Applying Anti-Counterfeit Devices Is Only Part of the Solution

Are more counterfeit drugs entering the pharmaceutical supply chain? Unfortunately, yes. In 2004, the FDA’s Office of Criminal Investigations (OCI) saw a 93% increase in the number of counterfeit drug cases compared to the previous year¹. Therefore, given the obvious threat to the security of the pharmaceutical supply chain, applying anti-counterfeiting devices to pharmaceutical packaging is clearly no longer an option. But, which devices are the preferred choice, and will adding anti-counterfeiting devices onto pharmaceutical products really warrant the time and money over the long term? According to changes to state laws (active and pending) and according to the FDA’s notice of enforcement of its long dormant Prescription Drug Marketing Act by the end of 2006, it seems that the choices have already been made.

Closeup of Counterfeit and Genuine Pills

According to the FDA’s final report on combating counterfeit drugs issued Feb. 18, 2004, it was concluded that RFID technology represents the “single most powerful tool available to secure the U.S. drug supply.” Hence, the FDA is urging widespread use of RFID tags on pharmaceuticals by the end of 2007. Furthermore, three states have prescription pedigree laws and 15 have similar legislation in their respective pipelines (Florida’s pedigree law came into effect in July 2006), all geared towards securing the U.S. drug supply chain.

The pedigree system will involve the recording of a series of product authentications at each trade of the product once it has left the manufacturer. The electronic version of these pedigrees will essentially become a series of authentication steps electronically recorded in a database. Furthermore, the PhRMA believes that the goal of real-time authentication of products at dispersing sites can be accomplished in the near term by using mass serialization and other available technologies. What does that mean for companies? It means that companies should be seriously looking at implementing the use of RFID tags and product serialization.

Of course, implementing the use of RFID tags and product serialization, only represents part of the solution. Once a device is present, it must be inspected and verified so that it will serve its purpose effectively and efficiently (ie., ensure that it will be read and/or be displayed correctly), all the way through the supply chain and records concerning its inspection must be made available so that a complete view of a product’s pedigree is always accessible. Furthermore, according to the FDA’s Compliance Policy Guide for Radio Frequency Identification Feasibility Studies & Pilot Programs for Drugs, dated November 2004:

Therefore, the use of any one device on its own will simply not be sufficient.

Then there is the additional information that is also present on a product’s label such as a bar code (if applicable), human readable information such as lot number and expiration date and any additional security features such holograms, special inks, and etc. Of course, these will also have to be verified, and in the case of bar codes, these should be also graded. And finally, all of these inspections should be carried out on-line without compromising packaging line speeds.

Therefore, once a company has moved towards the incorporation of anti-counterfeit devices product verifications may include:

• Serialized code verification
• RFID tag inspection and verification
• Bar code verification and grading
• OCV/OCR of codes
• Verification and inspection of all other essential components (label placement, cap presence, insert presence and positioning, etc.).

Furthermore, vision inspection systems providing these inspections and verifications must be able to provide 100% on-line inspection of all of these components 100% all of the time with no impact to line speeds, provide all of the inspection data in the required electronic format and be able to interface with databases.

It is evident that as companies move towards the use of anti-counterfeiting devices such as serialized bar codes and RFID tags, the pharmaceutical supply chain will become tighter and tighter, and this will bring about more numerous and more complex packaging component verifications and inspections. This in turn will put more emphasis on the need for highly accurate, flexible vision inspection.

At Optel Vision we take a proactive approach to meeting the challenges of this industry through the constant development of new vision inspection applications because we are committed to ensuring that only safe, authentic pharmaceutical products enter the supply chain.

¹ FDA, Combating Counterfeit Drugs: A Report of the Food and Drug Administration Annual Update, May 18, 2005.