Medicines should be stored according to the requirements in section 6.4 of the product’s Summary of Product Characteristics (SPC) www.medicines.org.uk. Some medicines need to be stored in a fridge (2-8°C).
Inadvertent temperature excursions
Occasionally, medicines that require refrigeration are exposed to an inadvertent temperature excursion.
SPS compile stability information of refrigerated medicines that have inadvertently been left out of the fridge or exposed to a temperature excursion. This supports NHS healthcare professionals conduct local risk assessment of affected medicines to avoid unnecessary waste.
Information we aim to make available on the SPS website are:
- The maximum temperature we know a medicine will be stable at
- The maximum time we know a medicine will be stable at this temperature
- Whether the product should be stored outside of the fridge if exposed to a temperature excursion
- Whether the expiry date needs to be reduced
We compile stability data based on a product’s Summary of Product Characteristics and additional off-label information provided by the manufacturer. We contribute information to the SPS medicines pages for every UK licensed medicine requiring refrigerated storage. If you find a product is missing from the database, let us know via email.
Accessing SPS Refrigerated Storage information
To find the stability information for a medicine, you need to:
Step 1: Enter the name of the generic medicine in the main search box at the top of the page.
Step 2: Click on the specific monograph.
Step 3: Use the contents function on the left-hand side to click on Refrigerated Storage.
Alternatively, you can scroll down the page until you find the Refrigerated Storage section.
Note: there may be multiple fridge stability monographs for the same drug if there are several different manufacturers.
General principles about stability of refrigerated medicines
If, based on the SPS Refrigerated Storage information, a clinical judgement is made to use a product affected by a temperature excursion, follow these general principles:
- Use products stored outside the fridge first.
- Where a change to expiry date is recommended, clearly label the outer packaging.
- Use products within recommended time frames or until the expiry date on the pack is reached (whichever is earlier).
- This advice applies to products that have been exposed to one temperature excursion only. For products that have been inadvertently left out of the fridge on two or more occasions, call your local MI service for further advice.
- This advice applies to unopened and undiluted medicines. It does not cover, for example, medicines prepared by a pharmacy aseptic unit.
- Content reviewed and minor changes made