Narendra R. Srivatsa

Business Development Manager

NEW JERSEY PACKAGING_Brand Protection

Anti-Counterfeiting—Is it Technology Driven or Business Process Driven?

The reports of counterfeiting seem to be on the increase, with no let down in sight. And while there are a number of effective technologies that address diversion and counterfeiting, their adoption rate appears to be very slow. Even FDA recognized this and convened another workshop on RFID and anti-counterfeiting in February to address the lack of appreciable progress.

Why are drug manufacturers willing to invest so much in developing products, yet hesitating to invest in protecting themselves and ensuring patient safety? Aren’t these companies leaving themselves open to significant liability by not adopting any anti-counterfeit measures that would provide layers for patient safety?

If we were to examine the drivers for anti-counterfeiting, we would find significant business value through the goals of patient safety, brand protection, differentiation, and supplychain efficiencies.

SUPPLY-CHAIN CHALLENGES

A look at the pharmaceutical supply chain shows a surprising number of opportunities for counterfeiters. Yet, many pharmaceutical companies appear to be doing little to thwart this. Such inaction could imply that pharmaceutical manufacturers believe that they have little influence over the supply chain or that they do not have any responsibility for the product.

One significant challenge in the existing supply chain is that the product moves through many different hands and at many different times in a circuitous path to the consumer. Figure 1 outlines the current supply chain, in which the manufacturer has to be able to get the data out of a very convoluted chain, analyze the information, and train its system with responses that work to deal with diversion or anti-counterfeiting. This chain could be referred to as the SMART approach. However, without clear identification of who has the product, where it is going next, and who owns the data, accessing the product and tracking it using the SMART approach can be a challenge.

The key step in the SMART approach is to secure the data — but this can be a significant issue if you do not know where your product is in the distribution chain. Once you get the data, then you need to manage the data in your system by integrating them into your IT and business processes. You would also need to define who in the supply chain has access to the data during this process. The analysis of the data against business rules tracking product diversion and counterfeiting becomes important, as these rules help determine the response required. The response could be a discussion with the supply-chain location or going after the counterfeiter. Once we have done the analysis and the response required, we need to train the system to become SMART so that it adapts to implement the response quickly. Additional issues in this SMART process are the ownership of the data, system integration to all the links in the distribution chain, and the transparency of information.

Additionally, the product morphs through the supply chain in different package forms as it gets repackaged and is finally delivered to the consumer. This is one area where unit-dose packaging may provide significant gains at some cost, as the product will at least remain in the original package form and with embedded tracking and anticounterfeiting features. The U.S. pharmaceutical industry remains far behind Europe in the adoption of unit-dose packaging.

However, unit-dose packaging itself may not be enough, and the supply chain will have to be simplified. If a manufacturer has one of the many simpler forms of supplying the drug product directly or with fewer intermediate steps to the consumer as outlined in Figure 2, the ability to track the product and embed it with features that would provide useful data back to the system will be easy and the SMART system of managing the supply chain will be more effective. This could lower the drug product costs to the consumer.

AUTHENTICATION ALTERNATIVES

A look at the various technology options listed below and referred to in Figure 2 reveals that in addition to RFID, there are a number of anti-counterfeiting and anti-fraud products available today that offer a wide range of reliable options for brand protection. These products make use of the latest technology in anti-diversion, anticounterfeiting, and anti-fraud printing methods to provide durable, easy-to-apply, and relatively affordable ways to guard against pharmaceutical product fraud and maintain consumer confidence and safety.

Overt features offer significant value in that consumers are able to see that security steps are being included by the manufacturer. Many of the overt features can employ covert capabilities, which help provide track and trace, as in RFID and other technologies.

These features include:

Holography. Featuring specialized coating technologies, holography for pharmaceutical companies can be embedded images that can include messages, bar codes, photographs, and more.

Serialization. Random serialization and Reduced Space Symbology include such pertinent information as lot code and expiration date as well as fill service with data management and additional functions. Senalization also provides human-readable codes and the capability for verification through on-line or phone-in systems.

Color Shift. Unique colors are available that can be assigned to individual companies and can be used to track diversion. Tamper Evidence. Frangible materials can leave behind a signature code on the package. Patterned adhesives are also available.

Patient safety and the adoption of track-and-trace and anticounterfeiting initiatives will increase significantly if the industry adopts a simpler supplychain process. This can also reduce drug costs to the consumer, as the product will move through fewer hands before it gets to the end-user. Technical solutions through packaging and data management systems are available today to provide the necessary means to track a product. Anti-counterfeiting adoption provides a significant incentive for manufacturers to understand how their product moves through the supply chain to gain better control of their product being dispensed reliably.

However, the will of the industry has to change before a Wal-Mart-sized drug product distribution company emerges to provide improved patient safety at lower cost — a compelling value proposition.

It is time for pharmaceutical manufacturers to do more with the available track-and-trace and anti-counterfeiting technologies to promote patient safety. They should do so before one of their own brands shows up in the headlines and they are left to fight to save it and their reputation. The business process of delivering drugs to the consumer should change in time to make it a safe and secure chain for all of us.