Safe handling of medicines requiring cold storage
Document Type Policy
Service Application Trust Wide
Policy Reference no. POL 201
This policy was developed by members of the Medicines Management
Change History – Version Control
Version Date Comments
0.1 Nov 2011 Initial document drafted and approved by Dudley
and Walsall Mental Health Partnership NHS Trusts
Medicines Management Committee
1.0 15/02/2012 Policy agreed for ratification by Policies and
Procedures Focus Group 09/02/2012 and ratified
by Governance and Quality Committee 15/02/2012
Link with National Standards
National Heath Service Litigation Authority
Care Quality Commission
National Institute for Health and Clinical Excellence
National Patient Safety Agency
West Midlands Quality Review
Essence of Care
Key Dates Day Month Year
Ratification Date 15 02 2012
Review Date 15 02 2012
Executive Summary Sheet
Document Title: Safe Handling of Medicines Requiring Cold Storage
Please tick () This is a new document within the Trust √
as appropriate This is a revised document within the Trust
What is the purpose of this document?
To ensure the ‘cold chain’ is maintained when handling medicines
requiring cold storage ensuring medicines are appropriate to use.
What key issues does this document explore?
This policy covers a range of issues including:-
Transporting medicines requiring cold storage
Storage of medicines requiring cold storage
Actions on temperature violations
Trust documentation for recording fridge temperatures.
Trust fridge audit standards
Who is this document aimed at?
All staff involved in the delivery, receipt and storage of medicines.
What other policies, guidance and directives should this document be
read in conjunction with?
British National Formulary (BNF)
Medicines Management Policy
How and when will this document be reviewed?
This policy will be subject to review every 2 years. This review will be
coordinated by nominated members of the Medicines Management
Document Index Pg No
1 Introduction 4
2 Scope 4
3 Roles and Responsibilities 4
4 Support and Training 4
5 General Information 4
6 Transport 5
7 Storage 5
8 Monitoring 6
9 Medicines stored at or below 0oC 7
10 Medicines stored above 8oC 7
11 Disposal 7
12 References 8
Document Appendices Pg No
1 Refrigerator Temperature Recording Chart 9
2 Refrigerator audit form 10
1.1 It is vital that medicines requiring refrigeration are transported and stored at the
1.2 This document covers the processes involved, how to ensure correct storage,
the documentation involved and what to do in the case of poor storage.
2.1 This policy provides guidance on the transporting and storage of medicines
requiring cold storage. It gives advice on the actions to be followed when
temperature violations occur. The policy contains Trust documentation for
recording fridge temperatures.
2.2 The policy contains Trust Audit Standards.
3. Roles and Responsibilities
3.1 Ward Manager / Team Manager –This individual has overarching responsibility
for ensuring that medicines within there area of service is stored appropriately in
line with this policy.
3.2 Nurse on charge – It is the responsibility of the Nurse in Charge to ensure that
his policy is implemented during their period or responsibility.
3.3 Pharmacy – It is the role of the pharmacy to ensure that this policy is
implemented and monitored across Dudley and Walsall Mental Health
Partnership NHS Trust
4. Support and Training
4.1 This policy will be disseminated to all Ward/Unit Managers who will be
responsible for ensuring their staff are familiar with the policy.
4.2 Medicines competencies framework will assess competency.
4.3 Ensure that the delegated person has received adequate training and is
competent to undertake the task of monitoring and recording fridge temperature,
and reporting any abnormalities to a relevant member of staff.
5. General Information
5.1 Some medicines require cold storage, usually between 2oC and 8 oC, and the
manufacturers’ guidance must be followed to ensure that the medicine will be
5.2 Medicines not stored in accordance with the manufacturer’s recommendations;
i.e. outside this range (warmer or colder) will deteriorate and become ineffective.
5.3 All staff involved in the delivery, receipt and storage of medicines must be aware
that some medicines require refrigeration and must take appropriate steps to
ensure that storage is optimal and place it in the refrigerator without delay.
5.4 The Ward Manager/Team Manager for has overarching responsibility for
ensuring that medicines are stored appropriately, with the nurse on charge
holding delegated responsibility for ensuring this policy is implemented during
the shift. This task may be delegated to a suitably trained member of staff.
6.1 Transport from the supplier must conform to the requirements of the storage of
the medicine so that the cold chain is maintained.
6.2 Refrigerated medicines ready for dispatch must be kept within the refrigerator as
late as possible to minimise the amount of time they are out of the refrigerator.
6.3 Refrigerated items should be transported in such a manner as to reduce heat
gain and keep the temperature of the product within the recommended range.
6.4 If refrigerated items are being transported then they should be delivered without
delay. They should not be left in the delivery vehicle longer than is necessary
and certainly never kept overnight.
6.5 Upon delivery the container should not be opened until refrigerator space is
immediately available and items should be placed in the refrigerator without
7.1 The refrigerator must be designed for the storage of pharmaceuticals and
vaccines. An ordinary domestic refrigerator should not be used as the
temperature can vary significantly from shelf to shelf.
7.2 The refrigerator must be sited away from direct sunlight and other heat sources.
7.3 The refrigerator must remained locked at all times when not in use; the key
should be kept secure with the medicines cupboard keys.
7.4 The refrigerator must be large enough to be never filled much more than half full
as this allows the cold air to circulate and warm areas do not develop.
7.5 The person responsible for ordering should be aware of seasonal demands
upon stocks required.
7.6 The opening of the refrigerator door should be kept to a minimum in order to
maintain a constant temperature within the refrigerator.
