For the majority of people, or people not taking dofetilide (Tykosin), this communication won't mean much, but it pertains to a bugaboo I have with (in this case) the pharmaceutical industry's effort to communicate with their presribing physicians. If this is not of interest, move on.
Otherwise, here's a tidbit I was unaware of until about 5 minutes ago from a letter dated 9 January 2008 to "All Tikosyn Registered Healthcare Professionals"
It seems Pfizer has a shortage of Tikosyn 0.5 mg (500 microgram) x 60 bottles have been "momentarily depleted and are currently on back order." They also go on to say that "Tikosyn 0.250 mg and 0.125 mg are also nearly depleted and are soon to be on back order as well. We are working diligently to have the product available as soon as possible."
The reason?
"This product outage is not result of any efficacy or safety concerns with Tikosyn. An unforeseen manufacturing issue coupled with distribution regulations for Tikosyn (this medication is only drop-shipped and there is no inventory held in trade) have resulted in the product outage."
When will the shortage cease? We're unsure:
"On Wednesday, January 16th, we will send you a follow-up communication to update you on the inventory status to help manage your Tikosyn patients appropriately."
Great. I never received this communication in the first place, even though I am registered with these guys. Unfortunately, I received this notice from our local pharmacy when a patient could not receive their medication refill. And this was despite having to endure an exhaustive process and registration to be allowed to prescribe this medication. I've checked e-mails, mail, faxes and have not found this notice. Nor have my colleagues who are also registered.
We went to the website, and no notice appears, nor a link to this important letter (I'll put it up on my server when I get a chance).
Yet the pharmacies got it (I guess they're considered the important "health care providers" here).
So now, how the heck am I to assume I'll get any update? (Maybe this blog will help)
I am left to ponder (without ANY guidance) what to tell these patients. Seeing as they had to be dosed for three days as inpatients just to take this drug, don't you think they can do better?
And we think the medical device recalls/advisories need work...
-Wes
Addendum: 16 Jan 2008 @ 1530 CST - Called Pfizer's "hotline" (1-800-438-1985) mentioned on their form letter and just got the message that the drugs might be available in "late" January on a recording - the recording went on to suggest that patients on Tikosyn "contact their doctor" and that doctors not start patients on Tikosyn and to "contact their patients to discuss treatment options." I was then offered to hold for a Pfizer medical specialist. I hung up after the phone after 20 minutes. Oh, and that follow-up notice we were promised on the 16th? Never showed.
-Wes
3 comments:
if you reinitiate therapy after a drug free interval, are you planning on readmitting for observation?
anony 07:56 -
Although Tikosyn's package insert requires the drug be started as an inpatient for three days, it does not mention "re-starting" the medication. Personally, if they started it once safely, I probably will not readmit them to re-start their med> Given the data that most Torsades occurred with initiation of the medication, however, I suspect most of us will never know the risk of doing it this way...
Nice. And yet the company almost certainly has the time to data mine* your prescriptions with big pharmacies and to pay for drug reps and pens.
*I was shocked the first time a rep mentioned data on my prescribing habits for a certain drug versus a partner's.
Of course the "emergencies" created by drug companies and insurance plans to switch medications, make therapeutic decisions, deal with shortages, generate different Rxs etc. etc. come without notice and generally tie up staff without reimbursement. Echodoc
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