Keynote Speaker The War Against Fake Medicines - IPEC
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 1 5/11/2015 Agenda • • • • • • • 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 2 5/11/2015 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 ? ? 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 3 5/11/2015 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 4 5/11/2015 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 5 5/11/2015 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 6 5/11/2015 Rx-360 Supply Chain Risk Management White Papers • • • • • • • • 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 7 5/11/2015 Security and Logistics Requirements Focus • • • • • • • • • 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 • • • Threat Reports Best Practices Education Campaigns Sharing Knowledge Collaborating for FUTURE Solving for NOW • • • • IPEC Standards / Certification GS1 Traceability Standards Rx360 SCS Program / Audits USP Monographs / Guidance Collaborating • APEC Roadmap Anticipating the FUTURE • • Global Partnerships WHO Surveillance Programs Innovating 8 5/11/2015 Patient Safety is Our Focus 9
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