Temperature monitoring, authenticity protection, traceability and patient compliance – all of these terms have been associated with radio-frequency identification (RFID) technology by those working in the clinical trial supply chain. "Smart labels, consisting of labels and RFID tags, offer solutions for each of these requirements", explains Marco Dieling, head of technical project management and product development at Faubel Pharma Services.
Temperature monitoring
RFID technology is versatile, easy to handle and is used for a range of things, including temperature monitoring. In most cases, it is essential not to interrupt the cold chain in pharmaceutical products, which is why Faubel uses labels that are equipped with RFID sensors to measure and monitor ambient temperature. The data that is collected by the built-in temperature sensor is automatically transmitted to a reader on-site and/or to the cloud by tag software that is located in active loggers. "If drugs are partially shipped by air, it makes more sense to use passive tags that have to be read out and do not actively transmit data. As a multiservice provider, we always adapt our labels to the requirements of the entire supply chain," adds Dieling.
Expiry updates
Together with the increasing demand for packaging that provides data for temperature monitoring, there is also a growing number of requests for stability data updates to become part of packaging concepts. Consisting of a booklet label, a RFID tag and an ePaper display, the Faubel-Med Label is a smart label that can be used to perform automatic-expiry updates. It complies with Annex XIII and facilitates the implementation of Annex VI requirements, given the fact that it can perform expiry updates on sealed kits. The Med Label provides benefits to various users, including sponsors, contract research organisations, contract manufacturing organisations, depots and sites. "It saves them from having to relabel whenever stability data changes, and it is even faster and safer. In addition to this, it results in considerable savings for global clinical trials, in terms of time and cost management," states Dieling.
Traceability
Drugs can be authenticated by using RFID technology – even if near-field communication (NFC) tags are being used, RFID can be used on smartphones at any time. No special readers are required, meaning that no additional costs are incurred and all the parties involved – including the patient – can authenticate products by themselves. In addition to this, RFID technology can be used to track and trace products seamlessly. Material and product flows can be monitored and controlled by sites and depots.
Patient compliance
"Track and trace processes are well established. Yet, we see potential for further development of our Med Label through research and the use of RFID technology as a communications channel," states Dieling. How critical patient compliance is to a successful treatment is unquestionable, and its influence is growing with self-medication. "Any help provided by RFID technology as a communications channel is welcome," states Dieling. The connection between the NFC tag and smartphones will be able to remind users to regularly take their medicine, as well as explain the right dosage to take in a user-friendly video tutorial.
"Reciprocal communication between all elements is the key to compliance," explains Dieling. All elements should match and interact with each other – from treatment instructions that are provided by doctors and nurses to the design of study kits, and primary and secondary packaging material down to digital sources of information. "To follow this holistic approach, we have integrated the complete infrastructure of clinical trial supply chains into our smart label concept", says Dieling.
Effective interaction will, therefore, involve collecting detailed patient data, which will automatically merge into a comprehensive and digital documentation that enables compliance monitoring. Dieling concludes that smart labelling is essential for highlighting data protection issues, and is vital in preventing patient compliance from being jeopardised.