Refrigeration of pharmaceutical products policy
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Policy Name:
Refrigeration of pharmaceutical
products policy
Version
1
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Policy summary:
This document details the correct
manner in which to store
pharmaceutical products
Introduction:
This protocol provides a general guide to the refrigeration of vaccines and products to be kept cold.
Reference should also be made to suppliers’ instructions for individual products.
All vaccines are sensitive biological substances and all will lose their potency – that is, their ability to
give protection against disease - with time. This loss of potency accelerates as vaccines are exposed
to higher or lower temperatures. In order to maintain their quality, all vaccines must be continuously
stored within the appropriate temperature range from the time they are manufactured until the
moment of use. Once vaccine potency is lost, it cannot be regained or restored and without proper
care, any vaccine may eventually lose all its potency. If this occurs, the vaccine will no longer provide
any protection against the target disease and is then useless. In some cases, heat exposure leading
to degradation and loss of vaccine potency may also mean that the vaccine is more likely cause
adverse reactions. Freezing also deteriorates some vaccines and may cause microscopic or overt
fractures of glass containers. The system of maintaining vaccines in good temperature controlled
conditions is called the cold chain. This consists of a series of storage and transport links, all of which
are designed to keep the vaccine within the correct temperature range until it reaches the user.
Different vaccines require different storage conditions, and what is correct for one vaccine may not
be for another, and so it is vital to know the correct storage conditions for each vaccine. Other
pharmaceutical products requiring refrigeration should be stored according to the manufacturer’s
requirements.
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Refrigeration of pharmaceutical products policy
Protocol:
Many pharmaceutical products and vaccines deteriorate if exposed to adverse environmental
conditions. These are usually detailed on the product pack.
It is therefore vital to ensure that products are not affected by unacceptable elevation of
temperatures. This is referred to as MAINTAINING THE INTEGRITY OF THE COLD CHAIN.
Cold chain policy
VERSION 1.docx
To achieve this, care has to be taken at all points of transfer.
The weakest points in general practice are when the products arrive at the surgery and the
dispenser/nurse is not present, or if the cold chain is not appreciated by the patient when he
receives the product i.e. Typhoid capsules, insulin, eye drops etc.
Integrity of thr cold chain:
On receipt of products identified as a fridge line (delivered in clear blue bag from pharmaceutical
wholesaler), Cold chain or recognised as vaccines, insulin, specific eye drops etc.:
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On receipt the delivery is checked for leakage or damage.
The recipient signs the form to be returned to wholesaler, to confirm time and date of
receipt.
Deliveries should be refrigerated immediately on receipt.
The signatory puts the products directly into the fridge and advises the nurse or dispenser
that stock has arrived and is in the fridge for his / her attention, to add to stock, to record
expiry date and batch number.
Batch number and expiry date should always be recorded on the computer dispensary stock
as soon as possible as this records the time of receipt.
The fridge temperature should be checked and recorded in the cold chain book daily by the
Practice Nurse.
All cold chain products dispensed directly to the patient should be collected from the fridge
and the patient informed of the importance of maintaining the cold chain.
Vaccines must not be frozen.
Records must be kept of any servicing and defrosting of the fridge.
Vaccines must not be tightly packed. Empty boxes may occupy space.
Vials and ampoules must remain in their original packaging so that information such as batch
numbers, expiry dates and advice on protection from light remains available.
A cool box should be available for the collection and transport of vaccines.
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Refrigeration of pharmaceutical products policy
Vaccine manufacturer
Vaccines
Transit storage facilities (+2° to
+8°C)
Primary vaccine store
Intermediate vaccine store
Refrigerators (+2° to 8°C)
Health Centre
Immunisation venue
Refrigerators (+2° to +8°C) and/or
cold boxes/vaccine carriers
Patient
The clinical system will record the following details:
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Patient identity
Date on which the drug was administered
Name of the product (including brand name, if known)
Name of pharmaceutical company who manufactured the drug
Date of manufacture
Date of expiry
Batch number
In accordance with the Misuse of Drugs Act the practice has a Controlled Drug Policy and a bound
record is kept of all such drugs, purchased, issued and administered by the doctors in the practice. A
record is kept of the individual doctors’ administration and a record is kept of all drugs returned
from the community.
Resources:
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Refrigeration of pharmaceutical products policy
www.nrls.npsa.nhs.uk
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