PharmoRx brings counterfeit detection to the masses

US company PharmoRx has developed an application for Apple's iPhone that could allow patients to check if their medicines are authentic simply by taking a photo of the barcode or inputting a human-readable code.

The system is still being refined but once implemented could provide an unprecedented direct communication conduit between drugmakers and consumers of their products.

The iPhone app had its first public airing at the Brand Protection Show in London, UK, earlier this month, and SecuringPharma.com caught up with Steve Wood, PharmoRx' chief executive for a hands-on demonstration of the system.

The app complements PharmoRx' AuthentiTrack system, which provides an end-to-end solution for drug and medical device companies covering product serialisation, track-and-trace and authentication technology at all levels down to the unit dose level.

In AuthentiTrack, products are identified using imaging techniques and/or human-readable and machine-readable codes printed using a range of regular and specialty inks. Printing technologies are supplied by PharmoRx' partner MSO, while specialty inks and taggants come from a collaboration with Sun Chemical. Track-and-trace data is stored on PharmoRx' secure servers and authentication takes place using a range of scanning devices.

The new iPhone app - dubbed Brand Loyalty and Integrity Service (BLIS) - is an addition to PharmoRx authentication technologies, and can be used by any link in the supply chain, right through to the patient. It allows an iPhone to be used to scan a code, which contains a unique serial number, lot and expiration date of the product.

Once the code is scanned, the app checks it against PharmoRx' database via the cellular network. If the code is authentic, the patient receives a message back, displayed on the app's dashboard, indicating the name of the product and the brand integrity code. It can even log the location of the user via the iPhone's GPS, and be used to deliver information.

For example, it could provide reassurance to patients if the appearance of a product has changed, give a promotional code for a discount on future purchases, or give instructions on what to do in the event of a lot recall.

BLIS can also be used using any touch-tone phone or via the Internet by tapping in a human-readable code.

"Using this new system, the brand owner will benefit because he will know where the product has been, which is good for security, but it also allows the pharmaceutical company to establish a link directly to the consumer, something which they've never had before because the distributors maintain that valuable information in-house" said Wood.

Adding GPS location raises some issues regarding patient confidentiality, but Wood stressed that the system makes use of an anonymous user identification code only, and does not request or store any personal information.

Of course the information exchange could also work the other way. It is entirely feasible for the system to allow the user to report information to the pharmaceutical manufacturer, which could for example allow early pick-up of an emerging adverse reaction problem.

"This kind of two-way dialogue could allow pharmaceutical companies to really engage with their customers and encourage brand loyalty," said Wood.

PharmoRx is showcasing the BLIS technology to pharmaceutical companies, and believes it could find a receptive audience among drugmakers who are required by the FDA to prepare a risk evaluation and mitigation strategy (REMS) submission to indicate how they will maximise patient safety and minimize the risk of product diversion and abuse.

Earlier this week the FDA issued draft guidance on REMS to ensure the safe use of certain drug and biologic products, such as opioid analgesics.

REMS cover a plethora of initiatives, including medication guides, patient package inserts, a communication plan for health care providers and elements to ensure safe use including requirements for those who prescribe, dispense, or use the drug.

PharmoRx believes a patient-oriented application such as BLIS could play a key role in that context.

SecuringPharma.com will explore the impact of REMS and the growth in direct distribution of pharmaceuticals from manufacturer to patient in the USA in a subsequent edition of our newsletter.


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