What is a temperature excursion? In the pharmaceutical industry, it refers to any temperature reading outside recommended ranges from the manufacturer’s package insert. Why is it important? Because out-of-range storage temperatures or inappropriate conditions for any vaccine can negatively impact the efficacy, and will require immediate action.
Fortunately, the Centers for Disease Control (CDC) have developed best practices to handle this emergency situation. If there is any question about whether vaccines may have been exposed to a temperature excursion due to the unit becoming too cold or too hot, take the following steps.
Step 1: Notify Supervisors
Any staff member who hears an alarm, receives an alert message, or notices a temperature excursion should notify the vaccine coordinator immediately or report the problem to a supervisor.
Step 2: Quarantine Vaccines
If a vaccine has been compromised, quarantine it immediately. Label exposed vaccines, “DO NOT USE,” and place them separately from other vaccines in the storage unit. Do NOT discard the compromised vaccines.
Step 3: Document the Event
The vaccine coordinator, supervisor, or if necessary, the person reporting the problem, should document the event. Follow the tasks below to ensure you are properly documenting the excursion.
Minimum and maximum storage unit temperature and room temperature during the time of the event
Length of time vaccine may have been affected
Listing of items in the unit (including water bottles) other than vaccines
Any problems with the storage unit and/or affected vaccines before the event
Other relevant information
Step 4: Get Guidance
Contact your immunization programor vaccine manufacturer for additional guidance on whether to use affected vaccines and for information about whether patients will need to be recalled for re-vaccinations. Be prepared to provide documentation of the event (e.g., temperature log data).
Step 5: Implement SOPs
Implement your facility’s Standard Operating Procedures (SOPs) to adjust the unit temperature to the appropriate range. At a minimum, check the temperature monitoring device to make sure it is appropriately placed in the center of the fridge.
Step 6: Wrap Up
Complete your documentation of the event, including the following:
What happened to affected vaccines
What you did with the vaccine and when
Whom you have contacted and instructions received
What you have done to prevent a similar future event
You never know when a temperature excursion may happen. If you have not yet incorporated these best practices into your monitoring program, now is a good time to start!
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