Pharmaceutical Safety Program Launched - Pharmaceutical Technology

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Pharmaceutical Safety Program Launched


ePT--the Electronic Newsletter of Pharmaceutical Technology

A United Kingdom consortium completed pilot runs of a pharmaceutical-safety program that uses electronic tracking and authentication to ensure the safety of drugs in the supply chain. The consortium, SecureTrace, comprises 10 UK companies and is led by authentication-company Authentix.

"The combined use of four sophisticated technologies, laser-surface authentication, and forensic signature inks that enable authentication and use of 2D barcodes and RFID [radio-frequency identification] make SecureTrace more comprehensive than any other programs being used to protect pharmaceuticals," Ian Eastwood, chief technology officer at Consortium Leaders, Authentix, said in a press statement. "Pharmaceutical counterfeiting is a growing threat and protecting patients means that the product, not just the barcode, needs to be absolutely verifiable."

The pilot run was hosted on a high-speed packaging line at Reckitt Benckiser in Hull (UK). First, pharmaceuticals were imprinted with 2D barcodes featuring authenticating markers in the ink, and laser-surface authentication was used to generate a natural fingerprint. Pack data were aggregated to cartons and pallets, and then barcodes and RFID labels were added.

The information is stored in a master database, which allows field readers to provide authentication and verification of products as they leave the packaging facility and travel throughout the supply chain.

According to SecureTrace, the US has been struggling to establish a "workable" system for more than two decades. Meanwhile, in Europe, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has "laid the groundwork" for a simple approach based on mass serialization using 2D barcoding. Many European countries, including Belgium, France, Greece, and Italy, are pursuing variations on this theme. However, SecureTrace describes this as a "fragmented" approach that "threatens the implementation of a clear strategy and effective protection programs."

"European countries have taken a fragmented approach to tracking drugs while the US has struggled to establish a workable pedigree system," Jim Rittenburg, vice-president of healthcare at Authentix, said in the press statement. "SecureTrace establishes a clear and workable strategy that has been developed and executed by all players involved in the process."

SecureTrace has said it will ensure that its project is aligned to EFPIA's objectives in order to support the agency's stance. However, it will also explore the inclusion of additional authentication technologies, which do not impact packaging design, as well as the integration of technology at the production line and in the supply chain.

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