Not FDA approved

Nurses General Nursing


If the FDA has not approved a drug to be used in a specific manner (a drug meant to be used as s.c. and instead used IV) what is the responsiblity of the nurse that is giving that drug under the MD order?

Specializes in ER, PACU, OR.

Nurs4kids and Canoehead

Nurse..... The versed issue. It doesn't matter, the company that makes versed also make a versed po syrup. The only diference, is it is supposed to be a little better tasting etc. So it was approved for IV/IM/po, just that the injectable says "IM or IV use only".

Canoehead - yes we have had orders from the admitting attendings, for IV VK. We don't usually give it though. There is absolutely no reason to give IV VK. The VK acts in the liver to increase the production of enzymes that create certain clotting factors. By dooing this, it drops the INR/PT. VK no matter how fast it gets to the liver, takes (if I remember correctly) up to 24 hours to reach its effectiveness. That extra 2-4 hours it would take for absorbtion from an IM injection is pretty much useless. If they feel the need to order it IV, then maybe asking the attending for an order of FFP would be much more appropriate.


Specializes in LDRP; Education.

Ok now I am sort of freaking out.

We routinely use cytotec as a means for inducing labor. It has been over and over again published as unsafe for pregnant women, etc. There has been documentation on both sides of the fence for this drug - however, the manufacturer does not condone this off-label use. I do carry my own - however, isn't the hospital even more liable than me as they still keep this MD on staff for Rx it?

If anyone has a reaction etc.. There should be a policy in place using Vit K IV. I don't think there is a benefit to this and risk would probably outweigh benefit. Jcaho requires a policy for all procedures. By having this in the SOP nurses would be better protected. I would guess that they would not write it to policy if asked :)

I have used both Cytotec and Prosteglandin E2 gel. Probably prefer the PE2 gel but could be biased due to the arguments with cytotec. They both seem to work.


[ May 28, 2001: Message edited by: kennedyj ]

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