The answer to all your questions about single-dose vials is...NO

January 12th, 2015

If you are unsure about any question dealing with a single-dose vial of medication beyond its strictly defined use, please assume the answer is ….No.

A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case/procedure/injection. Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative, according to the Centers for Disease Control and Prevention.

In light of recurrent confusion and a tragic history of hepatitis outbreaks involving reuse of the vials, the CDC recently posted a Q&A on the issue:

Can single-dose or single-use vials be used for more than one patient?

No. Vials that are labeled as single-dose or single-use should be used for a single patient and single case/procedure/injection. There have been multiple outbreaks resulting from healthcare personnel using single-dose or single-use vials for multiple patients. Even if a single-dose or single-use vial appears to contain multiple doses or contains more medication than is needed for a single patient, that vial should not be used for more than one patient nor stored for future use on the same patient. To prevent unnecessary waste or the temptation to use contents from single-dose or single-use vials for more than one patient, clinicians and purchasing personnel should select the smallest vial necessary for their needs when making treatment and purchasing decisions.

Is it acceptable to combine (pool) leftover medication from single-dose or single-use vials?

No. Do not combine (pool) leftover contents of single-dose or single-use vials or store single-dose or single-use vials for later use. Single-dose or single-use vials are intended for use on a single patient for a single case/procedure. There have been outbreaks resulting from pooling of contents of single-dose or single-use vials and/or storage of contents for future use.

In critical situations, is there any option for medication from a single-dose/single-use vial to be used for more than one patient?

It is optimal for the medication to be used for just one patient. Shortages of some essential medications may warrant implementation of meticulously applied practice and quality standards to subdivide contents of single-dose/single-use vials. In these cases, qualified healthcare personnel may repackage medication from a previously unopened single-dose/single-use vial into multiple single-use vehicles (e.g., syringes). This should only be performed under ISO Class 5 conditions in accordance with standards in United States Pharmacopeia General Chapter 797, Pharmaceutical Compounding – Sterile Preparations, as well as the manufacturer’s recommendations pertaining to safe storage of that medication outside of its original container.

When should single-dose or single-use vials be discarded?

Medication vials should always be discarded whenever sterility is compromised or questionable. In addition, the following recommendations are made for handling of single-dose or single-use vials:

•If a single-dose or single-use vial has been opened or accessed (e.g., needle-punctured) the vial should be discarded according to the time the manufacturer specifies for the opened vial or at the end of the case/procedure for which it is being used, whichever comes first. It should not be stored for future use.

•If a single-dose or single-use vial has not been opened or accessed (e.g., needle-punctured), it should be discarded according to the manufacturer’s expiration date.