Temperature Excursions

Part of Trial Pharmacy (PHARM) Training: Receipt and Storage.

About 2 minutes. Free, in your language, no account needed.

Why this matters

Excursions happen. Fridges fail, doors are left open, couriers are delayed.

What determines the consequence is not whether an excursion occurred. It is what the site did in the hour after it was discovered.

Quarantine first

The moment an excursion is identified, the affected product is quarantined. Physically separated, labeled, and not available for dispensing.

Do this before you calculate anything or call anyone. Product that stays on the shelf while a question is resolved is product that can be dispensed by someone who does not know there is a question.

Gather the facts the sponsor will need

Duration. From when to when, as precisely as the data allows.

Temperature reached. Minimum and maximum, not an average.

Which product. Kit numbers or batch, not "the fridge contents".

Prior excursions. Stability decisions are often cumulative, so previous events matter.

Send the logger data itself, not a summary of it.

You do not make the stability judgment

It may be obvious to you that thirty minutes at 8.5C is harmless. You still do not decide.

Stability data for this product is held by the sponsor or manufacturer. They may have information you do not, and cumulative exposure may have crossed a limit you cannot see.

Report and wait for release.

If product was already dispensed

Then it is no longer only a product question. Tell the investigator, because a participant received product of uncertain quality, and that may itself require action.

Report it as a deviation and follow the sponsor's direction.

In practice

A power interruption over a weekend leaves a fridge at 11C for an unknown period before the backup generator started.

You quarantine everything in that fridge, download the logger, record what is known and what is unknown, and escalate on Monday morning with the data attached.

"Unknown duration" is a legitimate and important thing to report.

What this looks like when it goes wrong

A pharmacist judges a short excursion to be within tolerance based on the product's labeled storage range, and continues dispensing.

The sponsor's stability data shows cumulative exposure limits that had already been reached in an earlier event. Product that should have been withdrawn was given to four participants.

The judgment was reasonable and the pharmacist did not have the data to make it.

Key takeaways