quality control issues?
was wondering if anyone thinks they may have had problems with byetta pens
over the summer months.
i may have as the new pens i have are working fabulously but over the summer
i am not so sure. i plan to contact the makers and bring this to their
attention. i had a pen replaced by them in may but question if others have
had pens they thought suddenly weren’t working.
i don’t think this is the fault of byetta but probably the pharmacies. more
specifically, how the pharms get the meds. i’m guessing that the walgreen’s
i get my script from gets the byetta on the same truck as they get tampax,
kleenex, pills etc. who knows how long or at what temp the meds are kept
while being transported!
i love the lizard spit and it is working now but i want to know what is
going on with the summer ones.
jodi
July 26th, 2005 at 12:40 am
I think the pen I used last month may not have worked properly. Just didn’t
seem to have any effect at all when I used it. However, I have already thrown
it away and the newer one seems some better. As I recall they were not the same
dates.
Also, I think you are right. The pens are not always refrigerated the same. I
stood at my pharmacys desk one day and the small refrigerator door stood open
for more than 15 minutes and everyone was doing their own thing back behind the
counter. I didn’t say anything and soon the pharmacy manager came by and closed
it. He was not the one that left it open. I was having thoughts about using
mailorder but in the summertime I doubt that would be any different. Any
opinions on that one?
Later, wb
July 26th, 2005 at 3:03 am
i avoid mail order for all my insulin and byetta. i had UPS bring me a
frozen supply of 8 bottles of lantus once. boxes are clearly marked keep
refrigerated, not keep frozen. they have no clue how it happened but who
knows.
jodi
I think the pen I used last month may not have worked properly. Just didn’t
seem to have any effect at all when I used it. However, I have already
thrown it away and the newer one seems some better. As I recall they were
not the same dates.
Also, I think you are right. The pens are not always refrigerated the same.
I stood at my pharmacys desk one day and the small refrigerator door stood
open for more than 15 minutes and everyone was doing their own thing back
behind the counter. I didn’t say anything and soon the pharmacy manager
came by and closed it. He was not the one that left it open. I was having
thoughts about using mailorder but in the summertime I doubt that would be
any different. Any opinions on that one?
Later, wb
July 26th, 2005 at 1:25 pm
Actually, most pharmacies get a separate delivery on usually a daily basis and
the drugs that need to be refrigerated do come in cold packs. Because drugs
delivered to pharmacies are controlled (need a scrip) the chain of possession is
controlled. So, only the tech that delivers the drugs and those who work in the
pharmacy handle the drugs.
was wondering if anyone thinks they may have had problems with byetta pens
over the summer months.
i may have as the new pens i have are working fabulously but over the summer
i am not so sure. i plan to contact the makers and bring this to their
attention. i had a pen replaced by them in may but question if others have
had pens they thought suddenly weren’t working.
i don’t think this is the fault of byetta but probably the pharmacies. more
specifically, how the pharms get the meds. i’m guessing that the walgreen’s
i get my script from gets the byetta on the same truck as they get tampax,
kleenex, pills etc. who knows how long or at what temp the meds are kept
while being transported!
i love the lizard spit and it is working now but i want to know what is
going on with the summer ones.
jodi
July 26th, 2005 at 9:24 pm
I’ve been using mail order for byetta for over a year and have never had
any problems. It comes wrapped in bubble wrap, in a styrofoam cooler
with two or three industrial strength ice packs, and shipped overnight.
Janie
July 27th, 2005 at 2:28 am
I had a very bad dose last month. I was violently nauseous (and that hasn’t
happened to me in months) with every injection. I also had that fatigue
feeling that I haven’t experienced since the first time. I started my next
month early and have not had any side effects. I do wonder about the quality
control on the pens.
Cynthia Heller
_____
–
Dave - 7:35:31 AM
[Non-text portions of this message have been removed]
July 27th, 2005 at 4:51 am
mail order pharmacies are fabulous about replacing product. it’s the
delivery people i am concerned about right now. who and how the product is
delivered to. even a mail order pharmacy has to get the product from
someone. as trisch said, there is a chain of command due to this drug being
a script only but a pharmacist is not driving the truck.
my husband drives a semi truck and works for the top produce company in the
world. all the product he delivers is refrigerated in a "reefer truck". he
has to take temps at each stop and if his truck gets too hot or cold, the
product does not get delivered. can you imagine a 53 foot semi hauling just
drugs like that? how many boxes of spit and insulins would you need to
justify a semi that big? even my hubby said it isn’t going to happen that
way. so it’s either going via small truck or big truck with other items and
simply kept in the boxes with the freezie packs.
