Safe Handling of Medicines Requiring Cold Storage by 7V93zV


									                               Document Title
           Safe handling of medicines requiring cold storage

                            Document Description
Document Type          Policy
Service Application    Trust Wide
Version                1.0
Policy Reference no.   POL 201

                           Lead Author(s)
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
Aims Standards

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.    Introduction

1.1   It is vital that medicines requiring refrigeration are transported and stored at the
      appropriate temperature.

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.    Scope

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.    Transport

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.    Storage

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
       medicines refrigerator.

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
       reading verified.

8.     Monitoring

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:-
        Current temperature
        Maximum temperature
        Minimum temperature
        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
       the thermometer.

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
       kept refrigerated.

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.    Disposal

11.1   Medicines that have to be destroyed must be disposed of in accordance with
       Trust policy.

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

12.       References

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.

     Appendix 2

     Fridge Audit – DWMHT

     Location –
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
     where applicable)

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?


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