Medicines and vaccines must be stored in an environment that assures their quality until they reach customers and patients. This means they must always be kept at the temperature range recommended by the manufacturer.
The majority of medicines and vaccines need to be kept refrigerated between 2 and 8°C. These ‘cold chain’ or ‘fridge line’ medicines include vaccines, insulin, antibiotic liquids, injections, eye drops and some creams.
Vaccines and medicines are valuable products, and storing them incorrectly not only presents safety issues but is costly for pharmacies. “Not being able to demonstrate that medicines that need to be refrigerated are stored within the correct temperature range is a common reason for failing standard 4.3,” says a spokesperson from the General Pharmaceutical Council (GPhC). “As part of an improvement action plan, one pharmacy addressed this issue by strengthening its standard operating procedures to ensure each fridge had a separate monitoring record. All staff received training on how to record and reset minimum and maximum fridge temperature readings, and on what steps should be taken if a reading was outside the correct range. The pharmacy team also carried out a cold chain fridge audit, which they scheduled to repeat annually.
“This is the kind of thing we examine on inspections – whether SOPs are in place to ensure medicines are kept at the right temperature/whether there are plans in place if something goes wrong/ if staff know what those are.”
Alwyn Fortune, Policy & Engagement lead at RPS Wales, says: “Common problems community pharmacies face can include not having sufficient storage for vaccines, particularly as there is seasonal variation in storage requirements. Community pharmacies are very busy practices and when orders arrive, it can sometimes be an issue to ensure refrigerated medicines are placed in the refrigerator immediately. When cold chain products are delivered, it is important they are checked in as a matter of priority and placed in the pharmacy refrigerator.”
Choosing the right pharmacy fridge
Domestic fridges are not suitable for storing temperature-sensitive medicines as their internal temperature fluctuates. Purpose built pharmacy refrigerators are carefully designed to meet the needs of pharmacies. A pharmacy fridge provides much greater temperature control and better insulation as well as built in features like alarms and monitoring, which assist in daily operations and compliance.
Labcold managing director Suzanne Clubley says: “It’s vitally important that pharmacies only use appropriate and approved cold chain equipment. There have been instances where domestic refrigerators have been used to store medicines and vaccines, which may have compromised their efficacy. Pharmacy staff should ensure the chosen refrigerator has a reliable and consistent temperature control system and can maintain the required temperature range for the pharmaceuticals you intend to store. The storage capacity and internal layout of the refrigerator should also not be overlooked and you should ensure it can accommodate the volume of pharmaceuticals your pharmacy routinely handles.
Peter Sanders, business unit manager at Lec Medical, advises: “Firstly, be clear about the storage capacity you require and where it will be within your pharmacy. You will also need to consider how much and how often you need to capture and record data.”
Consider how many items you need to keep refrigerated, as you need a fridge big enough to allow room for air circulation.
