Re: change in self-administration

[Guest guest]

This trend is truly disturbing. My hope is that I do not get caught up

in this, what I believe to be completely inappropriate and unnecessary

trend. Has anyone actually seen a written statement from the FDA that

they are " requiring " these shots to be given at the Dr's office?

Ron

On Jun 12, 2008, at 10:31 AM, pyle456 wrote:

> Accredo-Novafactor is now telling its patients that the FDA is making

> them strongly encourage self-injectors to get injected at the doctor's

> office, to the point that I had to pretty much promise the pharmacist

> that I'd do so - after self-injecting for almost 5 years.

>

> I told the pharmacist about this group and that there's only 3 of us

> self-injecting. She said there had been a recent trend of docs

> starting to allow self-injecting and at-home deliveries and she said

> she guessed the FDA wanted to stop that.

>

> The pharmicist and I discussed some holes in the FDA black box

> provisions and recommendation. 1) that we don't understand why the

> advisory did not include a recommendation that patients be given EPI

> pens. 2) the fact that the Xolair population is highly allergic and

> how do you determine that Xolair caused an anaphylactic reaction hours

> later AFTER the patient has been exposed to so many other things. 3)

> whether or not it was based on patient direct reports or physician and

> ER reports - that was her question, and it's a good one.

>

> So I called and left a message for my doc today about this. What a

> pain. Maybe they'll let me come give myself my shots in the office

> when I want to.

>

> Addy

> Group co-owner

>

>

>

[Guest guest]

Well, there go the chances of my doctor changing his mind about

letting me self inject. Sigh!

Doug

[Guest guest]

Here is a worse problem if the FDA mandates a doctor injects.

Insurance companies can change the coverage to patients. I can only

speak for Blue Cross of California, but Xolair would fall under

the " medical plan " not " pharmacy plan " if injected at a doctor's

office. Under BCC a medical plan charge for Xolair is 20% of the cost

of the drug, not a co-pay.

>

> Well, there go the chances of my doctor changing his mind about

> letting me self inject. Sigh!

>

> Doug

>

[Guest guest]

I haven't seen anything is writing but my dr office said our ins. co. requires

it to be given in the office. As of now I just pay my office co pay. I

personally rather have it done in the office because I don't think I could give

my self a shot. I hope it doesnt change for all who self administer now. Jean

---- Carpenter <cowtrail@...> wrote:

> This trend is truly disturbing. My hope is that I do not get caught up

> in this, what I believe to be completely inappropriate and unnecessary

> trend. Has anyone actually seen a written statement from the FDA that

> they are " requiring " these shots to be given at the Dr's office?

>

> Ron

>

> On Jun 12, 2008, at 10:31 AM, pyle456 wrote:

>

> > Accredo-Novafactor is now telling its patients that the FDA is making

> > them strongly encourage self-injectors to get injected at the doctor's

> > office, to the point that I had to pretty much promise the pharmacist

> > that I'd do so - after self-injecting for almost 5 years.

> >

> > I told the pharmacist about this group and that there's only 3 of us

> > self-injecting. She said there had been a recent trend of docs

> > starting to allow self-injecting and at-home deliveries and she said

> > she guessed the FDA wanted to stop that.

> >

> > The pharmicist and I discussed some holes in the FDA black box

> > provisions and recommendation. 1) that we don't understand why the

> > advisory did not include a recommendation that patients be given EPI

> > pens. 2) the fact that the Xolair population is highly allergic and

> > how do you determine that Xolair caused an anaphylactic reaction hours

> > later AFTER the patient has been exposed to so many other things. 3)

> > whether or not it was based on patient direct reports or physician and

> > ER reports - that was her question, and it's a good one.

> >

> > So I called and left a message for my doc today about this. What a

> > pain. Maybe they'll let me come give myself my shots in the office

> > when I want to.

> >

> > Addy

> > Group co-owner

> >

> >

> >

>

>

>

>

[Guest guest]

I have BCBS of Alabama and my Xolair is covered under medical instead

of pharmacy. I am very glad that it is as it is covered 100% with no

copay/deductibles and the charge for the doc's office giving the shot

is also covered 100% with no copay/deductible. If it was covered as

a pharmacy benefit it would have a $200 deductible then i'd pay 20%

until i met my out-of-pocket maximum (luckily that is only $600 right

now) and the office " visit " to get my shot would have the $30 copay

attached instead of nothing.

> >

> > Well, there go the chances of my doctor changing his mind about

> > letting me self inject. Sigh!

