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Key Challenges for Pedigree Authentication and Serialization
Figure 2: The Interplay of Challenges and Solutions within the Pharmaceutical Industry
Counterfeits and diversions
Supply network complexity increases risk for
conterfeiting and diversions; huge safety
Research and
concerns for patients—lives and risk
medical
technology
Primary care
Hospitals Eliminate counterfeiting
(providers) and diversions
Comprehensive serialization
solution; ePedigree solution
compliant with EPCIS standards
Life sciences
Patients
Services/alliances
(producers)
(CMO/CRO)
Regulatory mandates
US—CA/FL Pedigree
Europe–Turkey, Italy etc.
Suppliers/
Regulatory
wholesalers
agencies
Low supply chain visibility
Pharmacies
Inability to track and trace life-cycle
from production to consumption
Inability to serialize and authenticate
drugs/devices at the item level
Compliance with industry standards
EPCIS and GS1 standards-compliant framework
Ecosystem of partners supporting standards
Track and trace drugs/devices from plant to customers
Track and trace in real time
Authentication across chain of custody
Better manage recalls and returns
medical device companies to leverage technologies and best practices to obstacles to overcome before these issues can be solved, but the
address the challenges present within the industry (see pages 12–15). technology and capabilities to achieve a safe and secure supply chain are
available today. If they are properly deployed across the whole of the
Counterfeiting and diversions are among the many problems that the supply chain, they can prove to be invaluable tools in the ongoing
life sciences industries face, and it may appear that there are many mission to ensure patient safety. n
1. World Health Organization statistics. Available at: based on 2006 estimates by the World Health pharmpack_en.htm (accessed January 5, 2009).
www.who.int/medicines/services/counterfeit/impact/TheNew Organization (WHO). 4. California bill SB 1307, signed September 30, 2008.
EstimatesCounterfeit.pdf (accessed January 5, 2009). 3. EC Pharmaceutical Package. Available at:
2. Projections by Center for Medicine in the Public Interest, ec.europa.eu/enterprise/pharmaceuticals/pharmacos/
PHARMACEUTICAL SERIALIZATION & AUTHENTICATION
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