PharmTech: What challenges still exist in terms of coding and tracing drugs reliably and securely through the global supply chain?

Davison: One key issue for manufacturers is harmonisation of standards. The uncertainty in timing and variation in technical requirements worldwide is adding to the expense faced by manufacturers. Most major manufacturers must plan for multiple legal scenarios. On production lines, which might supply many different geographies, the most onerous coding regime determines the line configuration. An international coding convention would be a major step forward. GS1 standards provide one framework in terms of code formats, but the rules for which transactions need to be recorded and how data are stored and shared also need to be standardised.

Another key issue is ubiquity. How do we ensure that all countries have access to scanning equipment to check for counterfeits at the borders? There is a strong ‘network effect’ in product traceability—that is, the security of the system increases with the number of transactions that are verified. The logic of this approach is that we should involve developing countries in drug-traceability schemes as well as developed economies. In my view, one way to do this is by using mobile phone technology, which can empower billions of patients.

Coding and marking go quite a way towards building and operating a secure global supply chain, but need to be supported by other elements, such as risk assessment and management, to create a safe ‘whole supply chain’ picture.

There also needs to be more investment in technologies that support the coding and marking of drugs. It is ironic that, in most countries, a bottle of water can have more tamper-evident packaging than a £1000-oncology drug. Combining coding and marking with such strategies would be a huge help.

PharmTech: What new authentication technologies and system strategies can help to identify and prevent counterfeits?

Davison: The world is going mobile. It seems logical that this trend should be factored into product security strategies. The pharmaceutical industry still has an obligation to provide a secure supply chain, and there are new ways to enable authentication of codes, such as fingerprinting technologies. The industry must continue to invest in the safety of its supply chain. However, allowing the patient to verify their medicine as an additional last step gives millions of extra eyes and can provide excellent opportunities for data mining to discover patterns of counterfeiting. Consumer verification is proving to be very popular in the developing world. In India, in particular, the approach has been a useful addition to the arsenal of anticounterfeiting approaches. There are no easy answers to counterfeiting. It requires multiple layers of defence, concerted action by industry and constant vigilance by consumers.

Stobie: There are a handful of new authentication technologies and system strategies that can help to identify and prevent counterfeit medicines. A key one is mass serialisation. Although this technology comes with the associated challenge of reliable authentication, it can be highly effective in terms of offering producer to patient traceability and pinpointing risks. Other strategies that can help identify and prevent counterfeits are the inclusion of digital signatures, asymmetric encryption and covert features, which can be verified with a mobile phone.

Note

1. On Feb. 14, 2012, the media reported that counterfeit versions of Roche’s multibillion cancer drug, Avastin (bevacizumab 400mg/16mL), had been distributed in the United States.

Blue Sphere Health is a consultancy based in the United Kingdom, with a focus on global healthcare, pharmaceutical security, patient safety and anticounterfeiting. Domino Printing Sciences, a company specialised in coding, marking and printing technologies, formed an internal task force in 2011, dedicated to helping pharmaceutical manufactures comply with the new European Union’s Falsified Medicines Directive (FMD) that member states must begin implementing in Jan. 2, 2013.