Only a cross-functional and integrated approach can be successful in defeating counterfeiting and fraud, as well as the diversion of pharmaceutical products.
The fight against counterfeiting, tampering and diversion of pharmaceuticals is a global and complex challenge. No doubt, the traditional definition of drug safety has acquired the additional dimension of drug security-or more precisely, security of the supply chain and custody of the chain. But consumers, accustomed to their governments protecting them from "unsafe" drugs, for example, by requiring pharmaceutical manufacturers to perform exhaustive lab research as well as large-scale and costly clinical trials prior to approving a new drug, now also need to be sensitised to the fact that "only an authentic drug can be considered a safe drug."
Only a cross-functional and integrated approach can be successful in defeating counterfeiting and fraud as well as the diversion of pharmaceutical products. The use of security technologies in packaging does not prevent counterfeiting. Instead, it primarily supports product authentication, provides an indication of a drug's purity and allows the supply chain to be tracked. This enables pharmaceutical companies to raise the hurdle for criminals and to protect their most valuable assets: customer health, confidence and satisfaction.
Forensic taggants describe covert, in other words invisible, security features that can be authenticated only by advanced reading systems or laboratory analysis. Nanoparticles may be embedded in packaging substrates or prints. These taggants generally consist of inert materials, very thin aluminium particles or rare particles with a size of 20 - 40 micrometre or even smaller. The taggants carry customer-specific colour codes, engravings or maybe mixed in a special way so that they can be uniquely identified.
DNA markers are usually printed in a defined area. Based on the key-and-lock system a second testing liquid is used to prove the authenticity of the product. When the customised DNA pen applies the identifying liquid substance on the printed area either a colour change or luminescent reaction proves the authenticity.
Only if target groups (experts who dispense and/or administer drugs or customs inspectors) are able to easily authenticate the original product, can the use of authenticity features produce the desired effects. The protection level of security features is contingent upon their limited availability, the combination of different security attributes and easy education of the target group responsible for authenticating the product.
Obviously, the organisational and financial resources required for the integration of a security system play a key role. Security technology should have a reasonable relationship to the costs of the product as well as to the costs of packaging and distribution. The ideal security technology can be easily integrated into Standard Operating Procedures (SOPs) without any additional effort. A flexible system allows an individual adaptation and upgrade of the level of security in accordance with the threat posed by counterfeiters.
Experts opine that anti-counterfeiting security solutions must be based on the "best practices" of a "layered approach". At the first level of security are relatively simple, overt features involving the use of holographic technology and colour-shifting effects that are primarily intended to enable product authentication by non-experts such as healthcare professionals, pharmacists and consumers. At the next level, i.e. in the area of covert security features, there is a wealth of highly sophisticated technology available, including nano-sized taggants or chemical markers, and even DNA-based solutions.
For the dedicated target group of manufacturer specialists, forensic security features such as spectral fingerprints and molecular recognition markers may allow authentication by laboratory analysis. These features can be combined with each other as well as with simpler, overt features. The intelligent combination of such technologies can result in highly secure solutions. Key to their effectiveness is a careful analysis of the pharmaceutical manufacturer's security requirements by an experienced security technology expert who then develops an integrated, tailor-made solution that best meets the needs of the client.
While protecting the packaging with authentication devices the security for the patient can only be provided if the packaging indicates the integrity and purity of the product. In order to prevent form exchange or modification of the content, tamper-evident packaging seals may incorporate anti-copying devices such as transparent holograms, colour-shift or individual void effects in order to enhance product security.
Technology providers have developed a wide variety of sophisticated features, but to ensure their viability, it is of high importance to consult with packaging system integrators who have extensive experience in evaluating security technologies as well as in the area of GMP-driven integration of such technologies into packaging. Choosing the right security features is not a question of technical sophistication. In addition, ease of integration into existing pharmaceutical SOPS, implementation of specifications and validation of packaging processes are essential requirements. Understanding the threats of diversion and trafficking of products, it becomes clear that the implementation of security technologies demands reliable management and monitoring processes and practices-from data handling, sourcing, manufacturing, warehousing and all the way to transportation. Additionally, the implementation of a strategy needs to be supported by appropriate training and / or marketing tools to inform the target group performing the authentication of the product.
