Clifford Gevirtz, MD, is employed by RAA of New York and practices anesthesiology throughout New York and Long Island, N.Y. RAA is managed by Somnia.
Q: As a practicing consultant pharmacist to ambulatory surgery centers, I am often asked about the beyond use dating of medications drawn into syringes. Since most ASCs do not have an isolator or glove box for this procedure, I advocate following USP 797, and consider those pre-drawn syringes an immediate-use compounded sterile preparation, and suggest a one-hour beyond use dating. Is this too stringent? Does USP 797 apply in these situations if they are not IV admixtures but are, for example, injectable local anesthetics which are not given intravenously?
Dr. Clifford Gevirtz: Yes, I think you (the consulting pharmacist) are going a bit far in your interpretation. To quote from the USP 797 guideline (www.usp.org/audiences/pharmacist/797FAQs.html):
"The beyond use data after initially entering or opening (e.g. needle punctured) multiple dose container is 28 days." As an example, a multi-dose vial of lidocaine that was used to create a skin wheal prior to starting an IV would be good for 28 days after first being entered. However, if the expiration date of the vial is sooner than 28 days, then it expires on that date. Good practice is note the date first entered on the label.
"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."
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Read more from Somnia:
- White Paper on Warning Signs of Suboptimal Anesthesia Management Now Available From Somnia Anesthesia Services