Colin Burgess, senior technical manager for medical refrigeration specialist Lec Medical, outlines the regulations governing the storage of ‘cold chain’ medical products and explains how care homes can meet the highest safety standards without placing an undue burden on staff
Safe storage is a central plank of all guidance on the management and administration of vaccines and medicines within a care home setting.
Government guidelines state that: “As a minimum, training for care home assistants should cover: the supply, storage and disposal of medicines; safe administration of medicines; quality assurance and recordkeeping; and accountability, responsibility and confidentiality.”1
The pressure on care home staff to adhere to policies and procedures relating to drugs is rightly high, in order to protect vulnerable residents with often complex health needs. It is also understandable that staff might prioritise how drugs are given to residents, while paying less attention to how those drugs are stored
However, incorrectly stored medicines can threaten the health of residents as much as administering them inaccurately. And if an entire batch of medicines is stored in unsafe conditions, it could impact the health and safety of far more people.
Additionally, if sensitive pharmaceutical products are left in conditions which are too hot or too cold, the potential damage caused can render them ineffective and they must be discarded. The financial implications of this are serious, particularly at a time of ongoing cost pressures across the care sector.
Why is correct medicines storage important?
A number of drugs administered in care homes are temperature sensitive. Typical examples include flu and COVID vaccines, insulins, antibiotics, cancer drugs, anti-inflammatories, and glaucoma and other eye or ear drops.
These are considered ‘cold chain’ products, which means they must be kept in stable refrigerated conditions at temperatures between 2°C and 8°C from the point of manufacture until they are administered to the patient.
If cold chain medicines are stored outside the required temperature range, the active chemicals in them can change in molecular form. This can cause them to become less effective and to degrade more quickly, rendering manufacturer ‘use by’ dates defunct.
An easy visible example is an ointment that has gone off-colour and runny, or a gel capsule that has hardened or softened, making it obvious that they should not be used.
However, it is not always so simple. For example, vaccines are probably the most temperature-sensitive cold chain drugs. They are highly sensitive biological substances which contain antigens – living organisms from viruses and bacteria – which means they gradually biodegrade over time
Storing vaccines outside their recommended temperature range can speed up their natural loss of potency. This impact cannot be reversed, and a vaccine may then fail to create the desired immune response and give protection.
The Public Health Agency and Health and Social Care Board advise that if vaccines are stored outside of the recommended 2–8°C for longer than just 20 minutes, this is considered as a significant cold chain breach and immediate action is required.
CQC guidance on storing medicines
It is clear that temperature is one of the most important factors that can affect the stability of a medicine, and the CQC has issued specific guidance for care homes relating to cold chain medical products.
It is unequivocal about the type of refrigerator where cold chain products should be stored. It stresses:
“Dedicated medicines fridges should be of a suitable standard to keep medicines at the correct temperature … Some fridges are advertised as ‘medicines fridges’. But they may maintain temperatures in ranges that are too low or too high.”2
The CQC also details how the interior temperatures of the medicines fridge should be recorded, stating that care homes should:
- Complete temperature recordings on a daily basis.
- Record minimum, maximum, and current temperatures.
- Reset the thermometer after each reading.
- Ensure staff understand the recommended temperature range, how and why they must read and reset the thermometer, and what to do if the fridge temperature falls outside the recommended range.
- Keep records of any actions taken
This is no small task for care home staff who are already under tremendous strain in their day-to-day lives. The CQC’s own State of Care report 2022/23 states that: “Staff regularly fed back to us of being overworked, exhausted and stressed – sometimes to the point of becoming ill, injured or leaving their job altogether. They say this can affect their ability to provide safe and effective care to people.”3
Considered in this context, the daily monitoring and recording of fridge temperatures, although an essential task, is also a labour and time-intensive one, which staff members must often fit it in among a number of other responsibilities. It is easy to see how it might slip down the priority list.
Additionally, when temperatures are recorded, human error might creep into reporting procedures, while simple actions such as inadvertently leaving a fridge door open for too long can also increase fridge temperatures.
A medical refrigerator can contribute significantly to easing the burden on staff and at the same time ensure that resident safety is protected from the risk of damage being caused by storing sensitive cold chain medicines outside the recommended temperature range.
Benefits of NHS approved medical refrigerators
Reliability
The importance of using a medical fridge from an approved supplier cannot be overstated. A domestic fridge – even if erroneously labelled as a medicines fridge as highlighted in the CQC’s warning – simply is not up to the task of storing temperature sensitive medicines
In its advice relating to fridge temperatures, the leading consumer body Which? states that domestic fridges will not automatically set to within the manufacturer’s recommended temperature range and must be manually set – a situation which would introduce an unacceptable risk of human error from the outset within a care home setting.
It also warns: “Our testing [on domestic fridges] has found that you can’t always rely on these settings to work like they should.
“The manufacturer’s recommended setting on the worst models we’ve seen sends the temperature in the fridge soaring above 10°C – warm enough to invite heatloving bacteria inside.”4
The golden rule is that a medical fridge must be reserved exclusively for the storage of medical cold chain products – so not to be used to store anything that might present a contamination risk, such as food or drink.
