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Promoting Safe Medicine With Track and Trace Systems

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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

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Benefit of Medicine in Our Lives

Healing of Illnesses

Preventing more expensive interventions

Helping maintain quality of life under incurable illnesses

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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

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Dark Side of Prescription Drug Use

Prescription drug abuse

Drug diversion

Counterfeit drugs

Insurance fraud

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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.

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Overseers of Public Safety

Regulatory Agencies

Legislators

Watchdog groups

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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.

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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.

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Environmental Protections Agency

Mandate: The mission of EPA is to protect human health and the environment.

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Recent Legislation

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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.

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Safe Medicine Stakeholders

Regulatory Agencies

Pharmaceutical Manufacturers

Healthcare Providers

Consumers

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Track and Trace Systems

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Track and Trace Systems

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The Role of Technology

Many of the stakeholders don’t understand how

technology can help them accomplish their mission and

promote the public good.

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Key Features of an EffectiveTrack and Trace System Authentication

Verification

Automation

Interoperability

Visibility

Immediate reporting capability

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Product Authentication

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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

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

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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

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.

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Supply Chain Visibility

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State databases for monitoring prescriptions provide extended visibility

through the drug delivery phase

Prescription Drug Monitoring Programs

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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

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Benefits To Stakeholders

Efficient supply chain management

Counterfeit reduction

Diversion control

Efficient regulatory compliance

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Questions & Comments

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Thank You for Attending This Presentation