RFID and Smart Packaging in healthcare

Smart Blisterpacks

Data collection at point of use provides accurate information about drug usage and efficacy. Using smart blister packs, each event is recorded and time-stamped. User feed back is collected using an integrated questionnaire panel and answers are linked to medication events and information is rationally and securely exchanged with a host information system.

The increased precision saves time and money and ultimately enhances medication efficacy. The inability to follow drug regimen is instantly distinguished from lack of effect because the collecting of information at the point of use circumvents the problems of poor memory in patients. In addition, accurate information about drug usage is a valuable tool for marketing.

For example, Cypak of Sweden, DDMA of USA, Bang & Olufsen of Denmark and Information Mediary of Canada achieve this with electronic blister packs that monitor when each tablet is removed. Each unit holds a unique identity to allow it to be identified and linked to a database record. Typically the identity and the information are radioed to the physician’s computer from nearby. Each unit is assigned a unique number at the time of manufacturing and the unit identity cannot be altered during the product’s lifecycle.

Case history: Cypak, Sweden

Cypak of Sweden argue as follows that for security applications, it must be possible to authenticate a claimed identity. This can:

• Prevent counterfeiting.
• Prevent identity spoofing – “masquerading”.
• Prevent identity playback.

Such authentication can be performed by challenge-response transaction, secured by advanced encryption, if necessary.

For more general use, a smart package for drugs typically needs to store large amounts of information, the benefits are:

• Local information storage provides product information, without the need to query a database.
• Access to information must be protected from access by an unauthorised individual.
• Information update must be protected and secured in a network environment.

Monitoring its surroundings

The smart package knows about its environment and its state of usage. For example:

• Tamper and damage detection.
• Detection of opening and closing of the packaging.
• Product and/or item removal(s).
• Monitoring of temperature and other environmental parameters.

All events are time-stamped in the case of the Cypak device.

The smart packaging must be able to communicate seamlessly with a host computer system. Specifically:

• Information exchange must be bi-directional.
• Information exchange over the internet needs to be secured with cryptographic functions.
• Storing information in the unit about how to and where to connect enables the information exchange procedure to be automated and very easy to use.

A first conclusion

Cypak argue that these requirements call for a fairly advanced computer circuit embedded into the smart package, with at least a few kilobytes of non-volatile memory for data storage. Cypak offer high security encryption support and the device is fully programmable to be flexible enough to support a broad range of applications.

Whereas Information Mediary and Bang & Olufsen use RFID to download the data, Cypak has a capacitive close proximity system where the antenna can be printed with non-metallic ink at a very low cost. The host transceiver is claimed to be inexpensive. More power can be provided and there is high power efficiency, making it ideal for battery-powered equipment in their view. It has short reading distance but virtually no stray fields.

With the Cypak device, which costs $20 – 30 each from licensee Mead Westvaco in the US, all functionality for a broad range of applications is integrated into a single microchip. Its fully programmable microprocessor gives flexibility for a broad range of applications. It has extremely low power consumption which gives a long operating time using minimal battery power and physical information security is guaranteed.

In fact, the cost of assembly exceeds the cost of the electronics. The electronics is mounted as an adhesive label, in the Cypak version, rather than a circuit board. Integration of electronics is compatible with existing production processes and testing of the final product is optimised.

Case history : Information Mediary, Canada

Information Mediary of Canada reports on its alternative product as follows:

“Med-ic™ ECM™ (Electronic Compliance Monitor™)

Rx for the third millennium™

Information Mediary Corporation’s focus is on the financial and human costs associated with medication non-compliance. This has resulted in the development of the Med-ic™ ECM™, a revolutionary device that provides precise inventory control for blister packaged medication in clinical settings. The Med ic™ ECM™ is integrated seamlessly with the blister package dispensing procedure, adds no bulk to the blister package, and does not require the patient to do anything but dispense the pills from the blister package as usual.

Using state-of-the-art electronics, the Med-ic™ ECM™ records the time each pill or capsule is expelled from the blister package, keeping a record for later analysis. At the time of refilling or follow-up visit, the information is downloaded to the physician’s or pharmacist’s computer or handheld device where it can be displayed graphically. For clinical trials, the data can be stored for later analysis.

