A Learning Resource on the Storage and
Handling of Vaccines
Accessible Word Version
Date of development: July 2014
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Acknowledgements
NHS Education for Scotland gratefully acknowledges the hard work and effort
made by all who contributed to the development of this learning resource
which was adapted, with kind permission from an existing resource written by
Liz McGovern, Specialist Pharmaceutical Public Health, NHS Greater
Glasgow and Clyde.
Special thanks are due to:
Dr Diane Kelly, Assistant Director CPD, NHS Education for Scotland
Susan Kennedy, National Co-ordinator GPN, NHS Education for Scotland
Marion MacLeod, National Co-ordinator, Scottish Practice Management
Development Network, NHS Education for Scotland
William Malcolm, Pharmaceutical Adviser, HAI and Infection Control Group,
Health Protection Scotland
Liz McGovern, Specialist Pharmaceutical Specialist, NHS Greater Glasgow
and Clyde
Aileen Muir, Consultant in Pharmaceutical Public Health at NHS Lothian and
NHS Fife
Ruth Robertson, Health Protection Education Programme Manager, NHS
Education for Scotland
Disclaimer
While every precaution has been taken in the preparation of these materials,
neither NHS Education for Scotland nor external contributors shall have any
liability to any person or entity with respect to liability, loss or damage caused
or alleged to be caused directly or indirectly by the information therein.
Before undertaking this learning resource all staff should consult their NHS
Board’s local policy on the storage and handling of vaccines.
NHS Greater Glasgow & Clyde staff should access their local learning
resource via LeanPro
https://nhs.learnprouk.com/lms/login.aspx?ReturnUrl=%2flms%fuser_level%2f
welcome.aspx
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About this learning resource
Who is this learning resource for?
All staff working in the primary care setting. However, the general principles
are also applicable to staff working in the acute setting.
How long should it take?
This learning resource will take you approximately 30 minutes to complete
excluding the activities, depending on your own learning style and experience.
It is best to work your way through the sections from the beginning to the end
in a logical order, completing the activities for each section as you go.
Why should I complete this learning resource?

It provides practical tips and examples of best practice

It will help ensure correct storage of medicines

It identifies ways in which to avoid waste and patients being
recalled for repeat immunisation after vaccine incidents

It contributes to your Continuing Professional Development.
Multiple choice questionnaire assessment
Once you have completed this learning resource you should undertake the
multiple choice questionnaire assessment.
This will allow you to formally
check your knowledge and understanding of the resource.
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Contents
Section 1 Introduction
Section 2 Guidance and policies
Section 3 Ordering
Section 4 Receipt of vaccines
Section 5 The vaccine refrigerator
Section 6 Temperature recording and monitoring
Section 7 Action in the event of abnormal temperatures
Section 8 Handling of vaccines in clinics
Section 9 Multiple choice questionnaire assessment
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Section 1 - Introduction
The cold chain is the name given to the system of transportation and storage
of vaccines whilst maintaining the recommended temperature range between
2°C to 8°C. Heat speeds up the decline in potency of most vaccines. Freezing
of vaccines can cause loss of vaccine effectiveness, increased reaction at the
injection site and hairline cracks in the container, the latter leading to
contamination of the contents. Effectiveness cannot be guaranteed for
vaccines unless they have been transported and stored at the correct
temperature.
Cold chain maintenance has three main components:

Equipment used for transport and storage

Appropriately trained personnel

Procedures.
All three elements must combine to guarantee vaccine effectiveness is
maintained by ensuring the vaccine is transported and stored at the
recommended temperature up to the point that the vaccine is administered.
The maintenance of the cold chain is therefore important to:

