Nov 14, 2012When conducting clinical trials of a medication, pharmaceutical companies and research institutes must rely on participants to follow the recommended dosage regimen. Although patients may claim to have taken a medication at specific times, the information supplied may be inaccurate, affecting the test's outcome, and there is no way for the trial hosts to know about it. To remedy this problem, Information Mediary Corp. (IMC) offers RFID-based solutions that track the removal of pills packaged in blister packs and bottles, and then transmit that information to a reader. While the RFID-based systems have been available since IMC was founded in June 2001, the company is now developing a Near Field Communication (NFC) version of its products that will allow its customers to employ NFC-enabled phones to track medication usage in clinical trials and other environments.
IMC manufactures two RFID-based products for electronic compliance monitoring: Med-ic, for capsules and pills packaged in blister packs, and eCAP, which serves as a closure for a pill bottle or vial. Both solutions consist of the firm's Smart Label, a semi-passive RFID tag embedded in the packaging or cap, and a sensor or switch to indicate when either the blister packaging is broken or a lid is opened. It also includes IMC's RFID reader, which plugs into a computer, and its CertiScan software, to interpret read data, says Joanne Watters, IMC's research and product support specialist.
The data related to each medication activity is stored on the tag, and is then transmitted to a reader for use by the pharmaceutical company or research institute. In some cases, the system is also utilized by a patient, or by a patient's family, to ensure that medication is taken when recommended. In this scenario, the patient or family must purchase the reader and software in order to manage data collected from the RFID reads.
With the use of NFC technology, the company reports, the system could also be used with an NFC-enabled phone loaded with NFC-based applications provided by Information Mediary Corp. This would make it possible for a patient or researcher to use the solution without acquiring a reader or reader-based software, simply utilizing an app on his or her NFC-enabled phone.
The tag, powered by a 3-volt cell battery, can store sensor data from up to 31 tablet locations on the blister pack. In the case of the eCAP, the device is designed to sense each time that a bottle or vial is opened, and thus the time that the pills are removed. The RFID tag is embedded in the cap, along with a switch that detects each time that the cap rim loses contact with the bottle, thereby indicating its removal. That action, along with the time and date stamp, is then stored in the caps' tag, and can be read using an RFID interrogator. The cap tag can store 4,000 medication events.
The Med-ic Smart Label for blister packs comes with a Mylar-based printed electronic grid connected to the tag. The Med-ic Smart Label is attached to the blister pack via adhesive, so when a pill is removed from the pack, it is pushed through the foil wrap, thereby breaking part of the Smart Label's electronic grid. The tag detects this break in the grid, thus indicating that a pill has been removed, as well as which specific pill, based on the break's location. The tag then stores that break and location data, along with a date and time stamp.
Because blister-pack form factors vary, the Med-ic label is custom-designed for each product so that it will fit the particular medication's packaging and requirements, according to the size of the tablet or pill, as well as the form factor of the packaging itself.
According to IMC, the data not only provides proof to researchers that the trial was carried out properly by a participant at home, but also enables them to maintain records for the governing bodies that may need to see proof of the trial's details.
The researchers can send the empty blister pack back to Information Mediary Corp., which will then remove the RFID tag and reapply it to a new package of medication. A researcher can recycle and reuse the tag up to six times, paying only the single initial fee.
The Med-ic and eCAP systems have been employed by a number of research institutes and pharmaceutical companies, Watters says, though they have asked not to be named.
Increasingly, Watters observes, the pharmaceutical industry is showing an interest in the use of RFID technology. However, he says, an NFC-based solution—which the company intends to offer during the next 12 months or so—might make it more accessible for single users, such as patients, as well as for researchers.
