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Promoting Safe Medicine With Track and Trace Systems

Promoting Safe Medicine With Track and Trace Systems. SRC Technologies, Inc .

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Promoting Safe Medicine With Track and Trace Systems

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  1. Promoting Safe Medicine With Track and Trace Systems SRC Technologies, Inc.

  2. In keeping with the intent of this conference, the following presentation is solely intended to provide information to participants on the efficacy of track and trace technology in promoting safe medicine practices. The presenters have a financial interest in SRC Technologies, Inc, a technology company providing advanced knowledge based solutions within the government, healthcare and financial sectors.

  3. The Quest for Safe Medicine

  4. Benefit of Medicine in Our Lives • Healing of Illnesses • Preventing more expensive interventions • Helping maintain quality of life under incurable illnesses

  5. Growth of Prescription Drug Use • From 1994 to 2005, US drug purchases rose 71% compared to population growth of 9% - Kaiser Family Foundation • National prescription drug expenditures: • In 1990 = $40B • In 2005 = $200B

  6. Dark Side of Prescription Drug Use • Prescription drug • abuse • Drug diversion • Counterfeit drugs • Insurance fraud

  7. Michael Dobrushin is led in handcuffs from FBI headquarters Oct, 13 in New York. He is one of 73 people across the United States charged in what federal prosecutors say is the largest Medicare fraud on record.

  8. Overseers of Public Safety • Regulatory Agencies • Legislators • Watchdog groups

  9. Food and Drug Administration Mandate: Protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.

  10. Drug Enforcement Agency Mandate: To enforce the controlled substances laws and bring to the criminal and civil justice system those involved in the growing, manufacture, or distribution of controlled substances destined for illicit traffic in the US.

  11. Environmental Protections Agency Mandate: The mission of EPA is to protect human health and the environment.

  12. Recent Legislation HR 3580 – The Food and Drug Administration Amendment Act of 2007 GOAL - Bolstering public safety by ensuring the integrity and authenticity of pharmaceutical products through better supply chain management.

  13. HR 3580 (Sec. 913) Requires the Secretary to: (1) develop standards to secure the drug supply chain against counterfeit, diverted, sub-potent, substandard, adulterated, misbranded, or expired drugs; (2) prioritize and develop standards for the identification, validation, authentication, tracking, and tracing of prescription drugs; (3) develop a standardized numerical identifier for prescription drugs; and (4) expand and enhance resources and facilities for enforcement of this Act to secure the drug supply chain.

  14. Safe Medicine Stakeholders • Regulatory Agencies • Pharmaceutical • Manufacturers • Healthcare Providers • Consumers

  15. Track and Trace Systems

  16. Track and Trace Systems

  17. The Role of Technology Many of the stakeholders don’t understand how technology can help them accomplish their mission and promote the public good.

  18. Key Features of an EffectiveTrack and Trace System • Authentication • Verification • Automation • Interoperability • Visibility • Immediate reporting capability

  19. Product Authentication Comprehensive tracking involves cataloguing information on all of the different ingredients that make up an individual drug unit (e.g., pill or capsule) throughout the manufacturing process.

  20. Verification Once manufactured, individual drug dosages must be packaged in verifiable lots for shipping and delivery.

  21. Automation: Auto ID Technology • The key to ensuring the quality, integrity and availability of health care goods is the ability to track and trace individual items throughout their complete life-cycle from manufacturing to disposal. • The Auto-ID technology and information infrastructure will change the management and distribution of pharmaceutical products within the health care industry by enabling item level product traceability functionality throughout the supply chain.

  22. InteroperabilityThe GS1 Standard GS1 is an international not-for-profit association dedicated to the design and implementation of global standards and solutions to improve the efficiency and visibility of supply and demand chains globally and across sectors and industries. The GS1 system of standards is the most widely used supply chain standards system in the world.

  23. Supply Chain Visibility

  24. Prescription Drug Monitoring Programs • State databases for monitoring prescriptions provide extended visibility through the drug delivery phase

  25. Disposal of Unused Prescription Drugs • Models: Dropoff vs. Mail-in programs • Regardless of the program model, track and trace technology enhances drug return programs

  26. Advantages of Track and Trace • Authentication of product integrity • Verification of supply chain security • Increased barriers to counterfeit drugs • Better drug diversion controls • Improved information on drug disposal

  27. Benefits To Stakeholders • Efficient supply chain management • Counterfeit reduction • Diversion control • Efficient regulatory compliance

  28. Questions & Comments Thank You for Attending This Presentation SRC Technologies, Inc.

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