The Med-ic™ ECM™ can be tailored to specific clinical requirements such as monitoring the temperature, vibrations, humidity, radiation, light or shock to which the package might be exposed. Visual and auditory reminders can also be added to the device if required. The Med-ic™ ECM™ is environmentally safe, using a non-toxic power cell.

The Med-ic™ ECM™ adapts seamlessly to existing blister package configurations. It requires no specialised tooling or packaging design, allowing for the addition of the Med-ic™ ECM™ to existing medication production runs.

Med-ic™ ECM™ in clinical trials

The Med-ic™ ECM™ is designed to improve clinical trial results by facilitating the acquisition of accurate data on patient compliance with their dosing schedules. The Med-ic™ ECM™ streamlines data acquisition via an easy-to-use contactless reader and encrypted software. Non-compliant patients are identified so that their data will not bias clinical trial results against demonstrating clinical efficacy. The Med-ic™ ECM™ reduces clinical trial cost by eliminating the need for pill counting and medication diaries. Most importantly, however, the Med ic™ ECM™ can help avoid erroneous decisions to abandon or continue clinical trials.

Med-ic™ ECM™ in clinical settings

The Med ic™ ECM™ works in any clinical setting where blister packaged medication is used and where patient compliance is of interest to the clinician. The information available to the physician at the follow-up visit (eg on completion of a course of antibiotic for a infection) will permit rational assessment of the effectiveness of treatment and dictate further treatment strategies. For example, a poor clinical response in a non-compliant patient might discourage a physician from switching antibiotics unnecessarily.

In the case of chronically administered medication (eg for hypertension or migraine prophylaxis), the physician or pharmacist could target remedial education to those patients who are non-compliant.

Med ic™ ECM™ in custom applications

There are many situations where it is desirable to monitor the environmental conditions under which the packaged medication is stored or transported. The Med ic™ ECM™ can be adapted to monitor medication that is temperature, vibration, shock, humidity, radiation or light sensitive. Visual and sound devices can be used to warn of medication expiry dates, time for next dose, and give instructions on what to do about missed doses.

Med ic™ ECM™ in secure applications

The Med ic™ ECM™ is also useful in the prevention of counterfeiting by storing an encrypted unique identification in its memory module. This secure ID can be used to track grey-market activities or unauthorised sale. It can warn of expiration, facilitate recalls and generally provide information of interest from marketing, safety and logistics points of view.

Introducing Med ic™ Certiscan™ Compliance Monitoring Software and the Certiscan™ 13.56 MHz RF reader

Using an onboard CPU embedded in a blister package, Med ic™ ECM™ tags record the time a tablet or capsule is expelled from a blister-packaged wallet of medication, keeping a record for later analysis. At the time of refilling or follow-up visit, the information is downloaded through a 13.56 MHz RF wireless reader to the researcher’s computer where it can be displayed graphically.

Med ic™ Certiscan™ accurately displays the dosing data with an intuitive and easy to read graphic user interface with point and click “drill down” capabilities ranging from daily to annual “at a glance” views of patient compliance data”.

Case history : Bang & Olufsen Medicaid, Denmark

The Danish hifi company Bang & Olufsen has a healthcare division that has developed packaging for patient compliance monitoring. It reports,

“Oral Drug Compliance Devices

Compliance – the growth driver of the decade?

Even the best drugs cannot make any difference if the patients do not take the medication in the right doses at the right time. The topic of ‘compliance’ – also known as ‘adherence’ and ‘concordance’ – has become a key issue due to increasing difficulties of achieving point-of-differentiation and health economic objectives justifying premium pricing and reimbursement. Bang & Olufsen Medicaid offers compliance devices and services suitable for clinical trials as well as an integrated part of marketed drug concepts.

The compliance devices

The compliance devices vary in terms of features, complexity and price level but have intelligent compliance enhancement as a basic common denominator. Further more they are all based on blister packs due to the fact that the pharmaceutical clients want solutions which enhance brand loyalty and reduce competition.
 

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