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Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.
Protecting patients from counterfeit medicines is a pressing issue facing governments and the pharmaceutical industry.
Protecting patients from counterfeit medicines is a pressing issue facing governments and the pharmaceutical industry. According to a review published in March 2012 in the International Journal of Clinical Practice, the global sales of counterfeit medicines were estimated at more than $75 billion, having doubled between 2005 and 2010 (1). The rapid globalization of the pharmaceutical industry, an increasingly complex supply chain on a raw material and ingredient level, and more difficult-to-control sales channels, such as the Internet, have contributed to the challenge on how to better secure the pharmaceutical supply chain. According to the World Health Organization (WHO), one out of two pharmaceutical products purchased through the Internet is a counterfeit (2).
The EU Falsified Medicines Directive (FMD) that came into effect in January 2013 was designed to enhance the security of the pharmaceutical supply chain through a range of measures, including the use of anticounterfeiting technologies that enable identification, authentication, and traceability of medicines. “The key to increasing supply-chain security to better protect patients is the identification of each unit of packaging,” says Craig Stobie, global life-science sector manager of Domino Printing Science. “Counterfeiting thrives on the fact that items are indistinguishable from one another. Introducing a unique identity to every traded package allows you to confirm the package’s identity, provenance, history, movements, and distribution touch points; however, this only works if the identity is visible and readable throughout the lifespan of the packaging.” Anticounterfeiting technologies are categorized into overt and covert security features, forensic techniques as well as serialization and track-and-trace technologies.
Overt and covert
Overt (visible) features, such as holograms, optically variable devices, color-shifting security inks and films, security graphics, and sequential product numbering, enable end users to verify the authenticity of a pack. For them to be effective, however, public education and awareness are needed, which can be a challenge, particularly in developing markets. Moreover, there is the possibility of overt features being mimicked, reused, or refilled by counterfeits.
Covert (invisible) features, on the other hand, are designed to enable the brand owner to identify counterfeit products. Examples include invisible printing on primary or secondary packaging using special inks that can only be seen under ultraviolet (UV) or infrared (IR) light, digital watermarks that can only be decoded using special software programs, and laser coding to produce recognizable artifacts that are difficult to copy. Although valuable as investigative tools, covert features can still be copied by counterfeiters, especially those that are simpler.
Companies, such as Domino Printing Sciences, SICPA, and Payne Security, provide a range of overt and covert ink-based solutions, and when coupled with serialization, such strategies are not viable for counterfeiters to copy.
Forensic markers, a subset of covert technologies, rely on chemical and biological parameters and require laboratory testing or dedicated field test kits to scientifically prove authenticity. For instance, chemical taggants can only be detected by highly specific reagent systems and not by common analytical methods while biological taggants are incorporated into formulations and coatings at such low levels in the parts-per-million range or lower, that they are undetectable by conventional analysis and require specific “lock-and-key” reagent kits to authenticate. Microtaggants are microscopic coded information applied on or in the packaging, such as alphanumeric data depicted on small flakes or threads, or fragments of multicolored multilayered laminates with a signature color combination. Microtrace offers taggant technologies that can be uniquely encoded in liquids or on solid materials, and like fingerprints, these microtaggants are virtually impossible to duplicate.
Another forensic marker is isotope ratios, which can provide a natural fingerprint because they are highly characteristic of the identity of a compound and can be accurately determined by laser fluorescence or nuclear magnetic resonance techniques. While forensic technologies are advantageous in that they offer high security against counterfeiting, these licensed technologies are usually limited, costly, difficult to implement, and therefore, unlikely to be available to government authorities or the public.
Serialization and track and trace
As one of the most important anticounterfeiting strategies emerging in recent guidelines and legislations, serialization and track-and-trace technologies, such as two-dimensional (2D) data matrix codes and radio-frequency identity (RFID) tagging, enable products to be tracked through the supply chain, thereby providing traceability of an item. Track and trace involve assigning each product with a unique identifying code during manufacture, which remains with the product through the supply chain until consumption by the patient. It contains details of product name and strength, batch/lot numbers, and expiry date. Although track-and-trace labels can be copied or falsified by counterfeiters, security is further enhanced by the inclusion of distinct and random serialization, or nonsequential numbering, attributed to the individual package. The unique identifying code with its assigned serialization number is activated, validated, and entered into a central database that can be used to identify any duplicates, invalid serials, recalled or expired products, and products appearing in the wrong market. In 2014, a new EU serialization law will be introduced as part of the FMD to harmonize the coding of pharmaceutical products on an international level and manufacturers will be required to implement serialization systems.
Counterfeit medicines continue to be on the rise and “drug companies must maintain good reputations and act to protect their revenues,” observed Peter Williamson, pharmaceutical analyst at the business-information firm Visiongain, in an Oct. 29, 2012, press release. With a wide range of technology solutions available, manufacturers can use a combination of different technologies to form a multilayer approach for the best possible patient protection. For example, by combining tamper-evident features, serialization, and authentication technologies, manufacturers can create several layers of security for their pharmaceutical products. “The key to supply-chain security lies in the successful introduction of industry-wide standards worldwide,” Williamson said. “Cooperation and cohesion between regulatory authorities and manufactures must improve. Also, increasing public awareness will help fight against drug counterfeiters.”
1. G. Jackson, S. Patel, and S. Khan, Int. J. Clin. Pract. 66 (3) 241–250 (2012).
2. WHO, “Medicines: Spurious/Falsely-labelled/ Falsified/Counterfeit (SFFC) Medicines,” WHO website, accessed Jan. 15, 2013.