Philadelphia Dropping The Gavel On Counterfeit Drugs

  • 1,439 views
Uploaded on

Presentation I did in Philadelphia at Pharma Conference

Presentation I did in Philadelphia at Pharma Conference

  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Be the first to comment
    Be the first to like this
No Downloads

Views

Total Views
1,439
On Slideshare
0
From Embeds
0
Number of Embeds
1

Actions

Shares
Downloads
0
Comments
0
Likes
0

Embeds 0

No embeds

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
    No notes for slide
  • RCS <COUNT TO THREE> During today’s webinar we hope that you’ll be able to : <CLICK> Explore the key issues that keep your medical products safe from counterfeiting <CLICK> Identify the differences between serialization and e-Pedigree <CLICK> Learn how to implement a serialisation strategy in an evolving regulatory and compliance environment and <CLICK> Understand how serialization is the foundation for optimising business practices . Today we have two specialist speakers, Robert Neintker and Marcus Lawson, who’ll talk through how serialization will enable Pharmaceutical Manufacturers to beat counterfeiting to keep you and your customers safe.
  • The supply of counterfeit medical products is a growing problem worldwide. It is well recognized that counterfeiting of pharmaceutical drugs and medical devices is a real and constant threat to patient safety. It is a global issue that affects all of us. It doesn’t recognize borders or trade agreements and its supply chain is fast to react to new opportunities and, in particular, weaknesses in the legitimate production and supply of medicines and devices. World Health Organization estimates that the global market place for fake drugs will exceed $75 billion in 2010 and with a growth rate of 12-16%. – a 92% increase from 2005, equating to the combined 2008 revenue of Pfizer and Oracle. - WHO The FDA alone has seen an 800% increase in the number of new counterfeit cases between 2000 and 2006. It is estimated that counterfeit medicines will account for 10-30% of the market in developing countries – a constant threat to the health of millions. Counterfeit versions of Alli, a weight loss drug, were being sold in the United States, among other ways, through internet auction websites such as 2daydietshopping.com On March 23 2010 in Hawaii, Sengyang Zhou, a 30-year old Chinese national was charged by Criminal Complaint for illegally importing counterfeit weight loss medication produced to look like Alli. Qingming Hu was also arrested for participating in and aiding this illegal scheme. The counterfeit Alli contain undeclared active pharmaceutical ingredients, including Sibutramine (a controlled substance that can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke) Relatively speaking, the percentage of counterfeits found in the United States is lower (estimated at around 1%) than some underdeveloped countries (estimated as high as 50%). However, this does not paint the whole picture… The U.S. has almost 43% of the market share, which means there are still thousands of counterfeit pills in our distribution cycle. To the consumer that is a victim, it matters not whether he is in the company of many fellow victims or only a few.
  • The supply of counterfeit medical products is a growing problem worldwide. It is well recognized that counterfeiting of pharmaceutical drugs and medical devices is a real and constant threat to patient safety. It is a global issue that affects all of us. It doesn’t recognize borders or trade agreements and its supply chain is fast to react to new opportunities and, in particular, weaknesses in the legitimate production and supply of medicines and devices. World Health Organization estimates that the global market place for fake drugs will exceed $75 billion in 2010 and with a growth rate of 12-16%. – a 92% increase from 2005, equating to the combined 2008 revenue of Pfizer and Oracle. - WHO The FDA alone has seen an 800% increase in the number of new counterfeit cases between 2000 and 2006. It is estimated that counterfeit medicines will account for 10-30% of the market in developing countries – a constant threat to the health of millions. Counterfeit versions of Alli, a weight loss drug, were being sold in the United States, among other ways, through internet auction websites such as 2daydietshopping.com On March 23 2010 in Hawaii, Sengyang Zhou, a 30-year old Chinese national was charged by Criminal Complaint for illegally importing counterfeit weight loss medication produced to look like Alli. Qingming Hu was also arrested for participating in and aiding this illegal scheme. The counterfeit Alli contain undeclared active pharmaceutical ingredients, including Sibutramine (a controlled substance that can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke) Relatively speaking, the percentage of counterfeits found in the United States is lower (estimated at around 1%) than some underdeveloped countries (estimated as high as 50%). However, this does not paint the whole picture… The U.S. has almost 43% of the market share, which means there are still thousands of counterfeit pills in our distribution cycle. To the consumer that is a victim, it matters not whether he is in the company of many fellow victims or only a few.
