Sanjay Vyas, corporate vice president & Global SBU head of Clinical Trial Supplies & Logistics, PAREXEL International discusses the challenges in transporting certain medicines and how advancements in technology are making things easier.
Medicines Transportation
A growing number of drugs have a stringent stability profile and, with that, a certain best-practice temperature range that must be adhered to. Temperature monitoring of medication has become increasingly important; regulation changes have imposed an increase in what must be monitored, and an increase in complex, fragile, highly valuable medication has added to the difficulty of this task.
For any Investigation Medical Product (IMP) to be stored and administered safely, clinical trial sponsors must control the temperature conditions of the IMP throughout the supply chain and this means maintaining full visibility throughout the transportation process.
Traditional approach
Transporting any IMP means exposing it to several different environments. From shipping to storing at the trial site, one thing that must remain within the stability profile is temperature. While minor alterations in temperature are to be expected, any drastic single change or cumulative out-of-range exposure must immediately be flagged to a sponsor.
Historically, this was done via a USB temperature logger packed with the shipment at the distribution depot, the status of which is checked when the shipment arrives and is checked-in by the receiving clinical trial site. A simple LED indicates whether the logger has recorded a temperature excursion or not, and full details of the temperature history of the journey from depot to site can be retrieved from a PDF download from the logger, and then manually entered against the shipment in the IRT (Interactive Response Technology) or RTSM (Randomisation and Trial Supply Management) system. This which would then use the temperature information to decide whether the shipment is in good condition or needs to be quarantined while the temperature deviation is investigated.
However, there are some downsides to this approach. Firstly, loggers are only used to track temperature during transport from depot to site, so once removed from the shipment and processed, monitoring then relies on temperature logging devices used at the site. This means there could be gaps in the temperature history and it makes complete cumulative temperature history difficult to obtain.
Another issue is that any temperature deviation is not known until the logger is unpacked at the site. If there’s only a short time between the IMP shipment arriving at the site and the next patient visits requiring those medication kits, there’s a risk of being unable to dispense to the patient because there’s insufficient time to order and receive a replacement shipment. This is a particular risk for treatments that are both temperature and time sensitive (short shelf-life) such as gene and cell therapies.
The USB logger approach also creates a burden for site staff. It means that they need to manually transfer data from the logger into the IRT or RTSM, which also has the potential to introduce delays and errors.
Digital transformation
The industry is now investing in new ways to monitor temperature more effectively using new and transformative technologies. Smart packaging is increasingly being used by pharmaceutical companies and many logistics groups offer temperature-controlled shippers to ensure that the medication won’t have experienced an excursion whilst in shipment.
Furthermore, Bluetooth-enabled temperature monitoring solutions provide sites with wireless solutions to check the temperature status of an individual pack. Then there’s RTSM and IRT mobile applications, which can scan for loggers in the vicinity and then notify sponsors and site-staff of any packs which need to be quarantined, thus saving time. Not only does this improve the shipment arrivals process, but it also provides a solution with no “gaps” in monitoring.
Another available solution that saves site-staff time is near real-time temperature trackers which can be 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.
It has therefore become vital that sponsors choose technology that not only reduces the burden on sites but provides 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.
Barriers to adoption
Given the benefits described above, why isn’t this technology already being applied widely today? There are several challenges that can arise in deploying these internet -based technologies including:
- Lack of mobile network or Wi-Fi coverage means some sites have trouble with apps and devices that rely on internet connectivity.
- Import / export regulations make it either impossible or difficult to import the transmitting loggers or to be able to get them returned from the sites.
- Getting sites to return the loggers. Newer transmitting loggers are often more expensive and are reusable but there have been difficulties in getting sites to return the loggers, which adds costs to the supply chain.
- Introducing new ways of working at the site. While the mobile apps have clear benefits for reducing burden on sites and improving data accuracy and safety, they are a significant change in working for the site, and require provisioning of devices to the site staff unless a Bring-Your-Own-Device (BYOD) policy is employed, which has its own concerns with data privacy and security.
While there are some barriers to adoption, these are likely to deplete over time as more mobile and internet-enabled technologies are deployed at clinical trial sites, and the volume of temperature-sensitive IMP managed by sites increases. Ultimately, these developments must be employed to reduce the burden of medication management tasks on site staff and improve visibility of the supply chain to help ensure continuity of uncompromised IMP supply to patients in clinical trials.