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Philadelphia Dropping The Gavel On Counterfeit Drugs

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Presentation I did in Philadelphia at Pharma Conference

Publicada em: Negócios, Saúde e medicina
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Philadelphia Dropping The Gavel On Counterfeit Drugs

  1. 1. Dropping the Gavel on Counterfeit Drugs The challenges & benefits presented by product codification & serialization Pharma Packaging and Labeling, 18-19 May, Philadelphia Chris Miller
  2. 2. Agenda Welcome and Introductions Explore key issues that keep pharmaceuticals and medical devices safe from counterfeiting Identify the differences between serialization and ePedigree Learn how to implement a serialization strategy in an evolving regulatory and compliance environment Understand how serialization is the foundation for optimizing business practices
  3. 3. Counterfeit Drugs is Big Business <ul><li>Counterfeit drug commerce will grow 13% annually through 2010 </li></ul><ul><li>In 2010, this illegal business will generate $75B in revenues – a </li></ul><ul><li>92% increase from 2005, (Combined revenue of Pfizer andAstraZeneca) </li></ul><ul><li>FDA alone has seen an 800% increase in the number of new counterfeit cases between 2000 and 2006 </li></ul><ul><li>Counterfeit medicines may account for 10-30% of the market in developing countries </li></ul>
  4. 4. Protecting Patient Safety Fake Alli Sold on Internet in US Causes Heart Attacks
  5. 5. Protecting Patient Safety <ul><li>27 January 2010 – INTERPOL applauds Southeast Asia Operation Storm II’s success in disrupting trade of counterfeit medical products </li></ul><ul><li>Seizure of $20M in counterfeit and illegal medicines </li></ul><ul><li>An estimated $12M were counterfeits </li></ul><ul><li>Remaining $8M found to be drugs that were &quot;expired, diverted or unregistered” </li></ul>
  6. 6. Protecting Patient Safety <ul><li>2 Million Counterfeit Needles Found </li></ul><ul><li>in Europe </li></ul><ul><li>200,000 counterfeit needles in the Dutch market </li></ul><ul><li>500,000 in the United Kingdom </li></ul><ul><li>More than 1.3 million in Poland </li></ul><ul><li>30,000 still unaccounted in the Netherlands </li></ul><ul><li>*Source: MHRA & SaferMedicines.org </li></ul>
  7. 7. Protecting Patient Safety Counterfeit Viagra was found in the Summer of 2004 in two retail pharmacies in California. Bottles were for 100mg, 30-counts. Cost $270/bottle Cost < $1/bottle
  8. 8. Protecting Patient Safety Ponstan is an anti-inflammatory product. This counterfeit was found in Columbia. The yellow powder consisted of boric acid, floor wax, yellow highway paint. Pressed into tablets and placed in foil packs with labeling. Source: Pharmaceutical Manufacturer Research Association
  9. 9. Counterfeit Operation Source: Roger Bate; Author of Making a killing
  10. 10. Counterfeit Operation Source: Roger Bate; Author of Making a killing
  11. 11. The Global Face of Bad Medicine COUNTRY/ REGION WHO/IMPACT ESTIMATE United States <1% Europe <1% United Kingdom <1% COUNTRY/ REGION WHO/IMPACT ESTIMATE Russia 10% CIS 20% China 8% Indonesia 25% India 10-20% Nigeria 16% Kenya 30% Lebanon 35% Cambodia 13%
  12. 12. Why is counterfeiting a problem? <ul><li>Public health threat: </li></ul><ul><ul><li>Direct: Fake drugs containing harmful ingredients (e.g. heavy metals) </li></ul></ul><ul><ul><li>Indirect: Drugs with inadequate or wrong active ingredients have no curative power (e.g. many malaria deaths) </li></ul></ul><ul><ul><li>Wider Impacts: Drugs with only some of the correct ingredients can cause a patient to develop resistance to that particular drug, making it harder for the patient (and potentially the population as a whole) to be treated with effective medicines later on (drugs for TB, HIV, malaria badly affected). </li></ul></ul><ul><li>Intellectual property/brand integrity threat </li></ul><ul><ul><li>Threatens long-term innovation and development </li></ul></ul>
  13. 13. Why is counterfeiting a problem? &quot;Drug counterfeiting is mass murder! It is one of the greatest atrocities of our time. It is a form of terrorism against public health as well as an act of economic sabotage.&quot; Dr. Dora Nkem Akunyili - &quot;the iron lady&quot; former Director General of National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria and current Nigerian Minister of Information and Communications
  14. 14. A Multi-Layered Approach New Technologies ePedigree Codification Serialization
  15. 15. An Evolving Compliance Landscape – The Tide Has Turned Europe USA Asia
  16. 16. Latest News! Europe USA FDA Guidance for Industry Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages EFPIA Live pilot in Swedish Apoteket AB pharmacies 2009/10 Results of live pilot issued April 2010 were successful One constant theme is emerging. The requirement for product verification delivered using codification and mass serialization
  17. 17. A Closer Look at the EFPIA Code <ul><li>Standards based approach – GS1 </li></ul><ul><li>Manufacturer Product Code - GTIN [or Pseudo GTIN e.g. CIP code] ‘Global Trade Item Number’ according to GS1 Standards (14 numeric digits) </li></ul><ul><li>Unique serial number (randomized - 20 numeric digits) </li></ul><ul><li>Expiry Date (6 digit – YYMMDD) </li></ul><ul><li>Batch number (up to 20 alpha-numeric characters) </li></ul>Both GS1 and EPCglobal are playing a leading role in helping develop and introduce standards in this arena.
