Multi-dose Vials - Expectations for Managing Multi-dose Vials of Injectable Medication

What are the Joint Commission’s expectations for managing multi-dose vials of sterile, injectable medication ?

Any examples are for illustrative purposes only.

Definition:  
The Safe Injection Practices Coalition (2010), defines a multi-dose vial as a bottle of medication (injectable) that contains more than one dose of medication and is approved by the Food and Drug Administration (FDA) for use on multiple persons.
While there is not a specific Joint Commission standard that prohibits the use of multi-dose vials for more than one patient, organizations must comply with the original product manufacturer’s intended use.  
For example: 
  • Single dose/single patient use
  • Multi-dose/single patient use
  • Multi-dose/multi-patient use
Policies, procedures and practices regarding the use of multi-dose vials are expected to incorporate evidence-based practices, such as those published by the CDC (Safe Practices for Medical Injections) and the Safe Injection Practices as developed by the “One and Only Campaign”.

Expiration Dating:
Multi-dose vials are to be discarded 28 days after first use unless the manufacturer specifies otherwise (shorter or longer). Once the container has been punctured, an updated expiration date must be determined and applied to the container. The Joint Commission defines the expiration date as "the last date that the product is to be used".

Only guidelines published within the package insert are considered appropriate. Labeling the vial with the ‘date opened’ does not meet the intent of this requirement. If sterility is questioned or compromised, the multi-dose container should be discarded regardless of the date. A new, sterile needle and syringe should always be used to access the medication in a multi-dose vial.
Multi-dose pens, such as those used to inject medications such as insulin, must also follow these guidelines. 

Resources:
Frequently Asked Questions (FAQs) regarding Safe Practices for Medical Injections
Safe Injection Practices to Prevent Transmission of Infections to Patients

 
Last updated on June 16, 2020
Manual: Critical Access Hospital
Chapter: Medication Management MM

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