5/11/2015
Keynote Speaker
The War Against Fake Medicines –
What You Need To Know
Brian Johnson
Sr. Director Supply Chain Security –
Pfizer ‐ Rx‐360
The War Against Fake Medicines
Brian Johnson
Sr. Director Supply Chain Security Pfizer
Immediate Past Chair / Board Member Rx‐360
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Agenda
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Trends in Criminal Activity
Macro Industry Drivers
Regulatory Response
Industry Response
Importance of Supplier Quality Management
Impact on Excipient Suppliers
Looking Ahead
Tragic Consequences
Not If… But When and Where
How Fake Cancer Drugs Entered U.S.
Reference: Rx360
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Supply Chain Security
Trends
2193 criminal breaches in 2013 ( +9%) ‐ increasing yearly
327 medicines in 124 markets – global problem, opportunistic
20% (426 incidents) found in legitimate supply chain
Counterfeit anti‐malarials in Africa increase 63% ‐ regulatory oversight
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China and India source of counterfeits 66% of time
23% of incidents life saving injectable medicines – more money
Substandard, theft, and diversion of medicines a growing concern
Key Drivers of Pharmaceutical
Crime
A lot of money to be made The risk of getting caught is small
If caught the penalties are not severe
Cost pressures and manufacturing strategies
Complexity of global supply chains
Markets with poor regulatory infrastructure
Inconsistent supply chain standards and infrastructure globally
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Globalization and
Complexity
The change in value of cross‐
border flows between regions
Large Mfg. supply chain operations
Network
~7500 lanes
Criminals will exploit the
weakest link!
Globalization
Globalization
EMA
Terrorism
Counterfeit
Counterfeit
Diversion
Unknown
threats
EMA
Manufacturer
Importer
Wholesaler
Finished dosage form or
API
Cargo theft
Unknown
threats
Manufacturer
Wholesaler
Pharmacy
Terrorism
API and Inactive
Ingredients
Patient
Reference: U.S. Food and Drug Administration
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FDA Example
Regulatory Evolution
“As our world transforms and becomes increasingly globalized, it is vital that we come together as a global community – in new, unprecedented, and even unexpected ways – to build a public health safety net for consumers around the world.” – FDA Global Initiative website
Global Regulatory Evolution
The Past
The Future
Counterfeits, adulteration
Counterfeits, adulteration, theft,
illegal diversion, substandards
Illegitimate/black market risks
Increasing legitimate/grey market
risks
Enforcement / focused threats End‐to‐End supply chain safety
Individual country responses
China, Europe, India, and the US all raise the bar on GDPs
Globalization / Regulatory Convergence
EU FMD
(2011)
US FDASIA (2012)
US DQSA (2013)
Falsified Medical Products Strategy Pathway to Global Product Safety & Quality
Countries worldwide enact coding and serialization requirements
Nigeria’s Plan to eradicate SSFFCs
National Drug Safety Plan
What remains the same is the responsibility of all stakeholders to protect the safety and efficacy of medicines at every point in the supply chain, end‐to‐end
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Industry Efforts - Holistic Supply
Chain Security Programs
Reference: Rx360
Understanding Supply Chain Security
Raw Materials
Finished Dosage
•Supply Chain Mapping
•Supplier Assessment
•Supplier Oversight
•Material Qualification
•Quality Agreements
•Inspection & testing
•Security
•Transportation and logistics
•Brokers
• Contract Mfg. Oversight
•GMPs
• Site and IT Security • Incident reporting
• Anti‐counterfeiting packaging & labeling
• Serialization
• Waste management
Logistics
• Auditing
• LSP Mgmt
• Segregation
• Warehouse Security
• Shipping Tracking
• Inventory Control
• GMP and GDP
• Conveyance Security
Market/Patient
• Serialization
• Market Surveillance
• Reporting of events ‐
counterfeit, theft, adulteration, diversion
• Education and adoption of controls by wholesalers/distributors • Healthcare Provider and Consumer Awareness
The supply chain security ‘life cycle’ is an end‐to‐end, holistic approach focused on protecting patient safety from raw materials to patient
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Rx-360 Supply Chain Risk
Management White Papers
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Holistic Supply Chain Security Programs
Upstream Supply Chain Security Controls
Conveyance Risk Management
Risk Surveillance / Assessment of the Market Place
Audits and Assessments of LSP’s
Risk Mitigation Strategies to Prevent Diversion
Incident Management
Risk Mitigation of Supply Chain Security Breaches After a Drug Shortage
Available at www.rx‐360.org
Expansion of SQM Processes to
include Security and Logistics
Guiding Strategy
Build minimal requirements into
selection process
Supplier
Identification
Exceptions reviewed by
Security & Logistics
Perf.
Review
Risk
Tolerance
Supplier
Qualification
Q Agreement & Audit guides
include Minimum Requirements
Educate all Supplier visitors on
minimal requirements & reporting
expectations
Performance
Management
SQM Lifecycle
Model
Supply Chain Security
Include security/logistics items into
usability decision- SQ status
Security/Logistics document and
manage significant CAPAs
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Security and Logistics Requirements
Focus
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Physical security of the facility
Electronic security
Procedural security
Production area security
Warehouse area security
Material storage security
Destruction procedures
Handling of return/rejects
Transportation security
Industry & Associations
Evolution
Learning from the PAST
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Threat Reports
Best Practices
Education Campaigns
Sharing Knowledge
Collaborating for FUTURE
Solving for NOW
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IPEC Standards / Certification
GS1 Traceability Standards
Rx360 SCS Program / Audits
USP Monographs / Guidance
Collaborating • APEC Roadmap
Anticipating the FUTURE
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Global Partnerships
WHO Surveillance Programs
Innovating
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Patient Safety is Our Focus
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