> >

> > Doug

> >

>

[Guest guest]

After reading through this thread ... it sounds like we are all

getting variations on the theme (in a manner of speaking) on what is

going on. In some cases the patient(s) are told there is an FDA

implication, others it's insurance, and others it's the individual

doc. In my case it was Genentech - or that's what I was told by

CuraScript. Due to the non-standardization of the responses it

sounds like it's a rather political situation which it had been all

along but with even tighter politics. No one has ever died from this

drug and severe or serious reactions are very rare. After 15 months

on X I feel it's absurd - a one-size-fits-all approach. Perhaps for

newbies it's a consideration but not for everyone. It would

ultimately mean more hit-and-miss treatment for me and presumably

less benefit. It takes quite a while to mix and inject X - I allow

at least an hour and a half at home - so even if I mixed and injected

myself in doc's office it would still be time consuming. As for

waiting after the 3 shots ... no way. Of course, if something

happened and I reacted I would be driving home and more likely to be

injured so it really would be better if I just stayed home to do it.

I'll know in a few days what's going to happen in my case. It really

doesn't make sense ... something going on that we're not being told.

>

> Accredo-Novafactor is now telling its patients that the FDA is

making

> them strongly encourage self-injectors to get injected at the

doctor's

> office, to the point that I had to pretty much promise the

pharmacist

> that I'd do so - after self-injecting for almost 5 years.

>

> I told the pharmacist about this group and that there's only 3 of us

> self-injecting. She said there had been a recent trend of docs

> starting to allow self-injecting and at-home deliveries and she said

> she guessed the FDA wanted to stop that.

>

> The pharmicist and I discussed some holes in the FDA black box

> provisions and recommendation. 1) that we don't understand why the

> advisory did not include a recommendation that patients be given EPI

> pens. 2) the fact that the Xolair population is highly allergic and

> how do you determine that Xolair caused an anaphylactic reaction

hours

> later AFTER the patient has been exposed to so many other things.

3)

> whether or not it was based on patient direct reports or physician

and

> ER reports - that was her question, and it's a good one.

>

> So I called and left a message for my doc today about this. What a

> pain. Maybe they'll let me come give myself my shots in the office

> when I want to.

>

> Addy

> Group co-owner

>

[Guest guest]

Your doctor is behind the times a bit IT IS NOT PERMITTED FOR ANYONE TO GIVE

THEMSELVES THE XOLAIR SHOT ANY LONGER.

& gt;

& gt; & gt; Accredo-Novafactor is now telling its patients that the FDA is making

& gt; & gt; them strongly encourage self-injectors to get injected at the doctor's

& gt; & gt; office, to the point that I had to pretty much promise the pharmacist

& gt; & gt; that I'd do so - after self-injecting for almost 5 years.

& gt; & gt;

& gt; & gt; I told the pharmacist about this group and that there's only 3 of us

& gt; & gt; self-injecting. She said there had been a recent trend of docs

& gt; & gt; starting to allow self-injecting and at-home deliveries and she said

& gt; & gt; she guessed the FDA wanted to stop that.

& gt; & gt;

& gt; & gt; The pharmicist and I discussed some holes in the FDA black box

& gt; & gt; provisions and recommendation. 1) that we don't understand why the

& gt; & gt; advisory did not include a recommendation that patients be given EPI

& gt; & gt; pens. 2) the fact that the Xolair population is highly allergic and

& gt; & gt; how do you determine that Xolair caused an anaphylactic reaction hours

& gt; & gt; later AFTER the patient has been exposed to so many other things. 3)

& gt; & gt; whether or not it was based on patient direct reports or physician and

& gt; & gt; ER reports - that was her question, and it's a good one.

& gt; & gt;

& gt; & gt; So I called and left a message for my doc today about this. What a

& gt; & gt; pain. Maybe they'll let me come give myself my shots in the office

& gt; & gt; when I want to.

& gt; & gt;

& gt; & gt; Addy

& gt; & gt; Group co-owner

& gt; & gt;

& gt; & gt;

& gt; & gt;

& gt;

& gt;

& gt;

& gt;

[Guest guest]

I believe you are incorrect with that statement. To my knowledge there have

been no

revisions to the FDA " black box warning " . And, the warning is not a prohibition

but an

advisement.

> & gt;

> & gt; & gt; Accredo-Novafactor is now telling its patients that the FDA is

making

> & gt; & gt; them strongly encourage self-injectors to get injected at the

doctor's

> & gt; & gt; office, to the point that I had to pretty much promise the

pharmacist

> & gt; & gt; that I'd do so - after self-injecting for almost 5 years.

> & gt; & gt;

> & gt; & gt; I told the pharmacist about this group and that there's only 3 of us

> & gt; & gt; self-injecting. She said there had been a recent trend of docs

> & gt; & gt; starting to allow self-injecting and at-home deliveries and she said

> & gt; & gt; she guessed the FDA wanted to stop that.

> & gt; & gt;

> & gt; & gt; The pharmicist and I discussed some holes in the FDA black box

> & gt; & gt; provisions and recommendation. 1) that we don't understand why the

> & gt; & gt; advisory did not include a recommendation that patients be given EPI

> & gt; & gt; pens. 2) the fact that the Xolair population is highly allergic and

> & gt; & gt; how do you determine that Xolair caused an anaphylactic reaction

hours

> & gt; & gt; later AFTER the patient has been exposed to so many other things. 3)

> & gt; & gt; whether or not it was based on patient direct reports or physician

and

> & gt; & gt; ER reports - that was her question, and it's a good one.

