Vaccines are particularly vulnerable to temperature variations and may quickly lose their effectiveness if they become too hot, too cold, or are frozen at any time. Vaccines biodegrade naturally over time and storing them outside the recommended temperature range can speed up an irreversible loss of potency. The outcome may be that the patient is not protected by the vaccine and it can result in costly wastage of vaccines or even worse, lives.
The cold chain is the industry standard for transportation and storage of vaccines. By making sure that there are no breaks in the cold chain and using only specifically designed cool boxes and transport containers, the manufacturer’s recommended temperature range of 2-8˚C can be maintained, right up until the point of administration.
Domestic cool boxes are not suitable for the distribution or transport of vaccines and should not be used. Only validated cool boxes, which include appropriate temperature monitoring, should be used, with specialised ice packs. Cool boxes using thermoelectric or compressor operation may be used providing there is a digital display to be able to monitor the temperature at all times.
Vaccine storage guidelines
Based on the latest Department of Health Green Book and Royal Pharmaceutical Society of Great Britain guidelines:
- The expiry date on vaccines is dependent upon them being stored and transported in the correct manner;
- Breaks in the cold chain result in loss of potency of a vaccine, and ultimately to vaccine failure;
- The refrigerator should be specifically designed for the purpose – domestic refrigerators should not be used;
- Food, drink and clinical specimens must never be stored in the same refrigerator as vaccines;
- There should be sufficient room around the vaccines for air to circulate and, in the case of refrigerators over 150 litres, there should be forced air circulation;
- Ice should not be allowed to build up within the refrigerator, as this reduces effectiveness;
- Records of regular servicing, defrosting and cleaning should be kept;
- There should be a lock to protect from unauthorised access, or the refrigerator should be stored in a locked room;
- The pharmaceuticals should be stored between 2-8°C, and vaccines must never be frozen;
- Vaccine refrigerators should have temperature indication and recording of min/max temperatures, and temperatures must be monitored, recorded and documented, preferably on a daily basis;
- The calibration of thermometers should be checked annually to ensure that they are working correctly.
What to consider when buying a pharmacy refrigerator
An integral minimum and maximum thermometer system is a vital feature, and a digital temperature display is quicker to read at a glance. Some models include a safety thermostat to prevent dropping of the cold storage product’s temperature below 2°C, with an acoustic and visual alarm system and a back-up power supply in case of power outage. The ability to access an alarm history which stores all the relevant values during a temperature alarm – minimum, maximum and average temperature – as well as the duration of the alarm is very useful in the event of any type of unit failure.
Security is essential and lots of safety features are offered on specialist medical fridges. Key operation to switch the refrigerator on and off and a visible power switch helps safeguard against it being switched off accidentally. Automatic door closing is a sensible option and essentially, a door lock and door alarm which alerts if the door is left open at any time.
Pharmacy fridges come in various sizes, but the basic advice is to ensure the refrigerator is large enough to carry the stock with sufficient room around the packages for air to circulate, as this enables the temperature to remain constant. Forced air circulation increases cooling efficiency, maintaining the temperature despite frequent or extended door openings and ensuring that there are no hot and cold spots.
Fridges which use absorption technology are silent in operation, which may be a consideration if the unit is to be in a hospital ward or busy area. Glass or solid door options are available on many models, depending on preference and where it is to be sited. Clear doors make it easier to see the stock and can turn the fridge into a point of sale display. However, if sited in direct sunlight, a solid door would be preferable. Smaller fridges, which can be wall mounted on brackets, may be a consideration for use in areas with restricted space and in some cases the option to have the door opening on either side could be advantageous.
It is estimated that up to half of all pharmacies are still using domestic refrigerators, and there are clearly many issues surrounding this. Given the high levels of regulation pharmacists operate under today, added to the increasingly litigious nature of society, it is vital that urgent action is taken over the cold storage of medicines. Ultimately, with the next issue of the RPSGB guidelines expected to be even more stringent, a vast number of pharmacy fridges throughout the UK are going to need replacing.