You're asked to review a hospital or clinic operating instruction (OI) addressing a number of things, including multiple dose vials (MDV). The OI states all multiple dose vials will be refrigerated after initial use or thrown out. When you question the POC for this instruction, they state refrigeration is required on all MDVs because it deters bacterial growth.

Do you concur with the OI as written? Why or why not?

SELECT  here for discussion

Probably not!

Although commonly recommended in the past, routine refrigeration of multiple dose vials is NOT recommended unless specified by the manufacturer. Routine refrigeration may adversely affect the solubility of the drug (cause precipitation). Some antibacterial/antimicrobial agents used in MDVs are less effective at refrigerated temperatures. The recent mock-JCAHO inspectors asked us about MDVs and how we handled them. See a section cut from our MDWI below.

Per the WHMC medication use OI: "Reconstituted multiple dose vials are labeled with the diluent, concentration, expiration date, and initials.  All other multiple dose vials do not require a date or initial when opened, and retain the manufacturer's original expiration date.  All multiple dose vials are visually inspected for contamination or deterioration prior to each use.  Multiple dose vials are discarded upon the expiration date or when contamination is suspected. Multiple dose vials are refrigerated only if specified by the manufacturer." The CDC recommendations are printed in the Am J Infect Control 1996;24: 262-93.  The AF Infection Control course uses the APIC Text of Infection Control and Epidemiology.  On page 68-5 it states:

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e.    The number of entries may affect sterility of MDV's; however, there is no practical way to document this.  In addition, frequent use may cause vials to be used up more rapidly, thereby actually reducing the risk of infection.

f.    Time limits after first opening to ensure sterility and stability
        1.    Manufacturers' expiration dates apply to stability and sterility of unopened vials.

        2.    There are no specific guidelines with respect to expiration of unopened MDVs.  The USP considers "any time limit put on the use of a multiple-dose vial after its first opening as strictly arbitrary."

        3.    Discarding MDV's after one use is probably not necessary.

        4.    Some sources recommend dating all opened vials, although there is no evidence that dating vials has any effect on sterility.

        5.    Expiration of vials may need to vary according to other factors that affect sterility.

g.    The CDC recommends use of single dose vials whenever possible for admixture of parenteral products.  However, this may not be practical for IV admixture programs for reasons of economy and efficiency.

h.    When MDV's are used, the CDC recommends refrigerating the vials after opened IF recommended by the manufacturer, cleaning the rubber diaphragm of the vial with alcohol before inserting a device into the vial, using a sterile device each time a vial is accessed, and avoiding touch contamination of the device before penetrating the rubber diaphragm.  The MDV should be discarded when empty, when suspected or visible contamination occurs, or when the manufacturer's stated expiration date is reached.

Single dose vials (SDV) are an entirely different story. Single dose vials are just that - SINGLE dose vials. Use them once and throw them out. These SDVs do NOT have antimicrobial agent in them to prevent growth in the case on inadvertent inoculation of the vial. The only situation in which repeated use of a SDV MIGHT be appropriate is if they're opened in an aseptic area (i.e laminar flow hood or IV hood). Even then, you have to consider stability of the drug and the duration of use. These should not be removed from the hood nor should they be used for longer than 12-24 hours. The mock JCAHO inspectors found several places where SDVs were dated and time and left in a medication cart where they could (and would) be used again.