Same but different – implementation of a track-and-trace serialization of pharmaceuticals in the US

June 28, 2017

End-to-end vs. Track-and-trace verification

 

The ever-growing threats of illegal (falsified or substandard) pharmaceuticals entering the legal supply chain require specifications of systems effectuating measures to improve patient safety. These are defined by national and / or supranational legislative institutions.

The falsified medicines directive by the EU (2011/62/EU, including the Commission Delegated Regulation (EU) 2016/161) requires the implementation of an end-to-end serialization of pharmaceuticals to prevent falsified medicines from entering the legal supply chain (click here to read more on the EU directive).

In the US, the Drug Quality and Security Act (DQSA) was signed into law in November 2013. As part of this act, the Drug Supply Chain Security Act (DSCSA) outlines the requirements for the implementation of an electronic system to trace drugs distributed within the US.

In contrary to the end-to-end system for verification of medical products as it becomes obligatory in the EU from February 9th, 2019 onwards, the US DQSA and DSCSA goes one step further, demanding a track-and-trace system providing the ability to validate, if a product is genuine at all locations within the supply chain. While the implementation of such a system is easy in theory, only time will tell whether manufacturers and distributors will face challenges in the realization of this project.

How will medicine authentication be achieved?

Product serialization will be achieved by the placement of a unique product identifier on the packaging. By November 27th, 2017, manufactures will only be able to bring medical products into the legal supply chain which contain a 2D-barcode for identification. This barcode contains information on the National Drug Code, serial number, lot number and expiration date of the individual product.

End-to-end vs. track-and-trace verification

Although the general concept of serialization is similar for both respective systems, some differences between the two are emerging which lead to certain advantages or disadvantages of either system when implemented.

The track-and-trace system establishes the possibility to scan the barcode of a product at any location within the supply chain, making the track-and-trace system traceable, transparent and secured.

Opposed to this system, the end-to-end verification approach cannot track each of the individual steps of a product within the supply chain. While this reduced traceability supposedly is a disadvantage of the end-to-end verification system, the end-to-end verification system is less complex, hence potentially easier to implement and control, but yet maintains the ability to identify falsified products entering the legal supply chain.

Conclusion

The only way to counteract the distribution of falsified medicines is to improve safety of the drug supply chain. The implementation of product serialization, regardless of the exact criteria and guidelines this serialization is based on, form the basis to authenticate the product identity. Implementation of laws like the falsified medicines directive and the DSCSA, among others, helps us to fight the battle against the illegal distribution of substandard and falsified medicines to secure public health and therefore are invaluable.

If you are interested in finding out more about the mentioned guidelines on product serialization, feel free to contact KVALITO Consulting Group.

Author: Kristina Halbleib

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