It's going to take "several layers" of technology to mitigate risks in the drug supply chain. Smarter crooks who have their own access to and proficiency with tech tools promise to keep this chess game going for a long time to come.
"Once a drug leaves its manufacturer it is left wide open to be adulterated, completely faked, diluted, relabeled, and repackaged or manufactured without authorization," writes Duane Sword, a VP at Thermo Fisher Scientific, in PharmPro.
Sword outlines the five major threats: theft, illegal transport from one country to another, counterfeiting, contract breach, and fraud. He provides a snapshot overview of the technologies currently available to protect against the threats: RFID/ePedigree, thin layer chromatography, and near infrared and Raman spectroscopy.
Technology combinations are currently the best means of protecting the drug supply chain, says Sword. For example, drug authenticity can be checked via Raman spectroscopy for dosage-form analysis, while RFID adds security measures to packaging. Sword calls this combination a "pervasive, protective shield that provides deep visibility into the movement of a drug as well as a chemical analysis for each drug," at any point in the supply chain.
Combinations are also at the heart of NanoGuardian's NanoEncryption brand protection technology, which is slated for its commercial debut by a drugmaker whose candidate is currently in review. NanoEncryption protects against counterfeiting and diversion via overt, covert and forensic markings, which provide authentication and tracing data on capsules, tablets, vial caps, and single-use syringes. The overt and covert markings allow dose-level authentication while forensic NanoCodes aid in tracing.
The big question remains cost. Although chromatography and spectroscopy are common enough to be estimated, and are likely to provide a reasonable return on investment, publicly available data on RFID, e-pedigree and NanoEncryption technology for use in the pharma supply chain are still hard to come by. And given the number of hands through which drugs pass on their way to patients--and therefore the number of locations requiring the infrastructure to capture, store and communicate supply chain data--much work remains to develop a credible business case for the use of multiple technologies.
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