This Scottish Health Protection Network (SHPN) guide should be used alongside the external guidance that it relates to.
This guide covers the UKHSA 'Vaccine incident guidance: responding to errors in vaccine storage, handling and administration'.
This external guidance has been approved for use in Scotland by the SHPN Guidance Group (SHPN-GG).
This guidance is for health protection professionals only.
Other people who require advice should contact their local health protection team.
What the guidance covers
This document is intended to be used by a wide range of healthcare professionals, with a role in delivering immunisation programmes, in the investigation and management of vaccine storage or administration incidents.
These could include:
- general practice staff
- school immunisation providers
- screening and immunisation teams (SITs)
- health protection teams (HPTs)
- healthcare practitioners working in other service areas where immunisations are given
Guide for use in Scotland
The following recommendations for using this guidance in Scotland were agreed by the SHPN through the agreed review and adoption process.
Other useful resources:
- PHS guidance on vaccine storage and handling
- Promoting effective immunisation practice e-learning programme
There are different processes and actions in response to a breach in the cold chain. The following sections should be used to replace sections in the UKHSA document.
What constitutes a significant breach in the cold chain?
This refers to section 7.2.
Exposing vaccines to any temperature outside the manufacturers recommended storage range is considered a breach of the cold chain and may invalidate the product license.
It is however, both the length of time spent outside of the recommended cold chain conditions and the temperatures to which the vaccine(s) were exposed that may compromise the potency of a vaccine and as such, will determine the significance of the breach. While there are varying degrees of significance, each breach of the cold chain should be immediately acted upon and specialist advice should be sought in order to ascertain what action, if any, is required.
The SmPC’s for some vaccines will contain information on vaccine stability outside the normal +2°C to +8°C temperature range. Where available, this information can be used to determine whether or not a single temperature excursion is likely to have affected vaccine quality.
'One off'' fluctuations in refrigerator temperatures rising above +8°C but lasting less than 20 minutes, such as may occur when stock taking or restocking, are not likely to have breached the vaccine cold chain and as such do not require further action.
The cause of the 'excursion' should be documented on the temperature recording chart, the maximum/minimum thermometer reset, where used, and vaccines continued to be used to their expiry date.
This pragmatic approach is based on studies from the US National Institute of Standards Technology which demonstrated vaccine vials can maintain temperatures below +8°C for a minimum of 20 minutes despite the continuous influx of ambient air to the refrigerator.
Vaccines must be stored in their original packaging to preserve this temperature stability and providers should be confident that vaccines have been stored appropriately prior to this event.
Response to a significant breach in the cold chain
This refers to section 7.2.
The process or actions for response are outlined below.
- 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.
- The incident should be reported and documented according to NHS board procedures.
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
- 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
- What temperature monitoring has been recorded? (max/min/current
- 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.
For further information regarding temperature sensitivity/stability of vaccines, the following documents may be useful.
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.
Responding to errors in vaccine preparation and administration
This is additional text for Section 9.
Responding to errors in vaccine preparation and administration is included for Scotland to detail the procedure for responding to incorrect administration of certain vaccines to pregnant women.
UKHSA coordinates the UK-wide Vaccine in Pregnancy Surveillance Programme, which asks that healthcare professionals fill out a surveillance form and send it to PHE whenever any of the following occur:
- measles, mumps and rubella (MMR) vaccine: immunisation given from 30 days before last menstrual period to anytime during pregnancy
- varicella vaccine (chickenpox): immunisation given from 90 days before last menstrual period to anytime during pregnancy
- human papilloma virus (HPV) vaccine: immunisation given from 60 days before last menstrual period to anytime during pregnancy
Full details are available at on the vaccination in pregnancy (VIP) page of GOV.UK.
Using this information, a risk assessment will be undertaken to establish whether the following is the case.
- 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, 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 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.
Algorithm for managing a significant cold chain breach
Algorithm for where compromised vaccines may have been or have been administered to patients
View the external guidance
This external guidance should be used together with the guide for use in Scotland provided on these pages.