SMART PACKAGING M
edication adherence by patients is central to the success of clinical trials, and solutions that can improve
patients’ adherence to treatments in clinical trials are critically needed. Smart packaging is a technology solution that can improve medication adherence by patients.
What is smart packaging?
Smart packaging for medication adherence in clinical trials is electronic medication packaging that can record the time and date when patients open the package to take their medication. It can provide an objective and measurable tracking of patient adherence to the study dosing regimen in clinical trials. Smart packaging can also remind patients to take their medication using alerts. Some examples of smart packaging that can be used in clinical trials are smart caps that record when bottles are opened to remove a pill, or smart blister packaging that can record when pills are expressed from the packaging or when a pre- filled syringe is removed from the blister packaging. This data can be used to monitor patient adherence to the treatment regimen and can be potentially used to improve patient adherence to the dosing regimen in clinical trials.
Smart caps for bottles
Smart caps can alert the patient or caregiver to take the medicine by using an audible alarm, lighting up, and/or by providing an alert on an application on a smartphone. Smart caps can be fitted to commonly used medication bottles and record date and time when the bottle is opened. This adherence data can be transferred from the cap to an application on a smartphone or a server through a variety of wireless technologies such as near field communication
“The smart blister package looks like a traditional package, only slightly larger to include a circuit board within the intervening layer, so it’s not visible. The microchip in the circuit board records the date and time at which the pill is expressed.”
40 | Outsourcing in Clinical Trials Handbook
(NFC) or Bluetooth technology. The patient medication adherence data can be analysed by stakeholders such as study sponsors, clinical personnel, caregivers, etc.
One advantage of the smart cap is it requires less customisation compared to the smart blister package as it can be used to fit most commercial pill bottle sizes. However, smart caps provide less information compared to smart blister packaging, in that only the bottle cover needs to be opened to trigger an event, as opposed to expressing a pill from a smart blister, which can record precisely which pill in which location was expressed.
Smart blister packaging
A customised blister package is pre-assembled with electronic traces and printed circuit board that records the date and time of tablet, capsule, or pre-filled syringe removal. The electronic traces run across the blister cavity in between the foil backing and the card layer of the blister card. When a tablet, capsule or pre-filled syringe is expressed, the trace is broken, which is captured as an event by the microprocessor in the printed circuit board. A battery powers the printed circuit board and it typically lasts at least a few years after activation of the card at the packaging site. The electronic traces are not in contact with the drug product, and so there are no issues with contaminating the drug product.
How does the process work for using smart packaging in a clinical trial?
When a patient is enrolled in a clinical study and is screened, the clinical site scans a smart package (bottle with smart cap or smart blister package) using an NFC reader and sends it to the patient or caregiver. The NFC reader reads the data from the smart package and transfers it to a computer, which has medication-adherence software that associates that smart package with the patient, similar to associating a particular kit to a patient. The smart blister package looks like a traditional blister package, only slightly larger to include a printed circuit board and battery enclosed within the intervening layer of the card so it’s not visible. The patient or caregiver uses the smart blister package as they would a traditional blister package to express a pill to take the medication as per the study dosing regimen. The microchip in the printed circuit board records the date and time at which the pill is expressed.
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