This is an executive summary of a recently published thought leadership perspective co-authored by Andy De et al. and published by Touch Briefings, UK, September 2009.
Please click on the cover graphic below to view/download the PDF version, or alternatively, please click on the flip book at the end of this summary to access the eBook version of the white paper.
Executive Summary:
As medical science has advanced, so too have the number, type, and complexity of drugs and devices available. In order to carry this burgeoning product portfolio, the life sciences supply chain network has also enlarged and grown in complexity, and there are now more intermediaries than ever before between the manufacturer and the patient. It is a major challenge to account for the movement of all products within the supply network—and moreover to prevent diversions and counterfeits. However, in this networked, globalized world, where information travels fast, it is of critical importance to be able to secure the supply chain to ensure patient safety and maintain an unblemished reputation.
Counterfeits risk harming human life by containing incorrect active ingredients—or even no active ingredients at all. If allowed to flourish in the life sciences supply chain, these sub-standard products can damage the brand and reputation of the authentic manufacturer. Moreover, money from the sale of counterfeits will not go towards supporting the research and development (R&D) infrastructure of pharmaceutical and device manufacturers and may well be used to support illegal or harmful activities. The issue of diversions can be equally damaging as certain markets are denied their medications, while middlemen and traders enjoy profit by selling them on. It is impossible to do more than guesstimate the full impact of counterfeits and diversions (which run well into tens of billions of dollars a year), but they are undoubtedly a growing concern. As the Internet becomes ever more prevalent, it is easier and easier to hide the provenance of pharmaceutical products on sale.
The world is waking up to these problems. Certain countries, including the US and many in Europe and Asia, are developing legislation to help protect the life sciences supply network. By enhancing the ability of stakeholders within the network to be able to track and trace the products, it becomes harder to divert or insert items, and easier to ensure high levels of quality and safety.
As the life sciences industry operates on a global scale, these mandates need to fit within a wider framework, which is provided by global standards such as those from GS1 and Electronic Product Code Information Services (EPCIS). With guaranteed interoperability, it is possible to achieve accurate, reliable drug tracking and authentication at each node of the drug supply chain.
For life sciences executives concerned with ensuring the highest levels of patient safety and brand protection, the solution will be to adopt an enterprise-wide approach to addressing these issues. This will include considering how to proactively comply with emerging serialization mandates across the world, while at the same time balancing the costs and benefits of serialization and authentication and determining which products and brands to prioritize.
This publication explores some of these key challenges facing life sciences companies today from the insiders’ perspective. There is an overview of the problems of counterfeits and diversions and the role that serialization and authentication plays. It also addresses the critical role of industry standards and best practices in business process enablement using advanced IT solutions, and there is a case study of Cephalon’s success in addressing these challenges. In addition to addressing the tactical needs for compliance and supply chain visibility, the publication closes with an analysis of the strategic benefits of extending serialization to the patient bedside, including the potential benefits in terms of fewer medication errors and adverse events culminating in higher patient safety.
We hope you enjoy the articles and find them useful in helping to further your understanding of the potential strengths of the life sciences supply chain environment and to derive strategic plans to realize them.
- Andy De, Steve Winkler and Mandar Paralkar
Please click on the flip book above to access the full edition of the eBook in a new window, or please click on the cover graphic above to view/download the PDF version of the white paper.
