“The standards in this chapter (USP 797) do not pertain to the clinical administration of CSPs (compounded sterile preparations) to the patient via…infusion…injection…” i.e., the rate of infusion and duration is up to the clinician.
The product insert on propofol is of special interest; it states:
“Propofol Injectable Emulsion should be prepared for use just prior to initiation of each individual anesthetic/sedative procedure. The vial syringe rubber stopper should be disinfected using 70% isopropyl alcohol. Propofol Injectable Emulsion should be drawn into sterile syringes immediately after vials are opened. When withdrawing Propofol Injectable Emulsion from vials, a sterile vent spike should be used. The syringe(s) should be labeled with appropriate information including the date and time the vial was opened. Administration should commence promptly and be completed within 12 hours after the vials have been opened.”
The imported ampules of propoven actually suggest that the drug be filtered with a 5 micron needle filter to remove any particulates as part of the process of drawing up the medication.
Another common issue in providing analgesia in ambulatory settings involve local anesthetic/opiate infusions. The USP poses this Q&A:
“If a pharmacy prepares an epidural bag of bupivacaine in 100 mL normal saline, can an anesthesiologist add fentanyl to that same bag on the floor? If so, what would the BUD (beyond use date) be?
“If fentanyl is added in worse (dirtier) than an ISO Class 5 environment (outside of a sterile hood), then this becomes an Immediate-Use CSP, for which there is no administration duration requirement. The Immediate-Use CSPs’ section states a warning regarding potential harm to patients from extended administration durations of contaminated CSPs.”
Learn more about Somnia.
Read more from Somnia:
– Somnia Anesthesia Publishes Report on the Role of Anesthesia in Accountable Care Organizations