7.7 Medicines should not be stored next to the cooling plate nor in the bottom
drawer as temperatures may vary from the main body of the refrigerator. It is
important not to obstruct a fan as this will prevent the air circulating.
7.8 Stock should be rotated to ensure items with the shortest expiry date are used
first. Items should be kept in their original packaging as long as is possible.
7.9 The electricity supply to the refrigerator must be maintained at all times and the
plug should not be switched off and steps must be taken to prevent it happening.
7.10 Food and drink and other non pharmaceutical items must not be kept in the
7.11 The refrigerator should be defrosted and cleaned regularly. Ice must not be
allowed to build up. Whilst the refrigerator is being defrosted stock must be kept
cool by placing it temporarily in another refrigerator.
7.12 The refrigerator should be subject to appropriate servicing and the temperature
8.1 The refrigerator must be fitted with a maximum and minimum thermometer
which may be an integral system or a remote probe.
8.2 The maximum and minimum thermometer should ideally be fitted with an
audible alarm when temperatures inside the refrigerator are outside the set
8.3 Records must be made daily. The temperatures should be kept for a minimum
of 1 year, however the records must be retained for the life of any product stored
within the fridge, therefore if the expiry date of the medication is longer than the
1 year period then records should be maintained for the life of the product. The
measurements should preferably be taken at the same time each day and the
thermometer reset. The following records must be kept:-
Time of reset
Signature of person taking the readings and resetting the thermometer
8.4 It is important that the person making the record of the temperatures also resets
8.5 In addition the dates of defrosting and cleaning must be recorded and signed by
the person who undertook the duty.
8.6 If a temperature is outside the limits of 2oC to 8oC a comment on the reason
should be made and the steps taken to prevent it happening again together with
the people involved.
9. Medicines stored at or below 1oC
9.1 Upon finding that medicines have been stored at below 0 oC they should be
quarantined by placing them in a plastic bag and clearly labelled ‘Do not use’ so
that they can be separated from replacement stock.
9.2 Check when the temperature of the refrigerator was last within acceptable limits.
9.3 Contact supplier to see if the product can be used or has to be thrown away.
9.4 If it has to be discarded dispose of in accordance with policy.
9.5 Complete an ‘Incident Form’ in line with the Trusts Incident, Near Miss and
Serious Incident reporting policy.
9.6 If the reason for the excessive low temperature is not immediately obvious (eg.
wrongly set thermostat) call an engineer.
9.7 Replacement stocks should only be reordered once the refrigerator is working
10. Medicines stored above 8oC
10.1 If the temperature is above 8oC the working of the refrigerator must be checked.
Items to be checked include whether the door has been opened recently or
there may have been a power failure. Ensure that the plug is in the socket and
switched on. It may be appropriate to call an engineer.
10.2 If possible, move the contents to another refrigerator as soon as possible. A list
of all those items that were subject to the excessive temperature must be made
and the items quarantined by placing them in a plastic bag and clearly labelled
‘Do not use’ together with the reason. If there is enough space they must be
10.3 Check how long the refrigerator may have been malfunctioning and establish
how long the medicines have been stored above the recommended range.
Some medicines can be used even when stored at room temperature but there
may be a shortened expiry date.
10.4 Contact supplier to see if the product can be used or has to be thrown away.
10.5 Complete an ‘Incident Form’ and forward to the Governance department.
10.6 Replacement stocks should only be reordered once the refrigerator is working
11.1 Medicines that have to be destroyed must be disposed of in accordance with
11.2 Solid dose form should be separated from aerosols and liquids and injections
and all forms placed in a blue lidded bin clearly labelled for the disposal of
medicines. These boxes will be incinerated
Summary of product characteristics (SPC) for individual medicines.
Appendix 1- Refrigerator Temperature Recording Chart
Date Time Current Min Max Reset Signature Comments
o o o time
C C C
Defrosted by: Signature …………………………………..Date …………..
Cleaned by: Signature………………………………….. Date: ……………..
This form will be kept for the life of the medicines stored within the refrigerator or for 1 year
after completion of the form if this date is longer.
This form will be kept at the ward/unit.
Fridge Audit – DWMHT
1 Is there a fridge specifically for medicines?
2 How many?
3 Name of manufacturer
4 Does the fridge have a lock?
5 Is the fridge locked?
6 Where are the keys kept?
7 Any other fridge that contains items supplied by
Pharmacy e.g TPN?
8 Does the fridge contain anything other than medicines?
9 Does the fridge contain medicines that do not require
If yes, specify which item(s)
10 Does the fridge contain vaccines?
If yes, specify which vaccine(s)
11 Is there a temperature monitor?
If yes, is it built into the fridge?
12 Is there a separate thermometer?
If yes, where in the fridge is it placed?
13 Has the fridge been PAT tested?
Has the ‘next test due date’ expired?
14 Does the fridge have an ice compartment?
If yes, does the freezer need defrosting?
15 Does the fridge need defrosting?
16 Does the fridge look physically clean?
17 Is there any documentation for last cleaned date?
18 Is there a temperature log to show records of current,
min & max temperature readings?
19 Is there a Standard Operating Procedure for: (tick
20 Is there a comments section on the temperature log?
21 Is the documentation for temperature readings
22 Is there documentation for temperature ‘reset by’?
If yes, is this completed?
23 Has temperature been recorded at below range?
If yes, how often
Are there comments for action taken if out of range?
24 Has temperature been recorded at above range?
If yes, how often
Are there comments for action taken if out of range?