Give assurance/confidence in potency of vaccine

Ensure maximum effectiveness/clinical benefit from immunisation

Ensure compliance with manufacturer’s marketing authorisation

Minimise financial loss from vaccine wastage.
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Section 2 - Guidance and policies
There is a range of guidance and policies relating to the storage and handling
of vaccines. A key reference is the “Guidance on Vaccine Storage and
Handling” produced by Health Protection Scotland. This guidance sets out a
framework outlining the minimum standards required for storage and handling
of vaccines.
Another national reference is The Department of Health Publication
“Immunisation against Infectious Diseases” also known as the `Green Book`.
Regular updates are posted on the website so it is advisable to always refer to
the online version.
Each NHS Board will have developed local guidelines and policies related to
vaccine handling and storage. There are likely to be some differences
between NHS Boards and you should become familiar with the guidance for
your specific area by accessing the relevant documents and discussing the
content with your colleagues.
Activity: Access the local guidance on vaccine storage and
handling for your NHS Board and discuss the local procedures
with colleagues from your place of work.
Make a note of your discussions below.
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Section 3 - Ordering
Incorrect ordering can result in wastage and unnecessary costs to GP
practices and the NHS. Vaccine stocks must be monitored, by a designated
person, to avoid over-ordering or stockpiling.
There are two main ways of ordering vaccines:
1. Childhood vaccines and Hepatitis B for at risk babies should be
ordered from the vaccine holding centre using the appropriate order forms.
GP practices should normally have no more than two to four weeks supply of
vaccines at any time. Remember some vaccines come in multiple packs. It is
recommended best practice to order small quantities on a regular, scheduled
basis using Scottish Immunisation Recall System (SIRS) data to estimate the
number of vaccines required.
Arrangements for large clinics (or unscheduled / ad hoc catch-up) should be
discussed with the vaccine holding centre in advance to ensure sufficient
vaccine is available for the required date.
2. Winter, travel and adult booster vaccines should be ordered from a
community pharmacy using individual prescriptions (GP10) or exceptionally a
Stock Order Form (GP10a).
Close liaison between the practice and the community pharmacy is important
to discuss delivery arrangements and ensure the practice has sufficient
capacity to receive deliveries.
Activity: Note here who is responsible for ordering vaccines in
your place of work, the delivery day and ordering schedule.
Confirm the contact details for the vaccine holding centre.
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Section 4 - Receipt of vaccines
Refrigerate vaccine deliveries immediately. (This is the responsibility of the
member of staff accepting delivery).
Activity: Note here the location of the keys for vaccine
refrigerators in your place of work and how to access to them to
prevent delay in vaccines being stored at an inappropriate temperature.
Practice point
Your place of work should have a policy and procedure which clearly states
the steps to be followed and who should be advised of the receipt of vaccines.
Check the received vaccines against the order for discrepancies and for
leakage or damage as soon as possible as vaccines cannot be returned to the
vaccine holding centre later.
On receipt, all deliveries and existing stock should be routinely date checked
and rotated within the refrigerator to ensure that those vaccines with the
earliest expiry date are at the front and used first. Remember - the vaccine
with the shortest expiry date may not always be the most recently delivered.
Companies differ in the format they use for expiry dates. Please be careful
when checking expiry dates e.g.
Batch: 2585H
Expiry would be 31/10/2014
EXP: 10/2014
Batch: 68689Y
Expiry would be 30/09/2014
EXP BY: 10/2014
Batch: 2299J
Expiry would be 30/09/2014
USE BEFORE: 10/2014
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Record that a delivery has been received, expiry dates checked and stock
rotated on the temperature monitoring chart.
It is good practice to record the temperature and reset the thermometer when
this has been completed. A check should be made to ensure that the running
temperature is satisfactory (i.e. between 2°C to 8°C) 30 minutes later.
Any out of date stock should be labelled clearly, removed from the refrigerator
and returned for destruction as soon as possible. Local arrangements will
vary between NHS Boards.
Activity: Contact your vaccine holding centre to obtain details of
the local arrangements for dealing with out of date stock. Make a
note of your findings here.
Recall of vaccines
In the event of vaccines being recalled, all ordering sites will be notified by the
vaccine holding centre. The person in the practice responsible for vaccine
storage and handling must check all stock in the practice as soon as possible.
Any affected vaccines should be placed in refrigerated quarantine clearly
marked ‘NOT TO BE USED’.
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Section 5 – The vaccine refrigerator
Storage
Vaccines should be stored in their original packaging at 2°C to 8°C protected
from light. Exposure to ultraviolet light may cause loss of potency. Repeated
warming and cooling of vaccines may reduce potency.
Storage in the original packaging allows easy product identification, easy
checking of expiry dates and the packing offers some protection against
temperature fluctuation. Vaccines must never be exposed to below 0°C as
freezing may cause hairline cracks in the container, invisible to the naked eye,
which could lead to contamination of the contents.
It is generally recommended that vaccine refrigerators should be maintained
as close as possible to 5°C, as this gives a safety margin of +/- 3°C.
The vaccine refrigerator
Vaccines should always be stored within a pharmaceutical refrigerator that is
specifically designed for the purpose of storing vaccines or medicines, to
provide a stable, uniform and controlled temperature throughout the unit. Only
pharmaceutical refrigerators must be used for vaccine storage as domestic
refrigerators are unsuitable.
A pharmaceutical refrigerator must have:

