Vaccines should always be stored in accordance with the manufacturers licence. If the cold chain has been compromised a vaccine will fall outside the specifications of its product licence.
Depending on how long the vaccine has been outside the cold chain and based on additional stability studies the product remains a licensed product but any subsequent use will be considered “off-label”.
Unlicensed medicines cannot be supplied or administered under a PGD but off-label medicines can be included provided that there is documented evidence to support its inclusion. Assessment of the time out of the cold chain, reference to the manufacturer and/or via local Medicines Information team will be required to determine whether off-label use of a specific vaccine under these circumstances is appropriate.
Consideration of the stock levels to be wasted and impact on implementation of the national immunisation programme will also be important factors to consider at an organisational level. Generally these types of assessments are not consistent with the principles of inclusion in Patient Group Directions and are best managed on an incident case-by-case basis.
A leaflet describing the circumstances of off-label use of vaccines due to cold chain breaches has been produced as a brief guide for parents ‘The use of vaccines that have been temporarily stored outside the recommended temperature range’.
[Available at: https://www.gov.uk/government/publications/vaccines-stored-outside-the-recommended-temperature-range-leaflet]
[29 Aug 2019]