Not FDA approved

  1. 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?
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  2. 14 Comments

  3. by   GInurse
    You have a liscence that requires you to give safe and effectve care. If you are administering a drug via a route that is not FDA approved for that drug, you are responisble, no matter what the order is. Period. It is ALWAYS a nursing judgement call to administer ordered meds and treatments. A doctor's order is not a command from God. Doctors are human and make mistakes/bad decisions just like anyone else. We are the official patient advocate and we have the right and responsibility to refuse to follow dangerous orders.
  4. by   RNed
    If I am uncomfortable giving that drug, dose, route, etc. I inform the Doctor and suggest that "if he wishes the patient to receive that drug, etc." outside of identified parameters, "then he/she should administer or dispense the drug."
  5. by   NRSKarenRN
    Agree with RNed.
    Check your facility's policy re this practice.
  6. by   maikranz
    "...what is the responsiblity of the nurse that is giving that drug
    under the MD order? ..."


    To be sure s/he has really good malpractice insurance.

    (and ditto GInurse and RNed) I assure you that MD will
    NOT back you up if there is a bad outcome.
  7. by   moonshadeau
    It wasn't actually me that administered the drug. If she was comfortable administering the drug that is fine. But it was a determining factor that I knew my license was on the line in this facility. Too many things are done incorrectly or half-a**. Excuse my french. I kinda knew what the response bb was going to be. I am just scared that the MD is going to order something that he isn't familiar enough with and I am not going to know the truth and then I am screwed. I guess that it all comes down to confidence and instinct. I have no confidence in this facility and my instinct is screaming at me to get out.
  8. by   maikranz
    Originally posted by moonshadeau:
    <STRONG>It wasn't actually me that administered the drug. If she was comfortable administering the drug that is fine. But it was a determining factor that I knew my license was on the line in this facility. Too many things are done incorrectly or half-a**. Excuse my french. I kinda knew what the response bb was going to be. I am just scared that the MD is going to order something that he isn't familiar enough with and I am not going to know the truth and then I am screwed. I guess that it all comes down to confidence and instinct. I have no confidence in this facility and my instinct is screaming at me to get out.</STRONG>

    It was a "global" you. But re: meds--that's why there are PDRs and Nurses' Drug Guides, etc. Who can remember all that stuff!
    LISTEN to your gut and move on. Life is too short!
    Good luck!
  9. by   nurs4kids
    We give our kids IV form of versed PO (preop); have done this for years. After reading this post, &lt;ashamed to admit only 'til now&gt; I checked and we do have a hospital policy for doing this. Does this place the liability on the hospital?

    [ May 19, 2001: Message edited by: nurs4kids ]
  10. by   NRSKarenRN
    Liability is ALWAYS on the nurse to know what safe practice is and policys & procedures he/she is performing.

    If an institution comes up with a policy re non FDA/approved use of drug or procedure AND you are:
    1. Oriented/trained in procedure/drug.
    2. UNDERSTAND AND FOLLOW this procedure.
    3. Know when to seek advice if problems develop...
    Then liability shifts to the facility.

    [ May 19, 2001: Message edited by: NRSKarenRN ]
  11. by   CashewLPN
    On our floor in the hospital we have a rule. If we are unsure and cannot clarify with PDR or pharmacy, or we just feel uncomfortable with an order the MD is to push /administer no questions asked.
    we just follow our policy as uwual...
    enjoy...
    --Barbara
  12. by   P_RN
    We ran into this several years back with IV Toredol. All the literature said NO IV. The docs said to do it. We had the pharmacy on our side. Surprisingly when a doc is called by both the nurse and the pharmacist and told that HE/SHE (MD) will have to come in and give it, they ALL OF A SUDDEN decide to order a different medication. Never fails. Stick to your guns!
  13. by   canoehead
    Do any hospitals have a policy about giving Vitamin K IV? We have received orders to give it IV instead of IM, when a pt was not actively bleeding, but the references say that IV administration can cause (rarely) a hypersensitive reaction that can be fatal. Some nurses are OK with giving it- they trust the MD giving the order, and others are fearful because of the possibility of a fatal reaction.
  14. by   CEN35
    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.


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