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 refrigerator. Occasionally, medicines that require refrigeration are exposed to an inadvertent temperature excursion.
SPS compiles information about the stability of refrigerated drugs that have inadvertently been left out of the fridge. This is to support NHS healthcare professionals to conduct a local risk assessment and make a clinical judgement about whether a medicine is still suitable to be administered to a patient. In addition to supporting patient care, it should help avoid unnecessary medicines waste. Information that 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 medicine can be returned to the fridge
- Whether the expiry date needs to be reduced
We compile this information based on a product’s SPC and additional information from the manufacturer. We contribute information to the SPS medicines pages for every UK licensed medicine that requires refrigerated storage. If you find a product is missing from the database, let us know via email.
General principles about stability of refrigerated medicines
If, based on the Refrigerated Storage information, a clinical judgement is made that a product can be used subsequent to a fridge excursion, these general principles should be followed:
- Products that have been stored outside the refrigerator should be used first
- Where a change to expiry date is recommended, clearly label the outer packaging
- Products should be used 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 that have been prepared by a pharmacy aseptic unit.
How to access SPS Refrigeration Storage information
What is often referred to as The SPS Fridge Database is made up of the individual Refrigerated Storage sections that are embedded into each medicine page on the website.
To find the fridge stability information for a medicine, enter its name in the main search box at the top of the page and click on the specific monograph. You then need to scroll down the page until you find refrigerated storage data from the appropriate manufacturer (note there may be multiple fridge stability monographs for the same drug if there are a number of different manufacturers).