Temperature excursion during transport: what should happen next

There is no general list of permitted temperatures for medical transport. For medicines, the GDP guidelines say that storage conditions during transport must stay within the limits described by the manufacturer or shown on the outer packaging. The guidelines themselves give no figures anywhere. What appears on a pack is standardised in Europe: statements such as 'Do not store above 25 °C', 'Store in a refrigerator (2 °C - 8 °C)' or 'This medicinal product does not require any special storage conditions'. That statement follows from the product's stability data and is the limit against which transport is measured. Terms such as room temperature or ambient are not allowed on a label, precisely because they do not state a limit.

If no storage condition appears on the pack, that does not mean anything goes. The European inspectors explain that temperature during storage and transport must still be controlled and monitored, within limits appropriate to the European climate. The IGJ translates that for Dutch practice: without a storage condition, or with 'do not store above 25 °C' or '30 °C', the environment must be representative of room temperature, that is 15 to 25 °C; for short transports of at most a few hours the inspectorate applies a lower limit of 2 °C, and of 9 °C for products that do not belong in a refrigerator. That is supervisory policy, not statute, but it is the framework the inspectorate applies.

For laboratory specimens it works differently: there the laboratory decides, per test, which condition a specimen needs to remain usable. An excursion is then anything outside that instruction. How conditions and the cold chain fit together is explained in temperature-controlled transport.

Chapter 9 of the guidelines is short and clear on this: deviations from storage conditions during transport are reported to the distributor and to the recipient, and investigated. This is preceded by a risk assessment of the route, which determines where temperature control is needed. The measuring equipment used must be calibrated at least once a year.

The IGJ works that out for practice. Short domestic rides do not always have to be conditioned; that depends on a risk assessment that weighs the duration, the ambient temperature, the limits on the outer packaging, the packaging and the training of the drivers. Monitoring may be risk-based, with spot checks. Outliers must be investigated and reported by the carrier to the owner of the product. And a standard permitted deviation, along the lines of 'an hour above 25 °C is no problem', is only allowed with product-specific substantiation from stability data.

Reporting is therefore not a matter of goodwill but a requirement: to the client and to the recipient, and fast enough to still be able to act on it.

Not the courier. Whether a medicine can still be used after an excursion depends on the product, on how large and how long the excursion was, and on the manufacturer's stability data. A carrier does not have that data, and weighing it is not its role either. According to the IGJ the wholesaler or manufacturer remains responsible for the transport and cannot place that responsibility with the carrier by contract. The decision on release, recall or destruction therefore lies with the owner of the product or with the client's quality officer. How that division of roles works in outsourced transport is explained in GDP responsibilities in outsourced transport.

A sensible arrangement is then that a shipment with an excursion is not delivered quietly, but kept apart until the client has decided. The courier supplies the facts for that: what was measured, when, for how long, and under which circumstances. Without those facts nobody can decide properly.

For specimens the division of roles is the same: the laboratory judges whether a specimen is still usable for the test, the courier reports and documents.

A report is only worth something if the assessor can do something with it. In practice it comes down to the following data, per shipment.

All of this belongs in the file of the ride, so that the client can transfer it to its own deviation register.

• Which shipment: client, ride number, what was transported and, if known, the batch number.
• The agreed condition, and where it comes from (label, instruction from the manufacturer or from the client).
• The temperatures measured at pickup and at delivery, with time and method; if a logger travelled along, the course.
• The highest or lowest value, and how long the temperature stayed outside the condition.
• The circumstances: outside temperature, delay, an opened box, a failed cooling element.
• What was done: reported to whom, when, and what happened to the shipment pending the decision.
• The client's decision, by whom and when.

A measurement at pickup and a measurement at delivery show the start and the end of the ride. A data logger that travels along shows the course, including a brief peak while reloading. Which of the two is needed follows from the risk assessment of the route and from what the client asks; the IGJ accepts risk-based monitoring with spot checks, but when an excursion occurs everyone wants to see the course.

The equipment itself has to be reliable. The GDP guidelines require calibration at least once a year. For temperature recorders there is a European standard (EN 12830) that covers the device and its tests, and a standard for the periodic verification of recorders and thermometers (EN 13486). Those standards say something about the measuring instrument, not about the ride: a recorder that meets a standard does not make an overheated ride acceptable. More on measuring, logging, calibration and how it differs from validation is in temperature logging in medical transport.

Most disputes about an excursion arise because it was not agreed beforehand what the condition was, who had to be called, or what the courier had to do with a suspect shipment. A few agreements prevent that.

• The condition per shipment is in the order: 2-8 °C, 15-25 °C or another instruction, with its source.
• There is a contact for excursions who is reachable at the times rides take place.
• The courier reports immediately, does not deliver without a decision and keeps the shipment apart under the best possible condition.
• It is clear how measurements are taken (at pickup and delivery, or with a logger) and how they end up in the file.
• The client records the decision and reports it back, so that the file is complete.

UrgentX measures the temperature at pickup and at delivery and records it with the time and the driver's name. In the event of an excursion we report immediately to your contact person and do not deliver without your release; the excursion is recorded in the file of the ride. If no measurement was taken, the file says 'not recorded'; we never show 'in order' without a measurement. How that works for refrigerated and conditioned transport is described under refrigerated medical transport, and for medicines under transporting medicines in line with GDP.