Effective vaccine management (EVM)
Best practices and strategies for success
Steps for receiving vaccines
Step 1:
Check the name and address of the facility on the DELIVERY NOTE .
Step 2:
Check the PACKAGE/S
– check the number of packages as per the delivery note and check each package for any signs of damage.
Step 6:
Enter the names of the vaccines and diluents onto the STOCK CARDS and into the electronic stock system.
Step 5:
Pack the vaccines and diluents in the fridge according to FEFO or FIFO* principles (if the same expiry date) or vaccine vial monitor (VVM).
* FEFO = first-to-expire-first-out; FIFO = first-in-first-out
Step 3:
Stop the TEMPERATURE
MONITORING DEVICE and check the temperature and alarms on the device.
Note: For compromised or incorrect packages, record the details on the delivery note, report the incident to the pharmacist and facility manager, and follow up with the supplier for resolution.
Step 4:
Check the CONTENTS of the delivery against the INVOICE for quantity and quality (expiry, VVM, damage) of vaccine.
Correct vaccine arrangement in a fridge
Vaccines are heat-, freeze- and light-sensitive.
The arrangement of vaccines in the vaccine fridge (both front loading/ vertical fridges and top loading/ chest freezers) must take this into consideration.
Packing and arranging vaccines and diluents correctly in the fridge is vital if the vaccines and diluents are to be kept at the correct temperatures.
OPV may be refrozen after transportation. Store in the freezer compartment (as stipulated by the manufacturer).
and MR* vaccines Hexavalent/ pentavalent, BCG and RV** vaccines HPV, TT, TDaP and Hep B*** vaccines Thermometer Thermometer
Note: If the fridge has shelves in the door or a salad tray at the bottom, do not place vaccines in the door shelves or salad tray. The temperature in the door is too warm to store vaccines, and when the door is opened, door shelves are instantly exposed to room temperature.
* oral polio and measles-rubella
** bacille Calmette-Guérin and rotavirus
** human papillomavirus; tetanus, diptheria and acellular pertussis; and hepatitis B
How to pack a passive container
Step 1:
Select the correct passive container Select the correct passive container with the correct coolant packs for the purpose.
Step 2:
Condition the ice packs
• Remove frozen ice packs from the freezer.
• Lay them on a flat surface with a space between them.
• Wait.
• When you can hear the ice rattling in an ice pack, you have a conditioned ice pack that can be used with vaccines.
Considerations:
• Which vaccines will be transported?
• How many vaccine vials need to be transported?
• What is the duration of the journey?
Note:
Passive containers are insulated containers that come in two types: cold boxes (with a volume greater than 4 litres) and vaccine carriers (with a volume between 0,5 litres and 4 litres). Both types are lined with conditioned ice packs and protect vaccines from extreme and damaging heat and cold.
How to pack a passive container (continued)
At the end of the immunisation session, all coolant packs must be returned to the freezer. If OPV is stored in the same freezer, then first return the coolant packs to the fridge to cool down before placing them in the freezer.
Step 3: Pack the passive container correctly
Consider the temperature sensitivity of the vaccines.
Step 4: Add a continuous temperature monitoring device
• Add a continuous temperature monitoring device to the passive container.
• Place the device as close as possible to the vaccines.
1. Put conditioned ice packs on the bottom.
2. and 3. Put conditioned ice packs around all sides.
4. Put the vaccines in the container.
5. Put conditioned ice packs on top.
Note:
Vaccines that are not freeze-sensitive go at the bottom. When transporting a mixed group of vaccines:
• Close the lid.
• place OPV and MR vials at the bottom of the container (the coldest spot); next, place BCG vials; and place the other vaccines and diluents on top of the BCG vials. Monitor the temperature continuously.
Temperature excursions
What is a temperature excursion?
A temperature excursion is an event that occurs when vaccines are exposed to temperatures outside the ranges prescribed for storage and/or transport.
Monitoring and recording temperatures
High quality temperature monitoring and recording during receipt, storage and distribution and at the service delivery point is essential.
Who should monitor temperatures?
EVERYONE! It is a shared responsibility of all health-care workers who work with and/or use vaccines.
Why monitor temperatures?
This will ensure that timeous and appropriate action is taken in the event of a temperature excursion. VACCINES MUST REMAIN POTENT AND SAFE TO USE!
