RFID is emerging as an ideal way to protect consumers and drug companies from counterfeit drugs.

by Sushil Bhatia

One of the biggest concerns of the drug companies is the presence of counterfeit and spurious drugs in the marketplace by unscrupulous companies. Counterfeit drugs in the global supply chain cost the pharmaceutical industry between $50 and $100 million annually per company in lost revenue and brand reputation damage, and present potentially serious risks to patients in need of the actual prescribed medication.

The number of counterfeit drug investigations by the United States Food and Drug Administration (FDA) has quadrupled since 2000. In February, it issued a report “Combating Counterfeit Drugs.”

Until now, preventing the distribution of counterfeit drugs by providing accurate drug pedigrees has been complex and expensive for the pharmaceutical industry. The scale is mind-boggling: Wholesale distributors typically carry more than 40,000 drug stock keeping units to supply some 55,000 pharmacies that fill more than 3 billion prescriptions annually.

Counterfeit drugs don’t just create a patient safety issue, they are also a serious business problem. In addition to cheating drug companies of legitimate revenues, they can potentially harm firms’ brands and image. By maximizing brand security within the proposed FDA timeline, the pharmaceutical industry can meet its obligations and achieve significant return on investment, as well as improvements in efficiency and accuracy.

Existing Responses
Industry has responded to the threat posed by counterfeit drugs by offering different forms of package and label printing, software and hardware. The approaches have also included newer technologies like holographs, specialty watermarks, pedigree software, barcodes, color changing inks, embedded chips, threads and multi-layer labels, tear-resistant labels, line matching labels and many other innovative forms of packaging and printing of inserts.

Further, given their importance in patient safety, the printing of inserts, directions, etc. must be carried out in a secure environment, which should be as safe as printing of currency.

Like counterfeit currency, the spurious drug manufacturers are always trying to stay one step ahead of the game. They can afford to invest in newer technologies since they do not invest heavy amounts of R&D money into developing new drugs and getting them through the FDA maze for approval. As a result, the unscrupulous drug manufacturers catch up with these techniques very quickly. Consequently, there is need always to find newer ways to overcome that menace.

Secure Suppliers
To cope with this challenge, pharmaceutical firms are looking for suppliers who can print secure labels, inserts, outserts and other packaging-related materials. Such suppliers need to be trustworthy firms capable of serving as a dependable source of supply. In addition to companies, they are also looking for technologies that can guarantee the anti-counterfeiting measure.

In addition to what is available so far, one of the newly identified technologies which has been around for several years but has come into prominence more recently is RFID technology for bulk and individual item packaging.

RFID technology allows pharmaceutical companies to pilot their drug pedigree authentication programs. RFID is, fundamentally, a track-and-trace technology that can automate and streamline the collection of information about individual products and provide access to historical data as they move through the supply chain.

RFID centers can be set up utilizing proven hardware and software to enable pharmaceutical companies to create individualized solutions for combating drug counterfeiting in compliance with the recommendations of the FDA.

Automating drug tracking and pedigree management improves drug security and helps contain costs. Companies using software and testing methods will gain improvements in supply chain operations including accuracy, improved drug availability, reduced inventory costs, less product loss due to expiration and reduced labor costs.

To get involved in this area of RFID technology and to use it for brand authentication, it is necessary that companies have expertise in or access to following processes, technologies and issues:

• Packaging – materials and design
• Package printing and converting
• Knowledge of inks, adhesives
• Methods of application of printing and application of labels
• Labels of all kinds, e.g., pressure-sensitive, heat laminating, thermal transfer
• Environmental issues
• Nature of materials like papers, plastics, laminates
• Hardware, software and middleware

How can companies go about that? They can:

• Recruit or add to in-house expertise
• Bring in senior personnel in leadership positions with appropriate expertise in these fields
• Reach out and create alliances with the vendors and technology providers in the areas of package and label printing, software, hardware and middleware.
• Co-ordinate all the activities through an in-house expert
• Interact on a regular basis with the customers, others in the supply chain (wholesalers, retailers) and vendors
• Keep track of newer technologies as they become available and see how they apply to this particular area of concern to the pharmaceutical industry.
• Add software and middleware suitable for anti-counterfeiting of drugs
• Add other printing / packaging methods to expand authentication process like holographic printing, 3D printing and temperature-sensitive inks, UV invisible inks

The choice of technology will come from interaction with customers and what they want.

As the demographics shift and an aging population becomes more and more dependent on drugs for health and well being, it is necessary that safe and authentic drugs are provided to them. Though the same approach also applies to people of all ages, the significance is much greater with the elderly population because of its dependence on authentic medicines. Not only do they often face cash constraints, they must frequently cope with serious ailments where a spurious drug can wreak havoc with their health.

JMD Manufacturing, product ID specialists in Framingham, MA believes strongly that RFID technology is the best solution to fight counterfeit drugs. As a result, JMD has created alliances with other technology providers and is in the process of setting up an independent center for evaluation and testing. This center will test and evaluate RFID systems and will be equipped to demonstrate EPC Class 1 tags at 915 MHz.

The center was started because early RFID activities in supply chain applications have revealed a general need to understand and address many issues beyond the technical aspects of reader and tag specifications. The RFID center personnel and resources will be able to construct and evaluate specific application situations. The center provides hands-on experiences with readers, tags, antennas, PCs, products, and packaging.

Among the issues that pharmaceutical firms and their suppliers will be able to test at the center are:

1. RFID tag placement on products and packaging.
2. Interference effects from products and packaging materials.
3. Reading challenges introduced by the local environment, material handling equipment, wireless communications systems, people and even other tags.
4. Reader antenna quantities, placement and directional sensitivity related to products, motion and environment.
5. Tag reading techniques, timing and verification
6. Reader options, setup parameters and setup tools.
7. Tag reading metrics and methods.
8. Tag programming.

Through joint efforts by JMD, other technology suppliers and members of the pharmaceutical industry, we can minimize — if not eliminate — the threats posed by counterfeit drugs. And, a wonderful side effect is that the improvement in supply chain efficiency will help control costs and benefit both suppliers and consumers. Now that’s pain relief.

Dr. Sushil Bhatia is president of JMD Manufacturing, located in Framingham, MA. JMD provides knowledge base solutions for product identification, Auto-ID and RFID applications. JMD has been serving vertical industries including pharmaceuticals, food and beverage and HBA for over a decade with its marking and coding equipment and supplies, including inks, fonts, batch coders and label dispensers. Visit www.jmdmfg.com or call 1-800-752-5563.