Issue link: https://www.e-digitaleditions.com/i/1112785
10 May 2019 Tablets & Capsules ization. To meet the FDA's new requirements, many companies began pilot tests using cameras to track pack- ages with an embedded code, enabling traceability. However, without established industry standards to fol- low, companies have struggled to create a system. To address this hurdle, the FDA continues to work to imple- ment other provisions of the DSCSA to serve as addi- tional guidelines for serialization, but validation exercises could take months or even years, and the resulting solu- tions may not enable consumers to easily verify product authenticity in the way that blockchain could. Rick Fox, president and chief executive officer, Fox IV Technologies: The appeal of blockchain lies in the creation of a trusted network resting on a cloud-based environment that is nearly impossible to hack. Many companies pursuing higher supply-chain security struggle to reach that standard. In fact, in 2017, only 15 percent of pharmaceutical manufacturers in Europe reported that they would be able to implement an appropriate serializa- tion process by the deadline mandated in the EU Falsified Medicines Directive [1]. Some companies addressed the supply-chain security problem by developing proprietary internal systems to combat counterfeiting. However, such systems are still susceptible to hacking due to their reli- ance on passwords for data entry. Although blockchain is still in its infancy, its potential to improve serialization has not gone unnoticed. In enforcing the DSCSA, the FDA has begun calling for pilot programs using blockchain technology [2]. This could inspire the industry to implement blockchain within the next five years. It's possible that by 2023, block- chain technology may no longer be referred to theoretically in the pharmaceutical industry but rather as a realistic solution for drug counterfeiting. In the meantime, packaging suppliers are ready, willing, and able to help implement blockchain to a d v a n c e p h a r m a c e u t i c a l supply-chain security. Bill McBeath, chief research officer, Chainlink Research: Companies attempting to deter counterfeiting of their products can consider both serialization and non-serialization anti-coun- t e r f e i t i n g m e t h o d s . N o n - serialization methods include hard-to-forge markers on either the dosage form or packaging to authenticate drug products. However, the DSCSA mandates serial- ization to combat counterfeits. As of November 2018 (after the FDA delayed enforcement for one year), all pharmaceuticals in homogeneous cases must be serial- ized and compliant with the FDA's standardized numerical identification guidance [3]. The DSCSA also requires that, by November 2019, wholesalers must One possible solution that stands out as a strong defensive measure with inherent tracking capabilities is blockchain technology. Blockchain is a method of per- manently and verifiably recording transactions and stor- ing those records in a decentralized peer-to-peer network so they cannot be retroactively altered. However, block- chain is still in its infancy, and implementing the technol- ogy poses challenges to the current digital infrastructures of many pharmaceutical companies. In this article, three industry experts share their insights into whether block- chain technology may be a useful tool to counter the counterfeiters and protect the drug product supply chain. Tom Egan, vice president–industry services, PMMI: As counterfeiting efforts continue to become more sophisticated, distinguishing real drug products from imi- tations is increasingly difficult. Often, counterfeiters steal expired products, then repack and relabel them with falsi- fied dates and dosage information. Merely examining a product's packaging and corresponding labels is no lon- ger sufficient to verify its authenticity, especially as the machinery used to repackage these products is often as advanced as that of the original manufacturers. As a result, pharmaceutical companies—along with manufacturers from many other industries—are turning their attention to blockchain as a possible solution that will create an easy-to-follow trail of verification. Success- fully implementing blockchain technology would allow the industry to verify each transaction along the supply chain and securely store product information, preventing unverified drug products from entering the system. However, real world applica- tion of blockchain is still in the concept phase. While this tech- nology may prove to be a via- ble way to track and trace prod- ucts, pharmaceutical companies may hesitate to implement it due to the wide availability of product information to anyone in the supply chain with access t o t h e n e t w o r k . S t i l l , i f advancements to the technol- ogy and process alleviate those security concerns, blockchain may become a viable method of combating the growing epi- demic of counterfeit drugs. In the meantime, pharmaceu- tical companies are putting their eggs in multiple baskets by exploring other tech- nologies for counterfeit prevention, including the use of covert tags with radio frequency identification tech- nology (RFID), barcodes, or web portals that can be checked when products arrive at a facility. This helps companies verify the authenticity of their products after distribution. In 2013, the FDA announced the Drug Supply Chain Security Act (DSCSA) to strengthen the impact of serial- While blockchain may eventually offer a solution for establishing a secure traceability process for pharma, many companies are forging ahead using other, much more mature and proven technologies for serialization and traceability.