Cold Chain Management

19/06/2024

With the arrival of winter, and the ramping up of colds, flu and Covid within the community, vaccine services within community pharmacies will also become busier. The Pharmacy Council wishes to remind you of the requirements for managing cold chain products.

Vaccines, and other cold chain products are usually fragile, biological substances. If stored incorrectly, they can become less effective, or be destroyed if exposed to temperatures outside the recommended storage range.

The “cold chain” begins when the vaccine is made and ends when the vaccine is administered. The “Strive for 5” campaign promotes best practice in vaccine and temperature sensitive products storage.

Strive for 5

The National Vaccine Storage Guidelines “Strive for 5” is the gold standard for practice and provides information and advice for managing vaccine storage in Australia. The guidelines also contain a collection of resources, including posters, a vaccine storage self-audit tool and checklists for managing power failure and emergency storage.

Storage of vaccines and temperature sensitive products

Most vaccines lose effectiveness if they freeze, get too warm or are exposed to direct sunlight or ultraviolet (UV light), including fluorescent light. The ideal storage and transport temperature range is between the range of +2°C to +8°C (strive for +5°C: the midway point).

In NSW, vaccines must be stored in a purpose-built vaccine refrigerator specifically designed to store vaccines and should be used for all vaccine storage. They should have an alarm and safety features that alert to and/or prevent irregular temperature fluctuations in the cabinet and include an inbuilt digital temperature monitoring (inbuilt data logger) and/or digital temperature indicators (minimum and maximum temperature displays).

To protect vaccines from light exposure they must be stored refrigerator inside their original cardboard packaging. The original cardboard packaging ensures vaccines are protected against:

exposure to sunlight and ultraviolet (UV) light or fluorescent light
temperature fluctuations
possible breach of sterility
tampering
vaccine administration errors

Receipt of cold chain products

Cold chain products must be stored immediately upon receipt, to ensure that the cold chain is kept intact. Upon receipt, the product should be checked to ensure that the product is cool to touch, that the ice packs/ cold packs are still frozen in parts and that any cold chain monitors are checked for any breach of cold chain during transport. Any breaches must be immediately notified, and the product quarantined from usable stock. These products should still be stored in the vaccine refrigerator.

Products should be stored in the vaccine refrigerator, outside of any plastic bag or other extraneous material used for transport.

Vaccines should be stored:

in trays or containers for proper air flow.
as per their expiry dates. (Early expiry should be kept above the later expiry ones).
in original boxes with lids closed to prevent exposure to light.
in the middle of the fridge, at least 5cm from the walls, ceiling, floor, door, and cold air vent.

Patient Supply

When patients are taking cold chain items away from the pharmacy, be aware of maintaining the cold chain- enquire if they are going directly to the administrator, or if they will be storing the vaccine at home. Use of a silver foil bag is NOT adequate to maintain the cold chain. A foam esky and ice brick should be offered for transport. Patients should also be advised that vaccines should NOT be stored in the door or drawers of a fridge but should be stored on the middle or bottom shelf, not touching the back, or sides of the fridge.

Patients should be informed about products requiring cold storage. This is particularly important for ongoing medications that may have different temperature storage requirements. These may include products that need to be removed from the refrigerator immediately prior to administration (EPO, IVF medications), or a product stable at room temperature for 30 days (insulins). These products may also have different requirements with regard to light exposure. This information is important to relay to patients at point of contact, so they know how long they have to transport, store and use the product safely and with maximum efficacy.

Monitoring of Cold Chain

To ensure that temperature of vaccines and temperature sensitive medicines have been stored within the recommended temperature range of +2°C to +8°C, the temperatures to which vaccines are exposed must be monitored, recorded and reported throughout the cold chain.

Several vaccine temperature-monitoring devices can be used to monitor the cold chain. These include temperature chart recording systems, data loggers, thermometers, disposable cold chain monitors, automated temperature-monitoring systems and back-to-base systems. It is essential that regular monitoring and recording of the temperature is undertaken by staff, to ensure that the fridge remains within the desired temperature range for ideal storage. Records must be kept of these logs.

Each pharmacy that handles cold chain items must have robust written policies, procedures and protocols in place. This should include instructions for:

Monitoring and maintaining equipment,
ordering and receiving vaccine stock,
vaccine transport and emergency storage
actions and communications for cold chain breaches

Breach of cold chain

A cold chain breach is exposure of temperature sensitive products to temperatures outside the manufacturers recommended range of +2°C to +8°C. This excludes fluctuations of up to +12°C, which last no longer than 15 minutes, for restocking, cleaning the fridge or stock taking. These fluctuations are acceptable within strive for 5.

Pharmacies handling cold chain products should all have a written procedure to follow in the case of a cold chain breach. In NSW, all cold chain breaches 7involving vaccines should be reported to the local public health Unit. The procedures should at minimum include the following:

Isolate vaccines/ products and place a ‘DO NOT USE’ sign on the fridge.
Continue to store vaccines/ products between +2°C to +8°C. The vaccines/products may need to be transferred to an alternate purpose-built vaccine refrigerator or cooler if available, see below.
Do not discard any vaccines/ products.
Download and review the data logging report to assess the duration of the breach and temperature the refrigerator reached.
Complete the Cold Chain Breach and Vaccine Wastage Reporting Form and contact your local public health unit on 1300 066 055 as soon as possible during business hours to report the breach. If the breach occurs after hours, keep vaccines/ products isolated until the next business day.
If transferring vaccines/products to a vaccine cooler (e.g. Esky), record temperatures on the Vaccine Cooler Temperature Chart.
Refer to the NSW Cold Chain Breach Protocol.

It is important to not use vaccines exposed to temperatures below +2°C or above +8°C without getting further advice. Do not discard these vaccines until you gain advice. Recommendations for discarding vaccines may change between health authorities and manufacturers. For National Immunisation Program vaccines, isolate them and contact state or territory health authorities for advice. For privately purchased vaccines contact the manufacturer or supplier.

Training of pharmacists and staff

NSW Health has also introduced mandatory cold chain training requirements to strengthen cold chain management in NSW. From July 31, 2019, at least one staff member must have successfully completed the NSW Health Vaccine Storage and Cold Chain Management online learning module to order vaccines. However, it is strongly recommended that all persons responsible for ordering, storing, receiving and administering vaccines complete the on-line training module to ensure they understand the principles of vaccine storage.

This article has only touched on the requirements for cold chain management. Please see below for further resources to assist your practice management.

Resources