FIGHT AGAINST DRUG COUNTERFEIT

The way to be safe is never to be secureBenjamin Franklin

STOP COUNTERFIET

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Counterfeit ViagraCounterfeit 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

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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

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

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RFID Moves Forward, Hallie Forcinio, Pharmaceutical Technology/sPackaging Forum editor

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Paper Vs E- Solution

A paper solution will be very costly to the industry

• Florida has enacted pharmaceuical pedigree papers

• Paper pedigree must be maintained through the entire supply chain

• Estimation on distribution side alone shows that efficiency would go down by 85%

Electronic Solutions: Advanced Bar Coding and RFID

• Advanced bar coding (i.e 2D) and RFID technologies are potential technologies to enable efficient electronic pedigree

• RFID is emerging as the preferred solution for package level tracking

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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

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RFID Tag Manufacturing Details

Steps that were performed to create Jumpstart tags

Roll of Tags

Showing peelof tag from clear secondlayer of 2-plyconstruction

Notch used by printer to line up printing of EPC Number

on label

EPC Number printed on tag

Tag was not readable so VOID printed across tag. These have been removed from rolls sent to companies

printed EPC Number on label

converted inlay into 2-ply label

created inlay attaching chip to antenna

created chip with EPC Number