From the point of manufacture to the point of use, it is essential that vaccines are kept in a cold-chain. This ensures they remain at the correct temperature while being transported and stored.
These cold-chain conditions, a temperature range between +2oC and +8oC, are maintained by manufacturers and medical practitioners through the use of medical refrigeration units. For transportation, this usually means refrigerated containers.
If vaccines do fall out of these conditions for an extended period of time, it is likely that they will become spoiled and resultantly unusable for patients.
To avoid this prolonged exposure, our experts at CoolMed have collated some information to help you maintain the cold-chain for your vaccines, and how to maintain their shelf life if you find the cold-chain is compromised too.
How Does the Cold-Chain Become Broken?
While significant efforts are taken to ensure that vaccines and medicines remain within the required cold-chain temperature range, these conditions can be broken from time to time.
There can be several reasons for this, including:
- Delays in transportation
- Power outages
- Malfunctioning refrigeration units
- Human error
If a vaccine is exposed to conditions outside of the cold-chain for a significant amount of time, for example days, there is a risk that they could be spoiled. If this occurs, transfer the vaccines immediately to cold-chain conditions, and monitor them to assess their usability.
What to do if the Cold-Chain is Broken
If the cold chain is broken during the manufacturing or transportation process, the vaccine manufacturer themselves will be responsible for advising whether it is still safe to use.
In some cases, medical authorities such as Public Health England may also be consulted as to whether the medicine remains effective.
In either case, they will take into account how long the vaccine has been out of the cold-chain, and at what temperature it was kept at during this period.
If the vaccine falls out of the cold-chain while being stored at a medical practice, the practice itself is responsible for assessing the situation and notifying the manufacturer.
These are some of the steps you should take:
- Return the vaccines to the cold-chain in a state of quarantine
- Make a clear log of the incident and what happened
- Identify when the cold-chain was broken and what caused it to break
- Ascertain what temperature the vaccines have been kept at and for how long
- Contact the manufacturer to find out if the vaccines are still fit for purpose
If the manufacturer does confirm that the vaccine is still safe to use, it must now be classified as an “off-label” vaccine.
The medical practitioner administering the vaccine is obliged to notify the patient if they are going to administer an off-label vaccine and obtain their consent to do so.
How Medical Practices can Avoid Breaking the Cold-Chain
Medical practitioners are the primary individuals involved in the storage of vaccines. To store these vaccines, a dedicated medical fridge must be used.
In addition to this, and to ensure that vaccines are stored at the correct temperature, it is vital to keep an up-to-date temperature log. This should be monitored by a senior member of staff and should be checked at least twice daily; once in the morning and once at night.
Some medical fridges are fitted with alarms which sound when the temperature of the vaccines inside falls outside the determined range.
It is also important for medical fridges to be regularly cleaned and maintained – draw up a cleaning schedule and book an annual service with a qualified engineer.
