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

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.

The Quest for Safe Medicine 3 SRC Technologies, Inc.

Benefit of Medicine in Our Lives  Healing of Illnesses  Preventing more expensive interventions  Helping maintain quality of life under incurable illnesses SRC Technologies, Inc.

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 SRC Technologies, Inc.

Dark Side of Prescription Drug Use  Prescription drug abuse  Drug diversion  Counterfeit drugs  Insurance fraud SRC Technologies, Inc.

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. SRC Technologies, Inc.

Overseers of Public Safety  Regulatory Agencies  Legislators  Watchdog groups SRC Technologies, Inc.

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. SRC Technologies, Inc.

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. SRC Technologies, Inc.

Environmental Protections Agency Mandate: The mission of EPA is to protect human health and the environment. SRC Technologies, Inc.

Recent Legislation SRC Technologies, Inc. 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.

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. SRC Technologies, Inc.

Safe Medicine Stakeholders  Regulatory Agencies  Pharmaceutical Manufacturers  Healthcare Providers  Consumers SRC Technologies, Inc.

Track and Trace Systems SRC Technologies, Inc.

Track and Trace Systems SRC Technologies, Inc.

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

Key Features of an Effective Track and Trace System  Authentication  Verification  Automation  Interoperability  Visibility  Immediate reporting capability SRC Technologies, Inc.

Product Authentication SRC Technologies, Inc. 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.

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

SRC Technologies, Inc.21  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. Automation: Auto ID Technology

Interoperability The 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. SRC Technologies, Inc.

23 Supply Chain Visibility

SRC Technologies, Inc.24 State databases for monitoring prescriptions provide extended visibility through the drug delivery phase Prescription Drug Monitoring Programs

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

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 SRC Technologies, Inc.

Benefits To Stakeholders  Efficient supply chain management  Counterfeit reduction  Diversion control  Efficient regulatory compliance SRC Technologies, Inc.

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