BioScienceBioScience

Product Integrity Program

Anti-Counterfeiting Project for Baxter BioScience

Product Integrity Program

Anti-Counterfeiting Project for Baxter BioScience

Plasma Product Biotechnology 12 May 2009

Plasma Product Biotechnology 12 May 2009

Presentation ObjectivesPresentation Objectives• Introduction

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• BioScience– History of Events– Product Integrity Program– Next Steps

• Suggestions by Experts

• Background– Counterfeiting is a Worldwide Issue– Impact to our Business

• Questions & Answers

InquiryInquiry

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• How many of you have had counterfeiting issues?

• Does your company have a product integrity program?

• In parts of Africa, Asia, and Latin America over 30% of the drug supply is likely counterfeit

• In some Soviet republics, drug counterfeiting is higher than 20%

• In developing nations, drug counterfeiting is, on average, over 10%

Source: WHO International Medical Products Anti-Counterfeiting Task Force (IMPACT)

• In parts of Africa, Asia, and Latin America over 30% of the drug supply is likely counterfeit

• In some Soviet republics, drug counterfeiting is higher than 20%

• In developing nations, drug counterfeiting is, on average, over 10%

Source: WHO International Medical Products Anti-Counterfeiting Task Force (IMPACT)

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Counterfeiting is a Worldwide IssueCounterfeiting is a Worldwide IssueCounterfeiting is an ever-present and growing issue within the pharmaceutical community worldwide worldwide

According to the World Health According to the World Health Organization (WHO)Organization (WHO)……

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FDA Counterfeit Open Investigations 1997 FDA Counterfeit Open Investigations 1997 -- 20042004

Source: 1. Combating Counterfeit Drugs: A Report of the

FDA, 2/18/2004

• As much as 50% of the drug supply in China is likely counterfeit

• In the developing countries such as Argentina, Columbia, and Mexico, 40% is suspected

Source: New FDA Initiative to Combat Counterfeit Drugs

• As much as 50% of the drug supply in China is likely counterfeit

• In the developing countries such as Argentina, Columbia, and Mexico, 40% is suspected

Source: New FDA Initiative to Combat Counterfeit Drugs

According to the According to the FDAFDA……

Fake Pfizer medicines have been found in approximately 70 countries around the worldPfizer medicines that have been counterfeited include:

– Lipitor– Viagra– Norvasc– Zoloft– Celebrex– Aricept– Diflucan

Counterfeiting is a Worldwide IssueCounterfeiting is a Worldwide IssuePfizerPfizer’’s Growing Counterfeiting Problem s Growing Counterfeiting Problem --

US Lipitor Recall:Lipitor (indicated for high cholesterol) is the most prescribed medicine in the worldIn April 2003, patients complained that tablets had bitter taste and dissolved quickly in the mouthFDA recalled 18 million Lipitor tablets, the largest recall of counterfeit medicine in the US to dateCounterfeit Lipitor was found in 15 US states

UK Lipitor Recall:In July 2005, 3.6 million tablets (120K packs) were recalled due to counterfeiting claims106 UK pharmacies participated in the recallApproximately 50% of the returned medicine proved to be counterfeit

CounterfeitCounterfeit NorvascNorvasc 5Confidential

The absence of deterrent legislation in many countries also encourages counterfeiters since there is no fear of being apprehended and prosecuted.

Counterfeiting is a Worldwide IssueCounterfeiting is a Worldwide IssueRoot of the Problem Root of the Problem --

Counterfeiting medicines is a lucrative businessThe production of counterfeit drugs need not occur in large infrastructures or facilities. The majority of the counterfeiters apprehended so far carried out their activities in ordinary households, small cottage industries, or in backyards.

When prices of medicines are high and price differentials between identical products exist there is a greater incentive for the consumer to seek medicines outside the normal supply system.

Counterfeiting of medicines is a hugely lucrative business due to the continued high demand for medicines and low production costs.

In many countries the official supply chain fails to reach many communities, especially in rural areas. Poverty, and the lack of an official supply chain, are major factors in creating markets for counterfeit products.Source: World Health Organization, International Medical Products Anti-Counterfeiting Task Force (IMPACT)

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Counterfeited BioScience Products:Counterfeited BioScience Products:

• Counterfeit Baxter label (Immunate) applied to AHF-M product vial, to receive a higher price(cross-labeling, up-labeling)

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• BioScience products counterfeited in South America involving several counterfeiting scenarios: – Counterfeiting included tampering, cross-labeling and up-labeling

• Reused albumin containers by filling bottles with saline solution and capping with newly purchased caps (tampering)

• Local albumin manufacturer applied a counterfeit Baxter labelto their product to capitalize on Baxter’s position in the market, receiving a higher price (Biosimilar)

• Counterfeit 1000 IU Recombinate on an authentic 500 IU product vial, to receive a higher price (cross-labeling involving Baxter product and labels)

