As flu season approaches, we thought it the right time to consider guidance on storing and handling vaccines in general practice. Safe storage and management is essential; but fear not, Public Health England (PHE) has published comprehensive guidance to ensure immunisations are carried out safely and efficiently
Public Health England (PHE) has published comprehensive guidance on ordering, storing and handling vaccines, which applies to all practice staff involved in immunisation. It details standards for ordering and delivery, storage, maintenance of the cold chain, auditing and monitoring of stock and incident reporting – all of which should provide a basic check list for your practices vaccination protocol.
Why is it so important? Simple; effective management of vaccinations reduces the risk of compromising the quality, efficiency and safety of the vaccine programme and improves the service for patients.
Failure to effectively manage vaccines comes with some serious negatives, for example, they can lose their effectiveness if not stored at the right temperature – if they become to hot or too cold – at any time. Further, because they are naturally biodegradable, if they are stored outside of their recommended temperature range they can lose their potency – an effect that cannot be reversed – and which can ultimately result in poor protection.
Ordering and delivery essentials
The guidance says that at least two named, trained people must be responsible for ordering, receipt and care of vaccines – one from the nursing team and one from management, however, all members of the primary care team should be aware of the importance of good vaccine management.
Practices should ensure that;
- orders are placed every two to four weeks – according to need;
- vaccines are promptly stored in a fridge after delivery – maintaining ‘cold chain’ at all stages;
- there are no leakages, damage or discrepancies in the delivered vaccine;
- stock is properly rotated;
- a stock information system keeps track of orders, expiry dates and running total of vaccines;
- ordering is done in sufficient time to ensure that there is an adequate supply for the practice.
Note that vaccines are available for ordering through the ImmForm website. This ensures ordering is easier, more effective and efficient.
Register on ImmForm.
The ‘cold chain’
The ‘cold chain’ is used to describe the cold temperature conditions in which certain products need to be kept during storage and distribution. It’s important that those administering vaccines have training on the importance of maintaining the cold chain, that validated cool boxes from a recognised medical supplier are used to transport vaccines and that all those involved in administering vaccines – as well as the practice manager – understand what to do in the event of a failure in the cold chain.
Refrigeration is essential
There are specialised refrigerators available for the storage of pharmaceutical products and must be used to store vaccines and diluents. The PHE puts into perspective the impact of poor vaccine storage, highlighting that the loss of only one dose of Pediacel vaccine a month in each general practice would cost an estimated £4m a year. However, a specialised vaccine fridge will cost, on average, between £600 and £1,200
A validated vaccine fridge must be used by all practices. Be careful to ensure that;
- only pharmaceutical products are stored in the fridge;
- these vaccines are kept in their original packaging;
- it is large enough to hold the stock and allow sufficient space around the vaccine packages for air to circulate;
- it stores vaccines between +2 and +8°C – a mid-range of +5°C is good practice
- care is taken by the practice to reduce the probability of accidental interruption of electricity supply, a switch-less socket is advised so as to avoid them being turned off accidentally;
- the fridge is well-vented and away from heat sources so performance is not impacted;
- it’s secure and accessible only to authorised staff – it should be locked or kept in a locked room;
- it is safe – for example, by carrying out visual inspections and P&T testing.
It’s important that the correct temperature is maintained to avoid vaccines being spoiled. The PHE recommends that you observe the four ‘R’s: read, record, reset, react
Do make sure that the person making the recording:
- does it at the same time every day during the working week and signs the sheet;
- records it in a standard fashion and on a standard form;
- ACTS if the temperature falls outside +2 to +8°C;
- resets the thermometer after each reading.
Note: any vaccine that has not been stored at +2 to +8°C as per its licensing conditions is no longer a licensed product.
Keeping tabs of temperatures; thermometers
Minimum, maximum and actual temperatures of the medicines fridge must be recorded daily when the practice is open. The individual recording this should document on a standard form the min and max temperature, the time and then reset the thermometer and sign the form – which should be kept for a year.
The PHE advises that two thermometers should ideally be used so as to cross-check temperatures (for accuracy), but if not possible, the thermometer used should be recalibrated monthly to confirm accuracy. Also, care should be taken that the thermometer probe cable does not interfere with the door seal, causing the temperature to fall outside the permitted range.
Monitoring temperature data
This is a simple and effective procedure and should follow this schedule:
- Every week: fridge contents should be checked at least once.
- Every month: vaccine stock should be audited and recorded.
- Every three months: audit records of stock and temperature management can be shared with your local screening and immunisation teams.
In the event of a fridge failure the PHE provides the following guidance;
- inform the local NHS England screening and immunisation team;
- quarantine all vaccines affected by an incident from others (but maintain in the cold chain);
- record all details of the incident;
- implement any follow-up of the incident after discussion with the SIT;
- implement and share lessons learned from the incident;
- make sure written procedures for the disposal of vaccines are available locally;
- report the incident on the ImmForm website www.immform.dh.gov.uk