ok i just spoke to the pharmacist at my local walgreens and he told me to
call the supervisor on monday morning but he said refrigerated meds come on
a separate truck. however they come from their warehouse and he has no clue
how they are treated there or how long they are held. he hadn’t heard of a
lot of incidences of people saying the byetta stopped working but he also
said that due to the shortage this summer, they had to keep an update on
usage of the drug. it dropped off quite a bit so maybe folks gave up on it?
and that could have been due to it not working as it should have.
andrew, you said you quit it for a while. now you are using it again and
having good results. what do you think?
in case i hadn’t mentioned this, i had to once again lower my lantus dose
but
this week by 16 units so far. i had been dropping to the 60’s at night and
my bg pp rarely goes above 110 or so. i attribute it to the spit
remember that i started spit in april (went from 80 a day in lantus to 40)
and come may when i went to the 10 pen, no more control and had to go back
up to 80 a day of lantus. i just started on a new 3 month supply of spit and
boom…low bgs from the start. so it seems that the factor is byetta.
i’m certainly not complaining as i love the stuff! i just want consistency
with the product. for anyone familiar with ron at the dsm list (a diabetes
guru) here is an email he sent last night. i am omitting part of the email
directed to another person on the list as i have not heard if she cared if
this is cross posted. following is the part directed to me:
"I called Jodi and was able to piece together what seems to explain her
byetta mystery and her associated recent Lantus over dosing surprises. She
had been on the 5 mcg/dose pen then switched to the 10 mcg/dose pen. In
three days time after that switch she had to go back to her former nearly
double Lantus dose size and the higher dose of byetta seemed to be doing
nothing for controlling meals. .Meals were responding nicely when she was on
the 5 ml size. Very recently, 10 mcg/dose has started working again and
that contributed to the Lantus overdose crisis she described to us a few
days ago.
She contacted the Byetta maker and, as instructed, sent the pen back.
Surprisingly, they did not stipulate overnight shipping or a gel pac to
keep it cool. I believe that is circumstantial evidence they are less
careful in their instructions than they should be, given the extreme
temperature sensitivity of Byetta. If they do not tell the public (people
like Jodi) the right things to do when returning it, what are they telling
distributors supplying pharmacies, one wonders? You will see why I raise
that question in a moment.
They said hers was ok not long after she sent it in to be checked and it had
not occurred to her that that assertion was contradicted by other parts of
her experience. Believing the product was ok, she checked her refrigerator
and the one at her local pharmacy and, seeing they were both ok, simply
figured the problem was that she did not respond to Byetta any more.
The thing that explains that concern with refrigeration is that Byetta has
to be stored at a temp below 40 degrees F and that when it is exposed to
room temp it has a very short life. At room temp, the life is a few days.
Needless to say, the 140 degree summer time temperatures in an
unrefrigerated truck or warehouse would ruin it in a shorter time.
I asked her how it got to her drug store and she had not inquired. She
assumed it was properly shipped because it should be, given its fragility,
but she had no evidence to support that it had been. When I voiced my
doubts, she remembered that she has seen delivery trucks behind the store
but was not sure they contained that product. .
I was able to discard any notion about an auto immune rejection since it
has started to work again for her in recent days. That, and the fact that it
is once again a cool weather part of the year are probably not a
coincidence. Expiration dates were ok and all that I can think of to account
for her experience is storage and shipping conditions.
I concluded:
The claim that the efficacy of the returned product had been checked was
not valid
The distribution system her pharmacy and/or the sourcing company used did
not insure refrigeration door to door.
If byetta is left in a truck as it goes store to store, and that truck is
not refrigerated, during the summer months the byetta could experience 140
degrees for hours at a time. The same applies to an unrefrigerated
warehouse. I think byetta worked for Jodi in the cool months, stopped
working during the hot months, and now is ok again in the fall season for
the simple reason that it was not properly protected earlier in the year.
Since those correlations with season and lack of support for an autoimmune
hypothesis support an unambiguous conclusion, I further concluded that the
claim it had been checked for efficacy by the manufacturer after she
returned it simply could not be true."
part of post deleted for privacy
" Keep in mind that we do not have proof of mishandling. This is the only
hypothesis I can think of that fits her facts but it may be wrong.
