Heparin recall

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shaolinRX

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  1. Pharmacy Student
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Anyone know what's going on with this? I recently shadowed at an inpatient Hospital and they had issues with having to find alternatives to heparin due to a recall. The pharmacist attributed it to the recent lawsuit from Dennis Quaid (story here) where an incorrect dose was administered to his newborn twins....However, searching online it seems as though heparin is having other issues dealing with adverse allergic reactions (FDA letter). Anyone else having to deal with this?

I had to leave before the pharmacist was able to discuss in detail what alternatives might be used, so I was wondering if anyone had a solution. I believe it was for a medication delivered central IV.
 
I havent personally delt with it, but I did listen to a news story about it. Pretty tough recall to get done since Baxter makes a huge percentage of the herparin for the US market. Last I heard they were doing a staged recall to prevent any shortages while other manufactures ramped up production.
 
Anyone know what's going on with this? I recently shadowed at an inpatient Hospital and they had issues with having to find alternatives to heparin due to a recall. The pharmacist attributed it to the recent lawsuit from Dennis Quaid (story here) where an incorrect dose was administered to his newborn twins....However, searching online it seems as though heparin is having other issues dealing with adverse allergic reactions (FDA letter). Anyone else having to deal with this?

I had to leave before the pharmacist was able to discuss in detail what alternatives might be used, so I was wondering if anyone had a solution. I believe it was for a medication delivered central IV.


Think the issue was with a contaminant they identified in Baxter's heparin...oversulfated chondroitin sulfate. You want to know if there's an alternative manufacturer? Or do you mean whether there's an alternative to heparin?
 
There have been about 19 deaths attributed to Baxter branded heparin in the US (~90 deaths attributed to other branded heparin in Germany, I think). The only supplier of heparin in the US is currently Abraxis (chances are it will go on back order, but the FDA swears they have enough, "so please don't stockpile"). This was in the news one-two weeks ago, apparently crude heparin is coming from family farms in China that aren't being regulated.... at all. Last I heard FDA is stopping ALL heparin at the borders and testing before allowing it to be distributed (that was last Saturday).

The Dennis Quaid story is more about "operator error", similar to the same type of overdose in Illinois(?) in the last two years. Pharmacy staff has ultimately been blamed for filling Pyxis incorrectly, or nurses for not double checking the strength. Baxter responded by wrapping it's 5000U/ml and 10,000U/ml vials with labels that screamed "NOT FOR LOCK FLUSH". (Which led my hospital to replace all our vials with Baxter vials. Gee, that went well.)
 
Think the issue was with a contaminant they identified in Baxter's heparin...oversulfated chondroitin sulfate. You want to know if there's an alternative manufacturer? Or do you mean whether there's an alternative to heparin?

An alternative to heparin; at least, that's what my preceptor was discussing with me as I was leaving.
 
An alternative to heparin; at least, that's what my preceptor was discussing with me as I was leaving.

Well...this is all going to depend on the hospital you're rotating at and what they use/have on the formulary. But some alternatives to unfractionated are the low molecular weights...Lovenox, Fragmin, etc. Or maybe even Arixtra. I'm sure your precetor will (or should) go over the major differences with you (i.e. dosing, monitoring parameters, safety issues) versus heparin. Ask them why they do or don't go with the LMWH. Cost effectiveness? Safety? Convenience?

And remember when you're talking about heparin or the alternatives we're talking prevention of further clots and growth...not clot busting.
 
Our P&T Committee enacted an emergent therapeutic interchange policy allowing pharmacists to automatically switch patients from UFH to enoxaparin if our supply became critical. We haven't reached the point where we have needed to use it yet, mainly because our group has proactively recommended enoxaparin or fondaparinux over UFH in patients with decent kidneys and low risk of hemorrhage.
 
An alternative to heparin; at least, that's what my preceptor was discussing with me as I was leaving.

You or your preceptor were having a hard time coming up with alternative anticoagulants to heparin?!?!? Your preceptor is a Pharmacist???
 
You or your preceptor were having a hard time coming up with alternative anticoagulants to heparin?!?!? Your preceptor is a Pharmacist???

sheesh. We haven't even covered anticoagulants officially in class yet....I'm a P1...I consider it a coincidence that I know what heparin is at this point. I think you misunderstood. My preceptor wasn't having a difficult time coming up with an alternative; I was walking out the door as he received the script for it and didn't get the chance to discuss it with him (I was doing a required inpatient hospital shadow so I won't be going back). Can't blame me for being curious.
 
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