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Traceability and Serialisation - Effective Implementation

 

The complexities of the increasingly global healthcare supply chain are vast. Healthcare products are supplied through complex, multi-echelon global chains that currently lack transparency. Supply chains that deliver healthcare products cross in and out of geographic and political borders, with products changing ownership a number of times. Significant inconsistencies in the degree of legislation, regulation and resources exist from country to country, and these inconsistencies further complicate an already complex distribution system.

Combating Counterfeiting Through Traceability Systems

Counterfeit pharmaceutical products are, in the first place, a risk to public health, with consequences including treatment failure, drug resistance and sometimes death. It is almost impossible for patients and dispensing healthcare professionals to identify the fakes. Furthermore, counterfeit pharmaceutical products are not confined to developing countries, but are an growing global threat, and are becoming an increasing reality in developed countries in Europe and North America. Both European Customs and the US Food and Drug Administration (FDA) report an increase in counterfeiting activities and a more sophisticated ability to introduce fakes into legitimate drug distribution channels. Illegal opportunists take advantage of patient desperation and a supply chain that lacks transparency in an attempt to profit from the sale of substandard and counterfeit therapies, creating a situation whereby providers can unknowingly use impotent or harmful products, potentially causing patients to suffer ill effects.

The introduction of a unique identification for each and every pack of pharmaceuticals, where appropriate, will enable traceability systems with readily available technology, and will provide an indication of authenticity. This would significantly improve patient safety and the integrity and security of the supply chain. It would make it much more difficult for counterfeiters to intrude into the healthcare supply chain or, at least, make it uneconomical.


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Ulrike Kreysa is Director, Healthcare, at the GS1 Global Office in Brussels. She manages GS1 Healthcare, the global GS1 user group, formed by the stakeholders in the healthcare supply chain, with the primary focus on automatic identification, traceability and data synchronisation to improve patient safety. Before joining GS1 in October 2004, Ulrike worked at Global Healthcare Exchange (GHX) Europe, an international e-commerce platform, where she held the position of Managing Director for Benelux and France. She started her career as a Pharmacist, working in public pharmacies, and spent more than 11 years in the German University Hospital of Aachen, Germany.

Jan Denecker is Marketing Manager at the GS1 Global Office in Brussels, responsible for marketing of GS1 Healthcare and of the Global Data Synchronisation Network (GDSN). Prior to joining GS1 in January 2007, he worked for Agfa Healthcare as Global Marketing Manager, Digital Radiography and for British Telecom as Product Manager, Internet. Jan received a Masters in Law from Louvain University (Belgium) and an MBA from Ghent University – Vlerick School of Management (Belgium). He is also a Laureate of the Prince Albert Fund, and received a grant to work on international business development projects in Atlanta, US.

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Ulrike Kreysa
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Jan Denecker
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