It is an event in which a time- and temperature-sensitive pharmaceutical product (TTSPP) is exposed to temperatures outside the range(s) prescribed for storage and/or transport.
Cold Chain Storage and Excursion Events
The first thing to know is that ignoring or concealing a temperature excursion isn’t an option. An excursion can substantially impact the quality and efficacy of the pharmaceutical, most notably vaccines.
More importantly, an excursion can affect patient safety if it isn’t detected and communicated immediately.
Should an excursion occur, take immediate action and do the following:
NOTIFY ➔ DOCUMENT ➔ CONTACT ➔ CORRECT
- Quarantine the material. Direct the individual who advised you of the temperature excursion to sequester or quarantine the material until a ‘fit’ or ‘not fit-for-use’ statement can be obtained and/or researched by the manufacturer.
- Obtain the temperature readings. Extract data from the temperature reading device and ascertain the times and associated exposed temperature up until the identified excursion time.
- Forward temperature data to the manufacturer. Review the temperature excursion report and forward it to the manufacturer for drug disposition.
- Advise whether the drug is fit for use. In addition to informing the site about whether the drug is usable, regardless of the outcome, ensure that the site keeps a record of the temperature reading in the study folder.
- Keep a record. Maintain a record of any excursion and supporting data, such as lot number or material specific numbers, together with any other correspondence.
- Determine if patient visits should be rescheduled. Appointments may need to be rescheduled until the affected material is deemed fit for use, or until the material is resupplied by the sponsor.
This document describes immediate corrective actions following a vaccine storage unit temperature excursion:View Document