The EFPIA serialisation concept aims to establish a common standard for product coding in Europe (rather than having 27 different national code systems) and to increase traceability across the supply chain. The EFPIA code will use a Data Matrix based on the EAN.UCC (GS1) standard using an international syntax. The code is very robust in reading and can be applied with rather little extra costs by variable printing technologies. The use of a Data matrix will be mandatory in France by 1st January 2011. The system proposed by EFPIA is intended to be an end-to-end product verification process at the point-of-dispensing. A Pharmaceutical Interchange Logistics Link Database will allow security checks (e.g. for customs) and also allow reimbursement data for governmental tax surveillance programs. The data segregation will be handled by a central database system, generated by the manufacturer, linking back to the respective company database. The system requires that the pharmaceutical manufacturer installs adequate printing systems within their packaging lines whereas the pharmacies need to be equipped with 2D barcode readers. As a next step a pilot trial will be conducted in one European country in cooperation with key stakeholders by end of 2008. The small scale experiment should take place on a regional level with approximately 200 pharmacies with 1 million packs. It will not provide any reimbursement feature at this stage but should test the technical implications before a full European roll-out program is installed.
The complex, world-spanning supply chains and the increasing number of cross-border internet sales of pharmaceutical products that facilitate the introduction of fakes, or product packaging that is easy to copy or tamper with, require more and more sophisticated tools to monitor the distribution chains.
In addition to the physical anti-tampering security of product packaging, the traceability of drugs is a vital element in securing the pharmaceutical supply chain. The US Food and Drug Administration (FDA) currently requires a bar code identifier of the manufacturer and product on "the lowest level of packaging" for prescription drugs. In 2004 the FDA released a Counterfeit Drug Task Force Report and suggested a multi-layered approach to secure products and packaging by using appropriate technology and the serialisation of products to monitor the movement of drugs through the supply chain. While the FDA issues a pedigree statement documenting each sale or transaction of the product, in reality the US Federal law states that only wholesalers, who are not officially examined, need to pass a pedigree.
The use of Data Matrix was recommended by The European Federation of Pharmaceutical Industries and Associations (EFPIA) to establish a single European symbology for medications as an anti-counterfeiting measure and also for identification purposes. GIRP - the Association of Pharmaceutical Full-Line Wholesalers has also recommended the use of a Data Matrix code.
At the Global Forum of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of the WHO in February in Singapore the participants from international regulatory authorities and manufacturers recommended a global standardisation and serialisation syntax including country code, issuing authorities, manufacturer's product code and a unique serial number.
Today, some manufacturers already use encrypted serial codes to allow authentication of their medical products anywhere in the world via the Internet. For this application each product carries a unique and highly complex security code. The consumer or dispensing person enters the printed code on the brand owner's website or calls a hotline. If a true code is entered, the system confirms the authenticity, while a false code-suggesting the presence of a fake product-will prompt a warning message on the screen. The system logs each product query and rejects multiple entries of the same code at pre-defined levels. Should unauthorised multiple queries be made, this would clearly indicate trafficking of fake pharmaceuticals.
Securing the pharmaceutical supply chain and products is a challenging task. As varied as the threat itself are the means available to provide protection-for the consumer as well as the manufacturer. The key to a successful security strategy is a careful risk analysis, followed by the cross-functional development and implementation of an integrated anti-counterfeiting strategy.
The implementation of an efficient technological anti-counterfeiting strategy requires the following three principles:
1. The use of tamper-evidence packaging all products in order to guarantee the integrity of the packaging content.
2. An individual choice of overt, covert and forensic authentication features, such as colour-shifting inks, holograms, taggants should secure for high risk products.
3. The introduction of a harmonised and standardised serialisation coding system will allow a comprehensive surveillance of the pharmaceutical distribution chain.
The implementation of authentication technologies by specialised and security certified system integrators and packaging specialists leverage the best techniques and technologies currently available to deter, detect and avoid the criminal practices that jeopardise human lives and erode legitimate earnings.