  • What: counterfeit antibiotics, aniti-malarials, contraceptives, anti-tetanus vaccines, aspirin and drugs to treat erectile dysfunction. Who: Medical Products Counterfeiting and Pharmaceutical Crime (MPCPC); Singapore's Health Sciences Authority; the Counterfeit Drug Forensic Investigation Network (CODFIN); and the World Health Organization's International Medical Products Anti-counterfeiting Taskforce (IMPACT) program. When: Reported Jan. 28, 2010; operation carried out between July and November of 2009. Where: 8 countries in Southeast Asia: Cambodia, China, Indonesia, Laos, Myanmar, Singapore, Thailand and Vietnam. How: The seizure is credited to the collaboration between public and private organizations at the international level.
  • What: More than two million counterfeit insulin needles were found in established European distribution channels. When: July 1, 2009 Where: Netherlands, Poland and the United Kingdom How: A Dutch company purchased insulin needles from a wholesaler in Malaysia, which claimed the needles came from Iran. The needles were subsequently distributed throughout the UK and Poland. Who: Novo Nordisk BV; Netherlands Health Care Inspectorate The dangers of using counterfeit insulin needles include breakage during use; incorrect administration of the necessary dosage; and discomfort, skin irritation or infection due to any improper sterilization or handling that may have occurred.
  • Only last year 2 Million counterfeit needles were found in Europe. On 27th March 2009, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom reported the discovery of counterfeit NovoFine 31G insulin needles which are manufactured by Novo Nordisk. On 19th June 2009, the Netherlands Health Care Inspectorate issued a public warning following the discovery of the same counterfeit insulin needles in the Dutch market. The discovery came after the manufacturer received a patient complaint that a recently purchased needle didn’t fit properly on the insulin pen. The complaint led to the discovery of 200,000 counterfeit needles in the Dutch market; 500,000 in the United Kingdom; and more than 1.3 million in Poland. Thirty thousand counterfeit needles are still unaccounted for in the Netherlands and may be in circulation.
  • Only last year 2 Million counterfeit needles were found in Europe. On 27th March 2009, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom reported the discovery of counterfeit NovoFine 31G insulin needles which are manufactured by Novo Nordisk. On 19th June 2009, the Netherlands Health Care Inspectorate issued a public warning following the discovery of the same counterfeit insulin needles in the Dutch market. The discovery came after the manufacturer received a patient complaint that a recently purchased needle didn’t fit properly on the insulin pen. The complaint led to the discovery of 200,000 counterfeit needles in the Dutch market; 500,000 in the United Kingdom; and more than 1.3 million in Poland. Thirty thousand counterfeit needles are still unaccounted for in the Netherlands and may be in circulation.
  • Dr. Dora Nkem Akunyili went on the war path with the criminals in Nigeria after her sister had died from counterfeit insulin. Between violence and attempts at murdering her, she has, for the last six years, been carrying out a war without mercy against the traffickers of false medical drugs in Nigeria. – When she begun this mission, 62 percent of the drugs in Nigeria were counterfeit. This figure of 62% has since dropped to 20%. These criminals are exploiting your Discovery, Marketing, Branding, time and effort. They are also destroying your credibility whilst causing pain and suffering the world over. How much longer do you plan to stand by and simply allow this to happen?
  • In recognition of these types of risks, the industry has developed over many years a variety of anti-counterfeit strategies both covert and overt. They range from sophisticated pack design & labeling using special inks, holograms, tags, tamper evident seals and to field agents actively investigating instances of counterfeit product. However, new technology approaches in combination with these are seen as the way forward by the industry and the regulators. Approaches include <CLICK> E-Pedigree, Codification and Serialization We’ll cover these in more detail later on in the presentation
