Pharmaceutical Fridge Monitoring Procedure

Author Denise Gardner

Designation: Medicines Management Technician
Version 3
Date: 24th August 2015
Date Approved: 10th September 2015 (Drugs and Therapeutics Committee)
Lead Director: Approved by David Tait, Chief Pharmacist
Review Date:
 PROCEDURE FOR MONITORING DRUG REFRIGERATORS

1. PURPOSE

1.1. To ensure drugs that need a storage temperature range of between 2-8
degrees centigrade are stored correctly in order to maintain their integrity and
safety for use.

1.2. This procedure should be used in conjunction with the trusts approved Fridge
Temperature Record Sheet (Appendix 1) and should comply with the relevant
section of the Safe and Secure Handling and Disposal of Medicines Audit.

1.3. Medications that are stored out of their recommended temperature range may
be rendered ineffective or may have a shortened shelf life. It is therefore
essential that close monitoring of fridge temperature is maintained to ensure
the efficacy of all such Medications.

2. SCOPE

2.1. To provide clear information on the requirements of medication that has been
identified as needing a storage range of between 2-8 degrees centigrade.
Please note – there is a separate Trust policy for vaccines, “Cold Chain
Policy for Vaccine Delivery and Storage”. This policy remains in place
and should be referred to when working with immunisations and
vaccinations.

2.2. To state the importance of monitoring of this system.

2.3. To state how this monitoring is to be carried out.

2.4. To provide clear information on responsibilities and measures to be taken

should a drugs refrigerator go outside the recommended temperature range
of 2-8 degrees centigrade

3. DRUG REFRIGERATION CHECKLIST

The refrigerator shall be designed specifically for the storage of

pharmaceuticals and vaccines.
Refrigerators should have a mains electrical lead which is fitted to a spur point
which should be fused but not switched.
If there is no option other than the use of a standard plug and socket, the socket
should be as close to the refrigerator as possible, preferably behind it or out of
sight.
If socket covers are not available, plugs should have a label attached which
reads DON’T TURN ME OFF, to prevent disconnection for any purpose other
than defrosting or maintenance.

3.1. It is best practice that all drugs requiring storage at a temperature between 2-
8 degrees centigrade must be kept in locked pharmaceutical fridge. Under
exceptional circumstances where a pharmaceutical fridge is not available,

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 then the
drugs must be kept in a locked metal box in an ordinary fridge. (Contact
Medicines Management for further guidance in this situation).

3.2. This monitoring procedure applies equally to all circumstances where drugs
are stored at a temperature range between 2-8 degrees centigrade.

3.3. All drug refrigerators should be located in a suitable area (i.e. not next to a
heat source/radiator).

3.4. Do not store items on top, behind or around the fridge. Allow air to circulate
around the exterior of the fridge to ensure it doesn’t overheat.

3.5. Do not overfill the refrigerator. Place medicines in the refrigerator allowing
space around each item to enable the temperature to remain constant.

3.6. Refrigerator temperature records are to be kept for a minimum of 1 year or for
the life of any product stored therein (particularly vaccines).

3.7. When a drugs refrigerator is being cleaned/ defrosted any contents need to
be stored in another available drugs refrigerator until the procedure is
completed. If your fridge is not self-defrosting, defrost and clean the fridge
monthly to prevent a build-up of ice.

3.8. Ensure temperature is re-set after defrosting and document actual

temperature, on the fridge temperature record sheet (Appendix 1).

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4. THE PROCESS

4.1. Refrigerators that contain medication will be monitored on each working day
(with the date, time, and the maximum, minimum and actual temperature
being recorded). The record should also be signed and the fact that the
refrigerator has been reset after the monitoring should be noted on a Fridge
Temperature Record Sheet (see Appendix 1). A separate record sheet
should be maintained for each refrigerator.

4.2. Fridge Temperature Record Sheets should be audited by the manager of the
clinical area at least every six months.

4.3. If a problem occurs the senior member of staff on duty should be notified
immediately and an incident form completed.

