Transcript Cool Blue Water Fade

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
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.
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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 Effective
Track and Trace System
 Authentication
 Verification
 Automation
 Interoperability
 Visibility
 Immediate reporting capability
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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.
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Verification
Once manufactured, individual drug dosages must be
packaged in verifiable lots for shipping and delivery.
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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.
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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.
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Supply Chain Visibility
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Prescription Drug Monitoring Programs
State databases for monitoring
prescriptions provide extended visibility
through the drug delivery phase
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Disposal of Unused Prescription Drugs
 Models: Dropoff vs. Mail-in
programs
 Regardless of the program
model, track and trace
technology enhances drug
return programs
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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
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