Vaccine incident guidance: responding to errors in vaccine storage, handling and administration
SHPN guide to using the external guidance

Embargo the refrigerator and/or affected vaccines

• When a significant cold chain breach has been identified, it is important that all the vaccines exposed to temperatures outside those recommended in their SmPC are labeled, quarantined immediately and maintained in a functioning monitored refrigerator.
• The vaccines and any equipment or documentation associated with the incident should not be discarded until a full investigation and risk assessment of the incident has been undertaken and authorisation to do so is given by NHS board.
• All staff within the facility should be advised that the refrigerator contents have been embargoed until further notice and should ensure that the vaccines are not used.
• Arrangements should be made to replenish stock, if required, to avoid any unnecessary service disruption.

Report the incident

• The incident should be reported and documented according to NHS board procedures.

Investigate and risk assess the incident

An initial risk assessment of the incident will be undertaken by NHS board staff and full investigation of the incident will be carried out in line with NHS board policy if necessary.

• Has anyone potentially received compromised vaccines as a result of the incident?
• A site visit will be carried out if deemed necessary by an appropriately trained professional from the NHS board.
• The refrigerator temperature records should be checked and cold chain practice prior to this event discussed with staff:
  • What temperature monitoring has been recorded? (max/min/current
    temperature readings)
  • Have any of the affected vaccines previously been involved in a cold chain incident? (packaging may be marked with a cross)
  • Any explanations for temperature discrepancies should be sought - e.g. stock delivery, evidence thermometer was not re-set, untrained staff monitoring refrigerator, etc.
  • When was the cold chain last guaranteed?
  • What time period/s is involved? (hours/days/months)
  • What is the temperature range during this period?
  • The refrigerator alarm parameters should be checked to ensure they are set within manufacturer’s recommended temperatures
• The accuracy of current temperature recording devices in use should be confirmed in accordance with local procedures.
• Consider confirming the current refrigerator temperatures where possible through continuous temperature logging using a data logger. This should be carried out for a 72-hour period to establish temperature patterns of the refrigerator.
• The general condition of the refrigerator should be documented.
  • Is it a purpose-built vaccine refrigerator?
  • How old is the refrigerator? Is the refrigerator over 5 years old?
  • Are there any obvious signs of freezing or build-up of ice?
  • Is the door seal intact and does it make good contact with surface when door is fully closed?
  • Is it placed in a well ventilated area?
  • Is it used for any other purpose than vaccine storage?
  • When was the refrigerator last serviced?
• A check of historical audit data may give some indication as to when the refrigerator was last working properly if the incident is over an extended period of time. The audit history data may give an indication of how refrigerator/vaccines have been managed prior to this incident.
• Identify all vaccines stored in the refrigerator, their location in the refrigerator, the time they have been stored there, usual stock turnover and expiry dates.
• Identify which vaccines are given at the facility.
• Does the clinic administer routine national immunisation programme vaccines, travel vaccines and/or annual influenza vaccines? This may give an indication of time scale involved and draw attention to those at immediate risk.
• Contact vaccine manufacturers for all affected vaccines to obtain stability information based on the known particulars of the incident to determine if the vaccines have been compromised.
• Vaccines against the same disease but from different manufacturers must be considered individually.
• Check for any additional stability information contained within the SmPC.

Further information

For further information regarding temperature sensitivity/stability of vaccines, the following documents may be useful.

Temperature sensitivity of vaccines

View the WHO technical document on the temperature sensitivity of vaccines.

Summary of stability data for licensed vaccines

This document presents data on the relative stability of licensed vaccines based on published studies and product monographs/SmPCs. This does not always cover products used in the UK and there may be significant differences in manufacturer stability data between seemingly similar products. Where product-specific data is unavailable however, the summary of stability data for the vaccine is very useful.

View the summary of stability data for licensed vaccines.

Vaccines have not been compromised

• Vaccines have not been compromised and may continue to be administered using Patient Group Directions in line with NHS board procedures.
• Vaccines should be labelled to indicate affected by one cold chain incident.
• Advise to use first.
• Advise to contact NHS Board for advice if affected vaccines are further exposed to temperatures outwith +2.0°C to +8.0°C.

Vaccines have been compromised

• Vaccines have been compromised, however, there is no evidence that they have been administered to patients.
• These vaccines should now be destroyed in line with local procedures.

Vaccines may have been compromised

Vaccines may have been compromised and may have been or have been inadvertently administered to patients.

• Any remaining vaccine should now be destroyed in line with local procedures.
• An investigation summary report should be prepared for the Incident Management Team.