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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.
Refrigeration top tips
- Position your fridge so it has plenty of air clearance around it and is kept away from heat sources
- Protect your fridge from being accidentally switched off
- “Refrigerated medicines and vaccines must be stored between 2° and 8°C, with good practice to aim for 5°C and the cold chain maintained at all times,” says Alwyn Fortune, Policy & Engagement lead at RPS Wales
- Don’t overfill the fridge. “In general, the fridge should not be filled to more than 70 per cent capacity as this extra space allows enough airflow to aid temperature control,” says Peter Sanders, business unit manager at Lec Medical
- Pharmacy staff should ensure the fridge door is opened for the minimum period of time possible, and the door should not be left open while a task is performed,
- “Store medicines and vaccines in appropriate containers or packaging. Ensure that containers are sealed and labelled clearly with essential information,” says Labcold managing director Suzanne Clubley
- Clean spills promptly and do not store food items alongside medicines
- “Keep the fridge free from build-up of ice. If defrosting is required, ensure a suitable alternative refrigerator is available for temporary storage,” says Clubley.
- The temperature of the fridge or freezer must be monitored each day using an approved thermometer or monitoring device
- Medical fridges must have at least annual servicing
- Keep the fridge locked or in a lockable room
- Keep records of all servicing, cleaning, defrosting, calibration and electrical testing.
Monitoring the fridge temperature
The NHS Green Book says that temperatures in the fridge must be monitored and recorded at least once in each working day and documented on a chart. These records should be accessible and retained for at least 12 months.
The NHS Specialist Pharmacy Service recommends you have an air sensor and a load sensor in the fridge. The air sensor measures the air temperature, the load sensor measures the actual temperature of medicines kept in the fridge.
Clubley explains: “Digital temperature loggers or data loggers are invaluable tools for continuous temperature monitoring as well as evidencing past temperature control. Remote monitoring systems allow you to access temperature data from anywhere. Its important to remember to position temperature sensors or probes strategically to capture the most representative temperature readings and our second probe, which is used to mimic a vaccine, is really important.”
Transporting cold chain medicines safely
The temperature management of medicines during transport is just as important as long term storage. Domestic cool boxes must not be used to store or transport fridge medicines and vaccines. Cold chain transit containers and cool packs from a medical supply company should be used.
“Where a pharmacy provides transportation of medicines to people or businesses, the pharmacy is responsible for the medicines it delivers until they reach the intended recipient. When inspecting a pharmacy that deals with transportation of medicines, an inspector would look at the risk assessments in place, the SOPs and the indemnity insurance, for example,” says a GPhC spokesperson.
“A robust and consistent cold-chain infrastructure is required to prevent deviations that may compromise product quality. Continuous temperature monitoring is essential,” adds Clubley.
How to deal with a cold chain breach
If you discover that medicines or vaccines have been stored outside of their recommended temperature range, the first step is to quarantine any affected stock and attach ‘do not use’ labels while you investigate.
NHS Specialist Pharmacy Service advice is to:
- Establish the circumstances
- Gather information about the temperature. How warm/cold did the medicine get? How long was the medicine stored outside the recommended range?
- Examine data from your temperature recorder or data logger
- Assess the significance of the breach. Studies from the US National Institute of Standards & Technology have shown that vaccine vials can maintain temperature below 8°C for a minimum of 20 minutes where there is loss of power or a fridge door is left open. However, if an excursion is below 2°C it is potentially harmful and more exploration is needed
- Check the Summary of Product Characteristics (SmPc) for advice
- For vaccines, check the UKHSA’s vaccine incidence guidance
- Once you’ve gathered information, decide whether the affected medicines are safe to use. Discard any not suitable
- Record the outcome
- Take steps to prevent a recurrence.
Refrigeration market update
“Some of the main advances have been around providing greater reassurance on achieving and recording consistent temperatures, ease of use and time saving,” says Sanders.
Lec Medical is extending the connectivity on its Pharmacy Plus range with a new service app for remote support.
“Wireless temperature sensors have become increasingly popular,” says Clubley. “They offer flexibility in sensor placement and can transmit data wirelessly to centralised monitoring systems.
“Cloud-based monitoring solutions provide secure storage and remote access to data. Some monitoring devices now come with mobile apps, allowing pharmacy staff to monitor temperatures and receive alerts.”
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