Fridge Enquiries Guidance

Scope

To ensure that when products requiring storage between 2 - 8^oC are found to have been stored outside these temperatures for a specified duration of time:

• Stability data is available to support continued use.
• Expiry dates are adjusted, if necessary, according to available stability data.
• Products are destroyed if no satisfactory stability data is available.
• Products are identified to indicate exposure to temperatures outside the recommended range.

This procedure covers all fridge enquiries that come through MI, and a form is provided below to aid in the recording of information.

Also see webinar on 'Managing fridge temperature excursion enquiries' in UKMi Webinars section of the Members Area, and SPS pages on temperature management.

NOTE: This suggested process is based on a document produced by Ammar Abbas and Lesley McClellan, Wirral University Teaching Hospital NHS Foundation Trust, and is not official UKMi guidance.

Procedure

The following information must be obtained from the enquirer:

1. The enquirer’s name.

2. The location where the storage problem has occurred.

3. Whether this is:

• Inadvertent storage above 8^oC or below 2^oC.
• Whether the refrigerator is broken or malfunctioning.

4. For all the products concerned collect and record on the fridge Enquiry form (attached):

• The approved name.
• The brand name.
• The manufacturer.
• The pharmaceutical form (e.g. tablet, injection).
• The batch number(s).
• The expiry date(s).
• The pack size(s).
• The quantity, including the total for each batch, expiry date and pack size.
• The circumstances of the exposure (i.e. not put away, found on the shelf/in cupboard, TTH not collected etc).
• The length of time the product has been above 8^oC or below 2^oC, calculated from the time the product was removed from the refrigerator or the last time the refrigerator temperature was recorded as being between 2 - 8^oC. (See No. 5 and 6 below)
• Whether the product has a coloured sticker attached (see No. 7 and 8 below).

5. For products recently delivered into wards/departments from pharmacy:

• Failure to put into the fridge at the delivery destination.
• Whether the bag/container had a ‘Store in the Refrigerator’ label attached.
• The time of removal from the refrigerator [This can be obtained from the ePMA system for dispensed products and from Pharmacy Stores for ward stock (Top-Up) supplies].
• The maximum/minimum room temperature recorded in the specified time duration if available.

6. For products found to have been stored in a malfunctioning fridge, record:

• The last time the product was stored between 2 and 8^oC. (This can be obtained from the daily refrigerator temperature recording).
• The maximum/minimum temperature recorded in the specified time duration (Thermometer log)

7. A coloured sticker is to be attached to all products stored above 8^oC or below 2^oC deemed suitable for use with or without expiry date or storage temperature changes.

8. A ‘Do not Use After’ sticker with the new expiry date, if applicable, is to be attached to each product so affected.

9. The product is to be destroyed if:

• the time stored above 8^oC or below 2^oC cannot be ascertained.
• the product has a coloured sticker attached indicating previous exposure to temperatures above 8^oC or below 2^oC.
• The maximum/minimum storage temperature cannot be ascertained.

10. Advise enquirer to arrange replacement stocks if the time required to obtain the necessary stability information could result in a delay in patients’ treatment.

11. In case of malfunctioning fridge: an alternative functioning refrigerator storage must be available for any replacement stock due to be issued.

Check Trust guidance on need for completion of a non-clinical incident form.

Resources

• Summary of Product Characteristics of the particular brand in question (if available):
  • accessed via eMC or MHRA.
  • Record the date the monograph was accessed.
  • Record the date the monograph was last updated on the EMC website.

• SPS Refrigerated Medicines Stability Tool:
  • record the date of the entry.
  • record the date viewed.
  • An electronic copy of the monograph may be attached to the enquiry documentation.

• The Medicines Information Department(s) of the pharmaceutical manufacturer of the product(s) in question:
  • record the date contacted.
  • record the name of the person contacted.

• Past enquiries may be consulted if neither of the above resources are available, (or, in case the fridge database, has not been updated). A clinical decision must be made as to whether the information is sufficiently up-to-date, and the enquiry is no more than 12 months old.