5. OUT OF RANGE TEMPERATURE PROCESS

5.1. If on monitoring a refrigerator the temperature is found to be outside the

recommended 2 to 8 degrees centigrade it is then the responsibility of the
senior member of staff to notify Medicines Management Team or
Lloydspharmacy, stating medication may have been stored outside the
manufacturers recommended temperature and for what length of time. Ensure
all medication is marked not to be used until the temperature has been
clarified.

5.2. All medication must be segregated in the faulty refrigerator immediately or

stored elsewhere if possible in another suitable refrigerator (clearly marked
NOT FOR USE) until the problem can be rectified. It should be separately
identifiable in case it needs to be destroyed.

5.3. The Medicines Management Team or Lloydspharmacy will then issue

recommendations as to what should be done with any compromised
medication.

5.4. After speaking to a member of the Medicines Management Team and

reporting the fridge issue it is possible you will then need to speak to your
estates team to see if the fridge can be repaired. If a repair is not possible &
the fridge is condemned the Medicines Management Team can advise you on
a suitable drugs fridge to purchase for the ward/unit.

5.5. The Problem Record should be completed, (see Appendix 3). The original
Problem Record sheet should be kept with the Fridge Temperature Record
sheet, and a copy of the problem sheet sent to Medicines Management.

5.6. Exposure to temperatures above those indicated on the product packaging

might shorten the shelf life of the product; in some cases (vaccines) the
product will be ineffective after relatively short periods above the designated
temperature range. Exposure to temperatures below those indicated may also
adversely affect the product. In the case of glass vials (e.g. injection
ampoules) freezing can create hairline fractures, compromising the sterility of
the contents.

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 5.7. Note air temperature in the refrigerator will change more rapidly than the
temperature of the contents of vials etc.

Adjusting the fridge temperature:

 To increase the temperature you turn the fridge setting DOWN
 To lower the fridge temperature you turn the fridge UP
 For some makes of fridges the manufacturer may need to be contacted
for advice on adjusting the temperature.

6. IN THE EVENT OF POWER FAILURE - For Acute and community services.

 If possible do not open fridge door.

 Log temperature as above at the time of power failure (on fridges where
temperature display is still working).
 IF OUTSIDE 2-8 degrees centigrade FOLLOW ABOVE PROCEDURE as
outlined in part 5.
 When power is reinstated, take an actual, minimum & maximum reading and
record on temperature record sheet (Appendix 1).
 Reset temperature.

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Appendix 1
Fridge Temperature Record Sheet

Fridge Medicines must be stored at temperatures between 2º and 8ºC

If temperatures are outside this range advice MUST obtained from Trusts
Medicines Management Team on 02476536836 or Lloydspharmacy on
02476968081
Medicines must NOT be used if a temperature of 1ºC or below is recorded

Ward/Area Name…………………………………….

Month……………………………. Year………………….

Date Time Actual Min Max RESET Taken Record of any

Temp Temp Temp Remember By adjustment made
to reset (Name)
max and
min after
every
reading
(tick)

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Appendix 2

DRUG REFRIGERATOR MONITORING CHECKLIST

 ACTUAL, MINIMUM and MAXIMUM temperatures to be monitored and recorded

once every working day (readings should be signed by the member of staff
completing the Fridge Temperature Record Sheet).
Completed sheets should be kept on the ward/unit (see section 3.6).

 Thermometer to be reset after each recording.

 If on monitoring, the refrigerator the temperature is found to be outside the

recommended 2 – 8 degrees centigrade then:

1. Do not use medication.

2. Contact Medicines Management Team or Lloydspharmacy.
3. The thermometer is to be reset (after actual, minimum & maximum
temperatures have been recorded).
4. The refrigerator is to be left closed.
5. The relevant maintenance department should be notified if the fridge
is defective. The Problem Record sheet (appendix 3) should be
completed and a copy sent to the Medicines Management Team (see
5.5).

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Appendix 3

Problem Record

Ward/Area Name…………………………………….

Date Problem Medicines Person contacted Advice given Action taken Person Reporting
affected for advice Problem
(including
quantity)

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