  • So is there one global solution? <CLICK> Europe Similar situation as US, with each country (rather than s tate ) taking a different approach. However EU legislature now actively developing a coherent strategy. Pro-active leadership being shown by EFPIA proposing a unified approach. EFPIA proposing unified codification (2D barcode) and verification at pharmacy. Within the USA, Despite various Federal mandates, particularly around ePedigree, timelines have proved difficult. <CLICK> A State-by-State approach (e.g. California, Florida) has forced the pace and broadened the remit to include serialization. But over the last 18 months the Federal route is looking much healthier - critical timelines have been set and measures are being taken to preempt individual state regulation. <CLICK> Within the far east China is looking at a centralized pedigree & serialization scheme to protect public health and improve its tarnished reputation. So has serialization’s role now been recognized?
  • So where are these recommendations taking us? <CLICK> In March 2010 the FDA Announced a Guidance for Industry Standards for Securing the Drug Supply Chain –Standardized Numerical Identification for Prescription Drug Packages. <CLICK> During 2009-2010 EFPIA has been running a live pilot in Swedish Apoteket AB pharmacies. Results look positive from the report issued April 2010. As these recommendations and projects develop, the pharmaceutical market is getting closer to a global approach
  • You’ll here more about in a later presentation. GS1 is important – standards – Global view…
  • You’ll here more about in a later presentation. GS1 is important – standards – Global view…
  • With the evolving complaince whether California, FDA, Turkey, EFPIA… and beyond One constant theme is emerging, the requirement for product verification delivered using Codification and Mass Serialization
  • You can’t afford to be random about random numbers! Think scalable and sustainable – billions not millions Serial numbers can have complex aggregated relationships especially at different packaging levels e.g. case and pallet Serialization data needs to be strictly controlled and protected within an organization It creates core dependencies inside and outside the site/production environment i.e. QA validation and QC versus real-world supply chain and Pharmacy authentication (verification)
  • The impact of serialization will normally require input from multiple teams in a pharmaceutical manufacturing organization. Covering for example: Packaging & Design, ERP, Data management, Line configuration, WMS systems etc. Almost certainly, some new solutions and software applications will be required
  • The generation and allocation of serial numbers to the organization whether at regional, site or line level creates new responsibilities A huge amount of data associated with Serialization can move throughout the organization with different “owners” at various stages. Generation and Management: From the original generation of the unique serialized token, through its lifecycle and into audit logs, you need a highly flexible approach to mass serialization It will need to be based on a robust and scalable database and application platform for integration into existing ERP and MES or SCADA based approaches Completeness of Solution: The ability to manage and administer robust Mass Serialized number generation: high speed authentication, enterprise scalability, full cryptographic security, complete event auditing and lifecycle management Data Carriers: Consider a solution designed with future trends in mind – i.e. not tied to any specific data carrier. As technology changes, business process continuity can be maintained with minimal financial and security impacts upon an organization
  • So where can PRISYM ID and Oracle help? From the 1990’s we have helped many of the world’s leading life sciences companies meet their labelling and identification requirements. PRISYM Medica labelling software is purpose design labelling solution for Life Science organisations specifically developed to meet the FDA 's current 21 CFR Part 11 compliance requirements. PRISYM Medica is supplied as a validated labeling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model. Available both as a thin or thick client, PRISYM Medica allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print. Prisym Medica is the only purpose designed 21 CFR Part 11 compliant GMP based labelling solution available as both thin and thick client for medical device, clinical trial and pharmaceutical organisations. We support all printing technologies and are experienced in all aspects of integration with ERP, PLM, MRP, systems
  • Last slide <COUNT TO THREE> So Let me hand the webinar back to Ray for the questions and answers. Thank you for your time and attention. <COUNT TO THREE> RCS Thank you Robert. Thank you Marcus. Please bear with us for a short time while we collate some of the questions which have come in during the course of the presentation. If you have any additional questions that you would like to submit to Robert and Marcus, please submit it now using the question tool on screen. Thank you. We’ll try to answer as many as possible and will also provide a written response to all the questions asked during the webinar. <PAUSE> MUTE PHONE Thank you everyone. We will now be answering some of your questions. Questions:-

