Guidance for healthcare professionals on managing the risks associated with storage of medicines in clinical areas when temperature control is not possible

Purpose

The following information aims to provide guidance to healthcare professionals on managing the risks associated with storage of medicines outside their manufacturers’ recommendations within wards and clinical areas, when control of temperature is not reasonably practicable (e.g. in an ambulance or patients’ lockers). It is not intended to replace the principles of controlled temperature storage as defined in Good Distribution Practice.

Risk management measures

The risk-based approach to the storage of medicines in clinical areas takes a patient-centred 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

Frequently, 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 to optimise patient outcomes.

Assessing risk

The processes of risk identification and assessment are provided in more detail in the attached document, however there are practical considerations that can be taken in to account.

General considerations

The following practical considerations should be born in mind when assessing risk of a temperature excursion:

  • occasional brief excursions to higher temperatures than the stated range may not present any risk to the medicines
  • any contingency option also needs to consider capacity and access, and also safe and secure storage of medicines
  • some medicines do not have any special storage requirements, or may have an upper limit of 30°C, and so are much less at risk than those with lower temperature storage requirements or those that must not be frozen
  • ensure adequate stock rotation of medicines used less frequently within the clinical area

Medicine-dependent considerations

Storage out of range will have different effects on different medicines as described by some of the following examples.

Lower temperatures

  • at lower temperatures precipitation of solutions may occur, which may render them not fit for use
  • if frozen, some medicines (e.g. biologicals) or their containers (e.g. syringes) may be irreversibly damaged and become unfit for use immediately

Higher temperatures

  • at higher temperatures the shelf life may be reduced, but the medicine may still be fit for use if arrangements are made to reduce its expiry date (refer to appendix 4 in the document)
  • the shelf life may be reduced so much that the medicine becomes not fit for use at all
  • solid dose forms (e.g. tablets, capsules) are likely to be more stable than liquids
  • medicines that have been heat sterilised will be stable at high temperatures

Attachments

Change history

  1. Page re-formatted and title updated. Guidance still current.
  1. Published