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Originally Published PMPN November 2004

NEWS

Electronic Compliance Packaging Hits The Market

IMC’s eCAP consists of an RFID smart tag that reminds patients to take their medication and records when the bottle was opened.

The use of electronic compliance packaging continues to grow, with two recently launched products joining the fray. MeadWestvaco Healthcare Packaging (Mebane, NC) has begun initial testing of Cerepak, an electronic update of its award-winning Dosepak package. Information Mediary Corp. (IMC; Ottawa, ON, Canada), meanwhile, is currently testing the Med-ic ECM (electronic compliance monitor) blister package.

Cerepak employs smart technology to measure and improve patient compliance. It reminds patients when to take medication, records when they do, and reports that data back to their doctor or pharmacist. The package’s built-in ‘brain’ also provides real-time compliance measurement that can expedite drug development through clinical trials, enhance patient persistence, and improve the bottom line, according to Tom Grinnan, MeadWestvaco’s director of business development. “We really want to make this work as a high-volume, high-efficiency solution,” he says. “We’re moving forward with the full integration of our technology into this product.”

Grinnan says the company developed the technology with Cypak AB, a Swedish technology firm. Using a heat-sealed paperboard card, the package’s back layer has a conductive ink-trace pattern. “When you break the layer, a unique signal is sent to an RFID-enabled chip in the package,” he says. “Ultimately, this technology can be used for any type of blister package. It could also work with injectables.”

The technology allows the removal of each pill from a blister package. When a pill is removed, the package emits a slight beeping noise, recording the time and date of removal of medication. It also records which pill has been taken. In addition, a patient questionnaire is integrated into the package, featuring a log for patient side effects and time to onset. The questionnaire also measures pain and nausea.

Grinnan touts Cerepak’s ability to improve speed, cost, accuracy of packaging, and patient diary reconciliation. He says it also further enables electronic clinical trial monitoring. The product’s RFID reader uses MeadWestvaco’s proprietary frequency and can also be used with standard ISO frequencies. “In addition to trials we have ongoing in Europe at the University of Lund in Sweden, we’re working on some smaller trials in the United States,” says Grinnan. “And while we’re focusing on the clinical trial market for the time being, we will definitely target the commercial market in the near future.”

IMC’s Med-ic is also currently being tested in clinical settings. The package uses an electronic device that is integrated into a blister package. It tracks medication usage without active patient input and contains an RFID smart tag that records the time at which the tablet or capsule is expelled, logging the patient’s medication use. “By attaching our sensors to different platforms, we can make the package do a host of different things,” says James Neilson, product manager for IMC. “It can detect package tampering, the time that a package is opened, or it can be used for temperature monitoring. If you start with a multipanel, heat-sealable cardstock that is child-resistant and senior-friendly, we can equip that with an ECM.”

Similar to Cerepak, the ECM is useful in the prevention of counterfeiting. It stores an encrypted unique identification in its memory module. The secure ID can be used to track gray-market activities or any unauthorized sale. Following completion of a clinical trial, the patient can return the blister package to a clinician, who uses the RFID scanner to download the information into a database. The data are downloaded through a 13.56-MHz RF wireless reader to a researcher’s computer.

The Med-ic ECM is designed to streamline clinical data collection. It also integrates IMC’s CertiScan peripheral hardware and software with IT and packaging engineering support. The device also adapts to existing blister-package configurations, according to the company, and can be tailored to specific clinical requirements such as temperature monitoring, vibration, humidity, radiation, and light.

Elsewhere on the electronic compliance packaging front, IMC recently introduced eCAP, a smart RFID closure for medication bottles and vials. IMC teamed with Remind Cap International Ltd. on the packaging solution for the electronic reminder and monitoring system. It consists of the Med-ic RFID smart tag embedded in a Remind Cap bottle closure. Similar to the other packages, it reminds the patient when the next dose is due and records the time the patient opens the bottle to remove the tablet or capsule, logging compliance at that moment. The recorded data are then retrieved with IMC’s CertiScan reader for a physician or pharmacist to review.

Neilson says that eCAP is currently being used in clinical trial settings. He adds that it is currently performing well in two separate university studies. The company expects a complete supply- chain solution for pharmacies and drug manufacturers to be released this year.

Copyright ©2004 Pharmaceutical & Medical Packaging News