A related concern is this. Will more Byetta problems be seen later in the
year when it freezes instead of frying?
I grant permission to cross post this to other lists but if, and only if,
****** and Jodi also agree to that."
jodi
>
>
Been doing mail order for 5-6 ye ars now and only one problem, and that
was remedied quickly. They ship overnight air, either Fedex & UPS, and
the only problem I had was when one of the two rescheduled the delivery
(which was on the truck for Friday delivery) and it showed up Monday.
One call to the supplier and another batch went right out, ice packs & all.
–
Dave - 7:35:31 AM
July 28th, 2005 at 2:18 am
I hope you addressed the supplier and not UPS.. Certainly not their
fault, they didn’t pack it.
July 28th, 2005 at 6:39 am
it clearly was UPS’s fault but my insurance company told me to call the
online pharmacy and have them replace it. they felt it was their fault
because they chose the shipper. but yes, it was UPS’s fault.
jodi
I hope you addressed the supplier and not UPS.. Certainly not their
fault, they didn’t pack it.
July 28th, 2005 at 7:21 pm
Unfortunately, the problems goes far beyond Byetta, though it may
be clearly
ruining the Rx in this case…
Joe Graedon, a pharmacologist who has a syndicated column and
public TV
show, The People’s Pharmacy (and an excellent book of the same
name,
updated regularly) discussed a while back that drugs of all kinds
(most if
not all) must be kept between certain temperatures to be safe and
effective.
But when drug company reps visit doctors’ offices, they rarely if
ever have
been keeping their samples under controlled conditions. In the
summer,
especially, this can kill the drugs while they’re in their cars,
and people
may be given samples that might have worked had they been handled
correctly.
In a more recent column, Graedon said drugs are delivered to
pharmacies’
distribution warehouses under controlled conditions, but that when
they
are reshipped to individual pharmacies, that is often not the case.
Let’s hope that Byetta and insulin, being so obviously
heat-sensitive,
are mishandled only rarely.
NOTE—Unless I’m hallucinating, an article I saw yesterday about
new
diabetes drugs mentioned that the Byetta manufacturers are trying
to
develop a form of the drug that would be injected only once a
month>!!!
Brian
July 31st, 2005 at 7:44 am
it was winter, product came frozen. insulin was bubble wrapped, surrounded
by freezie packs, and in a Styrofoam container inside of a cardboard box.
that’s the way it always came no matter what the time of year.
the product had to have froze while under UPS’s care. we have 1 UPS facility
here locally. i have been there numerous times as that’s where we send
packages from. it’s nothing more than a huge warehouse with an office area
that folks go into to ship. the building doors are left wide open (in the
loading dock) which is right next to the parking area. in the winter,
employees are wearing clothes suited to the outdoors while in the warehouse.
i have used tracking numbers after items have been received just to see
where all they went to first. i have seen items sit at the local warehouse
from 2 am till they were loaded on a truck to go my house. it may be
overnight delivery for my insulin but it still sits for hours in a freezing
warehouse (it may be heated but having all those overhead doors open bring
the cold temps in). and the UPS trucks have heaters but only in the cab
area. same for the big semis they use. whatever the season, drugs are
subjected to adverse temps. when i go to retail pharms to get my insulin or
byetta, i make that my last stop before going home. and if it’s hot out, i
set the drugs on the floor of my car with the floor air on (same as i do if
i buy ice cream during the summer).
jodi
Ok, I hate to belabor the point here but I really want to know how it
possibly could be UPS’s fault. I have shipments going and coming all the
time, but in no way do they put ice packs in/on/around anything. Their
job is to simply deliver the item as packed, when specified.
They don’t leave stuff on a loading dock outside either. If it was
frozen I don’t see any other way but improper packing by the mail order
company.
–
Dave - 8:53:42 AM
July 31st, 2005 at 8:37 pm
i’ve had to decrease my total lantus dose by 16 units so far this week. was
going into the 50’s and 60’s in the middle of the night.
jodi
Andrew, are you still using Lantus to kill the dawn phenomenon,
along with the Byetta? I’m still up-titrating Lantus, up to 40 units
at bed-time, and still seeing BG 120 +/- before breakfast at 6AM.
The Lantus has reduced my post-meal highs a little, but once I
stabilize the Lantus dose, I’ll call the doc and see about adding
back Byetta.
Gary