In the world of biologics development, a temperature excursion is a rare, but serious matter. It occurs when clinical trial material is stored at a temperature outside of the specified temperature range defined on the label.
Considering the fact that temperature-controlled biological products are high-cost – some valued at $1,500 a vial – temperature excursions can carry a steep price tag for the sponsor if the product must be discarded and replaced.
The first thing to know is that ignoring or concealing a temperature excursion isn’t an option. An excursion can substantially impact a clinical trial by affecting the quality and efficacy of the study product. Most 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:
- 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 is issued by the manufacturer. This instruction should also be included in the paperwork sent to the investigator site at the point of dispatch by the distributor.
- Obtain the temperature reading. Ask the site staff to email a copy of the temperature reading if they haven’t already done so. Most temperature monitors allow the site to download the report containing this information directly onto the site’s computer.
- Forward temperature data to the manufacturer. Review the temperature excursion report and forward it to the manufacturer for drug disposition. Be sure to receive a written statement in return that contains information linking the ‘fit-to-use’ statement back to that particular shipment – in other words, the shipment or waybill number.
- Advise the site about 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. This is a precaution in case the information is needed again, such as during an audit.
- 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. Resupply could take some time, leading to considerable frustration on the part of the site staff and study patients. Unfortunately, delays can also result in patient dropouts, impacting the overall success of the trial.
Download Part 4 of the Fisher Clinical Services eBook series entitled "Considerations for Cold Chain Shipment of Clinical Supplies" for more details. In addition to addressing the issue of temperature excursions, this final part of the eBook series includes summary recommendations for sponsors on how to handle cold chain or investigational medical product (IMP) across the supply chain through delivery to investigator sites.
As always, I welcome your questions. Reach me at Royce.Heap@thermofisher.com