Monitoring strategy

An effective temperature monitoring strategy is essential to give assurance that medicines are being stored at the correct temperatures. Investing time upfront in developing a robust monitoring strategy, purchasing quality monitoring equipment and training staff in its use will ultimately 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.

There are a variety of technical solutions available when developing a monitoring strategy. This guidance will explain the options and help in the development of a strategy which best meets local requirements.

Considerations

A monitoring strategy requires consideration of the following:

• whether sensors will measure air temperature or product (load) temperature, or both
• the number and location of temperature sensors in a storage area
• how data from sensors is recorded
• how users will be alerted to an excursion
• sensor calibration

Enhanced monitoring

The functionality required for a monitoring device depends on the potential impact of an excursion on the medicines being stored, and the subsequent impact on patients and services. Enhanced monitoring and alerts systems may be required for medicines that are:

• highly sensitive to temperature excursions
• difficult to replace before they are needed by a patient
• expensive
• stored in large quantities