|
De-Mystifying the Single Dose Vial
By William Blair, Pharm.D., MBA
What is the difference in a "Single Dose
Vial" versus a "Multiple Dose Vial"? How many times may I use a "Single Dose
Vial"? How long may I keep a "Single Dose Vial"? Why do you package 30 ml
"Single Dose Vials" when the usual dose is 1 ml? May I reuse a "Single Dose
Vial" if I keep it in the refrigerator? If you have asked any of these
questions, you are not alone!
The joint USP-FDA Advisory Panel has met and
is recommending changes to clear up some of this confusion. The Panel
states, "the term "single use" is preferred over "single dose" for
injectable products meant to be used for one dose and then discarded. A
"single-dose" vial/syringe may actually contain enough drug for more than
one dose so "single-dose" can be misleading."
So far, the USP-FDA Advisory Panel is only in
the recommending stage. So in the meantime, this article will try to clarify
some of the questions:
Top of page
Q:
What is the difference between a "Single Dose Vial" versus a "Multiple Dose
Vial"?
A: "Single Dose Vials" contain no
preservatives whereas "Multiple Dose Vials" are preserved to help retard the
growth of bacteria that may be inadvertently introduced with the penetration
of the stopper by the needle. "Multiple Dose Vials" contain more than one
dose. "Single Dose Vials" may contain more than one dose.
Top of page
Q:
How many times may I
use a "Single Dose Vial"?
A: "Single Dose Vials" contain no
preservatives. Once the stopper has been penetrated, the contents of the
vial may not be sterile.
Top of page
Q:
How long may I keep a
"Single Dose Vial"?
A: Unopened, the contents are good until the
expiration date on the vial. Once opened, the contents of the vial may not
be sterile and should be consumed in a single use (i.e. one vial for
multiple IV sets at one time).
Top of page
Q:
Why do you package 30 ml "Single Dose Vials" when the usual dose is 1 ml?
A: "Single Dose Vials" are preservative-free
and are preferred by some Doctors and may be essential for patients allergic
to the preservative. "Single Dose Vials" may contain more than one dose.
Top of page
Q:
May I reuse a "Single Dose Vial" if I keep it in the refrigerator?
A: This is not recommended. "Single Dose
Vials" may contain more than one dose. But, since they do not contain a
preservative, the vial should not be reused over multiple days. Although
refrigerating an opened vial may retard the growth of bacteria which may
have been introduced during use, the lack of a preservative in the product
makes extended storage a significant risk for bacterial growth, even under
refrigerated conditions.
|