Trending in Pharmaceutical Packaging: Track and Trace
The demands of pharmaceutical development and production have become more complex than ever, thanks to the unrelenting rise of counterfeit drugs. With countless online pharmacies, both legitimate and fake, detecting fakes is difficult at best. As 2024 gets underway, advancing track and trace technology brings new hope for tackling the rampant and dangerous underworld of fake drugs.
TRACK AND TRACE / ANTI-COUNTERFEITING
Serialization, track and trace, and advanced microtaggants and watermarking are becoming the most powerful technologies for many aspects of pharmaceutical production, perhaps most importantly, as an anti-counterfeiting force to fight the estimated $20B to S50B USD business of fake drugs endangering patients and contaminating the pharma market around the world.
Serialization refers to the unique identifiers assigned to each of the smallest saleable units of a drug product. Serialization captures where the product originated, its manufacturing trail from formulation to finished goods and expiry date.
Over a decade ago, the US FDA and EU counterparts introduced the concept of taggants to the pharmaceutical industry. With the rapid miniaturization of so many things, taggant particulate was no exception and soon shrunk down to the molecular level.
Microtaggants are highly desired by many pharmaceutical customers, yet most have continued to rely primarily on higher level serialization methods. Modern microtaggants are more difficult to fake, thus their frontrunner status in drug authentication, particularly solid oral dosage forms.
Unique identifiers of microscopic data can be embedded into any solid oral dosage form. Microtaggants can be applied as an overt or covert strategy for patient use and anticounterfeiting surveillance. The challenge to more widespread use has often come down to cost. Effective though they are, the need for compatible readers and verification programs to track across markets is not cheap. The latest form of microtaggant could change all of that: DNA microtaggants.
Digital watermarking for solid oral dosage form medications is trending thanks to advanced printing using a fully edible recombinant luminescent silk protein to print an invisible watermark on individual dosed units. Sophisticated inkjet printers and machine learning for color accuracy create remarkable smartphone authentication that not only reassures patients but puts them on the frontlines of revealing and reporting potential fakes and their sources.
Tracking and Tracing
Tracking and tracing are tools that put serialization into action. They enable pharmaceutical manufacturers to keep tabs on every item in their supply chain as they are distributed. It records every location where that unit has been. Its many benefits include optimizing operational efficiency and speed in the manufacturing process. It also protects against theft and diversion; monitors products in transit to help ensure they remain safe and environmentally stable; and prevents counterfeit, adulterated, or expired medications from entering the supply chain.
Tracing keeps a more detailed history of everything (and every entity) that interacted with a serialized unit across your supply chain. It is a key component in supply chain visibility and transparency. Its many benefits include fast and accurate recall management capabilities, brand protection, accurate inventory management, and building consumer/patient confidence.
Counterfeiting of medications, particularly pills, is estimated to be a $20 to $50 billion dollar industry.
RFID technology, while not so new in and of itself, RFID is emerging as a change agent to overhaul persistent (and costly) inefficiencies in the clinical trial process. On its own, RFID is simply a data repository. The trend of interest is using RFID to create super-efficiency by pairing with smart computer systems that analyze and interpret the RFID data for better processes and more transparency. Fully developed, not only could this potentially realize vast cost (and time) savings across industry and stands to positively impact patient safety and efficacy needs.
These promising security advancements will keep all eyes on pharma security in the months ahead. It is an inspiring start to think that industry innovations have the potential to make real headway in the all-out efforts to crush counterfeit drugs once and for all.