  18. 18. A Closer Look at the EFPIA Code
  19. 19. An Evolving Compliance Landscape Source: U.S. Pedigree vs. European Pedigree , April 21, 2009: 2009 LogiPharma Europe <ul><li>Turkey </li></ul><ul><li>2D data matrix with EAN barcode, serial number, manufacturing date, expiry date </li></ul><ul><li>Will need to send serial numbers to MOH database July 1, 2009 </li></ul><ul><li>EFPIA </li></ul><ul><li>2D data matrix with product code, batch number, expiry data, and serial number </li></ul><ul><li>Each manufacturer to have a database server link to one global database </li></ul><ul><li>EU Commission </li></ul><ul><li>Pedigree serialization and central repository </li></ul><ul><li>Pedigree to be similar to U.S. pedigree </li></ul><ul><li>Italy </li></ul><ul><li>SN for reimbursement only but planning in traceability </li></ul><ul><li>Could have central DB </li></ul><ul><li>France </li></ul><ul><li>Currently use 7 digit PIC </li></ul><ul><li>By 2011 all products must use 13 digit data matrix PIC </li></ul><ul><li>Belgium </li></ul><ul><li>Currently using 8 char SN </li></ul><ul><li>Looking at a 16 char number </li></ul><ul><li>Brazil </li></ul><ul><li>Will pilot and scale up unit serialization over the next 3 years </li></ul><ul><li>Interested in capture technology as well as data storage capabilities </li></ul><ul><li>Countries With No SN </li></ul><ul><li>Austria, Bulgaria, Czech Republic, Denmark, Germany, Poland, Portugal, Slovakia, and Slovenia </li></ul><ul><li>Russia </li></ul><ul><li>Proposed serialization with track and trace </li></ul><ul><li>At issue is the amount of counterfeiting </li></ul>
  20. 20. Overview: European National Codification Systems
  21. 21. Various Approaches Europe/ EFPIA US Track ProActive Trace Retrospective Transaction Security (e)Pedigree ID Verify Physical Verify Product Security Authentication Safe and Secure Supply Chain
  22. 22. A Growing Common Thread - Serialization Europe/ EFPIA US ID Verify Physical Verify Product Security Authentication Track ProActive Trace Retrospective Transaction Security (e)Pedigree Safe and Secure Supply Chain Serialization
  23. 23. The Evolving European EFPIA Approach Focus on Serialization and Authentication Pharma Manufacturer Distributor Wholesaler / Trader Pharmacist/ Hospital Patient Unique Serialization Dispensing, Authentication, Confirmation * Source: EFPIA, Booz and Company Data Capture Product Flow 2D Data Matrix on 2°pack Verification Product Serialization Database*
  24. 24. The California ePedigree Approach Tracks Movement Through Each Node in the Supply Chain An ePedigree is an Electronic record , containing information regarding each transaction resulting in a change of ownership of a prescription drug , from sale by manufacturer , through acquisition and sale by a wholesaler , until final sale to a pharmacy or person furnishing, administering or dispensing the prescription drug. Pharma Manufacturer Wholesaler Wholesaler Pharmacist/ Hospital Patient Product Flow PEDIGREE ID PharmaDrug EPC Serial # Manufacturer PEDIGREE ID PharmaDrug EPC Serial # Manufacturer Wholesaler 1 PEDIGREE ID PharmaDrug EPC Serial # Manufacturer Wholesaler 1 Wholesaler 2 PEDIGREE ID PharmaDrug EPC Serial # Manufacturer Wholesaler 1 Wholesaler 2 Pharmacy
  25. 25. Combination of Regulatory, Global and Business Pressures <ul><li>California ePedigree </li></ul><ul><li>US State by State regulations </li></ul><ul><li>Will FDA act? EU Commission? </li></ul><ul><li>Turkey, Italy, Belgium serialization initiatives </li></ul><ul><li>About $2B annually and increasing </li></ul><ul><li>Controlling/Validating returns </li></ul><ul><ul><li>Systems to detect counterfeits </li></ul></ul><ul><ul><li>Assess and authorize valid returns </li></ul></ul><ul><li>Diverted product impacting profitability </li></ul><ul><li>Inventory shrinkage and damage control </li></ul><ul><li>Identification/reporting of suspect shipments </li></ul><ul><li>Parallel trade </li></ul><ul><li>Global Counterfeiting exceeds $50B </li></ul><ul><li>Impacts 3.4B prescriptions annually in US </li></ul><ul><li>As much as 1%, or 34M doses could be counterfeit </li></ul><ul><li>Systems to authenticate product </li></ul><ul><li>Protect brand integrity </li></ul>Channel Integrity Returns Regulatory Compliance Product Integrity