– Detection of the events is limited

BioScience Incidents in South AmericaBioScience Incidents in South AmericaCounterfeiting, Tampering Counterfeiting, Tampering

Product Booklet Label: Poor Condition vs. Intact

Injection Target: Small vs. Large Extension

Reused albumin containers by filling used bottles with saline Reused albumin containers by filling used bottles with saline solution and capping with newly purchased capssolution and capping with newly purchased caps

Counterfeit Baxter

Counterfeit Baxter

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BioScience Incidents in South AmericaBioScience Incidents in South AmericaCounterfeiting (Biosimilar) Counterfeiting (Biosimilar)

Counterfeit

Baxter

Local albumin manufacturer applied a counterfeit Baxter label toLocal albumin manufacturer applied a counterfeit Baxter label totheir product to capitalize on Baxtertheir product to capitalize on Baxter’’s position in the market, s position in the market, receiving a higher pricereceiving a higher price

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BioScience Incidents in South AmericaBioScience Incidents in South AmericaCounterfeiting, CrossCounterfeiting, Cross--labeling & Uplabeling & Up--labelinglabeling

Counterfeit Baxter Immunate label applied to AHFCounterfeit Baxter Immunate label applied to AHF--M product vial, M product vial, to receive a higher priceto receive a higher price

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Baxter Recombinate 1000 IU label applied to Recombinate 500 IU Baxter Recombinate 1000 IU label applied to Recombinate 500 IU product vial, to receive a higher priceproduct vial, to receive a higher price

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BioScience Incidents in South AmericaBioScience Incidents in South AmericaCounterfeiting, UpCounterfeiting, Up--labelinglabeling

Voice of the CustomerVoice of the CustomerRisks of not moving forward with antiRisks of not moving forward with anti--counterfeiting measurescounterfeiting measures

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Loss of Market Share

Loss of Loss of Market ShareMarket Share

Impact to Patient Safety

Impact to Impact to Patient Patient SafetySafety

Loss of Consumer Confidence

Loss of Loss of Consumer Consumer ConfidenceConfidence

Increased Regulatory Exposure

Increased Increased Regulatory Regulatory ExposureExposure

Impact to Customer

Needs

Impact to Impact to Customer Customer

NeedsNeeds

Loss of Control of Product Integrity

Loss of Loss of Control of Control of Product Product IntegrityIntegrity

BioScience moves forward…

BioScience Product Integrity Program:BioScience Product Integrity Program:Comprised of Implementing Three Distinct Measures Comprised of Implementing Three Distinct Measures --

Track & Trace Features

Tamper Evident Features

Product Authentication

Features

Product Integrity

Maintain Distribution Chain Integrity

• Distribution Monitoring

• Serialization

• ePedigree

Maintain Product Purity• Flip off caps on bottles serve

as tamper evident device

• Investigated additional tamper evident measures (e.g., tapes)

Authenticate Product• New vial labels

• New unit cartons

• Branded vial caps

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Product IntegrityProduct IntegrityProject FocusProject Focus

Safeguard the Safeguard the Distribution Distribution ChainChain

BioScience Product Integrity Program:BioScience Product Integrity Program:Product Authentication & Security Features Product Authentication & Security Features --

• To deter potential counterfeiting, up-labeling, cross-labeling, and tampering

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• Multi-layered approach using overt, semi-covert, & covert features

• Standard product integrity features were identified for:Labels

CapsUnit Cartons

• Standard features approved by the Product Brand Integrity Team for use on BioScience products– Ensures continuity and consistency of features– Simplifies implementation– Maximizes customer awareness & sensitivity of

authentic product

Product Integrity Features:Product Integrity Features:Product Authentication & Security Features Product Authentication & Security Features --

• Select BioScience Product Labels

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– The Baxter wordmark (logo) will be contained in a stripe using color-shifting ink on the label (overt)

– Security slits are placed around the perimeter of the base label, which causes part or all of the label to be destroyed if removed from the bottle (overt), or

– Void effect which upon removal leaves the label with the phrase "void" again mitigating re-use (overt)

– Covert features are not visible to the customer, but allow Baxter to confirm a product in the field is ours(NOTE: These will remain covert)

• Select BioScience Product Unit Cartons– Near-transparent varnish with the Baxter logo (overt)

– Micro-text (semi-covert feature)

Features for ADVATEFeatures for ADVATE

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Uni

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Vial

Lab

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Features for NG AlbuminFeatures for NG Albumin

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Baxter logo printed with color-shifting background

Security slits to Security slits to prevent removal of prevent removal of intact labelintact label

Product Authentication:

Color Shifting Ink (Overt Feature)

Product Product Authentication: Authentication:

Color Shifting Ink Color Shifting Ink ((Overt FeatureOvert Feature))

1

Product Authentication:

(Covert Features)

Product Product Authentication: Authentication:

(Covert Features)(Covert Features)

