA in 2008.

It is my understanding that the e-Flow device has to be approved by the FDA for each drug it is used with through a clinical trial.

This is a long process.


Please check this information with your CF center or with your CF doctor.

Jeanne
 
I

Imogene

Administrator
I met with the president of PARI e-FLOW last April.

He told me the e-Flow device is in clinical trials with the new Gilead drug and is due to be approved by the FDA in 2008.

It is my understanding that the e-Flow device has to be approved by the FDA for each drug it is used with through a clinical trial.

This is a long process.


Please check this information with your CF center or with your CF doctor.

Jeanne
 
M

mom2lillian

New member
Jeanne-the approval process through the FDA is for the device itself so it is now an approved device it doenst have to be approved with each medication.

However, that being said, many medications are approved or studied with certian delivery devices thus being where the confusion lies. TOBI was rx with conditions for what device to use sicne it is an antibiotic and you want to ensure your dosage is fairly consistent.

Becuase of the e-flows superior performance in delivery I believe that most new drugs are doing their studies using it and since it is so superior will probably write it into their rx instructions so as to ensure the same dose is delivered.



To Breezy-my doctor is having hte same issue with the e-flow. I finally wore him down enough that he is willing to rx me one but NOT let me use IV tobra as opposed to TOBI. He wants me still on regular TOBI since they have not rpoven the dosage equivalencies. THey have done some studies but not sufficient in most's eyes. He wants em to to TOBI with e-flow which I am researching right now because I think it will be too much TOBI and there has also been the mention that TOBI might clog my head.

You could try asking to just take your other meds with e-flow and see if that goes over. That is what I might try doing but I have to figure out if the CFSource will give me the eflow for only xopenex pulmozyme and hts.
 
M

mom2lillian

New member
Jeanne-the approval process through the FDA is for the device itself so it is now an approved device it doenst have to be approved with each medication.

However, that being said, many medications are approved or studied with certian delivery devices thus being where the confusion lies. TOBI was rx with conditions for what device to use sicne it is an antibiotic and you want to ensure your dosage is fairly consistent.

Becuase of the e-flows superior performance in delivery I believe that most new drugs are doing their studies using it and since it is so superior will probably write it into their rx instructions so as to ensure the same dose is delivered.



To Breezy-my doctor is having hte same issue with the e-flow. I finally wore him down enough that he is willing to rx me one but NOT let me use IV tobra as opposed to TOBI. He wants me still on regular TOBI since they have not rpoven the dosage equivalencies. THey have done some studies but not sufficient in most's eyes. He wants em to to TOBI with e-flow which I am researching right now because I think it will be too much TOBI and there has also been the mention that TOBI might clog my head.

You could try asking to just take your other meds with e-flow and see if that goes over. That is what I might try doing but I have to figure out if the CFSource will give me the eflow for only xopenex pulmozyme and hts.
 
M

mom2lillian

New member
Jeanne-the approval process through the FDA is for the device itself so it is now an approved device it doenst have to be approved with each medication.

However, that being said, many medications are approved or studied with certian delivery devices thus being where the confusion lies. TOBI was rx with conditions for what device to use sicne it is an antibiotic and you want to ensure your dosage is fairly consistent.

Becuase of the e-flows superior performance in delivery I believe that most new drugs are doing their studies using it and since it is so superior will probably write it into their rx instructions so as to ensure the same dose is delivered.



To Breezy-my doctor is having hte same issue with the e-flow. I finally wore him down enough that he is willing to rx me one but NOT let me use IV tobra as opposed to TOBI. He wants me still on regular TOBI since they have not rpoven the dosage equivalencies. THey have done some studies but not sufficient in most's eyes. He wants em to to TOBI with e-flow which I am researching right now because I think it will be too much TOBI and there has also been the mention that TOBI might clog my head.

You could try asking to just take your other meds with e-flow and see if that goes over. That is what I might try doing but I have to figure out if the CFSource will give me the eflow for only xopenex pulmozyme and hts.
 
M

mom2lillian

New member
Jeanne-the approval process through the FDA is for the device itself so it is now an approved device it doenst have to be approved with each medication.

However, that being said, many medications are approved or studied with certian delivery devices thus being where the confusion lies. TOBI was rx with conditions for what device to use sicne it is an antibiotic and you want to ensure your dosage is fairly consistent.

Becuase of the e-flows superior performance in delivery I believe that most new drugs are doing their studies using it and since it is so superior will probably write it into their rx instructions so as to ensure the same dose is delivered.



To Breezy-my doctor is having hte same issue with the e-flow. I finally wore him down enough that he is willing to rx me one but NOT let me use IV tobra as opposed to TOBI. He wants me still on regular TOBI since they have not rpoven the dosage equivalencies. THey have done some studies but not sufficient in most's eyes. He wants em to to TOBI with e-flow which I am researching right now because I think it will be too much TOBI and there has also been the mention that TOBI might clog my head.

You could try asking to just take your other meds with e-flow and see if that goes over. That is what I might try doing but I have to figure out if the CFSource will give me the eflow for only xopenex pulmozyme and hts.
 
M

mom2lillian

New member
Jeanne-the approval process through the FDA is for the device itself so it is now an approved device it doenst have to be approved with each medication.

However, that being said, many medications are approved or studied with certian delivery devices thus being where the confusion lies. TOBI was rx with conditions for what device to use sicne it is an antibiotic and you want to ensure your dosage is fairly consistent.

Becuase of the e-flows superior performance in delivery I believe that most new drugs are doing their studies using it and since it is so superior will probably write it into their rx instructions so as to ensure the same dose is delivered.



To Breezy-my doctor is having hte same issue with the e-flow. I finally wore him down enough that he is willing to rx me one but NOT let me use IV tobra as opposed to TOBI. He wants me still on regular TOBI since they have not rpoven the dosage equivalencies. THey have done some studies but not sufficient in most's eyes. He wants em to to TOBI with e-flow which I am researching right now because I think it will be too much TOBI and there has also been the mention that TOBI might clog my head.

You could try asking to just take your other meds with e-flow and see if that goes over. That is what I might try doing but I have to figure out if the CFSource will give me the eflow for only xopenex pulmozyme and hts.
 
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