A lock

An integral thermometer capable of reading minimum, maximum and
actual temperature

An alarm for when the temperature is out of range.
Pharmaceutical refrigerators do not usually have storage space in the door.
Where a refrigerator with door space is being utilised, do not store vaccines in
the refrigerator door, to avoid the risk of a temperature rise when the door is
opened.
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Practice point
Where the purchase of a pharmaceutical refrigerator is being considered
advice should be sought from the appropriate person in your NHS Board.
Check your local guidance for details of who to contact.
For maximum efficiency, the refrigerator should be positioned away from a
radiator or any other heat source (including direct sunlight), be well ventilated
and at a comfortable working temperature. Further information is available
from the manufacturer’s user guide.
Vaccines should be spaced evenly throughout the refrigerator, to allow cool
air to circulate around the vaccine packages. They should be stored in the
middle of the refrigerator away from any freezing component such as the back
wall in a self-defrosting refrigerator.
Vaccine stock should be arranged systematically so that any member of staff
looking for a product can determine quickly whether that product is available
in the refrigerator.
Practice point
It is good practice to post a list of products stored in the refrigerator with a
shelf location (as appropriate) on the outside of the door. This will minimise
the amount of time the refrigerator door is open.
There should be sufficient refrigerator capacity to store the maximum vaccine
storage needs (including influenza vaccine). Do not overfill the refrigerator,
even at maximum stock level no more than two thirds (66%) should be filled to
allow circulation of air.
Vaccines should not be stored in enclosed plastic drawers with a lid or directly
on the floor of the refrigerator since this restricts airflow circulation.
Do not store foodstuffs in the vaccine refrigerator at any time.
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Ensure the power supply is protected ideally with a switchless socket and a
fixed unit over the plug and socket to ensure it cannot be turned off by
accident.
Practice point
Where this is not possible any plugs/switches used to connect refrigerators to
the power supply should be clearly marked ‘Refrigerator – Do Not Switch
Off’
Practice point
Vaccines are prescription only medicines (POMs) and should be stored under
locked conditions. Refrigerators should either be lockable or within a room
that is locked when not occupied by a member of staff. When the refrigerator
is not in use the key should be removed and held by the appropriate person
as detailed in local procedures.
Activity: Check the storage arrangements in the refrigerator in
your place of work and ensure capacity is sufficient even during
busy periods. Can you estimate the percentage capacity filled in the
refrigerator at this point in time? Note down what action you need to
take, if any.
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Refrigerator maintenance
Routine maintenance should be carried out by appropriate staff (for full
instructions consult the manufacturer’s user guide). Generally, this should
include cleaning and/or defrosting the vaccines refrigerator on a regular basis.
Unless the refrigerator has an auto defrost facility, it should be defrosted at
least quarterly.
Before routine maintenance:

Ensure vaccine stock levels are at a minimum

Remove/transfer the vaccines to another monitored refrigerator.
Record “vaccine removal/transfer” on both sets of temperature
recording sheets (in the comments section)

Replace the vaccines in the refrigerator only once it has returned to the
correct temperature after cleaning/defrosting.
If an alternative refrigerator is not available a validated and approved cool box
may be used.
Cleaning and defrosting
Clean/defrost the refrigerator ensuring:

An
appropriate/compatible
cleaning
agent
is
used
(check
manufacturer’s instructions but generally a dilute solution of sodium
bicarbonate and water or detergent and water can be used for routine
cleaning)

The drainage hole for self-defrosting models is wiped well and not
blocked

The door seal is washed to remove all dust/debris and is checked to
ensure it is intact and free from any punctures

The door hinges are checked and are dust free

The element at the back of the refrigerator is regularly dusted and
remains dust free

Temperatures are recorded and the thermometer reset before and after
cleaning and defrosting.
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Build up of ice
Some models of refrigerators are self-defrosting and there should be no ice
build up in the cabinet. If ice build up does occur, it may be an indication that
there is moisture in the cabinet, which may be due to:

The room being too warm -- or even damp

The refrigerator thermostat/temperature is set too low

Cardboard packaging may have come in contact with the back wall at
some point and is wet

