The priority of every clinical trial is the safety of the patients participating. So it is vital that the Investigational Medicinal Product (IMP) dispensed to the patient is both the correct drug and dose, and is in good condition.
Given that so many trial drugs have a strict stability profile, the acceptable temperature range for the drug to be deemed safe is, at times, restricting. This makes it essential that clinical trial sponsors are able to control the temperature conditions of the IMP as well as have visibility of any excursions prior to dispensation.
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From manufacture to dispensation, the IMP will be exposed to a multitude of environments during packaging, shipment and on site in storage. It is vital that at all points in this process, the sponsor is alerted to any temperature excursions. It is also important that traditional USB temperature loggers have provided sponsors with the capabilities to identify excursions during shipment. Then once in storage at site, site staff can frequently monitor loggers in the fridges that store the medication.
This provides some visibility of the temperature the IMP is exposed to, but with large gaps in the data. For example, the staff may unpack a shipment, remove the logger and leave the IMP on the side for a period before placing in appropriate storage. The temperature of the room may cause an unacceptable excursion, but it would go undetected. Inevitably, Murphy’s Law would state that temperature excursions, defined as deviations in temperature from written instructions, are likely to occur in the time periods without temperature monitoring and the site staff wouldn’t know to quarantine the medication.
Packaging a temperature logger into the pack with the medication enables temperature tracking at a pack level, which subsequently means the logger can stay with the pack through shipment and storage. This end-to-end approach (tracking the temperature from packaging to dispensation) provides a seamless temperature history for an individual pack, assuring site staff, sponsors and ultimately patients of the safety of that pack.
Many temperature monitoring solutions require additional manual work, in order to retrieve the data. This burdens already busy site staff with further tasks, and can often lead to delays in on-site medication availability. The manual upload of temperature data from a USB stick can take days to be processed by the sponsor and checked for safety. During this time the IMP is unavailable to be dispensed. In addition to the burdens placed on-site staff, this introduces the risk of patients attending visits but not being able to receive their medication. Overall, this delay in dispensation due to temperature condition error costs time and money and can negatively impact the patient’s wellbeing.
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Introducing a Bluetooth-enabled temperature monitoring solution provides sites with a wireless solution to efficiently check the temperature status of an individual pack or perform a whole stock check. Using a Randomization and Trial Supply Management (RTSM, also known as Interactive Response Technology -IRT) mobile application, they can scan for loggers in the vicinity and the application will notify them of any packs to be quarantined. This improves the shipment arrivals process and also provides a solution with no “gaps” in monitoring; the logger is switched on at the time of packaging and is required to be checked before the medication can be dispensed to a patient.
Another available solution that removes the need for manual upload of data is near real-time temperature trackers that are placed into a shipment and monitor IMPs from packaging at depots through transit to clinical trial sites. This innovation in clinical supply chain management allows a quick response to any temperature complications, which can reduce safety risks for patients as well as manufacturing and shipment costs for clients.
Some vendors offer a solution using loggers with NFC (Near Field Communication). This allows for temperature information to be retrieved from the loggers upon contact with a receiving NFC device. Again, this improves the site user experience by reducing the effort required.
The industry is increasingly seeing smart packaging being used — many logistics groups offer temperature controlled shippers, adding to the assurance the medication can’t have experienced an excursion whilst in shipment.
Clinical trials require an identity check of the patient upon dispensation to prevent the wrong IMP being dispensed- often this is a check of patient details. By introducing the mobile application, site staff members are able to confirm the identity of the dispensing pack, by scanning the barcode. If correct, this will trigger a Bluetooth scan of the associated logger to confirm that the pack has not undergone any temperature excursions. This provides the sponsor, site staff member and patient with full assurance that the pack they are receiving is the correct one for them and hasn’t been temperature-compromised.
Temperature monitoring of medication has become increasingly important with regulation changes that have imposed an increase in what must be monitored, and an increase in complex, highly valuable medication has added to the difficulty of this task.
This focus inevitably will have an effect on sites by increasing the number of loggers. It is therefore vital that sponsors choose technology that not only reduces the burden on trial sites but also provide more complete data on the temperature conditions that IMP has been exposed to. Using technology that communicates with the RTSM system via Bluetooth enables users to be mobile in their tasks, reducing the time they need to spend on temperature checking, and increasing the time they have available for patients. By placing loggers into packs, sponsors have complete temperature data from packaging to dispensation; therefore, assuring that no temperature compromised packs can be dispensed.
Photo: Martin Barraud, Getty Images
