The Pharmacy Chick

Flying the Coop in Retail

Recall City- what is safe?

Filed under: Uncategorized — pharmacychick at 9:42 pm on Saturday, July 19, 2008

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?

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7 Comments »

Comment by The Ole' Apothecary

July 20, 2008 @ 7:17 am

I used to roar against the idea of people going on those Canadian trips to get cheaper meds, but I think not only is the fox is not only in charge of the hen house now, he also bought the place and is opening chains of them–cluck, cluck, cluck! But we are selling imported drugs at U.S. prices, aren’t we? You’ll have to correct me on this, because I don’t work in retail. I don’t know how much you’d pay for that Ranbaxy generic in Detroit vs. across the water in Windsor, Ontario. Maybe someone can tell me.

I do sense the following: people care about the drug, not the pharmacist. Be they consumer or manufacturer, I think all of them would like to repeal the Durham-Humphrey amendment and sell everything without a prescription, like they do in Mexico. When will the suits and skirts gather to try floating this decision? Or, maybe they float it annually? The funny part is, who are they going to use to tell the drugs apart unless they give rise to a whole new kind of consumer labeling? Here’s the antihypertensive section, the thyroid section, the NSAID section, in Wal-Mart.

Comment by Blonde Super Tech

July 20, 2008 @ 7:18 am

pharm chick,
I agree! Recalls SUCK!! With the great digoxin recall I had lord only knows how many patients ask me “why are you people trying to kill me?” then explain we don’t make the pills we just dispense them and how sorry I am for the manufacturers mistake yadda yadda yadda….Luckly we didn’t have any of the morphine sulfate in stock, my customers prefer hydromorphone and percs. lol. Hope all is well in the pharmacy world w/yall!

Comment by Frustrated and on medications

July 20, 2008 @ 8:14 am

Sadly the FDA, like many other government agencies, suffers policy and leadership changes as political policy and presidential leadership changes. The agency is run by who ever is owed a favor or is a friend of a friend of the current administration. Before anyone says, “stop bashing Bush”, this has gone on for years with both parties and needs to stop before many Americans lose their lives due to inadequate safety. The FDA needs to be completely restructured. It needs proper leadership with honest oversight. Generic drugs need to be approved faster with adequate oversight and testing. This can be achieved by cutting the red tape and backroom deals out of the picture. Selling drugs made only in America will not solve the problem if the people responsible for our safety are to busy having lunch with lobbyists to do their jobs.

Thank you for letting me vent my views.

Comment by PharmacyJim

July 20, 2008 @ 1:06 pm

Here’s what scares me. The FDA is about to (or may have already)approve some Chinese companies for generic manufacturing. Now, please, this is not a slam at Chinese people, but, at their government’s lack of oversight of all their products. How many times in the last couple of years have there been problems with products of Chinese origin. It is my opinion that the Chinese govt doesn’t give a rat’s behind about their exports to other countries. As for me, I am letting my superiors at my company know how I feel about this, and also my patients…..in a rational, but forceful way. I don’t want Chinese manufactured pharmaceuticals in my store. Again, I mean nothing bad about the Chinese people….the folks living in China suffer many hardships, and I would not want to trade places with them. That being said, my concern is my family, my patients, and, yes, my profession. Am I overreacting?

Comment by pharmacychick

July 20, 2008 @ 3:51 pm

PharmacyJim
No I dont think you are over-reacting. I dont think the chinese govt gives a rat’s behind about their own people if it comes right down to it. They look out for their own interests, its a country of the haves and the have-nots. they still censor what their people can do, say and have. They will cut every corner in the book to produce a product to sell even it its harmful (read: melamine in the dog/cat food). You dont think they knew this? come on. Credo: Do it til you get caught, then blame somebody else. Regarding India, I have INDIA patients who dont want India made drugs. What does that tell you? I’ve been there and I could tell you stories that would make you sick. Someday I fear there will be a large scale adulteration of medication that reaches large populations of people because of an infiltration of a manufacturing plant overseas where controls are lack or absent. I’m just sayin’….

Comment by CPhT

July 22, 2008 @ 4:31 am

PC,
I think the only Actavis products I have left on my shelf are all the strengths of Lovastatin. I was going to add Nystatin, but they phased that back into Taro-branded ones when we ran out of Actavis. My outside vendor sends recall forms even though we do them intra-company, and the last batch of recall forms I got was literally in its’ own envelope. It was probably over 100 pages of Actavis recalls that I had to sign, date, initial, write our company name, and our customer number on. It was a nightmare.

It may be that the FDA is going a little too far. I mean, like you said — Purpac/Actavis recalled multivitamins. Oh well if they don’t maintain 100% potency until the 5 year expiration or whatever. I’d be much more concerned if there was a recall on Synthroid, something that is necessary to be as potent as it says on the bottle.

Our solution when people get angry about these new generic brands is to tell them the US address on the bottle. We don’t support them importing from India and, God forbid one day, China, but with all the cheap outsourcing, it doesn’t seem that the FDA is too concerned with trying to reel some of these companies back into the States.

Comment by Mike, SPTC

August 12, 2008 @ 6:34 pm

How about that damned recall for the generic Primacare One? “Manufacturer misrepresented generic status.” Nice job, FDA. Fantastic, in fact.

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