Why do temperature excursions occur?
Possible reasons are cold chain equipment failure, a power outage, incorrect use of cold chain equipment and not adhering to standard operating procedures.
Temperature excursions must be taken seriously and action taken immediately.
What to do if a temperature excursion has occurred
Move the vaccines to the cold chain and follow contingency plans, if applicable.
Quarantine and label ‘DO NOT USE’ and record the date and time.
Record the temperature when the excursion occurred.
Complete the incident reporting form in the Cold Chain Manual.
Please consult the Cold Chain Manual for more information.
Submit the incident report to the cold chain manager/person responsible.
Conduct an investigation:
• Determine if the vaccines are safe to use (refer to the temperature sensitivity table, if applicable); and
• Manage the incident.
Await instruction from the cold chain manager/person responsible, if needed.
Undertake corrective actions as needed.
Conduct patient recall if revaccination is deemed necessary after consultation with facility manager/cold chain manager/person responsible.
Heat-sensitive vaccines: Using vaccine vial monitors
VVMs are small indicators attached to vaccine vials. VVMs change colour as the vaccine is exposed to cumulative heat, letting health-care workers know whether the vaccine has exceeded a pre-set limit beyond which the heatsensitive vaccine should not be used.
Expiry date not passed. Use the vaccine.
The inner square is lighter than the outer circle. If the expiry date has not passed, USE the vaccine.
As time passes, the inner square is still lighter than the outer circle. If the expiry date has not passed, USE the vaccine.
Do NOT use the vaccine.
Discard
point:
The colour of the inner square matches that of the outer circle. DO NOT use the vaccine.
Beyond the discard point:
The colour of the inner square is darker than that of the outer circle. DO NOT use the vaccine.
Multi-dose vial policy
Rules to follow with all multi-dose vials
• The expiry date has not passed.
• The vaccines are stored under appropriate cold chain conditions (between +2 °C and +8 °C with temperature monitoring and recording).
Fully liquid vaccines
Opened vaccine vials of OPV, TT, TDaP and Hep B may be used in subsequent immunisation sessions for a maximum of 28 days after opening , if all the rules stipulated above are met.
• The vaccine vial septum has not been submerged in water.
• Aseptic technique has been used to withdraw all doses.
• The VVM (if attached) has not reached the discard point.
Reconstituted vaccines Other
Opened vials of measles, BCG and yellow fever vaccine must be discarded at the end of each immunisation session or at the end of 6 hours of reconstitution, whichever occurs first , if all the rules stipulated above are met.
Fully liquid vials of HPV must be discarded at the end of each immunisation session or at the end of 6 hours of reconstitution, whichever occurs first , if all the rules stipulated above are met.
The shake test
The shake test is the gold standard to test for freezing.
• It indicates whether freeze-sensitive vaccines have been damaged by exposure to freezing conditions.
• Vaccines may still be in a liquid state even when exposed to temperatures below 0 °C.
Tip: Remember which vaccines are sensitive to freezing by looking for the ‘T’ in the name of the vaccines. This also applies to the vaccine diluents.
Suspect vial:
Freeze-sensitive vaccine exposed to temperatures ≤ 0 °C
1. Prepare a control vial: Take a vaccine vial from the same batch, freeze until solid and then let it thaw. Do not heat the vial.
Suspect Control
2. Shake the control and suspect vials vigorously for 10–15 seconds.
Suspect Control OR
3. Observe: Place vials side by side on a flat surface and leave to rest . Observe the sedimentation in both vials until the test has been completed.
5–30 minutes later
4. Suspect vial clears gradually and sediment forms slowly. SAFE TO USE.
Suspect Control
4. Control vial clears fast and thick sediment forms quickly. DO NOT USE.
Managing cold chain incidents
Protect vaccines
• Maintain vaccines between +2 °C and +8 °C.
• Only move vaccines to alternative storage if this temperature range cannot be maintained during equipment failure or power outage.
Isolate compromised vaccines
Reinstate vaccines
• Return vaccines to the original equipment only when it has been repaired or the power has been restored and the correct temperature has been maintained for 24 hours.
• Ensure temperature stays between +2 °C and +8 °C while moving vaccines.
Priority use
If compromised vaccines are considered safe to use, use them first.
Report faults
• Report equipment issues to the pharmacist or facility manager.
