With a power cut, a failed fridge or a door left open, the first step is the same: do not dispense, set the product aside and prepare the record. The pharmacy does not decide the outcome; the record goes to the wholesaler and the marketing authorisation holder, and the answer comes back in writing.
During a pharmacy incident the work comes down to three verbs: stop, record, report. The reasoning behind all three goes back to what the cold chain is.
- Stop: do not dispense the cold-chain products. If the outage continues, keep the door shut; a closed fridge holds the cold it has left. Move the products to a working fridge or a place kept at +2 to +8 °C, on a separate shelf, labelled as not for use.
- Record: the start time and the time it was noticed, the fridge's highest and lowest temperature, the affected products and batches, and how full the fridge was. Do not switch off the logger or erase its history; the current display reading does not replace the temperature seen during the event.
- Report: send the record to the wholesaler, the pharmacy's responsible person and, where needed, the marketing authorisation holder.
Cold-chain products are kept within the range on the licence, +2 to +8 °C. After an excursion, the product's stability data decides whether it can still be used, and that data sits with the marketing authorisation holder. Until the written answer arrives the product is not returned to stock, sent back or destroyed.
Write the root cause before closing the case: a replacement plan for an ageing appliance, training for a door habit, a backup plan for outages. A spare thermometer, a one-page outage note and the wholesaler's emergency number should be in place before an event.