I'm writing because I'm at a new job in an anti-aging, functional medicine clinic. At this clinic we administer Myers cocktail (a mixed vitamin IV bag) to patients which the RNs mix under a hood in the back of the clinic. We were shown how to do this by the NP who works here at the clinic. It has 7 to 14 vitamin ingredients that we add to sterile water under the hood. To mix I use the sterile technique that I always have to draw up drugs.
I have recently become worried that this mixing may be outside of my scope of practice in the state of California because of what I read here in the Nutse Practice act. I worry that this might constitute "compounding."
"2725.1(b) No clinic shall employ a registered nurse to perform dispensing duties exclusively. No registered nurse shall dispense drugs in a pharmacy, keep a pharmacy, open shop, or drugstore for the retailing of drugs or poisons. No registered nurse shall compound drugs. Dispensing of drugs by a registered nurse, except a certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51 or a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, shall not include substances included in the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code). Nothing in this section shall exempt a clinic from the provisions of Article 13 (commencing with Section 4180) of chapter 9"
This is the definition of compounding that I found:
Pharmacy compounding is the art and science of preparing personalized medications for patients. Compounded medications are made based on a practitioners prescription in which individual ingredients are mixed together in the exact strength and dosage form required by the patient.
Also i'm worried that a complicated formulas with 7 or more ingredients may require a more sterile environment than a mixing hood located in the hallway, based on some pharmaceutical articles I have been reading.
Am I making up things to worry about or could I be practicing inappropriately? Any information you guys have on this topic would be helpful!
That does sound like practicing pharmacy to me. Plus, aseptic technique aside, what is your system of checking for accuracy? In the hospital, we can't even hang TPN without a dual checkoff... I would NOT be willing to mix an IV bag like that.
This is not a legal practice for an RN in California or any state I'm aware of. Even for those allowed to compound IV medications, and in most licensed compounding situations, only two accesses of the bag is allowed, if more components need to be mixed then this typically must be done at a more dedicated compounding facility with a special license for these mixtures.
Technically, putting any medication into an IV bag can be considered compounding. In addition, there are many instances where Lidocaine is mixed with Bicarb for pain control, Nurses in the ER are administering and mixing Myers solution for alcohol intoxication, electrolytes are mixed in IV solution for administration in the hospital. By this assumption, it would seem like all of these regularly performed RN duties would be considered "out of scope of practice", but Nurses do this every day all over the country and the world. In addition, there are many infusion centers under throughout California where nurses are mixing drugs in IV bags every day.
Thanks for your comments everyone, it seems like the difficult part of this question is what exactly is "compounding." A definition I have found of compounding as defined by compounding pharmacies is "the creation of a custom medication for a patient." That does seem broad and a bit unclear.
When I contacted the California board ask line the person who responded to my inquiry stated that mixing was "compounding" and should be done by a pharmacist. She stated that any nurse who took on the act of mixing IVs could be held liable for negative outcomes.
I also had a conversation with a pharmacist familiar with Myers cocktail who said that compounding is the act of taking raw materials and deriving an administrable component from them. This pharmacist said that nurses mix the components of Myers cocktail at many clinics in California and that it is not out of the norm.
What I've found during my career is that just because it's "being done" doesn't mean that you would be protected from a negative outcome in a malpractice case. What protects someone is that they can prove they followed policy and practiced within their scope.
Of course RNs are reconstituting IV antibiotics all the time, this is not mixing. This is clearly allowed.
TPN is also a different much riskier thing to administer than other IV medications and this requires special procedures for mixing and administration that other mixed IV Meds do not.
I am interested in what was said about no more than two ingredients may be added. I would think a rule like this would exist because of the risk for contamination. I am curious if there is a time window after ingredients have been added before that bag has to be used to reduce risk of bacterial colonization.
I have writen the pharmacy board ask line and will update with further information I find.
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