Sterile Water for injection…….not for infusion!!

I have always speculated that medication errors and near misses outside of hospitals and acute care settings have been under reported or perhaps never reported at all.  Here’s a case that I was made aware  involving an RN who added a medication to a 250mL bag of Sterile Water(unintentionally) and administered by infusion via a peripheral IV  to a patient.

Setting: A physician based office infusion center primarily infusing biologic agents for immune mediated inflammatory disorders. The registered nurse is responsible for the reconstitution of the vials, adding the reconstituted product to the IV bags, and administering the infusion. Routinely, the nurse will add the reconstituted product to a 250 mL bags of 0.9% Normal Saline, which are stored on a shelf.  The RN is a part time employee and responsible only for the infusion process when the infusion area is open, which is a few days a week.  IV started are peripheral IVs. Being a physician based office, there is no pharmacy or a pharmacist on staff and someone else in the office is responsible for ordering and stocking the infusion area.

Event: On more than one occasion, the RN reported that patients, who have previously received infusions of the same medication  in their office, began to complain of pain on the PIV site during the infusion. The RN inspected the site and no signs of infiltration or redness was noted. Even with slowing the rate, the patients continued to complain of pain. Somehow the patients tolerated the pain and completed the infusion. The RN suspected that the cause of the pain at the IV site could have been a bad lot of vials and reported it the the manufacturer.  The manufacturer took the information and informed the RN that they had no current problems with lot numbers.

The next time the RN infused a patient, the pain at the IV site  became intolerable and the patient was in severe pain only after a few minutes of starting the infusion. The RN stopped the infusion and checked the IV bag only to find out that it was Sterile Water that was hanging on the IV pole and not 0.9% Sodium Chloride. The RN went to check the shelf and all the IV bags were Sterile Water when the shelf should have contained bags of  0.9% Sodium Chloride.

Outcome: Aside from the severe pain during infusion and the minor phlebitis, the patients infused using  Sterile Water did not have  signs of hemolysis.

Lesson learned: The prescribing information for Sterile Water for Injection states that it is a sterile, nonpyrogenic water for injection intended only for dilution purposes. It has a pH of 5.4 and a calculated osmolarity of 0 mOsm/L.  Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity. Therefore, it is contraindicated for intravenous administration without admixing.

  • As nurses, do we all know not to give Sterile Water as a direct infusion?
  • In my opinion, there shouldn’t even be bags of sterile water in this office. It was an ordering mistake which no one caught in this office.

I have to say that I did not witness this event nor did I talk to the RN. The nurse is an experienced infusion nurse with 25 years of nursing experience. I can only imagine how the RN might have felt when she realized that all along she was using Sterile Water, not 0.9% Normal Saline. According to the RN, she did not notice anything unusual with the packaging and because she has always pulled IV bags from the same shelf for as long as she has worked there,  she didn’t even inspect the bags.

  • Sometimes, nursing care can become so routine that we go through the process without true comprehension as is the case with this nurse.

If this was in a hospital setting, the mistake would have been caught since checks and double checks are now in place prior to the medication administration in an effort to prevent mediation errors. Again, this event raises the issue of the lack of  processes and double checks in non-hospitals or acute care settings where medications are administered.

  • Medication errors happens outside of hospitals and acute care settings, but no one focuses on them and usually the event is never reported.
  • As nurses, let’s remember that the principles of medication administration and prevention of medication errors applies regardless of where we are practicing. Five rights…check and double check…read labels!!
  • It is unknown whether the process has changed in this office to prevent this and any other potential errors from happening in the future. Sad but true, unless the event causes death or disability, in this setting,  it often is swept under the rug.

I know that some of you may say that nurses shouldn’t be even doing reconstitution in physician offices because of USP 797 standards. I fully agree, but the reality is, it is happening.

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