Open plastic airtight containers are being used and are attracting
moisture.
You must investigate why ice is building up, as the self-defrosting refrigerator
will not be working at full efficiency when there is any ice build up.
Additional / annual maintenance
All vaccine refrigerators should have an electrical check undertaken regularly
(usually annually) as part of the workplace routine approach/contract for
portable appliance testing (PAT testing).
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Section 6 – Temperature recording and monitoring
Roles and responsibilities
It is everybody's responsibility to ensure the cold chain is monitored.
There should be a named person for monitoring the temperature. Deputising
arrangements are required to be in place to cover any staff absences, e.g.
holidays and sickness.
Activity: Note down who is the deputy in your workplace to
ensure the cold chain is monitored in the event of the named
person being unavailable.
All staff should be trained to use the equipment and respond to any abnormal
readings.
Any staff involved with immunisation should ensure that the vaccines they
administer have been stored within the correct range of 2 ºC to 8ºC.
Thermometers
Thermometers must be able to continually monitor the minimum, maximum
and actual temperatures of the refrigerator. If the refrigerator does not have
an integral thermometer, a stand-alone digital thermometer is required. When
a new vaccine refrigerator or a calibrated maximum/minimum digital
thermometer is being procured the thermometer should be independent of
mains power, so temperatures can be measured in the event of electricity
loss, advice should be sought from the appropriate person in your NHSB
Board. Check your local guidance for details of who to contact.
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Some thermometers/temperature monitoring devices measure air temperature
but simulated vial temperature is preferred.
Recalibrate
the
thermometer
regularly
according
to
manufacturer’s
recommendations.
Recalibration can be expensive and replacement of the thermometer may be
cheaper.
Calibration of the thermometer needs undertaken regularly. This is part of the
annual audit practices that should be undertaken.
Temperature monitoring and recording
Refrigerator temperature readings (maximum, minimum and current) must be
read and legibly recorded, as a minimum, at least once every working day. In
each NHS Board there will be standard charts to record these temperatures.
Temperature records relating to a particular refrigerator should be kept close
to that refrigerator (but not inside) for ease of reference and should be clearly
identified as relating to that appliance. A separate temperature record should
be kept for each refrigerator.
Activity: Do you have a Board policy for temperature recording?
Note down the key points from the policy below.
Locate the
standardised recording sheet.
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The thermometer should be reset after each reading. Different thermometers
may have slightly different ways of resetting. To check the reset has been
carried out correctly, the maximum, minimum and current temperatures
should be checked again and if the thermometer has been correctly reset
these should all show the same (current) temperature.
It is good practice to record the temperature at a similar time each day e.g.
first thing in the morning before the refrigerator door is opened for the first
time. This will allow review of trends in results recorded; help highlight any
changes in temperatures recorded and deviation in refrigerator performance.
If there has been a vaccination clinic the temperature should be recorded and
the thermometer reset after this has finished and a note made on the
comments section.
Review temperature records at the end of the month for temperature drift. Any
trend of increasing or decreasing temperatures within the recommended
range should be investigated before temperatures exceed the recommended
range.
Retention of records under the NHS Code of Practice (Scotland) is governed
by CEL 31 (2010) issued by the Scottish Government.
Under pharmacy
records: quality assurance it is recommended that a refrigerator temperature
records should be retained for the life of any vaccine stored therein with a
minimum of a one year retention period.
http://scotland.gov.uk/Publications/2012/01/10143104/0
Activity: Note here who has responsibility for reviewing
temperature charts in your place of work.
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Setting temperature alarm parameters
Where a refrigerator has an integral alarm to alert high and low temperatures
it is important to ensure that the appropriate parameters for the alarm are set.
It is recommended that the alarm should be set to sound after the temperature
has been below 2ºC or higher than 8ºC for more than 15 minutes.
Activity: Note down here your refrigerator’s alarm parameters
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Section 7 - Action in the event of abnormal temperatures
Action should be taken immediately if a temperature out with the range of 2 ºC
to 8ºC is observed. There should be a procedure in the workplace to describe
the actions that should be taken in the event of the temperature going outside
the recommended range.
Consider whether the temperature could be explained by the door being left
open or a new delivery of stock etc. Action must be taken in the event of
unexplained temperatures above 8°C or any recording below 2°C. In such
cases the individual with overall responsibility for vaccine storage must be
informed and action taken.
Activity: Check the temperature records for your workplace for
the last month and note down any unexplained temperature
readings and what action was taken e.g. how they were reported and
reviewed to prevent further occurrence.
Responding to abnormal temperatures
After quarantining stock involved, advice may be needed on the vaccine and
its viability.