• Request repair services promptly.
• Note the breakdown on the daily temperature monitoring log/chart.
• Complete an incident report and conduct a root cause analysis investigation.
Note:
When moving vaccines to a different location, remember:
• Always use a passive container to transport the vaccines.
• Always use the correct number of conditioned ice packs.
• Always place a continuous temperature monitoring device with the vaccines.
Contingency planning: What is it?
A contingency plan for vaccines is a proactive strategy designed to address unforeseen events or disruptions in the cold chain system. It ensures that vaccines remain viable and effective, even in challenging circumstances.
Develop a checklist for each type of emergency.
Assess equipment hold over time .
Identify a suitable alternative vaccine storage location.
Inform all staff of the plan and of the requirements and activities that may be necessary during an emergency, and train staff accordingly.
Identify clear roles and responsibilities for the people who will implement the contingency plan.
Secure resources needed to use the alternative location .
Document contingency plan actions as part of the standard operating procedures . Periodically update the contingency plan and contact information .
Conduct refresher training for staff.
Preventative maintenance: Key steps
Preventative maintenance is the servicing of equipment according to a predefined plan and schedule in compliance with the standard operating procedures. Planned preventive maintenance helps avoid unexpected failures of the cold chain equipment.
1. Check installation
Make sure the vaccine fridge:
• is NOT placed in direct sunlight;
• is placed in a well-ventilated area and clear of any heat source;
• is on a level floor; and
• is placed where there is enough space for air circulation, i.e.:
– at least 100 mm between the back of the fridge and the wall;
– 100 mm between the side of the fridge with the grille and wall; and
– 200 mm between vaccine fridges.
2. Protect power supply
The power supply to the vaccine fridge must be protected with:
• a DO NOT UNPLUG sign at the plug point;
• a DO NOT SWITCH OFF sign at the plug point; and
• a voltage regulator.
DO NOT unplug or switch off this fridge.
Preventative maintenance: Key steps (continued)
3. Comply with vaccine fridge requirements
The vaccine fridge:
• must have a continuous temperature monitoring device; and
• must not store food or drink.
A contingency plan in the event of equipment failure or power interruption must be displayed nearby.
4. Arrange vaccines
Make sure that vaccine vials:
• are not stored in the fridge while still in the tertiary packaging;
• are arranged so that there is sufficient air circulation;
• are not stored in contact with the walls and back of the fridge or freezer;
• are not stored directly in front of a fan or outlet; and
• are arranged correctly so that vaccines with the earliest expiration date are easiest to access.
Preventative maintenance: Key steps (continued)
5. Important vaccine fridge care
DAILY
• Check and record the temperature in the fridge each morning and afternoon.
• Take action if the fridge temperature is less than 2 °C or greater than 8 °C.
• Ensure that the door and rubber gasket are completely sealed when the fridge is closed.
• Check for ice build-up of 10 mm or more and defrost if necessary.
How to defrost a vaccine fridge
1. Transfer vaccines and diluents to a functional fridge or passive container with prepared ice packs.
2. Turn off the power supply to the fridge.
3. Leave the lid or door of the fridge open and wait for the ice to melt. Do not try to remove the ice with a knife or other sharp object as doing this can permanently damage the lining.
WEEKLY
• Water that accumulates at the bottom of the fridge should be wiped up with a cloth or drained through the draining hole.
• Water droplets that form on the inside walls of the fridge should be wiped off.
MONTHLY
• Clean the fridge with lukewarm water and mild detergent (which should not contain ammonia) approved for use at the health facility.
• Clean the grille on the side or back of the fridge to ensure there is no accumulation of dust.
4. Once the ice has melted, clean and dry the inside of the fridge.
5. Turn on the power supply to the fridge again.
6. When the temperature falls to +8°C or less (but not less than +2°C) return the vaccines and diluents to the fridge.
Please consult the Cold Chain Manual for more information.
Abbreviations and acronyms
°C degree(s) Celsius
BCG bacille Calmette-Guérin
EVM effective vaccine management
Hep B hepatitis B
HPV human papillomavirus
mm millimetre(s)
MR measles-rubella
OPV oral polio vaccine
RV rotavirus
TDaP tetanus, diptheria and acellular pertussis
TT tetanus
VVM vaccine vial monitor
Acknowledgements