  26. 26. Serialization Business Benefits Source: AMR Research, “The Track and Trace Paradox: Will the Healthcare Value Chain be Ready to Comply Globally?”, Wayne McDonnell, William McNeill, and Hussain Mooraj, April 2009 Q: What are the business benefits your organization intends to reap from item-level serialization? N = All industries excluding healthcare providers and payers and planning to have a pilot, 147 Expected Business Benefits From Item-Level Serialization Percent
  27. 27. Serialization Business Benefits <ul><li>Accelerating a product launch by 2 years could increase the revenue by $600 million </li></ul><ul><li>An effective Clinical Trial Inventory Management can help to improve the product launch date </li></ul>
  28. 28. <ul><li>Serialized packaging (labeling) code data has to fulfil a defined lifecycle from generation to allocation on product and beyond </li></ul><ul><li>Once past the Pilot phases, Serialization has strategic implications at a regional and global level </li></ul><ul><li>A poor Serialization approach could create unintended consequences and increase vulnerability </li></ul>So What’s So Difficult about Serialization? There’s more to serialization that just generating numbers…
  29. 29. Whose Project & Budget? <ul><li>Whilst it can easily become over complex don’t ignore that serialization can involve radical change </li></ul><ul><li>New methodologies and processes will need to be defined and validated </li></ul><ul><li>Where possible leverage existing investment in technologies and processes – e.g. site level vision systems and printers </li></ul>
  30. 30. Managing & Administering Serialization is Perhaps the Greatest Challenge <ul><li>Generation and Management </li></ul><ul><li>Completeness of Solution </li></ul><ul><li>Data Carriers: RFID – 2D Data Matrix </li></ul>
  31. 31. How does Serialization Affect Labeling? Security <ul><li>Security of data at rest and in transit is of paramount importance </li></ul><ul><li>Will be a target for counterfeiters – weak links are probably human </li></ul>Data Volumes <ul><li>Volumes will be large – terabytes </li></ul><ul><li>Manufacturing performance must not be compromised by data handling </li></ul>Complexity & Flexibility <ul><li>Integration to multiple systems </li></ul><ul><li>Cross-site, multi discipline coordination of serial generation </li></ul><ul><li>Future proof – moving legislation </li></ul>
  32. 32. PRISYM ID & Oracle’s Joint Offering
  33. 33. Secure Serial Labeling <ul><li>Oracle Partner </li></ul><ul><li>25+ years experience in Life Sciences printing applications </li></ul><ul><li>Prisym Medica application built on Oracle technology </li></ul><ul><li>Working with OPSM development team to exchange product unit serial data via web services </li></ul>
  34. 34. Drug Supply Chain Business Process Vision Wholesaler Plant Pharmacy/ Hospital Patient Distributor Pack Site Re-Packer Item Information Store Regulatory Database Material Flow Information Flow: Point of Dispense Authentication Information Flow: Track & Trace Authentication Information Flow: Serial IDs Information Flow: ePedigree OPSM Interaction Point
  35. 35. Oracle Pedigree & Serialization Manager Complete, Open, and Integrated + + Integrated serialization and pedigree management. Purpose-built for and with the pharmaceutical industry. Delivers regulatory compliance and business value.
  36. 36. www.prisymid.com [email_address] Q & A

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