IV Compounding--documentation for how often to change needle?

[CellarDoor]

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I have a scenario in which our hospital pharmacy will be preparing an investigational drug in our clean room (ISO 5 laminar flow hoods, ante room, etc). I, however, don't agree with the sponsor's directions that they provided for preparing the drug.

The prep is straightforward--we essentially just have to transfer the contents of 5 vials (10 ml each) into an empty bag, straight draw.

They are stating that we should change the needle with EACH vial that we draw up (5 different needles). First they stated that it was because of coring... then when I pushed back to clarify why (is the stopper unusually thick?), they changed their answer and said it was because of sterility. I'm thinking someone doesn't know IV compounding there and assumes that changing a needle every single time is automatically better. I would argue that more manipulation would actually probably increase the risk of contamination--but I can't find anything to back me up or to state what the norm is for changing needles during IV compounding.

Thoughts? Anyone have a reference speaking to this?

 

[naseuy]

http://m.globalrph.com/?url=http://www.globalrph.com/aseptic.htm&utm_referrer=#2970

Here they recommend 8-10 punctures per needle.

 

[Monsterdaddy]

The sterility excuse is just that, an excuse. Coring is a more valid concern as needles will get more blunt with each poke. But most IV rooms use rather low gauge (thicker) needles so I don't think I've seen much blunting with 16 or 18 gauge needles but it could very well depend on how thick the stoppers are. And some stoppers are indeed harder on needles, you won't know until you try it.

In my opinion, I would just do as they ask and change the needle each time. I assume you are drawing each vial in sequence into a 60 mL syringe before doing one poke into the bag?

 

[CellarDoor]

Thanks--hard to find any solid references beyond global RPh though. Sometimes it's hard to find references for things that are common sense.

The kicker is that in their initial instructions, they wrote to transfer ONE VIAL AT A TIME into the bag. I was able to persuade them that drawing all of the vials into a syringe (with one puncture to the bag) would be far better. 🙂

 

[Monsterdaddy]

Thanks--hard to find any solid references beyond global RPh though. Sometimes it's hard to find references for things that are common sense.

The kicker is that in their initial instructions, they wrote to transfer ONE VIAL AT A TIME into the bag. I was able to persuade them that drawing all of the vials into a syringe (with one puncture to the bag) would be far better. 🙂

Looks like people who have never worked in an IV room wrote them up.

 

[sakigt]

Im no legal expert but if those dorks require such detailed garbage in their studies are they going to have to require such garbage to be typed up on their package insert? Are they really interested in sending out drug reps to have to explain this?

 

[lord999]

Im no legal expert but if those dorks require such detailed garbage in their studies are they going to have to require such garbage to be typed up on their package insert? Are they really interested in sending out drug reps to have to explain this?

IND, so no. This is to try to deal with efficacy by removing possibilities for chemical reaction, but this is over the top (and if the combination is that delicate, there's manufacturing GMP's that need to make the combo more idiotproof than this). Trissel's and King's are the guidelines that would normally apply in these circumstances although when it comes down to it, USP and HP would be the codified rules for sterile procedure.