SMART PACKAGING
“There are some limitations to smart packaging. The event being recorded is the opening of the packaging, which is used as a proxy for patient medication adherence. However, the opening of the packaging does not necessarily mean the medication has been ingested by the patient.”
When the patient or caregiver returns to the clinic for a follow-up visit, they return the used smart blister package to the clinic. The clinic scans the used smart blister package using the NFC reader, and the data is transferred to a PC installed with the adherence software. The data files are encrypted by the adherence software and transferred from the clinic to a database on a cloud server. Stakeholders such as the sponsor and contract research organisation (CRO) are given selective access to the data collected on the adherence platform by the micro-electro- mechanical systems (MEMS) adherence software vendor. Sponsor and CRO can perform data analysis using the adherence platform to derive insights on patient adherence to medication during the trial.
What is the process for developing a smart package for a clinical trial?
Implementing smart packaging in a clinical trial has two parts: one is the development and manufacture of the smart package, and second is managing the data collected using the smart package. And two different vendors with expertise in these two areas is preferable in the case of smart blister packaging to ensure the best outcome in terms of the smart packaging and the clinical data being collected. It is beneficial to choose vendors that work cohesively to ensure smooth execution of the project. The smart packaging vendor has the expertise to develop the smart blister package based on your existing traditional packaging, manufacture and help implement it at your current packaging and clinical distribution partner. To manage the data collected using the smart
package, a MEMS adherence software vendor is needed that has experience implementing MEMS devices at clinical sites, collecting clinical data using NFC-compliant readers and software, transferring data securely to cloud servers, and providing data access and analysis to stakeholders such as sponsors and CROs. The steps involved in the smart package
development include design and development, verification testing, design modification, design finalisation, production and release. The first step is to initiate the smart package design and development. The design of the smart package, especially for the electronic traces to the blister package, is important as it ensures that the expression of the pill leads to the breakage of the electronic trace to allow it to register as an event. The second step is verification testing and design modification. In this step, the smart package can be tested for ease in expression – whether each expression is captured as an event, and the impact of robustness testing of the packaging on the reliability of the electronics, such as folding cycles for blister packaging. Once fully tested, the design can be finalised and moved to production, and finally released to be sent to the packaging vendor to incorporate the blister containing the drug with the smart card to create the final smart package for clinical distribution. The MEMS adherence software vendor would work through the steps of MEMS set-up, configuration, user access testing, and deployment.
There are some limitations to smart packaging.
The event being recorded in smart packaging is the opening of the packaging, which is used as a proxy for patient medication adherence. However, the opening of the smart packaging does not necessarily mean that the medication has been ingested by the patient. Also, in cases where patients take multiple medications and use a pill dispenser, the patient or caregiver may dispense all the pills for the week into a daily pill counter. This would defeat the use of smart packaging for patient medication adherence, as pills have to be removed at the time of ingestion for measurement of medication adherence by patients to work. However, smart packaging is a relatively simple, easier method and is more amenable for use in a wider patient population to monitor medication adherence compared to more complicated methods such as recording the patient taking the medicine or having a sensor on the pill.
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