Why temperature control is important
Medicines should be stored in such a way that assures their continuing quality until the end of administration to the patient. In practice, this means always storing medicines according to the directions on their packaging.
Our web pages can help you to achieve this by providing guidance on:
- selecting and setting up fridges, freezers and ambient storage areas correctly
- routine use and maintenance of fridges and freezers
- transport of medicines that require refrigeration
- monitoring temperatures to ensure that any problems are identified quickly
If this guidance is followed, the likelihood of temperature excursions will be kept to a minimum and will increase the chance of excursions being rapidly detected. This in turn will reduce the impact of excursions, the risk to patients and the associated resource and financial costs.
However, sometimes excursions do occur, so we have also provided guidance on managing temperature excursions.
All organisations that store or transport medicines should have a local policy for temperature control. This should be tailored to the organisation taking into account the number of fridges, freezers and ambient storage areas, the quantity and criticality of the medicines being stored. It should also consider the regulatory requirements placed on different types of organisations that handle medicines.
Local policies and procedures should include:
- responsibility and accountability for storage of medicines
- planning and choosing medicines storage areas
- how to set up a new fridge or freezer, including the temperature set point
- monitoring and recording storage temperatures
- how to routinely maintain fridges and freezers
- maintaining the correct temperature during transportation
- how to handle incidents and temperature excursions
- contingency plans in the event of breakdown of temperature controls
Understanding storage conditions
Medicines are assigned storage conditions and shelf lives based on:
- chemical degradation of the active ingredient or any of the other ingredients (excipients)
- physical degradation of the medicine or its container
- whether the medicine or its container may be damaged by freezing
- whether it is necessary to prevent microbial growth
This means that different medicines may have very different storage requirements and shelf lives, which will always be detailed on the packaging.
Meeting regulatory requirements and national standards
Regulators place certain expectations on healthcare providers to store medicines appropriately:
- the General Pharmaceutical Council Standards for registered pharmacies regulates the storage of medicines in registered pharmacies
- the Care Quality Commission regulates the storage of medicines in care settings including hospitals, GP practices and care homes
- the MHRA regulates pharmacies that hold MHRA Specials (MS) and Wholesale Dealer (WDA) authorisations. Licence holders must comply with Good Manufacturing Practice and Good Distribution Practice. The MHRA also publishes occasional advice on its blog
- the MHRA also regulates clinical trial sites who are required to store investigational medicinal products in line with Good Clinical Practice. The sponsors requirements are detailed in the trial protocol and further detail is available in the pharmacy manual as appropriate
Medicines requiring temperature-controlled storage
Ambient temperature medicines
Most medicines are stored at room temperature, also known as “ambient” temperature. This may be expressed on packaging in different ways e.g. “between 15ºC and 25ºC” or “below 30ºC”. Sometimes there are no special storage requirements stated. Some medicines should not be refrigerated. If so, this will be stated on the pack.
Further information can be found in our article about storing medicines at ambient temperatures.
Many other medicines may require refrigeration between 2 and 8ºC. Medicines that require refrigeration are often referred to as “cold chain” medicines or “fridge lines”.
Cold chain medicines may have shelf lives of years, as in the case of most licensed medicines, down to a few days or hours in the case of aseptically prepared injectable medicines, or some extemporaneously prepared oral liquids.
Further information about selection and use of fridges, taking into account the needs of the medicines that are to be stored within them, can be found in our article on using fridges to store medicines.
A small number of medicines require freezer storage. This is usually between -15 and -25ºC, but individual medicines may require a slightly different temperature range. Occasionally ultra-low temperatures (below -50ºC) are required.
Medicines that are stored in freezers are also sometimes referred to as “cold chain” medicines. Further information about selection and use of freezers can be found in our article on using freezers to store medicines.
Temperature controlled transport
It is important to take steps to make sure that intended storage conditions are maintained when medicines are being transferred from one location to another. For more information see our article about maintaining temperature control when transporting medicines.
Monitoring the temperature in ambient storage areas, fridges and freezers is essential to give assurance that medicines are being stored at the correct temperatures. Good monitoring systems can help identify problems quickly so that action can be taken promptly to protect the medicines from temperature excursions.
Further information can be found in our series of articles on monitoring the storage temperature of medicines.
Dealing with temperature excursions
Sometimes temperature excursions may happen in even well-controlled and well-monitored situations. Our guidance will help with managing temperature excursions.
The NHS Pharmaceutical QA Committee produced the following document, which has not been reviewed since 2015. However, it still has valid content that can assist with risk management and local decision making.
- Risk Management document attached