> & gt; & gt;

> & gt; & gt; So I called and left a message for my doc today about this. What a

> & gt; & gt; pain. Maybe they'll let me come give myself my shots in the office

> & gt; & gt; when I want to.

> & gt; & gt;

> & gt; & gt; Addy

> & gt; & gt; Group co-owner

> & gt; & gt;

> & gt; & gt;

> & gt; & gt;

> & gt;

> & gt;

> & gt;

> & gt;

[Guest guest]

Please tell me what FEDERAL LAW prohibits my doctor from allowing me

to self-inject Xolair? I had a lengthy conversation with a

pharmacist at Accredo Novafactor on Thursday, June 12, who told me

that there was no law prohibiting such and that she could only

encourage me to have a medical provider provide the injection. My

doctor says I can do what I want. I've read all the research, I know

what my medical rights are. If there is a new federal law

prohibiting me from self-administration, please cite it for me.

Thank you.

Addy

Group co-owner

Duke Graduate

Former paralegal

well-informed asthmatic for 37 years

> & gt;

> & gt; & gt; Accredo-Novafactor is now telling its patients that the

FDA is making

> & gt; & gt; them strongly encourage self-injectors to get injected at

the doctor's

> & gt; & gt; office, to the point that I had to pretty much promise

the pharmacist

> & gt; & gt; that I'd do so - after self-injecting for almost 5 years.

> & gt; & gt;

> & gt; & gt; I told the pharmacist about this group and that there's

only 3 of us

> & gt; & gt; self-injecting. She said there had been a recent trend of

docs

> & gt; & gt; starting to allow self-injecting and at-home deliveries

and she said

> & gt; & gt; she guessed the FDA wanted to stop that.

> & gt; & gt;

> & gt; & gt; The pharmicist and I discussed some holes in the FDA

black box

> & gt; & gt; provisions and recommendation. 1) that we don't

understand why the

> & gt; & gt; advisory did not include a recommendation that patients

be given EPI

> & gt; & gt; pens. 2) the fact that the Xolair population is highly

allergic and

> & gt; & gt; how do you determine that Xolair caused an anaphylactic

reaction hours

> & gt; & gt; later AFTER the patient has been exposed to so many other

things. 3)

> & gt; & gt; whether or not it was based on patient direct reports or

physician and

> & gt; & gt; ER reports - that was her question, and it's a good one.

> & gt; & gt;

> & gt; & gt; So I called and left a message for my doc today about

this. What a

> & gt; & gt; pain. Maybe they'll let me come give myself my shots in

the office

> & gt; & gt; when I want to.

> & gt; & gt;

> & gt; & gt; Addy

> & gt; & gt; Group co-owner

> & gt; & gt;

> & gt; & gt;

> & gt; & gt;

> & gt;

> & gt;

> & gt;

> & gt;

[Guest guest]

Is there a source for this information?

> & gt;

> & gt; & gt; Accredo-Novafactor is now telling its patients that the

FDA is making

> & gt; & gt; them strongly encourage self-injectors to get injected at

the doctor's

> & gt; & gt; office, to the point that I had to pretty much promise

the pharmacist

> & gt; & gt; that I'd do so - after self-injecting for almost 5 years.

> & gt; & gt;

> & gt; & gt; I told the pharmacist about this group and that there's

only 3 of us

> & gt; & gt; self-injecting. She said there had been a recent trend of

docs

> & gt; & gt; starting to allow self-injecting and at-home deliveries

and she said

> & gt; & gt; she guessed the FDA wanted to stop that.

> & gt; & gt;

> & gt; & gt; The pharmicist and I discussed some holes in the FDA

black box

> & gt; & gt; provisions and recommendation. 1) that we don't

understand why the

> & gt; & gt; advisory did not include a recommendation that patients

be given EPI

> & gt; & gt; pens. 2) the fact that the Xolair population is highly

allergic and

> & gt; & gt; how do you determine that Xolair caused an anaphylactic

reaction hours

> & gt; & gt; later AFTER the patient has been exposed to so many other

things. 3)

> & gt; & gt; whether or not it was based on patient direct reports or

physician and

> & gt; & gt; ER reports - that was her question, and it's a good one.

> & gt; & gt;

> & gt; & gt; So I called and left a message for my doc today about

this. What a

> & gt; & gt; pain. Maybe they'll let me come give myself my shots in

the office

> & gt; & gt; when I want to.

> & gt; & gt;

> & gt; & gt; Addy

> & gt; & gt; Group co-owner

> & gt; & gt;

> & gt; & gt;

> & gt; & gt;

> & gt;

> & gt;

> & gt;

> & gt;