Recall City- what is safe?
For the umpteeth time this year, I have had to process and respond to yet another drug recall sent out by manufacturers. As I was stuffing yet another confirmation of recall response into my file cabinet I commented outloud (perhaps too loud for my employees) “Do we live in a freaking third world country? Are we simply incapable of making drugs anymore that work and last thru their expiry date?” It set off an interesting conversation.
Honestly lets ask ourselves that question. In my early years of pharmacy, we’d have 3-5 drug recalls per year, maybe less. Gads, I process hundreds a year now. Most say something like “drug my not maintain potency thru expiration date”. Some recent ones like the ever popular Digoxin recall, required a lot of work of notifying patients and processing returns and reimbursements. Who is going to reimburse me and my staff for the TIME? Nobody. And then, on the heels of that one, we got the morphine recall of an erie similarity: tablet might be of double size. Back to the drawing board: notify patients and accept returns. Ironically on this recall , of the 3 patients I had, nobody would bring theirs back. Seems they get a little possessive of their narcotics. Whatever, I am not going to beat down their door. Honestly I’d think I would notice a tablet DOUBLE the size coming out of a bottle, but hey, apparently they don’t have much quality control in the plant.
Does anybody remember the ABLE Pharmaceutical fiasco a few years ago. My company was out several thousand dollars on that one when they declared bankruptcy on the heels of their own company wide recall. Now I hear the FDA wants into Ranbaxy to look at their records.
Ya know what? Maybe we need to start manufacturing our drugs in the US again. It seems I get more and more people wanting to know WHERE their drugs come from. And since India seems to be the driving force of generics nowdays, “India” seems to be the meek answer I give people more and more. I do not feel comfortable with this. I believe I have a personal responsbility to my patients to provide them with safe and effective medications and if I dont feel very confident about the source of the drugs, why should they?
I have no more control over what I carry anymore than I do the price of gas. The company negotiates contracts with whomever and we get whatever they agree to. It creates interesting conversation at the cash registers every year at this time when the “new contract” goes into effect and just about every generic I have been using has changed. I cringe when I hear a patient say something like “oh it changed again? I quit looking, it changes all the time”. Apotex this month, Ivax the next month, Aurobindo the next month after that.
It used to be that I could identify a loose tablet just by looking at it. When I carried the same generics for years, it was easy and sometimes a fun game: Identify this loose tab: and more often than not, I got it right the first time. Now, who knows.
How many times did we have a levothyroxine recall? three? four? AND, Daytrana recently sent out their second one for the same patches. Purpac (actavis) recalled most of the vitamins they manufacture. I could go on and on.
What is going on? Are drug manufacturers slacking on their manufacturing practices? recordkeeping? Do they make it and hope nobody asks? or is the FDA crossing the line and saying “hey you didn’t dot this “i” and we are going to pull your entire product line”?
Any opinions?
Tags: law, pharmacy life, recalls | |
