Practice advice Q&A – Power blackout product safety

Q: A blackout knocked out power to our fridges. How do I determine what is still safe to use?

A: Refrigeration is required for temperature-sensitive products to maintain product efficacy and safety. While you determine what is still safe to use, quarantine the affected stock so it isn’t inadvertently dispensed.

A number of factors determine whether the products are still viable for use. First, review temperature logger data to determine the temperature reached inside the fridge, and the timeframe that this was outside the range of 2–8 C. Both heat and freezing may affect the product, and repeated episodes of temperatures outside of the required range can cause cumulative and irreversible effects.

Refrigerated vaccines have very strict cold chain requirements and guidance from state or territory health departments should be referred to for advice on managing breaches. The National Vaccine Storage Guidelines ‘Strive for 5’ also provides useful information on vaccine storage, including management of power failures.¹

The Product Information (PI) for the refrigerated product is a useful source of information. It will specify storage requirements, expiry and when storage variations are permitted. For example, Sativex and many insulin pen cartridges must be stored in the fridge, but the container or cartridge in use may be kept at room temperature for a defined period.

It can be useful to contact the product manufacturer(s) as they should be able to advise whether their product can still be used, or if conditions are placed on use such as a shortened expiry date.

Pharmacies that hold significant quantities of temperature-sensitive products (particularly high-cost ones) should consider installing alarmed temperature monitors to alert when temperatures are exceeded and check what’s covered by their insurance policy.

Bob Buckham is the Manager of Strategic Policy at PSA.

References
[1] National Vaccine Storage Resource Collection. 2nd Ed. 2013 (updated 2018). Australian Government Department of Health and Aging. https://beta.health.gov.au/resources/publications/national-vaccine-storage-resource-collection

[2] Cold chain management. In: Sansom LN, ed. Australian pharmaceutical formulary and handbook. 24th edn. Canberra: Pharmaceutical Society of Australia. 2018.