STM Article Repository

Pharmaceutical serialization is a regulatory compliance that assures a unique identifier assigned to every unit of prescribed medicine. This unique identifier is used for product tracking and authentication in the supply chain. Initially, in 2018, the Drug Supply Chain Security Act (DSCSA) implemented pharmaceutical drug serialization regulations to mitigate the risk of counterfeit medicine entering the US market. Under this regulation, the pharmaceutical drug manufacturer is required to print a 2D data matrix barcode encoded with unique identification on each drug unit. Basically, printing a unique identification code on each prescribed drug for authenticity and traceability is not sufficient to eliminate the risk of drug counterfeiting. Subsequently, criminals and drug counterfeiters can still supply illicit or stolen drugs into the supply chain through an illegal source or online trade by imitating the same information in multiple units. After this regulation's enforcement, we observed that the US market lacks a mechanism to authenticate individual drug units with a centralized, secure repository before dispensing them to patients. Since the COVID-19 pandemic, drug counterfeiters and criminals have produced large quantities of contaminated drugs, which they then distribute through their illicit networks and underground social media platforms. Furthermore, COVID-19 supply chain disruptions, non-business resilience, and the fear of ransomware have all contributed to a rise in the mass fabrication of counterfeit medications. Ultimately, the United States needs a centralized cloud-based database hub where all authorized trading partners should be connected for medicine authentication. In this process, the manufacturer must update the product's unique identifier in the centrally connected hub database before supplying drugs to the market. Further, the dispenser, pharmacy, or hospital should authenticate the unique identifier of the product using the same database before dispensing it to patients. Finally, this process will ensure that patients are getting authenticated medicine and will mitigate the risk of dispensing counterfeit or illegal drugs.