promoting safe medicine with track and trace systems
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Promoting Safe Medicine With Track and Trace Systems. SRC Technologies, Inc . - PowerPoint PPT PresentationTRANSCRIPT
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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
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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