Activity: Note down here who should be contacted in your NHS
Board if there is an incident where vaccines may have been
exposed to temperatures outwith the recommended range.
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You may also need to consider while the stock is under quarantine if further
supplies are needed to meet immediate clinical need.
All incidents occurring in the managed service require to be recorded on the
web-based incident reporting system e.g. Datix.
http://www.datix.co.uk/products-services/modules/uk-and-europe/incidentreporting/
Where incidents occur within a general practice setting, independent
contractors and their staff should be encouraged to use local NHS Board
procedures for incident reporting. This will provide details of the incident and
action taken to reduce the risk of recurrence.
Contingency arrangements
In the event of a refrigerator failure it is important to have arrangements in
place for suitable storage of vaccines whilst advice is sought on whether the
vaccines are suitable for future use.
Pharmaceutical refrigerators can normally be expected to maintain their
temperature for up to four hours in the event of a power failure. Therefore if
the power supply has been interrupted for a period of four hours or less, the
refrigerator door should be kept closed and close monitoring of temperatures
undertaken to ensure it is operating within normal temperature limits.
If the failure lasts longer than four hours a suitable back-up or alternative
refrigerator is required. Transfer the vaccines and record “vaccine
removal/transfer” on both sets of temperature recording sheets.
In emergencies, where there is no alternative appropriate storage available,
contact the supplying vaccine holding centre in the first instance for advice.
Keep a record of these discussions to enable you to create a standard
operating procedure for future occasions.
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Section 8 - Handling of vaccines in clinics
Use in clinics
When running a clinic in a room that does not have a refrigerator, it is not
necessary to store the vaccines in a validated and approved cool box during
the clinic session. Only remove the minimum vaccine required from the
refrigerator. Reconstituted vaccines and opened multi-dose vials should be
disposed of at the end of an immunisation session in a 'sharps' box.
Practice point
Any surplus vaccine not used during a short clinic session should be returned
and marked `use first` for the next clinic session. Any vaccine not used during
second session should be discarded.
All relevant details should be recorded as per local/national guidance ensuring
that the batch number and expiry date are recorded accurately.
This is
necessary to provide an audit trail in the incidence of product withdrawal or
adverse reaction, which may be attributable to the vaccine.
Local NHS Board hand washing guidelines should always be adhered to
before and after vaccine administration to a patient.
Activity: Note down the arrangements in place for transport
outside your place of work.
Transportation from practice to another location
When vaccines are required outside the practice validated and approved cool
boxes should always be used. Return surplus marked ‘use first’ to prioritise
its use.
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Larger cool boxes are not normally practical for GP practices since they take
up a lot of space and require several shelves of refrigerator space to store the
cool packs prior to their use.
Practice point
Smaller validated and approved cool boxes are available for transport of up to
10 vials of vaccine. They require the insertion of a frozen cool pack for
accredited use and are validated for up to 18 hours.
Disposal
Disposal of
vaccines should
take
place
in
accordance
with
local
clinical/pharmaceutical waste arrangements. Vaccines which are unfit for use
through being out of date or because of storage irregularities, and opened or
prepared vials of vaccines that have not been used during a clinic session,
should be disposed of in the correct container or returned by prior
arrangement (telephone) to the vaccine holding centre for destruction.
Do not:
Flush vaccines down the toilet or sink
Return vaccine devices bearing attached sharps without prior discussion with
Pharmacy Public Health.
Spillages
Contaminated waste and spillages should be dealt with according to the local
NHS Board Clinical Waste Policy and Decontamination Guidelines and the
Prevention and Control of Infection Manual respectively.
In the event of eyes being splashed with vaccine, they should be rinsed with
copious amounts of Sodium Chloride 0.9% and immediate medical advice
sought.
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Audit
A self audit is recommended to be undertaken annually in line with HPS
guidance, click on the link below and view Appendix 1: Vaccine Storage and
Handling Specimen Self Audit Tool
http://www.documents.hps.scot.nhs.uk/immunisation/general/vaccine-storagehandling-2013-09.pdf
Activity: Review the summary report from the previous self audit
for your place of work. Have all the recommendations been
undertaken? When is the next self audit due? Note your answers here.
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Section 9 - Multiple choice questionnaire assessment
Now that you have completed this learning resource you are ready to
undertake the multiple choice questionnaire assessment. This will allow you
to formally check your knowledge and understanding of the module.
Please note:

Pharmacists and pharmacy technicians should complete the multiple
choice questionnaire via Portal www.portal.scot.nhs.uk

All other healthcare professional should complete the multiple choice
questionnaire using the following link
https://response.questback.com/nhseducationforscotland/l5wb8whzrp

The learning resource can be accessed repeatedly and can be used to
refresh your knowledge at any time.
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