Is It Really Vital?

By Narendra Srivatsa, Business Development Manager, Brand Authentication, New Jersey Packaging

Product security in pharmaceuticals has been a much discussed topic in recent years. Several issues have come to the forefront of this discussion including FDA mandates, we are not affected (WANA) syndrome leading to disastrous consequences when it happens, privacy when using RFID etc. This article examines the several options available to the industry, some of the things which may need to change before the industry addresses this issue in a very aggressive manner. Definitely it will take us to a safer place knowing that the drugs we do take have nothing other than their benefits and associated "side-effects". It is all about helping people lead healthier lives.

Patient safety is a key driver in the pharmaceutical business. An important element in assuring patient safety is making sure that the patient receives the genuine product and not a counterfeit drug. Given this enormous importance, it is interesting to see that pharmaceutical manufacturers are still looking at product security as cost of goods sold and struggling with value from this. This is especially intriguing given that the additional costs involved with the array of security arsenal available to the manufacturers are in the "noise" level of the final product price. However, the industry has distracted itself by focusing on RFID, through FDA discussions and claims of a high tech solution for track and trace. The benefits of RFID can be realized only when the supply chain is enabled to provide full electronic track and trace capabilities. While the whole area of RFID implementation is getting sorted out, patient safety through counterfeit products still remains a significant threat.

When we look at the array of security arsenal available to manufacturers then we begin to understand quickly there are a number of low cost options which provide higher benefits than the current option of doing nothing. For example " a color shift" option provides the consumer with a visible security or a taggant provides a nice covert feature. Alternately serialization provides a low cost track and trace security option capable of additional benefits of collecting market data and lowering distribution costs. The benefits of including many of these options in existing graphics is tremendous.

Different Options

A look at the various technology options 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, anti-counterfeiting 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 be embodied with covert capabilities, which help provide track and trace, as in RFID and other technologies. RFID is both overt and covert.

They include:
Holography - Featuring specialized coating technologies, holography for pharmaceutical companies can be embedded images that can include messages, barcodes, photographs, and more.
Serialization - Serialization with 2D barcodes appears to be gaining acceptance. Random serialization, RSS, includes such pertinent information as lot code and expiration date, and fill service with data management and additional functions. Provides human readable code and capability for verification through online or telephone systems.
Color Shift - Unique colors are available that can be assigned to individual companies and can be used to track diversion.
Tamper Evident - Frangible materials that leave behind a specific message on the package. Patterned adhesives are also available.

Locus of Change

What will force the change on this industry? A headline event like the e-coli scare or other? Or the realization that many of these security options can be tailored to provide manufacturing cost efficiencies higher than the cost for including the security features. Several things need to happen:

1) The industry should stop looking towards the FDA for a mandate on product security. While they are waiting, counterfeiters are actively seizing market share from them.
2) The industry needs to get pro-active at lowering drug costs to the consumer by evaluating it's distributions models. Simplification of distribution models will allow for increased profits and improved patient safety, while keeping drug manufacturing in the US.
3) Don't get distracted by RFID as the cure-all for product authentication. Start RFID evaluation with the right business rules and objective in a manageable pilot and move it across other product lines. In the meantime, use many of the high touch solutions available to increase your market share and patient safety.
4) The different Pedigree laws at the state level demonstrate that track and trace is important for promoting patient safety.
5) RFID for asset management in hospitals and patient ID should continue at a rapid pace as these impact both costs and patient safety.

Patient safety and the adoption of track and trace/anti-counterfeiting will increase significantly if the industry adopts a simpler supply chain 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.

It is time for pharmaceutical manufacturers to do more with the available track and trace/anti-counterfeiting technologies in promoting patient safety before one of their brands shows up in the headlines and they have to fight to save it and their reputation. The business process of delivering drugs to the consumer will change in time to make it a safer and secure chain for all of us.

Patient safety through product security solutions is a high touch option and does not have to be high cost. By promoting the company and the brand as offering security to protect the consumer, one is only showing the high touch. There are numerous options available today to implement product security successfully and make more profits. Let us look forward to the industry taking a more pro-active stance, instead of waiting for a disaster to wake us all up.

About the Author:

As Business Development Manager, Brand Authentication for New Jersey Packaging, Dr, Srivatsa is responsible for developing and marketing the company's comprehensive package of anti-counterfeiting and anti-fraud offerings. Prior to joining New Jersey Packaging, he spent 15 years in a number of different key roles at International Paper, helping to create new products and markets. He holds a Ph.D. in Chemical Engineering from SUNY at Buffalo and an undergraduate degree of Bachelor of Technology in Chemical Engineering from I.I.T. Madras, India.