2

Security Feature T-cuts Prevent Label

Re-use

Security Security Feature TFeature T--cuts cuts Prevent Label Prevent Label

ReRe--useuse

3

Product Authentication for the Product Authentication for the Crimp CapCrimp Cap

• Anti-Tampering: provides evidence of first opening(flip off cap)

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– Overt Baxter wordmark visible throughout the chain of custody, wallpaper print on the aluminum shell

BioScience Product Integrity Program:BioScience Product Integrity Program:Implementation for All BioScience Products Implementation for All BioScience Products --

• Implementation to mitigate counterfeiting issues

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• Proactively, Baxter established the Therapy Integrity Program was to safeguard its products & therapies now –for the future welfare of its patients

• ADVATE and GAMMAGARD LIQUID

AntiAnti--Counterfeiting vs. ePedigreeCounterfeiting vs. ePedigree

Typically anti-counterfeiting measures involve the primary package design, often employing multi-layers of product authentication & security features

ePedigree is a matter of regulatory compliance and provides a means of determining where product is being diverted or counterfeit goods may enter the system

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Anti-Counterfeiting

Product integrity features make counterfeiting more difficult and time consuming, making the product less attractive to criminal elements

Product integrity features can help the customer authenticate the product without the use of hardware or electronics

ePedigree

By its nature, e-Pedigree requires electronic equipment/systems to detect or interpret the information

Pedigree ModelsPedigree Models

© Copyright 1995-2007 Baxter Healthcare Corporation. All rights reserved.

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Normal Chain of Distribution

Florida Pedigree Model

California Pedigree Model

•Pedigree Document Created by Wholesaler•Pedigree Passed to Subsequent Wholesalers•Pedigree Updated and Passed to Customers•Pedigree done at case level•Pedigree Has: Lot # - Exp. Date – Strength –Dosage - Receivers – Legal Signature

•Manufacturer must document wholesaler as Authorized Distributor of Record•Pedigree only required when transaction is outside of Normal Chain•Must be licensed & have contracts

•Pedigree Document Created by Manufacturer•Pedigree Passed to Subsequent Wholesalers•Pedigree Updated and Passed to Customers•Pedigree at each level•Pedigree Has: Unique Serial Number/each•Pedigree Must be Electronic and Interoperable•Drug Must be able to be tracked and traced

Wholesaler

Manufacturer

Customer

Wholesaler

Wholesaler

Manufacturer

Customer

Wholesaler

Wholesaler

Manufacturer

Wholesaler

Customer

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• Provides traceability and pedigree– Compliance dates delayed until 2015/2016

Serialization & ePedigreeSerialization & ePedigree

Will provide additional

data on dist. chain once in

place

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– Serialization on unit carton, shipper & pallet– Provide product tracking, but will stop short of sending

pedigree data electronically

• Serialization implementation (pilot) will allow tracking of product in manufacturing (facility) & at the 3rd party logistics (distribution)

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Product and Information Flow:Product and Information Flow:Future State for ePedigree Future State for ePedigree --

Product Flow

Information Flow

Manufacturer Plant

Manufacturer DC

Distributor DC

Hospital / RetailPharmacy

DATA Read Point

• Leverage “2-D barcodes” to capture and track the movement of pallets, cases and individual units through the distribution chain

• Provide up- and downstream inventory visibility through a distributed, standards based data repository

Next StepsNext Steps

• Continued Implementation

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– Worldwide across geographies for all products• According to established implementation plans• Developing artwork• Seeking MoH approvals

– Launch label, unit carton, and cap product integrity features simultaneously when possible

– Establish a Product Integrity Business System to mitigate counterfeiting over time

• Monitor Data Streams

Suggestions by Industry ExpertsSuggestions by Industry Experts

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Source: Ten Tips to Fight Pharmaceutical Counterfeiting, By Raymond P. Castello, see http://www.pharmamanufacturing.com/articles/2008/071.html

• Monitor Your Processes – Personnel, inventory, & suppliers

• Monitor Your Distribution Chain – Know what is happening to your products

• Distributors, wholesalers, etc.• “You Don’t Know What You Don’t Know”

– Ask questions– Returned goods

• Assess Your Risks – Learn about counterfeiting– Think like a counterfeiter

QualityVision / Mission

StrategicPillars

Product Integrity Program aligns with business objectives to enhance the safety of life-saving therapies and consumer confidenceLead by a Product Integrity Governance Board

Product Integrity Program

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Product Integrity is an integral part of the business, mitigating risk to the franchise by protecting the integrity of products and therapies for our patients

Product Integrity Program:Product Integrity Program:Concept Concept –– Future StateFuture State

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FoundationalPrinciples

Strategy Statement

Product Integrity Governance Board:Represents the interest of the Business with respect to Product Integrity

Based on Industry

Benchmarking

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Saving and Sustaining Lives Worldwide

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BioScienceBioScience

Questions ?Questions ?Questions ?