The Specialist Pharmacy Service have offered general information and guidance common to all COVID-19 vaccines.
We consider the safe storage of vaccines and medical fridges in practices under the safe key question.
This relates to key line of enquiry (KLOE) S4: How does the provider ensure the proper and safe use of medicines, where the service is responsible?
Public Health England (PHE) has published guidance about ordering, storing and handling vaccines.
- Immunisation against infectious disease (the Green Book), Chapter three: Storage, distribution and disposal of vaccines
- Protocol for ordering, storing and handling vaccines.
All staff involved in immunisation should follow this guidance to store and manage vaccines properly.
Vaccines may lose their effectiveness if they become too hot or too cold at any time. They naturally biodegrade over time. Being stored outside the recommended temperature range, including during transport, may speed up loss of potency. This cannot be reversed. A vaccine may then fail to create the desired immune response and give protection. Storing and transporting vaccines inappropriately causes waste and unnecessary cost.
Management of vaccines
When ordering and taking delivery of vaccines, staff should:
- Place orders every two-four weeks, according to need.
- Vaccines should be stored according to the manufacturer’s summary of product characteristics (SPC). Usually between +2˚C and +8˚C and protected from light and transferred to a fridge promptly after delivery.
- Rotate stock– use the shortest expiry date first.
- Place orders in time so there is an adequate supply for clinics.
At least two designated members of staff who have received appropriate training should be responsible for ordering, receipt and care of vaccines. However, all members of the primary care team should understand importance of good vaccine management.
The vaccine fridge
The Green Book gives detailed guidance on vaccine fridges and includes the following:
- Store vaccines in a validated fridge specifically designed for pharmaceutical products. Do not use a domestic fridge.
- Only use it to store pharmaceutical products. Do not store food and clinical specimens alongside vaccines.
- Maintain the temperature between +2 and +8⁰C. Keep the vaccine fridge secure. It should only be accessible to authorised practice staff. Therefore, keep it locked or in a locked room.
- Reduce the possibility of accidentally interrupting the electricity supply. For example, install a switchless socket or clearly label the plug with a cautionary notice: ’Do not unplug/switch off’.
- Use a large enough fridge to allow enough space around the vaccine packages for air to circulate.
- Keep the fridge clean with no build-up of ice. Make sure that you:
- follow the manufacturer's servicing recommendations
- calibrate the temperature gauge
- include it in portable appliance testing.
- Keep vaccines in their original packaging.
The cold chain policy
All providers should have a policy which includes how to handle vaccines to maintain the cold chain from the point of delivery to administration. It should include transport of vaccines outside the practice, actions to take in the event of a breach in the cold chain and details of how the practice will ensure learning from cold chain incidents.
Temperature monitoring should follow the Green Book guidance which gives details of the four Rs: Read, Record, Reset, React.
The person making the recording of the fridge temperature should:
- record temperature at least once every day during the working week and sign the temperature record sheet
- record it in a standard fashion and on a standard form to include: current, maximum and minimum temperature readings
- act immediately if the temperature falls outside +2 and +8⁰C
- reset the thermometer after each reading.
Ideally, use a second thermometer independent to the integral thermometer in the vaccine fridge. This second reading cross-checks the accuracy of the temperature. It monitors the temperature if the electricity supply to the vaccine fridge is interrupted.
You can use a data logger in the vaccine fridge, yet each working day you must still:
- read and record temperatures on the integral fridge thermometer (minimum, maximum and current)
- reset the min/max thermometer.
This will assure you the fridge contents have been stored correctly and are safe to use.
If you use a data logger and only check it weekly or monthly, you risk missing cold chain breaches. It is possible that you used vaccines that were stored outside the recommended temperature range. If you use an alarm system to alert that the fridge temperature is out of range, is it possible the alarm could turn itself off once it is back in range, without being investigated?
Data loggers are useful to gain more detailed information about the fridge temperature if there is a cold chain failure, for example a power cut.
When we inspect
During a CQC inspection, inspectors will expect to see evidence of maintenance of the cold chain. Providers will be asked to show how they follow the PHE recommendations. This includes receipt of vaccines into the practice until administration to the patient. Inspectors may also ask to see evidence of the log of fridge temperatures, maintenance checks and a policy for what to do if a temperature breach occurs. Inspectors may also check the fridge to see if the vaccines are being stored appropriately.