Placing a domestic fridge in a medical care setting might mislead staff into treating it like the one they have at home, for example by keeping milk or packed lunches in it, which would introduce a threat of contamination
Accurate temperature monitoring and recording
Advanced medical refrigerators such as our Lec Medical Pharmacy Plus range have inbuilt technology which removes the need for staff members to take multiple manual temperature recordings on a daily basis and maintain hand-written or typed records.
Smart technology enables completely contactless temperature readings using a Bluetooth enabled controller. Data can be downloaded directly to a phone or tablet and shared with approved personnel directly, via an app. A display panel on the fridge itself provides readily available information about the interior temperatures
We have also developed dual air and load probes to deliver the pinpoint temperature measurement vital to storing sensitive vaccines and medicines.
The first probe monitors the internal temperature of the fridge, while a second probe sits within a silicon oil formulated to mimic a vaccine. It means the temperature of the vaccine is monitored – not just the fridge temperature.
This dual digital temperature monitoring delivers accuracy that manual readings cannot achieve. The technology also removes staff responsibility for recording fridge temperatures, as well as for analysing the information on the spot
Safety alerts App data will alert management if the fridge contents have fallen outside the recommended temperature ranges at any point, for example if there are any power outages, or a door has been left open
Temperature alarms are both audible and visual and an extra layer of safety is provided by a power failure alarm with battery back-up and data retention.
Added safety
Additionally, an intelligent fan management system prevents warm air being drawn in when the fridge door is open and automatically restarts when it closes, ensuring temperatures remain stable at all times
These features serve to free up a significant amount of time, remove added responsibilities and therefore ease the pressure on busy care home staff.
Reduced medicines waste
NHS statistics on pharmaceutical waste in the UK make for sobering reading. An estimated £300m of NHS prescribed medicines are wasted each year.
The NHS estimates that approximately £50m worth of NHS supplied medicines are disposed of each year by care homes. This accounts for 17 per cent of the total prescription medicine wastage in England each year.
This situation is unlikely to improve as an increasingly aging and infirm population is only likely to swell the population of nursing homes and, by logical implication, increase the amount of wasted medicines generated in the care home sector.
With the health and care sector arguably under pressure like never before, the need to use every means possible to reduce costly medicines waste becomes everybody’s responsibility.
A medical refrigerator is clearly not a silver bullet. However, it can play some significant part in preventing pharmaceutical waste.
Consider just the total value of vaccines – which cost the NHS and estimated £200m a year (equating to an additional £6m a year for Northern Ireland).
Ensure that these highly sensitive medical products are not damaged simply through inadequate refrigerated storage, and the collective saving is obvious
Added security
The very nature of care homes – which often have an ‘open door’ policy and experience large numbers of family visitors in addition to routine deliveries and maintenance workers – can make them susceptible to security breaches.
Care home staff are among the most dedicated, often working unsocial hours in very busy environments to care for residents who have multiple physical and emotional needs. However, as in any other industry they are also human, and the number of controlled drugs registered on the Controlled Drug (CD) reporting tool as either lost, stolen, or otherwise missing amounted to 2,899 in 2018/19.
An approved medical fridge comes with double manual or digital locks as standard, limiting the risk of unauthorised access and tightening security procedures
Maintaining a fridge for safety and efficiency
If you have invested in an approved medical refrigerator to store your cold chain products, there are a number of simple measures you can take to ensure it operates to its optimum capacity, and that you get value for money.
A medical fridge should be sited in a well-ventilated room which is maintained between 10°C and 25°C, away from external windows and all heat sources such as radiators or direct sunlight, and at least 5-10 cm from walls and other units
Some products can be irreversibly degraded even by brief periods at sub-zero temperatures, particularly vaccines. To avoid any possibility of freezing, do not place any medicines against the walls or the floor of the fridge.
The fridge should be filled to no more than 75 per cent capacity to allow adequate air circulation, and stock should be stored according to first expiry
It must be kept clean and serviced regularly, according to the manufacturer’s instructions.
An investment in an advanced medical fridge need not place an undue financial burden on a care home. There is a wide range of model designs and capacities range from 47 to 400 litres – in other words, a product to cater for even the smallest independent care home.
There is huge added value to be gained from contactless temperature readings, data retention, and automated alarm systems and back-up, in terms of workload efficiency, reduced waste, and in ensuring costly medicines – and, most importantly, your residents – are kept safe.
Colin Burgess
Colin Burgess is senior technical manager for Lec Medical. He has 40 years’ experience in the design and manufacture of white goods, primarily in refrigeration and heat pump and solar technologies, and has been working as a product design manager for 20 years
Reference
1. https://assets.publishing.service.gov. uk/media/5a7f354de5274a2e87db474b/ Medicines_in_care_homes_A.pdf
2. https://www.cqc.org.uk/guidance-providers/adult-social-care/storingmedicines-fridges-care-homes
3. https://www.cqc.org.uk/publications/ major-report/state-care/2022-2023 4. https://www.which.co.uk/reviews/fridges/ article/how-to-store-food-safely-in-thefridge-a05PO7F3s4m