Questions about Multi-dose vials

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1. What is a multi-dose vial?

A multi-dose vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that contains more than one dose of medication. Multi-dose vials are labeled as such by the manufacturer and typically contain an antimicrobial preservative to help prevent the growth of bacteria. The preservative has no effect on viruses and does not protect against contamination when healthcare personnel fail to follow safe injection practices.

2. Can multi-dose vials be used for more than one patient? How?

Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should only be kept and accessed in a dedicated clean medication preparation area (e.g., nurses station), away from immediate patient treatment areas. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters an immediate patient treatment area, it should be dedicated for single-patient use only.

3. What are examples of the “immediate patient treatment area”?

Examples of immediate patient treatment areas include operating and procedure rooms, anesthesia and procedure carts, and patient rooms or bays.

4. Our hospital uses bar code technology that requires scanning of medication vials and drawing up medication in the patient room. If multi-dose vials (e.g., insulin) are dedicated for single-patient-use only, can they be accessed in the patient room?

Ideally, from an infection control perspective, all medication preparation should occur in a dedicated clean medication preparation area (e.g., nurses station), away from immediate patient treatment areas. However, if there is a need to access multi-dose vials in the patient room (e.g., for the purposes of bar-coded medication administration) the vial must be dedicated for single-patient-use only, the patient should be housed in a single-patient room, and all medication preparation should be performed in a designated clean area that is not adjacent to potential contamination sources (e.g., sink, used equipment). Following medication preparation, the vials should be stored, in accordance with manufacturer’s instructions, in a manner to prevent inadvertent use for more than one patient and/or cross-contamination.

5. When should multi-dose vials be discarded?

Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed. In addition, the United States Pharmacopeia (USP) General Chapter 797 [16] recommends the following for multi-dose vials of sterile pharmaceuticals:

  • If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial.
  • If a multi-dose vial has not been opened or accessed (e.g., needle-punctured), it should be discarded according to the manufacturer’s expiration date.

The manufacturer’s expiration date refers to the date after which an unopened multi-dose vial should not be used. The beyond-use-date refers to the date after which an opened multi-dose vial should not be used. The beyond-use-date should never exceed the manufacturer’s original expiration date.

For information on storage and handling of vaccines please refer to the CDC Vaccine Storage and Handling Toolkit or the manufacturer’s recommendations for specific vaccines.