11-12-2012 01:55 PM
I am hoping you can provide some clarification for a question a pharmacist has.
In your powerpoint presentation you state “Treat all CSPs repackaged from SDVS as a medium-risk level CSP”
1.What about when Nitroglycerin is drawn up and put into multiple empty glass vials. Can this be listed as a medium risk? One pharmacist feels since it is in a glass vial vs. being drawn up into multiple syringes it should be treated as a single-unit container and given 6 hours. However, since it is considered an “final product” I feel it should be considered a medium risk regardless of whether it is in an empty glass vial that had to be punctured vs. a syringe vs. a piggyback.
2. Think about the situation when you have only ONE single-use vial and you need to use it for 3 days in a patient (due to needing multiple doses and no other vials are available). Unfortunately once made, the piggyback are stable for only 6 hours. Can you draw the drug from the single dose vial into multiple syringes and refrigerate them (and give them medium risk dating of 9 days). Then use one of the syringes to mix up drug into a piggyback and then use final sterility product dating of 9 days minus # days syringe in refrigerator). Ex: 1st day of month draw drug up into 8 syringes. 24 hours later you take one syringe and make it into a piggyback and assign it 8 days exp. (sterility dating).
11-18-2012 09:38 AM
If you a repackaging the nitroglycerin into glass vials to preserve the drug you need to find stability data to demonstrate that the chemical integrity of the nitroglycerin is not affected. Assuming chemical stability, if these repackaged vials are the final container, then can treat them as medium-risk level CSP. If you are going to use them to further manipulate them, then the vial should be treated as a single-dose vial.
In your second question, what drug are you referring to? Where does the 6 hour stability come from? Chemical stability, if shorter than the microbial sterility of the CSP according to the default BUDs in the chapter must dictate the BUD of the final dosage unit.