Understanding ambient temperature storage

Medicines manufacturers may define ambient storage temperature as being within a variety of different ranges between 8ºC and 30ºC. If there are specific requirements, these will be stated on the packaging.

In our guidance, we use “ambient temperature” as a general term and include advice related to specific ranges where necessary. Medicines may be stored at ambient temperature in a variety of different areas including:

• a Pharmacy store or dispensary
• a ward or clinic medicines cupboard
• an ambulance
• a GP surgery
• a community midwife’s bag

Ideally, all medicines storage areas would be controlled between 15ºC and 25ºC, which is suitable for all ambient medicines. Pharmacy departments are expected to be able to provide this level of temperature control for medicines. In practice, many locations do not have air conditioning that gives this level of control. Nevertheless, there are steps that can be taken to optimise ambient storage areas.

Optimising temperature control

Air conditioning should be installed, if possible.

Store medicines away from radiators and warm air ventilation inlets. Direct sunlight may create hot spots, especially in summer. If this is the case, consider moving affected medicines into a shaded location or adding reflective film to the windows.

Keep windows and doors closed as much as possible. Windows may be opened to aid cooling but only if it is cooler outside, and be cautious of security risks.

If air conditioning cannot be installed, consider the use of ambient storage cabinets for small quantities of stock. These look like fridges or incubators but the chamber is maintained between 15ºC and 25ºC. The principles outlined in our article on using fridges and freezers to store medicines will apply if ambient storage units are used.

Consider temperature mapping to identify warm spots and cool spots, and re-organising the storage accordingly. Medicines that may be stored down to 8ºC could be stored in the coolest spots or medicines with no specific storage requirements could be stored in the warmer spots.

Monitoring ambient areas

Monitor the temperature within the storage area. For more information refer to our article series about temperature monitoring.

Heatwaves and exceptionally cold weather

Actions such as those described above are not always possible, or do not give full assurance that the temperature is reliably controlled. If it is foreseeable that there will be temperature excursions in warm or cool weather, steps can be taken pro-actively to minimise their impact.

Information on managing unexpected temperature excursions can be found in our series on managing temperature excursions.

High temperatures and heatwaves

Monitor stock turnover closely; keep stock levels to the minimum and ensure stock is strictly rotated:

• for high stock turnover areas, this means that the medicines will only be exposed to high temperatures for a brief time before being used
• for low stock turnover areas, this means that the minimum quantity of medicines will be affected by the excursion

A system of manually reducing the expiry date on medicines that are frequently exposed to temperatures a few degrees above their required storage temperature may also be used. Some medicines also have additional information in their SmPCs permitting storage at higher temperatures.

Low temperatures

Most medicines that require ambient storage do not have a lower temperature limit. Those that do may precipitate or solidify at low temperatures. In some cases, this precipitation is reversible and will be explained in the SmPC. In other cases, precipitation may not be reversible so these medicines need to be protected from routine low excursions of any duration.

Risk assessment

Medicines in the supply chain between the manufacturer and the pharmacy department must stored be in suitably controlled environments, in accordance to Good Distribution Practice. However, once the medicines have left the pharmacy controlled supply chain (e.g. ward, ambulance, outreach service) strict temperature control cannot always be achieved. This is because there are other considerations to be taken into account, such as timely access to medicines. Examples include the need for rapid access in emergency care, or where patients are self-administering their own inhalers or insulin.

Storage considerations

A decision to store a medicine outside the stated temperature range must be informed by a robust risk management approach which balances the following needs:

• to have medicines readily available for patients
• to store medicines safely and securely
• to ensure the quality of the medicines is assured

Healthcare professionals are faced with the challenge of delivering these sometimes conflicting requirements. When all three elements cannot be fully addressed, a benefit/risk management approach will need to be taken. Each circumstance should be assessed individually to determine the appropriate storage and monitoring requirements, and where appropriate to plan contingency arrangements.

Risk assessment overview

Risk assessments may be made for individual medicines or groups of medicines with similar storage needs, or for whole storage areas, depending on the situation. Assessments should be documented, steps should be taken to control risks and the assessment should be reviewed at intervals to ensure that it is still valid and that risk controls are still effective. The steps below describes the approach that may be taken to assess and manage the risks for a whole clinical area (e.g. hospital ward)

Risk assessment Steps

Step1: Gather information about the area and medicines stored in it.

Step 2 : Identify if there is enough information about temperature control to be able to determine  whether control is adequate?

Step 3: Evaluate risks and benefits, and decide whether additional control is required, either permanently or temporarily e.g.:

• Mechanical temperature controls (fridges or air conditioning)
• Stock rotation measures
• Expiry reduction (routine or in exceptional weather)
• Additional temperature monitoring

Step 4: Document the risk assessment either our template risk assessment or using local risk assessment documentation. Our template risk assessment will be published shortly.

Step 5: Prepare an action plan for

• implementation of all of the necessary controls
• any additional monitoring

Step 6: Add to local Risk Register if necessary

Step 7: Review the effectiveness of the controls and check that the risk assessment is still valid at suitable intervals.

Local governance

Storage of a medicine outside of its stated conditions is outside the medicine’s licence and requires review under local clinical governance arrangements.

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