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The way to be safe is never to
be secure
Benjamin Franklin
FIGHT AGAINST DRUG
COUNTERFEIT
STOP COUNTERFIET
Counterfeit Viagra
Counterfeit
Viagra was
found in the
Summer of
2004 in two
retail
pharmacies
in California.
Bottles were
for 100mg,
30-counts.
                    Cost                       Cost
                 < $1/bottle                $270/bottle
                                                  3
Counterfeit Ponstan




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
                                                                             4
Drug Counterfeiting
   Cumulative US Counterfeiting Losses: Over $1 Billion
   Average impact to major manufacturer: $50 to $100 Million annually
   7% of the World Drug Supply Chain is Counterfeit—WHO
   Additional losses occur due to negative brand impacts and the costs
    of recalling suspect product




                   http://www.fda.gov/oc/initiatives/counterfeit/report/interim_report.html#IIA
Potential Solutions


 Product based solutions
    Self-contained positive identification of the genuine product

    Holographic labels, embed technology in the packaging or

     product


 Supply chain level solutions
    Stop counterfeit product from entering the supply chain

    Tightly control the chain of custody with documented pedigree

    Solution is only as effective as the weakest link in the supply

     chain


 RFID Moves Forward, Hallie Forcinio, Pharmaceutical Technology/s
 Packaging Forum editor
                                                                     6
Paper Vs E- Solution


                                Electronic Solutions:
A paper solution will be        Advanced Bar Coding
very costly to the
industry                        and RFID

                                •Advanced bar coding
• Florida has enacted           (i.e 2D) and RFID
  pharmaceuical pedigree        technologies are
  papers                        potential technologies to
• Paper pedigree must be        enable efficient
  maintained through the
  entire supply chain           electronic pedigree
• Estimation on                 •RFID is emerging as
  distribution side alone       the preferred solution for
  shows that efficiency         package level tracking
  would go down by 85%




                                                       7
)


 A group of premier organizations in the Pharmaceutical Supply Chain have
  worked together to explore the potential of RFID/EPC
 The limited test validated the feasibility of RFID in the pharmaceutical
  supply chain
 A number of issues and limitations were identified
 While not a complete success, Jumpstart was a good first step




                                                                             8
RFID Tag Manufacturing Details

 Steps that were performed to create Jumpstart tags

                    printed EPC Number on label


                   converted inlay into 2-ply label


               created inlay attaching chip to antenna


                   created chip with EPC Number                           EPC Number
                                                                          printed on tag
                                                                                            Notch used by
                                                                                             printer to line
                                                         Showing peel                        up printing of
                                                         of tag from                         EPC Number
                                                         clear second                              on label
                                                                          Tag was not
                                                         layer of 2-ply   readable so
                                                         construction     VOID printed
                                                                          across tag.
                                                                          These have
                                                                          been removed
  Roll of Tags                                                            from rolls sent
                                                                          to companies

                                                                                                  9
Pharma

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Pharma

  • 1. The way to be safe is never to be secure Benjamin Franklin FIGHT AGAINST DRUG COUNTERFEIT
  • 3. Counterfeit Viagra Counterfeit Viagra was found in the Summer of 2004 in two retail pharmacies in California. Bottles were for 100mg, 30-counts. Cost Cost < $1/bottle $270/bottle 3
  • 4. Counterfeit Ponstan 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 4
  • 5. Drug Counterfeiting  Cumulative US Counterfeiting Losses: Over $1 Billion  Average impact to major manufacturer: $50 to $100 Million annually  7% of the World Drug Supply Chain is Counterfeit—WHO  Additional losses occur due to negative brand impacts and the costs of recalling suspect product http://www.fda.gov/oc/initiatives/counterfeit/report/interim_report.html#IIA
  • 6. Potential Solutions  Product based solutions  Self-contained positive identification of the genuine product  Holographic labels, embed technology in the packaging or product  Supply chain level solutions  Stop counterfeit product from entering the supply chain  Tightly control the chain of custody with documented pedigree  Solution is only as effective as the weakest link in the supply chain RFID Moves Forward, Hallie Forcinio, Pharmaceutical Technology/s Packaging Forum editor 6
  • 7. Paper Vs E- Solution Electronic Solutions: A paper solution will be Advanced Bar Coding very costly to the industry and RFID •Advanced bar coding • Florida has enacted (i.e 2D) and RFID pharmaceuical pedigree technologies are papers potential technologies to • Paper pedigree must be enable efficient maintained through the entire supply chain electronic pedigree • Estimation on •RFID is emerging as distribution side alone the preferred solution for shows that efficiency package level tracking would go down by 85% 7
  • 8. )  A group of premier organizations in the Pharmaceutical Supply Chain have worked together to explore the potential of RFID/EPC  The limited test validated the feasibility of RFID in the pharmaceutical supply chain  A number of issues and limitations were identified  While not a complete success, Jumpstart was a good first step 8
  • 9. RFID Tag Manufacturing Details  Steps that were performed to create Jumpstart tags printed EPC Number on label converted inlay into 2-ply label created inlay attaching chip to antenna created chip with EPC Number EPC Number printed on tag Notch used by printer to line Showing peel up printing of of tag from EPC Number clear second on label Tag was not layer of 2-ply readable so construction VOID printed across tag. These have been removed Roll of Tags from rolls sent to companies 9

Editor's Notes

  1. To start with, you have the big pharma companies whomanufacture prescription drugs. Then the next stage in this distribution chain are the largewholesalers who buy in bulk quantities. They then supply these drugs at varying prices tobig traders, regional distributors, national level pharmacy chains and large retailers likeWal-Mart, as well as to hospitals. Between these entities, there are the large logisticsservice providers, warehousing companies and transporters who physically ship thesedrugs.