Transcript

  • 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. 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. Counterfeit Drugs is Big Business
    • Counterfeit drug commerce will grow 13% annually through 2010
    • In 2010, this illegal business will generate $75B in revenues – a
    • 92% increase from 2005, (Combined revenue of Pfizer andAstraZeneca)
    • FDA alone has seen an 800% increase in the number of new counterfeit cases between 2000 and 2006
    • Counterfeit medicines may account for 10-30% of the market in developing countries
  • 4. Protecting Patient Safety Fake Alli Sold on Internet in US Causes Heart Attacks
  • 5. Protecting Patient Safety
    • 27 January 2010 – INTERPOL applauds Southeast Asia Operation Storm II’s success in disrupting trade of counterfeit medical products
    • Seizure of $20M in counterfeit and illegal medicines
    • An estimated $12M were counterfeits
    • Remaining $8M found to be drugs that were "expired, diverted or unregistered”
  • 6. Protecting Patient Safety
    • 2 Million Counterfeit Needles Found
    • in Europe
    • 200,000 counterfeit needles in the Dutch market
    • 500,000 in the United Kingdom
    • More than 1.3 million in Poland
    • 30,000 still unaccounted in the Netherlands
    • *Source: MHRA & SaferMedicines.org
  • 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. 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. Counterfeit Operation Source: Roger Bate; Author of Making a killing
  • 10. Counterfeit Operation Source: Roger Bate; Author of Making a killing
  • 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. Why is counterfeiting a problem?
    • Public health threat:
      • Direct: Fake drugs containing harmful ingredients (e.g. heavy metals)
      • Indirect: Drugs with inadequate or wrong active ingredients have no curative power (e.g. many malaria deaths)
      • 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).
    • Intellectual property/brand integrity threat
      • Threatens long-term innovation and development
  • 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. A Multi-Layered Approach New Technologies ePedigree Codification Serialization
  • 15. An Evolving Compliance Landscape – The Tide Has Turned Europe USA Asia
  • 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. A Closer Look at the EFPIA Code
    • Standards based approach – GS1
    • Manufacturer Product Code - GTIN [or Pseudo GTIN e.g. CIP code] ‘Global Trade Item Number’ according to GS1 Standards (14 numeric digits)
    • Unique serial number (randomized - 20 numeric digits)
    • Expiry Date (6 digit – YYMMDD)
    • Batch number (up to 20 alpha-numeric characters)
    Both GS1 and EPCglobal are playing a leading role in helping develop and introduce standards in this arena.
  • 18. A Closer Look at the EFPIA Code
  • 19. An Evolving Compliance Landscape Source: U.S. Pedigree vs. European Pedigree , April 21, 2009: 2009 LogiPharma Europe
    • Turkey
    • 2D data matrix with EAN barcode, serial number, manufacturing date, expiry date
    • Will need to send serial numbers to MOH database July 1, 2009
    • EFPIA
    • 2D data matrix with product code, batch number, expiry data, and serial number
    • Each manufacturer to have a database server link to one global database
    • EU Commission
    • Pedigree serialization and central repository
    • Pedigree to be similar to U.S. pedigree
    • Italy
    • SN for reimbursement only but planning in traceability
    • Could have central DB
    • France
    • Currently use 7 digit PIC
    • By 2011 all products must use 13 digit data matrix PIC
    • Belgium
    • Currently using 8 char SN
    • Looking at a 16 char number
    • Brazil
    • Will pilot and scale up unit serialization over the next 3 years
    • Interested in capture technology as well as data storage capabilities
    • Countries With No SN
    • Austria, Bulgaria, Czech Republic, Denmark, Germany, Poland, Portugal, Slovakia, and Slovenia
    • Russia
    • Proposed serialization with track and trace
    • At issue is the amount of counterfeiting
  • 20. Overview: European National Codification Systems
  • 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. 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. 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. 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. Combination of Regulatory, Global and Business Pressures
    • California ePedigree
    • US State by State regulations
    • Will FDA act? EU Commission?
    • Turkey, Italy, Belgium serialization initiatives
    • About $2B annually and increasing
    • Controlling/Validating returns
      • Systems to detect counterfeits
      • Assess and authorize valid returns
    • Diverted product impacting profitability
    • Inventory shrinkage and damage control
    • Identification/reporting of suspect shipments
    • Parallel trade
    • Global Counterfeiting exceeds $50B
    • Impacts 3.4B prescriptions annually in US
    • As much as 1%, or 34M doses could be counterfeit
    • Systems to authenticate product
    • Protect brand integrity
    Channel Integrity Returns Regulatory Compliance Product Integrity
  • 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. Serialization Business Benefits
    • Accelerating a product launch by 2 years could increase the revenue by $600 million
    • An effective Clinical Trial Inventory Management can help to improve the product launch date
  • 28.
    • Serialized packaging (labeling) code data has to fulfil a defined lifecycle from generation to allocation on product and beyond
    • Once past the Pilot phases, Serialization has strategic implications at a regional and global level
    • A poor Serialization approach could create unintended consequences and increase vulnerability
    So What’s So Difficult about Serialization? There’s more to serialization that just generating numbers…
  • 29. Whose Project & Budget?
    • Whilst it can easily become over complex don’t ignore that serialization can involve radical change
    • New methodologies and processes will need to be defined and validated
    • Where possible leverage existing investment in technologies and processes – e.g. site level vision systems and printers
  • 30. Managing & Administering Serialization is Perhaps the Greatest Challenge
    • Generation and Management
    • Completeness of Solution
    • Data Carriers: RFID – 2D Data Matrix
  • 31. How does Serialization Affect Labeling? Security
    • Security of data at rest and in transit is of paramount importance
    • Will be a target for counterfeiters – weak links are probably human
    Data Volumes
    • Volumes will be large – terabytes
    • Manufacturing performance must not be compromised by data handling
    Complexity & Flexibility
    • Integration to multiple systems
    • Cross-site, multi discipline coordination of serial generation
    • Future proof – moving legislation
  • 32. PRISYM ID & Oracle’s Joint Offering
  • 33. Secure Serial Labeling
    • Oracle Partner
    • 25+ years experience in Life Sciences printing applications
    • Prisym Medica application built on Oracle technology
    • Working with OPSM development team to exchange product unit serial data via web services
  • 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. 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. www.prisymid.com [email_address] Q & A