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Post by liane on Aug 2, 2014 14:08:27 GMT -5
Off licence and off label prescribing in children: litigation fears for physicians adc.bmj.com/content/90/suppl_1/i17.fullThis is a British paper, but it highlights off-label pediatric use of meds. Bottom line, so many drugs have not been tested in the pediatric population, that physicians frequently must go off-label to properly care for these patients. Afrezza is so convenient and relatively safe that I see it being used in the T1 pediatrics long before any study is performed.
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Post by thekindaguyiyam on Aug 2, 2014 14:27:40 GMT -5
good post. I'd had that children have an obvious greater aversion to needles than adults. technospere is a far superior way to have a lesser emotional affect on kids.
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Post by hammer on Aug 2, 2014 14:31:22 GMT -5
Off licence and off label prescribing in children: litigation fears for physicians adc.bmj.com/content/90/suppl_1/i17.fullThis is a British paper, but it highlights off-label pediatric use of meds. Bottom line, so many drugs have not been tested in the pediatric population, that physicians frequently must go off-label to properly care for these patients. Afrezza is so convenient and relatively safe that I see it being used in the T1 pediatrics long before any study is performed. Liane, You are so correct! You may not see it with the very young but physicians will use it on teens and preteens. As far as off label goes, I think you will be seeing some physicians using Afrezza as first in T2's as well.
Anecdotally, I see a lot of patients who are in their teens, and a fair amount of them are T1's. I always bring up Afrezza to both them and their parents. It is always welcomed with eyes widening. Have only met one elderly man who could care less, but that's why he was T2 along with a list of other medical problems. Just this week discussing this with a teenage T1, the mother said, "her endo is always trying to get her to try new therapies he will try this."
Its going to sell well.
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Post by alcc on Aug 2, 2014 14:47:22 GMT -5
Why would use in children be off-label? The label is silent on this, as I recall.
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Post by liane on Aug 2, 2014 16:14:15 GMT -5
Afrezza has only been tested in patients over age 18. It is unknown if it is safe and effective in the pediatric population. The label does not specifically prohibit its use in peds, but neither does it condone it. Therefore, it would be considered off-label in this population.
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Post by nialla44 on Aug 2, 2014 16:46:20 GMT -5
You’re losing me here. If the label does not mention peds one way or another as in adults one way or another (except for smokers, etc.) then prescribing it would not be off label. I suppose because the trials were conducted on patients no younger than 18, then why would it not mention that fact on the label and warn against it. I’m assuming here, if it is not mentioned on the label then the FDA is OK with that.
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Post by liane on Aug 2, 2014 17:00:10 GMT -5
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Post by liane on Aug 2, 2014 17:08:58 GMT -5
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Post by nialla44 on Aug 2, 2014 17:27:52 GMT -5
You don't have to answer, I'm probably a little too picky and you're probably correct but, if the label does not specifically mention peds as being unapproved then isn't it logical to assume that they are approved? The FDA is so good in making sure all the do's and don'ts are listed to a fault, then it is either approved or this is labeling phobias. I see even if the age group were listed as unapproved it is still legal for doc.'s to prescribe Afrezza off label.
"Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, unapproved dosage, or unapproved form of administration."
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Post by 4Balance on Aug 2, 2014 17:35:14 GMT -5
This is what the Prescribing Information says about pediatric patients:
"8.4 Pediatric Use AFREZZA has not been studied in patients younger than 18 years of age."
It's good to know that Afrezza is not contraindicated for patients younger than 18...I had inadvertently fallen into that trap...probably due to conversations concerning it not being "recommended" for these young people.
But, I suppose, if it is possible to convert, say, Humalog dosing to Afrezza dosing, that's most (if not all) you really need.
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Post by liane on Aug 2, 2014 17:40:57 GMT -5
The label specifically states:
"AFREZZA® is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus."
While it does not prohibit use in peds (which is good), it is still considered off-label - because it's not been studied in them.
Picky - maybe; but that's OK. The FDA is also picky with their label which is specific to the group studied. Like I said, off-label is done all the time and it's perfectly legal.
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Post by nialla44 on Aug 2, 2014 17:42:40 GMT -5
Thanks for the reply and I agree.
Ni
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Post by 4Balance on Aug 2, 2014 17:43:50 GMT -5
You don't have to answer, I'm probably a little too picky and you're probably correct but, if the label does not specifically mention peds as being unapproved then isn't it logical to assume that they are approved? The FDA is so good in making sure all the do's and don'ts are listed to a fault, then it is either approved or this is labeling phobias. I see even if the age group were listed as unapproved it is still legal for doc.'s to prescribe Afrezza off label. "Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, unapproved dosage, or unapproved form of administration." The way I see it, Nialla44, the FDA only approves a use after some form of scientific evidence is presented...like a study. Since MNKD has not performed studies on adolescents or younger children, the FDA is unable to approve the use of Afrezza in those populations. The label does not explicitly say Afrezza in not approved...it only implies that...which, to me, tells doctors, "caveat emptor." So, what's the big deal? In this country there might be doctors who have a very conservative approach to their practice, and would not take the risk of an off-label prescription. Secondly, insurance companies might be loathe to cover such usage.
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Post by alcc on Aug 2, 2014 17:48:01 GMT -5
Really? That logic seems odd to me. If it hasn't been tested on Asian women between 20-30, would its use in that population be deemed off label? Or is there an FDA sanctioned protocol re trial subject coverage which permits extrapolation of label in some cases but not others? I am not trying to be argumentative, only seeking clarification re what constitutes off label. I have always assumed that off-label usage applies to treatment of a disease for which the drug had not been tested, e.g. Avastin for AMD.
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Post by 4Balance on Aug 2, 2014 17:55:00 GMT -5
Really? That logic seems odd to me. If it hasn't been tested on Asian women between 20-30, would its use in that population be deemed off label? Or is there an FDA sanctioned protocol re trial subject coverage which permits extrapolation of label in some cases but not others? I am not trying to be argumentative, only seeking clarification re what constitutes off label. I have always assumed that off-label usage applies to treatment of a disease for which the drug had not been tested, e.g. Avastin for AMD. Would there be a reason to suspect differing reactions among ethnic groups? No. Hence, no need to test that specific population. I think studies are designed to test reactions, within the populations seen to offer varying reactions. We know kids can be ultra-sensitive to certain drugs, so there are minimum age limits associated with "approved" usages.
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